Study: NCT00132678

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 154 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 154 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 154 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 154 at risk

Adverse event: Nasal polyps
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 154 at risk

Adverse event: Sommolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of insomnia in the Serious Adverse Event table.
Frequency: 12 affected / 154 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of anxiety in the Serious Adverse Event table.
Frequency: 4 affected / 154 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 154 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 154 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 149 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 149 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 149 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 149 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 149 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 149 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 149 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 149 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 149 at risk

Adverse event: Sommolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 149 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of insomnia in the Serious Adverse Event table.
Frequency: 9 affected / 149 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of anxiety in the Serious Adverse Event table.
Frequency: 6 affected / 149 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 149 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 149 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 440 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 440 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 440 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 440 at risk

Adverse event: Duodenal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 440 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 440 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 440 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 440 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 440 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 440 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 440 at risk

Adverse event: Sommolence
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 440 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of insomnia in the Serious Adverse Event table.
Frequency: 23 affected / 440 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of anxiety in the Serious Adverse Event table.
Frequency: 6 affected / 440 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 440 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 440 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 501 at risk

Adverse event: Bipolar I disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 12 affected / 501 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 501 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 501 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 501 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 501 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Drug dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Chemical poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Hepatic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 501 at risk

Adverse event: Accidental death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 501 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 501 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 501 at risk

Adverse event: Sommolence
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 501 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of insomnia in the Serious Adverse Event table.
Frequency: 66 affected / 501 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Number affected in Open-Label RISPERDAL CONSTA does not include the event of anxiety in the Serious Adverse Event table.
Frequency: 23 affected / 501 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 501 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 501 at risk