Abilify Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions are discussed in more details in other sections of the labelling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see WARNINGS and Increased Mortality in Elderly Patients with Dementia-Related Psychosis under PRECAUTIONS].
Cerebrovascular Adverse Events, Including Stroke [see Cerebrovascular Adverse Events, Including Stroke under PRECAUTIONS].
Suicidal Thoughts and Behaviours in Children, Adolescents, and Young Adults [see WARNINGS and Suicidal Thoughts and Behaviours in Children, Adolescents, and Young Adults under PRECAUTIONS].
Neuroleptic Malignant Syndrome (NMS) [see Neuroleptic Malignant Syndrome (NMS) under PRECAUTIONS].
Tardive Dyskinesia [see Tardrive Dyskinesia under PRECAUTIONS].
Extrapyramidal symptoms [see Extrapyramidal symptoms (EPS) under PRECAUTIONS].
Venous Thromboembolism [see Venous Thromboembolism under PRECAUTIONS].
Metabolic Changes [see Metabolic Changes under PRECAUTIONS].
Orthostatic Hypotension [see Orthostatic Hypotension under PRECAUTIONS].
Leukopenia, Neutropenia, and Agranulocytosis [see Leukopenia, Neutropenia, and Agranulocytosis under PRECAUTIONS].
Seizures/Convulsions [see Seizures/Convulsions under PRECAUTIONS].
Potential for Cognitive and Motor Impairment [see Potential for Cognitive and Motor Impairment under PRECAUTIONS].
Body Temperature Regulation [see Body Temperature Regulation under PRECAUTIONS].
Suicide [see Suicide under PRECAUTIONS].
Dysphagia [see Dysphagia under PRECAUTIONS].
Pathological Gambling and Other Compulsive Behaviours [see Pathological Gambling and Other Compulsive Behaviours under PRECAUTIONS].
Sleep apnoea and related disorders [see Sleep apnoea and related disorders under PRECAUTIONS].
Falls [see Falls under PRECAUTIONS].
The most common adverse reactions in adult patients in clinical trials (≥ 10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia and restlessness.
The most common adverse reactions in the paediatric clinical trials (≥ 10%) were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased.
ABILIFY has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, Dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately 7,619 patient-years of exposure to oral ABILIFY. A total of 3,390 patients were treated with oral ABILIFY for at least 180 days and 1,933 patients treated with oral ABILIFY had at least 1 year of exposure.
ABILIFY has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's disorder and who had approximately 1,342 patient-years of exposure to oral ABILIFY. A total of 959 paediatric patients were treated with oral ABILIFY for at least 180 days and 556 paediatric patients treated with oral ABILIFY had at least 1 year of exposure.
The conditions and duration of treatment with ABILIFY (monotherapy and adjunctive therapy with antidepressants or mood stabilizers) included (in overlapping categories) double-blind, comparative and non-comparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.
Adverse events during exposure were obtained by collecting volunteered adverse events, as well as results of physical examinations, vital signs, weights, laboratory analyses, and ECG. Adverse experiences were recorded by clinical investigators using terminology of their own choosing. In the tables and tabulations that follow, MedDRA dictionary terminology has been used to classify reported adverse events into a smaller number of standardized event categories, in order to provide a meaningful estimate of the proportion of individuals experiencing adverse events.
The stated frequencies of adverse events represent the proportion of individuals who experienced at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. There was no attempt to use investigator causality assessments; i.e., all reported events are included.
The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatment, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse event incidence in the population studied.
Clinical Trials Experience: Adult Patients with Schizophrenia: The following findings are based on a pool of five placebo-controlled trials (four 4-week and one 6-week) in which ABILIFY was administered in doses ranging from 2 to 30 mg/day.
Commonly Observed Adverse Reactions: The only commonly observed adverse reaction associated with the use of ABILIFY in patients with schizophrenia (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) was akathisia (placebo 4%; aripiprazole 8%).
Adult Patients with Bipolar Mania: Monotherapy: The following findings are based on a pool of 3-week, placebo-controlled bipolar mania trials in which ABILIFY was administered at doses of 15 or 30 mg/day.
Commonly Observed Adverse Events: Commonly observed adverse reactions associated with the use of ABILIFY in patients with bipolar mania (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 18. (See Table 18.)

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Less Common Adverse Reactions in Adults: Table 19 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks in schizophrenia and up to 3 weeks in bipolar mania), including only those reactions that occurred in 2% or more of patients treated with ABILIFY (doses ≥ 2 mg/day) and for which the incidence in patients treated with ABILIFY was greater than the incidence in patients treated with placebo in the combined dataset. (See Table 19.)

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An examination of population subgroups did not reveal any clear evidence of differential adverse reaction incidence on the basis of age, gender, or race.
Adult Patients with Adjunctive Therapy with Bipolar Mania: The following findings are based on a placebo-controlled trial of adult patients with bipolar disorder in which ABILIFY was administered at doses of 15 or 30 mg/day as adjunctive therapy with lithium or valproate.
Adverse Reactions Associated with Discontinuation of Treatment: In a study of patients who were already tolerating either lithium or valproate as monotherapy, discontinuation rates due to adverse reactions were 12% for patients treated with adjunctive ABILIFY compared to 6% for patients treated with adjunctive placebo. The most common adverse drug reactions associated with discontinuation in the adjunctive ABILIFY-treated compared to placebo-treated patients were akathisia (5% and 1%, respectively) and tremor (2% and 1%, respectively).
Commonly Observed Adverse Reactions: The commonly observed adverse reactions associated with adjunctive ABILIFY and lithium or valproate in patients with bipolar mania (incidence of 5% or greater and incidence at least twice that for adjunctive placebo) were: akathisia, insomnia, and extrapyramidal disorder.
Less Common Adverse Reactions in Adult Patients with Adjunctive Therapy in Bipolar Mania: Table 20 enumerates the incidence, rounded to the nearest percent, of adverse reactions that occurred during acute treatment (up to 6 weeks), including only those reactions that occurred in 2% or more of patients treated with adjunctive ABILIFY (doses of 15 or 30 mg/day) and lithium or valproate and for which the incidence in patients treated with this combination was greater than the incidence in patients treated with placebo plus lithium or valproate. (See Table 20.)

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Paediatric Patients (13 to 17 years) with Schizophrenia: The following findings are based on one 6-week, placebo-controlled trial in which oral ABILIFY was administered in doses ranging from 2 to 30 mg/day.
Adverse Reactions Associated with Discontinuation of Treatment: The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated paediatric patients (13 to 17 years) was 5% and 2%, respectively.
Commonly Observed Adverse Reactions: Commonly observed adverse reactions associated with the use of ABILIFY in adolescent patients with schizophrenia (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) were extrapyramidal disorder, somnolence, and tremor.
Paediatric Patients with Bipolar Mania: The following findings are based on one 4-week, placebo-controlled trial in which oral ABILIFY was administered in doses of 10 or 30 mg/day.
Adverse Reactions Associated with Discontinuation of Treatment: The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated paediatric patients (10 to 17 years) was 7% and 2%, respectively.
Commonly Observed Adverse Reactions: Commonly observed adverse reactions associated with the use of ABILIFY in paediatric patients with bipolar mania (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 21. (See Table 21.)

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The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: somnolence, extrapyramidal disorder and fatigue. In the paediatric population, somnolence and fatigue were observed more frequently in patients with bipolar disorder compared to patients with schizophrenia.
Paediatric Patients (6 to 17 years) with Autistic Disorder: The following findings are based on two 8-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 15 mg/day.
Adverse Reactions Associated with Discontinuation of Treatment: The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated paediatric patients (6 to 17 years) was 10% and 8%, respectively.
Commonly Observed Adverse Reactions: Commonly observed adverse reactions associated with the use of ABILIFY in paediatric patients with autistic disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 22. (See Table 22.)

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Paediatric Patients (6 to 18 years) with Tourette's Disorder: The following findings are based on one 8-week and one 10-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 20 mg/day.
Adverse Reactions Associated with Discontinuation of Treatment: The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated paediatric patients (6 to 18 years) was 7% and 1%, respectively.
Commonly Observed Adverse Reactions: Commonly observed adverse reactions associated with the use of ABILIFY in paediatric patients with Tourette's disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 23. (See Table 23.)

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Less Common Adverse Reactions in Paediatric Patients (6 to 18 years) with Schizophrenia, Bipolar Mania, Autistic Disorder, or Tourette's Disorder: Table 24 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks in schizophrenia, up to 4 weeks in bipolar mania, up to 8 weeks in autistic disorder, and up to 10 weeks in Tourette's disorder), including only those reactions that occurred in 2% or more of paediatric patients treated with ABILIFY (doses ≥ 2 mg/day) and for which the incidence in patients treated with ABILIFY was greater than the incidence in patients treated with placebo. (See Table 24.)

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Adult Patients Receiving ABILIFY as Adjunctive Treatment of Major Depressive Disorder: The following findings are based on a pool of three placebo-controlled trials of adjunctive ABILIFY in patients with MDD who had an inadequate response to at least two treatments with antidepressants in the current episode, one of them demonstrated prospectively, in which aripiprazole was administered at doses of 2 mg to 20 mg as adjunctive treatment to continued antidepressant therapy for up to 6 weeks.
Adverse Reactions Associated with Discontinuation of Treatment: The incidence of discontinuation due to adverse reactions was 6% for adjunctive ABILIFY-treated patients and 2% for adjunctive placebo-treated patients. Akathisia, the most common adverse event leading to discontinuation in the aripiprazole group, led to withdrawal of 1.3% of aripiprazole-treated patients and 0% of patients on placebo.
Commonly Observed Adverse Reactions: The commonly observed adverse reactions associated with the use of adjunctive ABILIFY in patients with major depressive disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) were: akathisia, restlessness, insomnia, constipation, fatigue, blurred vision, and somnolence.
Less Common Adverse Reactions in Adult Patients with Major Depressive Disorder: Table 25 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks), including only those adverse reactions that occurred in 2% or more of patients treated with adjunctive ABILIFY (doses ≥ 2 mg/day) and for which the incidence in patients treated with adjunctive ABILIFY was greater than the incidence in patients treated with adjunctive placebo in the combined dataset. (See Table 25.)

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Dose-Related Adverse Reactions: Schizophrenia: Dose response relationships for the incidence of treatment-emergent adverse events were evaluated from four trials in adult patients with schizophrenia comparing various fixed doses (2, 5, 10, 15, 20, and 30 mg/day) of ABILIFY to placebo. This analysis, stratified by study, indicated that the only adverse reaction to have a possible dose response relationship, and then most prominent only with 30 mg, was somnolence ([including sedation] placebo, 7.1%; 10 mg, 8.5%; 15 mg, 8.7%; 20 mg, 7.5%; 30 mg, 12.6%).
In the study of paediatric patients (13 to 17 years of age) with schizophrenia, three common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder (incidences were placebo, 5.0%; 10 mg, 13.0%; 30 mg, 21.6%); somnolence (incidences were placebo, 6.0%; 10 mg, 11.0%; 30 mg, 21.6%); and tremor (incidences were placebo, 2.0%; 10 mg, 2.0%; 30 mg, 11.8%).
Bipolar Mania: In the study of paediatric patients (10 to 17 years of age) with bipolar mania, four common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder (incidences were placebo, 3.1%; 10 mg, 12.2%; 30 mg, 27.3%); somnolence (incidences were placebo, 3.1%; 10 mg, 19.4%; 30 mg, 26.3%); akathisia (incidences were placebo, 2.1%; 10 mg, 8.2%; 30 mg, 11.1%); and salivary hypersecretion (incidences were placebo, 0%; 10 mg, 3.1%; 30 mg, 8.1%).
Autistic Disorder: In a study of paediatric patients (6 to 17 years of age) with autistic disorder, one common adverse reaction had a possible dose response relationship: fatigue (incidences were placebo, 0%; 5 mg, 3.8%; 10 mg, 22.0%; 15 mg, 18.5%).
Tourette's Disorder: In a study of paediatric patients (7 to 17 years of age) with Tourette's disorder, no common adverse reaction(s) had a dose response relationship.
Extrapyramidal Symptoms: Schizophrenia: In the short-term, placebo-controlled trials of schizophrenia in adults, the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 13% vs. 12% for placebo. In the short-term, placebo-controlled trials in schizophrenia, the incidence of akathisia-related events for ABILIFY-treated patients was 8% vs. 4% for placebo. In the short-term, placebo-controlled trial of schizophrenia in paediatric patients (13 to 17 years), the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 25% vs. 7% for placebo; and the incidence of akathisia-related events for ABILIFY-treated patients was 9% vs. 6% for placebo.
Objectively collected data from those trials was collected on the Simpson Angus Rating Scale (for EPS), the Barnes Akathisia Scale (for akathisia) and the Assessments of Involuntary Movement Scales (for dyskinesias). In the schizophrenia trials, the objectively collected data did not show a difference between ABILIFY and placebo, with the exception of the Barnes Akathisia Scale (aripiprazole, 0.08; placebo, -0.05). In the paediatric (13 to 17 years) schizophrenia trial, the objectively collected data did not show a difference between ABILIFY and placebo, with the exception of the Simpson Angus Rating Scale (ABILIFY, 0.24; placebo, -0.29).
Similarly, in a long-term (26-week), placebo-controlled trial of schizophrenia, objectively collected data on the Simpson Angus Rating Scale (for EPS), the Barnes Akathisia Scale (for akathisia), and the Assessments of Involuntary Movement Scales (for dyskinesias) did not show a difference between ABILIFY and placebo.
Bipolar Mania: In the short-term, placebo-controlled trials in bipolar mania in adults, the incidence of reported EPS-related events, excluding events related to akathisia, for monotherapy ABILIFY-treated patients was 16% vs. 8% for placebo and the incidence of akathisia-related events for monotherapy ABILIFY-treated patients was 13% vs. 4% for placebo. In the 6-week, placebo-controlled trial in bipolar mania for adjunctive therapy with lithium or valproate, the incidence of reported EPS-related events, excluding events related to akathisia for adjunctive ABILIFY-treated patients was 15% vs. 8% for adjunctive placebo and the incidence of akathisia-related events for adjunctive ABILIFY-treated patients was 19% vs. 5% for adjunctive placebo. In the short-term, placebo-controlled trial in bipolar mania in paediatric (10 to 17 years) patients, the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 26% vs. 5% for placebo and the incidence of akathisia-related events for ABILIFY-treated patients was 10% vs. 2% for placebo.
In the adult bipolar mania trials with monotherapy ABILIFY, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between ABILIFY and placebo (ABILIFY, 0.50; placebo, -0.01 and ABILIFY, 0.21; placebo, -0.05). Changes in the Assessments of Involuntary Movement Scales were similar for the ABILIFY and placebo groups. In the bipolar mania trials with ABILIFY as adjunctive therapy with either lithium or valproate, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive ABILIFY and adjunctive placebo (ABILIFY, 0.73; placebo, 0.07 and ABILIFY, 0.30; placebo, 0.11). Changes in the Assessments of Involuntary Movement Scales were similar for adjunctive ABILIFY and adjunctive placebo. In the paediatric (10 to 17 years), short-term, bipolar mania trial, the Simpson Angus Rating Scale showed a significant difference between ABILIFY and placebo (ABILIFY, 0.90; placebo, -0.05). Changes in the Barnes Akathisia Scale and the Assessments of Involuntary Movement Scales were similar for the ABILIFY and placebo groups.
Major Depressive Disorder: In the short-term, placebo-controlled trials in major depressive disorder, the incidence of reported EPS-related events, excluding events related to akathisia, for adjunctive ABILIFY-treated patients was 8% vs. 5% for adjunctive placebo-treated patients; and the incidence of akathisia-related events for adjunctive ABILIFY-treated patients was 23% vs. 4% for adjunctive placebo-treated patients.
In the major depressive disorder trials, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between adjunctive ABILIFY and adjunctive placebo (ABILIFY, 0.27; placebo, 0.01 and ABILIFY, 0.23; placebo, 0.03). Changes in the Assessments of Involuntary Movement Scales were similar for the adjunctive ABILIFY and adjunctive placebo groups.
Autistic Disorder: In the short-term, placebo-controlled trials in autistic disorder in paediatric patients (6 to 17 years), the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 18% vs. 2% for placebo and the incidence of akathisia-related events for ABILIFY-treated patients was 3% vs. 9% for placebo.
In the paediatric (6 to 17 years) short-term autistic disorder trials, the Simpson Angus Rating Scale showed a significant difference between ABILIFY and placebo (ABILIFY, 0.1; placebo, -0.4). Changes in the Barnes Akathisia Scale and the Assessments of Involuntary Movement Scales were similar for the ABILIFY and placebo groups.
Tourette's Disorder: In the short-term, placebo-controlled trials in Tourette's disorder in paediatric patients (6 to 18 years), the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY-treated patients was 7% vs. 6% for placebo and the incidence of akathisia-related events for ABILIFY-treated patients was 4% vs. 6% for placebo.
In the paediatric (6 to 18 years) short-term Tourette's disorder trials, changes in the Simpson Angus Rating Scale, Barnes Akathisia Scale and Assessments of Involuntary Movement Scale were not clinically meaningfully different for ABILIFY and placebo.
Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Additional Findings Observed in Clinical Trials: Adverse Reactions in Long-Term, Double-Blind, Placebo-Controlled Trials: The adverse reactions reported in a 26-week, double-blind trial comparing ABILIFY and placebo in patients with schizophrenia were generally consistent with those reported in the short-term, placebo-controlled trials, except for a higher incidence of tremor [8% (12/153) for ABILIFY vs. 2% (3/153) for placebo]. In this study, the majority of the cases of tremor were of mild intensity (8/12 mild and 4/12 moderate), occurred early in therapy (9/12 ≤ 49 days), and were of limited duration (7/12 ≤ 10 days). Tremor infrequently led to discontinuation (< 1%) of ABILIFY. In addition, in a long-term (52-week), active-controlled study, the incidence of tremor for ABILIFY was 5% (40/859).
A similar profile was observed in a long-term monotherapy study and a long-term adjunctive study with lithium and valproate in bipolar disorder.
Other Adverse Reactions Observed During the Premarketing Evaluation of ABILIFY: The following listing does not include reactions: 1) already listed in previous tables or elsewhere in labelling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.
Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients: Adults: Blood and Lymphatic System Disorders: rare - thrombocytopenia.
Cardiac Disorders: infrequent - bradycardia, palpitations; rare - atrial flutter, cardio-respiratory arrest, atrioventricular block, atrial fibrillation, angina pectoris, myocardial ischemia, myocardial infarction, cardiopulmonary failure.
Eye Disorders: infrequent - photophobia; rare - diplopia.
Gastrointestinal Disorders: infrequent - gastroesophageal reflux disease.
General Disorders and Administration Site Conditions: frequent - asthenia; infrequent - peripheral oedema, chest pain; rare - face oedema.
Hepatobiliary Disorders: rare - hepatitis, jaundice.
Immune System Disorders: rare - hypersensitivity.
Injury, Poisoning, and Procedural Complications: infrequent - fall; rare - heat stroke.
Investigations: frequent - weight decreased; infrequent - hepatic enzyme increased, blood glucose increased, blood lactate dehydrogenase increased, gamma glutamyl transferase increased; rare - blood prolactin increased, blood urea increased, blood creatinine increased, blood bilirubin increased, electrocardiogram QT prolonged, glycosylated haemoglobin increased.
Metabolism and Nutrition Disorders: frequent - anorexia; infrequent - rare - hypokalaemia, hyponatremia, hypoglycaemia.
Musculoskeletal and Connective Tissue Disorders: infrequent - muscular weakness, muscle tightness; rare - rhabdomyolysis, mobility decreased.
Nervous System Disorders: infrequent - parkinsonism, memory impairment, cogwheel rigidity, hypokinesia, myoclonus, bradykinesia; rare - akinesia, myoclonus, coordination abnormal, speech disorder, Grand Mal convulsion; <1/10,000 patients - choreoathetosis.
Psychiatric Disorders: infrequent - aggression, loss of libido, delirium; rare - libido increased, anorgasmia, tic, homicidal ideation, catatonia, sleep walking.
Renal and Urinary Disorders: rare - urinary retention, nocturia.
Reproductive System and Breast Disorders: infrequent - erectile dysfunction; rare - gynaecomastia, menstruation irregular, amenorrhea, breast pain, priapism.
Respiratory, Thoracic, and Mediastinal Disorders: infrequent - nasal congestion, dyspnoea.
Skin and Subcutaneous Tissue Disorders: infrequent - rash, hyperhidrosis, pruritus, photosensitivity reaction, alopecia; rare - urticaria.
Vascular Disorders: infrequent - hypotension, hypertension.
Paediatric Patients: Most adverse events observed in the pooled database of 1,686 paediatric patients, aged 6 to 18 years, were also observed in the adult population. Additional adverse reactions observed in the paediatric population are listed as follows.
Eye Disorders: infrequent - oculogyric crisis.
Gastrointestinal Disorders: infrequent - tongue dry, tongue spasm.
Investigations: frequent - blood insulin increased.
Nervous System Disorders: infrequent - sleep talking.
Renal and Urinary Disorders: frequent - enuresis.
Skin and Subcutaneous Tissue Disorders: infrequent - hirsutism.
Post-marketing Experience: The following adverse events were reported during the post marketing use of aripiprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: occurrences of blood glucose fluctuation, allergic reaction (anaphylactic reaction, angioedema, laryngospasm or oropharyngeal spasm), hyper sexuality, pathological gambling, hepatic failure, hiccups, oculogyric crisis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), restless legs syndrome, blood prolactin decreased and sleep-related eating disorder (SRED).