Study: NCT01101035

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 3098 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Bifascicular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Defect conduction intraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Atrial thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Notes: Three treatment-emergent deaths occurred during treatment with febuxostat and are not related.
Frequency: 3 affected / 3098 at risk

Adverse event: Cardiac discomfort
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 12 affected / 3098 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 51 affected / 3098 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 8 affected / 3098 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.
Frequency: 8 affected / 3098 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Ten treatment-emergent deaths occurred during treatment with febuxostat and are not related; Eight treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 124 affected / 3098 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3098 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 6 affected / 3098 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 63 affected / 3098 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 3098 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Eleven treatment-emergent deaths occurred during treatment with febuxostat and are not related; Seven treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 41 affected / 3098 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 8 affected / 3098 at risk

Adverse event: Silent myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Mitral valve prolapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Cardiac hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 3098 at risk

Adverse event: Chronotropic incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3098 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 65 affected / 3098 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 10 affected / 3098 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3098 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Eleven treatment-emergent deaths occurred during treatment with febuxostat and are not related; Eight treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 17 affected / 3098 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Four treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 25 affected / 3098 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Adrenocortical insufficiency acute
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Blindness unilateral
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Alcoholic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Duodenal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Pancreatic cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Poor dental condition
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 3098 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Haemorrhagic erosive gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3098 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Oesophageal achalasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Oesophageal food impaction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Gastrointestinal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Colonic haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Vomiting projectile
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 18 affected / 3098 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Varices oesophageal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Incarcerated umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3098 at risk

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Condition aggravated
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Implant site inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 3 affected / 3098 at risk

Adverse event: Haemorrhagic cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 3098 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 34 affected / 3098 at risk

Adverse event: Surgical failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hepatic haematoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Granulomatous liver disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3098 at risk

Adverse event: Colonic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3098 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3098 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3098 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 30 affected / 3098 at risk

Adverse event: Cellulitis of male external genital organ
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3098 at risk

Adverse event: Oral bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Bursitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 15 affected / 3098 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Oropharyngeal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: CNS ventriculitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3098 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Gas gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Labyrinthitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Herpes zoster meningomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Groin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3098 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Medical device site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3098 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 9 affected / 3098 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 3098 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Six treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 67 affected / 3098 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Proteus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Pseudomonal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3098 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 24 affected / 3098 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 7 affected / 3098 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3098 at risk

Adverse event: Carbuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3098 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3098 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Cellulitis pharyngeal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 3098 at risk

Adverse event: Lymphangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3098 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Post procedural myocardial infarction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Exposure to toxic agent
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Open globe injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 6 affected / 3098 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 7 affected / 3098 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Post concussion syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Three treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3098 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Procedural hypertension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Postoperative respiratory distress
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Tracheostomy malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Scrotal haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3098 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3098 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3098 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Ejection fraction decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Prothrombin time ratio decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Heart rate increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Heart rate irregular
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3098 at risk

Adverse event: Laboratory test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Blood creatine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Cardioactive drug level increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Influenza B virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3098 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 3098 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 3098 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 3098 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 3098 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 3098 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Exostosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 3098 at risk

Adverse event: Muscle haemorrhage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 3098 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 3098 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 3098 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Anal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: B-cell lymphoma stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 8 affected / 3098 at risk

Adverse event: Bladder transitional cell carcinoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Breast cancer female
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Brain neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3098 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 3098 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Large intestine benign neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Gastrointestinal stromal tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Hepatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Laryngeal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Benign anorectal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Metastases to pleura
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Metastases to spine
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Myelofibrosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Polycythaemia vera
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Adenosquamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Head and neck cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Lung adenocarcinoma stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Lung squamous cell carcinoma stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Malignant neoplasm of eyelid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Ovarian adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Three treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3098 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Prostate cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Clear cell renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3098 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3098 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Lung carcinoma cell type unspecified stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Three treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3098 at risk

Adverse event: Malignant melanoma stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Neuroendocrine carcinoma of the skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Lipoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3098 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3098 at risk

Adverse event: Petit mal epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Brain stem stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cerebellar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 6 affected / 3098 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 45 affected / 3098 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Carotid arteriosclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 3098 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Uraemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Normal pressure hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 3098 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Slow speech
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Spinal cord disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cerebral ventricle dilatation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 25 affected / 3098 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3098 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 3098 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3098 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3098 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Delirium tremens
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Shared psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Suicidal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Three treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 139 affected / 3098 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 3098 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 19 affected / 3098 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Polyuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pelvic haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Female genital tract fistula
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 3098 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 3098 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Hypersensitivity pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3098 at risk

Adverse event: Pulmonary sarcoidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Idiopathic pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Restrictive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 13 affected / 3098 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 20 affected / 3098 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Seven treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 34 affected / 3098 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related. One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3098 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; Seven treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 17 affected / 3098 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Dysphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Blood blister
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3098 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 3098 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 3098 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 9 affected / 3098 at risk

Adverse event: Leriche syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 2 affected / 3098 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3098 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3098 at risk

Adverse event: Peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Arterial rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 3098 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 3098 at risk

Adverse event: Dry gangrene
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3098 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3098 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 3098 at risk

Adverse event: Aortic arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 3098 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 3098 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 3098 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3098 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 3098 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 74 affected / 3098 at risk

Adverse event: Gastrointestinal vascular malformation haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3098 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 157 affected / 3098 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 299 affected / 3098 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 156 affected / 3098 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 168 affected / 3098 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 214 affected / 3098 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 242 affected / 3098 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 146 affected / 3098 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 148 affected / 3098 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 258 affected / 3098 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 216 affected / 3098 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 137 affected / 3098 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 222 affected / 3098 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 209 affected / 3098 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 3092 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Hypochromic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Aortic valve calcification
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Aortic valve sclerosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Notes: Three treatment-emergent deaths occurred during treatment with febuxostat and are not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Malignant hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Heart valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 7 affected / 3092 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3092 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 58 affected / 3092 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3092 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 3092 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 9 affected / 3092 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.
Frequency: 9 affected / 3092 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Ten treatment-emergent deaths occurred during treatment with febuxostat and are not related; Eight treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 109 affected / 3092 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 8 affected / 3092 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 68 affected / 3092 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 3092 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Eleven treatment-emergent deaths occurred during treatment with febuxostat and are not related; Seven treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 51 affected / 3092 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Subendocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cardiac aneurysm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Systolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related.
Frequency: 6 affected / 3092 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Chronotropic incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 64 affected / 3092 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 12 affected / 3092 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Accelerated idioventricular rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Eleven treatment-emergent deaths occurred during treatment with febuxostat and are not related; Eight treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 11 affected / 3092 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Four treatment-emergent deaths occurred during treatment with febuxostat and are not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 6 affected / 3092 at risk

Adverse event: Ventricular tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 25 affected / 3092 at risk

Adverse event: Lymphatic malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Sudden visual loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Abdominal hernia obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Volvulus of small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Duodenal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 3092 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Oesophageal achalasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Oesophageal food impaction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Gastrointestinal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Gingival bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Mesenteric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 17 affected / 3092 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Oesophageal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 3092 at risk

Adverse event: Medical device pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Accidental death
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3092 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Strangulated hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Necrobiosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 3092 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 3092 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 3092 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Surgical failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Vascular stent occlusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 3092 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 3092 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 3092 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3092 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3092 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Rectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Bronchitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 3092 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Incisional hernia gangrenous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 9 affected / 3092 at risk

Adverse event: Osteomyelitis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Lyme disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3092 at risk

Adverse event: Sialoadenitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Helicobacter gastritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Herpes simplex meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Varicella zoster virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Abscess rupture
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Groin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Infected bite
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Injection site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3092 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Postoperative abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3092 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3092 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Six treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 88 affected / 3092 at risk

Adverse event: Pneumonia necrotising
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Pseudomonas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3092 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 24 affected / 3092 at risk

Adverse event: Septic embolus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Two treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 10 affected / 3092 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3092 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Endocarditis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3092 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3092 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3092 at risk

Adverse event: Staphylococcal parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Cellulitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3092 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3092 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 3092 at risk

Adverse event: Lymphangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3092 at risk

Adverse event: Post procedural myocardial infarction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Vascular injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Epidural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3092 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 6 affected / 3092 at risk

Adverse event: Pneumothorax traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3092 at risk

Adverse event: Open fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Intestinal anastomosis complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Postoperative ileus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3092 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3092 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 6 affected / 3092 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3092 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3092 at risk

Adverse event: Scapula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3092 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Psychosis postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 13 affected / 3092 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Three treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3092 at risk

Adverse event: Failure to anastomose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Incisional hernia, obstructive
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Procedural hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3092 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3092 at risk

Adverse event: Postoperative thoracic procedure complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3092 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3092 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3092 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3092 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3092 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Electrocardiogram T wave abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Electrocardiogram abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Faecal occult blood positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Computerised tomogram abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3092 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Body temperature increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: White blood cell count increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3092 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Diabetic complication
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hyperosmolar state
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Hyperlipidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 3092 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 3092 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 3092 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 3092 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 3092 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 3092 at risk

Adverse event: Vertebral osteophyte
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3092 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3092 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Invasive lobular breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3092 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Malignant fibrous histiocytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Large intestine benign neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Gastrointestinal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Laryngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Laryngeal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3092 at risk

Adverse event: Chronic myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Benign salivary gland neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Squamous cell carcinoma of the oral cavity
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Metastases to lymph nodes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Metastases to spine
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Chronic myelomonocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Lung adenocarcinoma stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Non-small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Tumour ulceration
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Ductal adenocarcinoma of pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Three treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 4 affected / 3092 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Squamous cell carcinoma of pharynx
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3092 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3092 at risk

Adverse event: Prostate cancer stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Renal perivascular epithelioid cell tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3092 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Three treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3092 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3092 at risk

Adverse event: Poorly differentiated thyroid carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Benign neoplasm of bladder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3092 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cerebellar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 44 affected / 3092 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 6 affected / 3092 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Thalamic infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Thalamus haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Carotid arteriosclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 3092 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 34 affected / 3092 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Encephalitis autoimmune
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hypoglycaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cluster headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Nerve compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Quadriparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 3092 at risk

Adverse event: Spinal claudication
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Spinal cord disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Spondylitic myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 3092 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 3092 at risk

Adverse event: Device lead issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3092 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3092 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3092 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 3092 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Substance use disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Notes: Two treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Intentional self-injury
Serious: yes
Organ System: Psychiatric disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 2 affected / 3092 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Bladder outlet obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Urinary bladder haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Renal haematoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Three treatment-emergent deaths occurred during treatment with allopurinol and are not related.
Frequency: 132 affected / 3092 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3092 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 19 affected / 3092 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Malignant renal hypertension
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 3092 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Renal vein thrombosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Vaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Prostatomegaly
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 3092 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 3092 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 3092 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Laryngeal dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 4 affected / 3092 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 23 affected / 3092 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 4 affected / 3092 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 5 affected / 3092 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 14 affected / 3092 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Seven treatment-emergent deaths occurred during treatment with febuxostat and are not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 43 affected / 3092 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related. One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Five treatment-emergent deaths occurred during treatment with febuxostat and are not related; Seven treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 22 affected / 3092 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Dermatitis exfoliative
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 3092 at risk

Adverse event: Dermal cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Leg amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3092 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 3092 at risk

Adverse event: Aortic occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related.
Frequency: 1 affected / 3092 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Lymphoedema
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with febuxostat and is not related; One treatment-emergent death occurred during treatment with allopurinol and is not related.
Frequency: 3 affected / 3092 at risk

Adverse event: Peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 3092 at risk

Adverse event: Jugular vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3092 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3092 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 3092 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3092 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Poor peripheral circulation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Essential hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 3092 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 3092 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3092 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 3092 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3092 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 3092 at risk

Adverse event: Neuroendocrine tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3092 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 59 affected / 3092 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 125 affected / 3092 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 284 affected / 3092 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 132 affected / 3092 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 183 affected / 3092 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 212 affected / 3092 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 267 affected / 3092 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 180 affected / 3092 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 161 affected / 3092 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 311 affected / 3092 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 187 affected / 3092 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 159 affected / 3092 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 218 affected / 3092 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 261 affected / 3092 at risk