Summary of the safety profile:
The most commonly reported adverse reactions in placebo-controlled trials are akathisia and nausea each occurring in more than 3% of patients treated with oral aripiprazole.
List of adverse reactions:
All ADRs are listed by system organ class and frequency; very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified as "not known".
Blood and lymphatic system disorders:
Not known: Leukopenia, neutropenia, thrombocytopenia.
Immune system disorders:
Not known: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria).
Not known: Diabetic hyperosmolar coma, diabetic ketoacidosis, hyperglycaemia.
Metabolism and nutrition disorder:
Common: Diabetes mellitus.
Not known: Hyponatraemia, anorexia, weight decreased, weight gain.
Common: Insomnia, anxiety, restlessness.
Uncommon: Depression, hypersexuality.
Not known: Suicide attempt, suicidal ideation and completed suicide (see Precautions), pathological gambling, aggression, agitation, nervousness.
Nervous system disorders:
Common: Akathisia, extrapyramidal disorder, tremor, headache, sedation, somnolence, dizziness.
Uncommon: Tardive dyskinesia, dystonia.
Not known: Neuroleptic malignant syndrome (NMS), grand mal convulsion, serotonin syndrome, speech disorder.
Common: Vision blurred.
Not known: Sudden unexplained death, torsades de pointes, QT prolongation, ventricular arrhythmias, cardiac arrest, bradycardia.
Uncommon: Orthostatic hypotension.
Not known: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis), hypertension, syncope.
Respiratory, thoracic and mediastinal disorders:
Not known: Aspiration pneumonia, laryngospasm, oropharyngeal spasm.
Common: Constipation, dyspepsia, nausea, salivary hypersecretion, vomiting.
Not known: Pancreatitis, dysphagia, diarrhoea, abdominal discomfort, stomach discomfort.
Not known: Hepatic failure, hepatitis, jaundice, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased gamma glutamyl transferase (GCT), increased alkaline phosphatase.
Skin and subcutaneous tissue disorders:
Not known: Rash, photosensitivity reaction, alopecia, hyperhidrosis.
Musculoskeletal and connective tissue disorders:
Not known: Rhabdomyolysis, myalgia, stiffness.
Renal and urinary disorders:
Not known: Urinary incontinence, urinary retention.
Pregnancy, puerperium and perinatal conditions:
Not known: Drug withdrawal syndrome neonatal (see Use in Pregnancy & Lactation).
Reproductive system and breast disorders:
Not known: Priapism.
General disorders and administration site conditions:
Not known: Temperature regulation disorder (e.g. hypothermia, pyrexia), chest pain, peripheral oedema.
Not known: Blood glucose increased, glycosylated haemoglobin increased, blood glucose fluctuation, increased creatine phosphokinase.