Study: NCT01535014

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 410 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 410 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 410 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 410 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 410 at risk

Adverse event: iron-deficient anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: mild disease
Frequency: 1 affected / 410 at risk

Adverse event: Сoronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 410 at risk

Adverse event: Autoimmune thyroiditis. Subclinical hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 410 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 410 at risk

Adverse event: Dentalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 410 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 410 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 410 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 410 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea after taking the drug before eating
Frequency: 1 affected / 410 at risk

Adverse event: Heaviness in the right hypochondrium
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 410 at risk

Adverse event: Enzymatic insufficiency
Serious: no
Organ System: Gastrointestinal disorders
Notes: ulcerative disease
Frequency: 1 affected / 410 at risk

Adverse event: Сhronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: acute exacerbation of a chronic disease
Frequency: 1 affected / 410 at risk

Adverse event: Frequent stool up to 3 times a day
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 410 at risk

Adverse event: Pastosity of the shins
Serious: no
Organ System: General disorders
Frequency: 1 affected / 410 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 410 at risk

Adverse event: Increase of ability to work
Serious: no
Organ System: General disorders
Frequency: 1 affected / 410 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 410 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 410 at risk

Adverse event: Acute respiratory viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 410 at risk

Adverse event: Acute respiratory disease
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 410 at risk

Adverse event: Acute respiratory disease
Serious: no
Organ System: Infections and infestations
Notes: with tracheobronchitis
Frequency: 1 affected / 410 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 410 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 410 at risk

Adverse event: Acute rhinopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 410 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 410 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 410 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 410 at risk

Adverse event: Increase in arterial pressure
Serious: no
Organ System: Investigations
Frequency: 2 affected / 410 at risk

Adverse event: LDL increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 410 at risk

Adverse event: C-reactive protein increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 410 at risk

Adverse event: Glucose level increase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 410 at risk

Adverse event: Total cholesterol increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 410 at risk

Adverse event: HDL increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 410 at risk

Adverse event: Erythrocyte sedimentation rate increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 410 at risk

Adverse event: Lymphocytosis level increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 410 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 410 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Feeling appetite suppressed, decreased feelings of hunger
Frequency: 1 affected / 410 at risk

Adverse event: Suppressing appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 410 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 410 at risk

Adverse event: Suppressing appetite
Serious: no
Organ System: Investigations
Notes: Suppressing appetite, feeling of saturation, has become overeat
Frequency: 1 affected / 410 at risk

Adverse event: Hyperglycaemia fasting
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 410 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 410 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 410 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 410 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: for sweet food
Frequency: 1 affected / 410 at risk

Adverse event: Dorsopathy of a spine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 410 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: left
Frequency: 1 affected / 410 at risk

Adverse event: Stiffness in hands
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 410 at risk

Adverse event: Lumbar osteochondrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 410 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 410 at risk

Adverse event: Unpleasant sweetish taste in a mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 410 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 410 at risk

Adverse event: Clinical anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 410 at risk

Adverse event: Subclinical anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 410 at risk

Adverse event: Increased anxiety on a scale HADS
Serious: no
Organ System: Psychiatric disorders
Frequency: 42 affected / 410 at risk

Adverse event: Mood changes: a tendency towards depression, aggressiveness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 410 at risk

Adverse event: Subclinical depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 410 at risk

Adverse event: Major depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 410 at risk

Adverse event: Increased depression on a scale HADS
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 410 at risk

Adverse event: Exaggeratedly mood, unreasonable euphoria
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 410 at risk

Adverse event: Unpleasant smell of urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 410 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 410 at risk

Adverse event: Hoarseness and throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 410 at risk

Adverse event: Skin rash (allergic reaction)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 410 at risk

Adverse event: Increased brittleness of nails
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 410 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 410 at risk

Adverse event: Hypertensic crisis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 410 at risk

Adverse event: Hypotonia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 410 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 83 at risk

Adverse event: Complaints about palpitations, sweating
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 83 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: exacerbation of chronic pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Thirst perception
Serious: no
Organ System: General disorders
Notes: drinks more fluids
Frequency: 1 affected / 83 at risk

Adverse event: Acute respiratory viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 83 at risk

Adverse event: Acute rhinopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 83 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Ligamentous injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1st metacarpophalangeal right hand joint
Frequency: 1 affected / 83 at risk

Adverse event: Increase in arterial pressure
Serious: no
Organ System: Investigations
Frequency: 1 affected / 83 at risk

Adverse event: HDL increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 83 at risk

Adverse event: Erythrocyte sedimentation rate increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 83 at risk

Adverse event: ALT increase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 83 at risk

Adverse event: Basophilia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 83 at risk

Adverse event: Erytrocytosis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 83 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 83 at risk

Adverse event: Monocytosis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 83 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 83 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 83 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: for sweet food
Frequency: 1 affected / 83 at risk

Adverse event: Periodic strong desire to eat something
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Right shoulder joint arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Left hip joint arthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Vertebral radiculopathy with moderate musculo-tonic and pain syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 83 at risk

Adverse event: Subclinical anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 83 at risk

Adverse event: Increased anxiety on a scale HADS
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 83 at risk

Adverse event: Subclinical depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 83 at risk

Adverse event: Increased depression on a scale HADS
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 83 at risk

Adverse event: Increased brittleness of nails
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Xerosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 83 at risk