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Abilify (Aripiprazole) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Aripiprazole has been evaluated for safety in 8456 patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, and dementia of the Alzheimer’s type, and who had approximately 5635 patient-years of exposure to oral aripiprazole and 749 patients with exposure to aripiprazole injection. A total of 2442 patients were treated with oral aripiprazole for at least 180 days and 1667 patients treated with oral aripiprazole had at least 1 year of exposure.

The conditions and duration of treatment with aripiprazole included (in overlapping categories) double-blind, comparative and noncomparative 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; ie, 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.

ORAL ADMINISTRATION

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials of 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 oral aripiprazole was administered in doses ranging from 2 to 30 mg/day.

Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials

Overall, there was little difference in the incidence of discontinuation due to adverse events between aripiprazole-treated (7%) and placebo-treated (9%) patients. The types of adverse events that led to discontinuation were similar between the aripiprazole and placebo-treated patients.

Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Schizophrenia

The only commonly observed adverse event associated with the use of aripiprazole in patients with schizophrenia (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) was akathisia (placebo 4%; aripiprazole 8%).

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania

The following findings are based on a pool of 3-week, placebo-controlled, bipolar mania trials in which oral aripiprazole was administered at doses of 15 or 30 mg/day.

Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials

Overall, in patients with bipolar mania, there was little difference in the incidence of discontinuation due to adverse events between aripiprazole-treated (11%) and placebo-treated (9%) patients. The types of adverse events that led to discontinuation were similar between the aripiprazole and placebo-treated patients.

Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania

Commonly observed adverse events associated with the use of aripiprazole in patients with bipolar mania (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) are shown in Table 1.

Table 1: Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Bipolar Mania Treated with Oral ABILIFY
Percentage of Patients Reporting Event

Preferred Term
Aripiprazole
(n=597)
Placebo
(n=436)
Constipation136
Akathisia153
Sedation83
Tremor73
Restlessness63
Extrapyramidal Disorder52

Adverse Events Occurring at an Incidence of 2% or More Among Aripiprazole-Treated Patients and Greater than Placebo in Short-Term, Placebo-Controlled Trials

Table 2 enumerates the pooled incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy (up to 6 weeks in schizophrenia and up to 3 weeks in bipolar mania), including only those events that occurred in 2% or more of patients treated with aripiprazole (doses ≥2 mg/day) and for which the incidence in patients treated with aripiprazole was greater than the incidence in patients treated with placebo in the combined dataset.

Table 2: Treatment-Emergent Adverse Events in Short-Term, Placebo-Controlled Trials in Patients Treated with Oral ABILIFY
Percentage of Patients Reporting Eventa
System Organ Class
   Preferred Term
Aripiprazole
(n=1523)
Placebo
(n=849)
a Events reported by at least 2% of patients treated with oral aripiprazole, except the following events, which had an incidence equal to or less than placebo: diarrhea, toothache, upper abdominal pain, abdominal pain, musculoskeletal stiffness, back pain, myalgia, agitation, psychotic disorder, dysmenorrheaf, rash.
b Including blood pressure increased.
f Percentage based on gender total.
Eye Disorders
   Vision Blurred 3 1
Gastrointestinal Disorders
   Nausea1612
   Vomiting126
   Constipation117
   Dyspepsia108
   Dry Mouth54
   Abdominal Discomfort32
   Stomach Discomfort32
   Salivary Hypersecretion21
General Disorders and Administration Site Conditions
   Fatigue65
   Pain32
   Peripheral Edema21
Musculoskeletal and Connective Tissue Disorders
   Arthralgia54
   Pain in Extremity42
Nervous System Disorders
   Headache3025
   Dizziness118
   Akathisia104
   Sedation74
    Extrapyramidal Disorder64
   Tremor53
   Somnolence54
Psychiatric Disorders
   Anxiety2017
   Insomnia1914
   Restlessness53
Respiratory, Thoracic, and Mediastinal Disorders
   Pharyngolaryngeal Pain43
   Cough32
   Nasal Congestion32
Vascular Disorders
   Hypertensionb21

An examination of population subgroups did not reveal any clear evidence of differential adverse event incidence on the basis of age, gender, or race.

INTRAMUSCULAR ADMINISTRATION

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials of Patients with Agitation Associated with Schizophrenia or Bipolar Mania

The following findings are based on a pool of three placebo-controlled trials of patients with agitation associated with schizophrenia or bipolar mania in which aripiprazole injection was administered at doses of 5.25 mg to 15 mg.

Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials

Overall, in patients with agitation associated with schizophrenia or bipolar mania, there was little difference in the incidence of discontinuation due to adverse events between aripiprazole-treated (0.8%) and placebo-treated (0.5%) patients.

Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials of Patients with Agitation Associated with Schizophrenia or Bipolar Mania

There was one commonly observed adverse event (nausea) associated with the use of aripiprazole injection in patients with agitation associated with schizophrenia and bipolar mania (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo).

Adverse Events Occurring at an Incidence of 1% or More Among Aripiprazole-Treated Patients and Greater than Placebo in Short-Term, Placebo-Controlled Trials of Patients with Agitation Associated with Schizophrenia or Bipolar Mania

Table 3 enumerates the pooled incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy (24 hour), including only those events that occurred in 1% or more of patients treated with aripiprazole injection (doses ≥5.25 mg/day) and for which the incidence in patients treated with aripiprazole injection was greater than the incidence in patients treated with placebo in the combined dataset.

Table 3: Treatment-Emergent Adverse Events in Short-Term, Placebo-Controlled Trials in Patients Treated with ABILIFY Injection
Percentage of Patients Reporting Eventa
System Organ Class
   Preferred Term
Aripiprazole
(n=501)
Placebo
(n=220)
aEvents reported by at least 1% of patients treated with aripiprazole injection, except the following events, which had an incidence equal to or less than placebo: injection site pain, injection site burning, insomnia, agitation.
Cardiac Disorders
   Tachycardia2<1
Gastrointestinal Disorders
   Nausea93
   Vomiting31
   Dyspepsia1<1
   Dry Mouth1<1
General Disorders and Administration Site Conditions
   Fatigue21
Investigations
   Blood Pressure Increased1<1
Musculoskeletal and Connective Tissue Disorders
   Musculoskeletal Stiffness1<1
Nervous System Disorders
   Headache127
   Dizziness85
   Somnolence74
   Sedation32
   Akathisia20

Dose-Related Adverse Events

Schizophrenia

Dose response relationships for the incidence of treatment-emergent adverse events were evaluated from four trials in patients with schizophrenia comparing various fixed doses (2, 5, 10, 15, 20, and 30 mg/day) of oral aripiprazole to placebo. This analysis, stratified by study, indicated that the only adverse event 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%).

Extrapyramidal Symptoms

In the short-term, placebo-controlled trials of schizophrenia, the incidence of reported EPS-related events, excluding events related to akathisia, for aripiprazole-treated patients was 13% vs. 12% for placebo. In the short-term, placebo-controlled trials in schizophrenia, the incidence of akathisia-related events for aripiprazole-treated patients was 8% vs. 4% for placebo. In the short-term, placebo-controlled trials in bipolar mania, the incidence of reported EPS-related events, excluding events related to akathisia, for aripiprazole-treated patients was 15% vs. 8% for placebo. In the short-term, placebo-controlled trials in bipolar mania, the incidence of akathisia-related events for aripiprazole-treated patients was 15% vs. 4% 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 aripiprazole and placebo, with the exception of the Barnes Akathisia Scale (aripiprazole, 0.08; placebo, -0.05). In the bipolar mania trials, the Simpson Angus Rating Scale and the Barnes Akathisia Scale showed a significant difference between aripiprazole and placebo (aripiprazole, 0.61; placebo, 0.03 and aripiprazole, 0.25; placebo, -0.06). Changes in the Assessments of Involuntary Movement Scales were similar for the aripiprazole and placebo groups.

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 aripiprazole and placebo.

In the placebo-controlled trials in patients with agitation associated with schizophrenia or bipolar mania, the incidence of reported EPS-related events excluding events related to akathisia for aripiprazole-treated patients was 2% vs. 2% for placebo and the incidence of akathisia-related events for aripiprazole-treated patients was 2% vs. 0% for placebo. Objectively collected data on the Simpson Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) for all treatment groups, did not show a difference between aripiprazole and placebo.

Laboratory Test Abnormalities

A between group comparison for 3- to 6-week, placebo-controlled trials revealed no medically important differences between the aripiprazole and placebo groups in the proportions of patients experiencing potentially clinically significant changes in routine serum chemistry, hematology, or urinalysis parameters. Similarly, there were no aripiprazole/placebo differences in the incidence of discontinuations for changes in serum chemistry, hematology, or urinalysis.

In a long-term (26-week), placebo-controlled trial there were no medically important differences between the aripiprazole and placebo patients in the mean change from baseline in prolactin, fasting glucose, triglyceride, HDL, LDL, and total cholesterol measurements.

Weight Gain

In 4- to 6- week trials in schizophrenia, there was a slight difference in mean weight gain between aripiprazole and placebo patients (+0.7 kg vs. -0.05 kg, respectively), and also a difference in the proportion of patients meeting a weight gain criterion of ≥7% of body weight [aripiprazole (8%) compared to placebo (3%)]. In 3-week trials in mania, the mean weight gain for aripiprazole and placebo patients was 0.0 kg vs. -0.2 kg, respectively. The proportion of patients meeting a weight gain criterion of ≥7% of body weight was aripiprazole (3%) compared to placebo (2%).

Table 4 provides the weight change results from a long-term (26-week), placebo-controlled study of aripiprazole, both mean change from baseline and proportions of patients meeting a weight gain criterion of ≥7% of body weight relative to baseline, categorized by BMI at baseline:

Table 4: Weight Change Results Categorized by BMI at Baseline: Placebo-Controlled Study in Schizophrenia, Safety Sample
BMI <23BMI 23-27BMI >27
PlaceboAripiprazolePlaceboAripiprazolePlaceboAripiprazole
Mean change from
baseline (kg)
-0.5-0.5-0.6-1.3-1.5-2.1
% with ≥7% increase BW3.7%6.8%4.2%5.1%4.1%5.7%

Table 5 provides the weight change results from a long-term (52-week) study of aripiprazole, both mean change from baseline and proportions of patients meeting a weight gain criterion of ≥7% of body weight relative to baseline, categorized by BMI at baseline:

Table 5: Weight Change Results Categorized by BMI at Baseline: Active-Controlled Study in Schizophrenia, Safety Sample
BMI <23BMI 23-27BMI >27
Mean change from baseline (kg)2.61.4-1.2
% with ≥7% increase BW30%19%8%

ECG Changes

Between group comparisons for a pooled analysis of placebo-controlled trials in patients with schizophrenia or bipolar mania, revealed no significant differences between oral aripiprazole and placebo in the proportion of patients experiencing potentially important changes in ECG parameters. Aripiprazole was associated with a median increase in heart rate of 5 beats per minute compared to a 1 beat per minute increase among placebo patients.

In the pooled, placebo-controlled trials in patients with agitation associated with schizophrenia or bipolar mania, there were no significant differences between aripiprazole injection and placebo in the proportion of patients experiencing potentially important changes in ECG parameters, as measured by standard 12-lead ECGs.

Additional Findings Observed in Clinical Trials

Adverse Events in Long-Term, Double-Blind, Placebo-Controlled Trials

The adverse events reported in a 26-week, double-blind trial comparing oral 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 adverse event profile was observed in a long-term study in bipolar disorder.

Other Adverse Events Observed During the Premarketing Evaluation of Oral Aripiprazole

Following is a list of MedDRA terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with oral aripiprazole at multiple doses ≥2 mg/day during any phase of a trial within the database of 8456 patients. All reported events are included except those already listed in Table 2, or other parts of the ADVERSE REACTIONS section, those considered in the WARNINGS or PRECAUTIONS, those event terms which were so general as to be uninformative, events reported with an incidence of ≤0.05% and which did not have a substantial probability of being acutely life-threatening, events that are otherwise common as background events, and events considered unlikely to be drug related. It is important to emphasize that, although the events reported occurred during treatment with aripiprazole, they were not necessarily caused by it.

Events are further categorized by MedDRA system organ class and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Blood and Lymphatic System Disorders: Infrequent - anaemia, lymphadenopathy, leukopenia (including agranulocytosis, neutropenia); Rare - leukocytosis, thrombocytopenia, idiopathic thrombocytopenic purpura, thrombocythaemia.

Cardiac Disorders: Frequent - tachycardia (including ventricular, supraventricular, sinus); Infrequent -bradycardia, palpitations, cardiac failure (including congestive and acute), myocardial infarction, cardiac arrest, atrial fibrillation, atrioventricular block (including first degree and complete), extrasystoles (including ventricular and supraventricular), angina pectoris, cyanosis, bundle branch block (including left, right), myocardial ischaemia; Rare - atrial flutter, cardiomegaly, cardiomyopathy, cardiopulmonary failure.

Ear and Labyrinth Disorders: Infrequent - ear pain, vertigo, tinnitus; Rare - deafness.

Endocrine Disorders: Infrequent - hypothyroidism; Rare - goitre, hyperparathyroidism, hyperthyroidism.

Eye Disorders: Frequent - conjunctivitis; Infrequent - eye redness, eye irritation, dry eye, blepharospasm, visual disturbance, eye pain, eye discharge, blepharitis, cataract, lacrimation increased; Rare - eyelid function disorder, oculogyration, eyelid oedema, photophobia, diplopia, eyelid ptosis, eye haemorrhage.

Gastrointestinal Disorders: Frequent - loose stools; Infrequent - flatulence, dysphagia, gastroesophageal reflux disease, gastritis, haemorrhoids, abdominal distension, faecal incontinence, haematochezia, gingival pain, rectal haemorrhage, abdominal pain lower, oral pain, retching, faecaloma, gastrointestinal haemorrhage, ulcer (including gastric, duodenal, peptic), tooth fracture, gingivitis, lip dry; Rare - abdominal tenderness, chapped lips, periodontitis, aptyalism, gastrointestinal pain, hypoaesthesia oral, inguinal hernia, swollen tongue, colitis, haematemesis, hyperchlorhydria, irritable bowel syndrome, oesophagitis, faeces hard, gingival bleeding, glossodynia, mouth ulceration, reflux oesophagitis, cheilitis, intestinal obstruction, pancreatitis, eructation, gastric ulcer haemorrhage, melaena, glossitis, stomatitis.

General Disorders and Administration Site Conditions: Frequent - asthenia, pyrexia, chest pain, gait disturbance; Infrequent - malaise, oedema, influenza-like illness, chills, general physical health deterioration, feeling jittery, mobility decreased, thirst, feeling cold, difficulty in walking, facial pain, sluggishness, condition aggravated; Rare - inflammation localized, swelling, energy increased, inflammation, abasia, xerosis, feeling hot, hyperthermia, hypothermia.

Hepatobiliary Disorders: Infrequent - cholecystitis (including acute and chronic); Rare - cholelithiasis, hepatitis.

Immune System Disorders: Infrequent - hypersensitivity.

Infections and Infestations: Frequent - respiratory tract infection (including upper and lower), pneumonia; Infrequent - cellulitis, dental caries, vaginitis, vaginal infection, cystitis, vaginal mycosis, eye infection, gastroenteritis, onychomycosis, vaginal candidiasis, otitis media, folliculitis, candidiasis, otitis externa, pyelonephritis, rash pustular; Rare - appendicitis, septic shock.

Injury, Poisoning, and Procedural Complications: Frequent - fall, skin laceration, contusion, fracture; Infrequent - blister, scratch, joint sprain, burn, muscle strain, periorbital haematoma, arthropod bite/sting, head injury, sunburn; Rare - joint dislocation, alcohol poisoning, road traffic accident, self mutilation, eye penetration, injury asphyxiation, poisoning, heat exhaustion, heat stroke.

Investigations: Frequent - weight decreased, blood creatine phosphokinase increased; Infrequent - blood glucose increased, heart rate increased, body temperature increased, alanine aminotransferase increased, blood cholesterol increased, white blood cell count increased, haemoglobin decreased, aspartame aminotransferase increased, blood urea increased, electrocardiogram ST segment abnormal (including depression, elevation), haematocrit decreased, hepatic enzyme increased, blood bilirubin increased, blood glucose decreased, blood creatinine increased, blood alkaline phosphatase increased, blood pressure decreased, blood potassium decreased, blood urine present, electrocardiogram QT corrected interval prolonged; Rare - transaminases increased, blood triglycerides increased, blood uric acid increased, cardiac murmur, eosinophil count increased, neutrophil count increased, platelet count increased, red blood cell count decreased, white blood cell count decreased, white blood cells urine positive, bacteria urine identified, blood lactate dehydrogenase increased, blood potassium increased, neutrophil count decreased, urine output decreased, blood creatine phosphokinase MB increased, ECG signs of myocardial ischemia, electrocardiogram T-wave inversion, heart rate decreased, tuberculin test positive, glucose urine present, glycosylated haemoglobin increased, glucose tolerance decreased, glycosylated haemoglobin decreased, muscle enzyme increased.

Metabolism and Nutrition Disorders: Frequent - decreased appetite (including diet refusal, markedly reduced dietary intake), dehydration; Infrequent - anorexia, increased appetite, hypercholesterolaemia, hypokalaemia, hyperglycaemia, diabetes mellitus, hypoglycaemia, hyponatremia, diabetes mellitus non-insulin-dependent, hyperlipidaemia, obesity (including overweight), polydipsia; Rare - hypertriglyceridaemia, gout, hypernatraemia, weight fluctuation, diabetes mellitus inadequate control.

Musculoskeletal and Connective Tissue Disorders: Frequent - musculoskeletal pain (including neck, jaw, chest wall, bone, buttock, groin, flank, musculoskeletal chest, pubic, and sacral), muscle rigidity, muscle cramp; Infrequent - muscle twitching, joint swelling, muscle spasms, muscle tightness, arthritis, osteoarthritis, muscular weakness, joint range of motion decreased, sensation of heaviness; Rare - tendonitis, osteoporosis, trismus, arthropathy, bursitis, exostosis, night cramps, coccydynia, joint contracture, localised osteoarthritis, osteopenia, rhabdomyolysis, costochondritis, rheumatoid arthritis, torticollis.

Nervous System Disorders: Frequent - lethargy, dyskinesia; Infrequent - disturbance in attention, parkinsonism, dystonia, drooling, cogwheel rigidity, dysarthria, paraesthesia, hypoaesthesia, loss of consciousness (including depressed level of consciousness), hypersomnia, psychomotor hyperactivity, balance disorder, cerebrovascular accident, hypokinesia, tardive dyskinesia, memory impairment, amnesia, ataxia, dementia, hypotonia, burning sensation, dysgeusia, restless leg syndrome, hypertonia, Parkinson’s disease, akinesia, dysphasia, transient ischaemic attack, facial palsy, hemiparesis, myoclonus, sciatica; Rare - bradykinesia, coordination abnormal, cognitive disorder, syncope vasovagal, carpal tunnel syndrome, hyporeflexia, intention tremor, muscle contractions involuntary, sleep apnea syndrome, dementia Alzheimer’s type, epilepsy, hyperreflexia, mastication disorder, mental impairment, nerve compression, parkinsonian gait, tongue paralysis, aphasia, choreoathetosis, formication, masked facies, neuralgia, paresthesia oral, parkinsonian rest tremor, cerebral haemorrhage, dizziness exertional, hyperaesthesia, haemorrhage intracranial, ischaemic stroke, judgment impaired, subarachnoid haemorrhage.

Psychiatric Disorders: Frequent - schizophrenia (including schizoaffective disorder), depression (including depressive symptom), hallucination (including auditory, visual, tactile, mixed, olfactory, and somatic), mood altered (including depressed, euphoric, elevated, and mood swings), paranoia, irritability, suicidal ideation, confusional state, aggression, mania, delusion (including persecutory, perception, somatic, and grandeur); Infrequent - tension, nervousness, nightmare, excitability, panic attack (including panic disorder, panic disorder with agoraphobia, and panic reaction), abnormal dreams, apathy, libido decreased, hostility, suicide attempt, bipolar disorder (including bipolar I), libido increased, anger, delirium, acute psychosis, disorientation, bruxism, hypomania, obsessive-compulsive disorder (including obsessive thoughts), mental status changes, crying, dysphoria, completed suicide, flat affect, impulsive behaviour; Rare - blunted affect, cognitive deterioration, logorrhea, psychomotor agitation, social avoidant behaviour, psychomotor retardation, suspiciousness, affect lability, anorgasmia, fear, homicidal ideation, tic, premature ejaculation, dysphemia, bradyphrenia, derealisation, depersonalisation.

Renal and Urinary Disorders: Infrequent - pollakiuria, dysuria, haematuria, urinary retention, renal failure (including acute and chronic), urinary hesitation, enuresis, nephrolithiasis, micturition urgency, polyuria; Rare - nocturia, proteinuria, glycosuria, calculus urinary, azotaemia.

Reproductive System and Breast Disorders: Infrequent - erectile dysfunction, vaginal discharge, amenorrhoea, vaginal haemorrhage, menstruation irregular, menorrhagia, premenstrual syndrome, testicular pain, genital pruritus female, ovarian cyst, benign prostatic hyperplasia, prostatitis; Rare - gynaecomastia, priapism (including spontaneous penile erection), breast pain, pelvic pain, epididymitis, galactorrhoea, uterine haemorrhage.

Respiratory, Thoracic, and Mediastinal Disorders: Frequent - dyspnoea (including exertional); Infrequent - sinus congestion, rhinorrhoea, wheezing, epistaxis, asthma, hiccups, productive cough, chronic obstructive airways disease (including exacerbated), rhinitis allergic, pneumonia aspiration, pulmonary congestion, sinus pain, respiratory distress, dry throat, hoarseness; Rare - bronchopneumopathy, haemoptysis, respiratory arrest, sneezing, hypoxia, pulmonary embolism, pulmonary oedema (including acute), respiratory failure, brochospasm, nasal dryness, paranasal sinus hypersecretion, pharyngeal erythema, rhonchi, tonsillar hypertrophy, asphyxia, Mendelson’s syndrome.

Skin and Subcutaneous Tissue Disorders: Infrequent - hyperhydrosis, erythema, pruritis (including generalised), dry skin, decubitus ulcer, dermatitis (including allergic, seborrhoeic, acneiform, exfoliative, bullous, neurodermatitis), ecchymosis, skin ulcer, acne, eczema, hyperkeratosis, swelling face, skin discoloration, photosensitivity reaction, skin irritation, alopecia, rash maculopapular, cold sweat, scab, face oedema, dermal cyst, psoriasis, night sweats, rash erythematous; Rare - rash scaly, urticaria, rosacea, seborrhoea, periorbital oedema, rash vesicular.

Vascular Disorders: Frequent - hypotension; Infrequent - hot flush (including flushing), haematoma, deep vein thrombosis, phlebitis; Rare - pallor, petechiae, varicose vein, circulatory collapse, haemorrhage, thrombophlebitis, shock.

Other Adverse Events Observed During the Premarketing Evaluation of Aripiprazole Injection

Following is a list of MedDRA terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with aripiprazole injection at doses ≥1 mg/day during any phase of a trial within the database of 749 patients. All reported events are included except those already listed in Table 2 or 3, or other parts of the ADVERSE REACTIONS section, those considered in the WARNINGS or PRECAUTIONS, those event terms which were so general as to be uninformative, events reported with an incidence of ≤0.05% and which did not have a substantial probability of being acutely life-threatening, events that are otherwise common as background events, and events considered unlikely to be drug related. It is important to emphasize that, although the events reported occurred during treatment with aripiprazole injection, they were not necessarily caused by it.

Events are further categorized by MedDRA system organ class and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Ear and Labyrinth Disorders: Infrequent - hyperacusis.

General Disorders and Administration Site Conditions: Infrequent - injection site stinging, abnormal feeling, injection site pruritus, injection site swelling, venipuncture site bruise.

Infections and Infestations: Infrequent - bacteruria, urinary tract infection, urosepsis.

Investigations: Infrequent - blood pressure abnormal, heart rate irregular, electrocardiogram T-wave abnormal.

Psychiatric Disorders: Infrequent - intentional self-injury.

Respiratory, Thoracic, and Mediastinal Disorders: Infrequent - pharyngolaryngeal pain, nasal congestion.

Vascular Disorders: Infrequent - blood pressure fluctuation.

Other Events Observed During the Postmarketing Evaluation of Aripiprazole

Voluntary reports of adverse events in patients taking aripiprazole that have been received since market introduction and not listed above that may have no causal relationship with the drug include rare occurrences of allergic reaction (eg, anaphylactic reaction, angioedema, laryngospasm, oropharyngeal spasm, pruritis, or urticaria), grand mal seizure, and jaundice.



REPORTS OF SUSPECTED ABILIFY SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Abilify. The information is not vetted and should not be considered as verified clinical evidence.

Possible Abilify side effects / adverse reactions in 18 year old female

Reported by a physician from France on 2011-10-02

Patient: 18 year old female

Reactions: Psychotic Disorder

Suspect drug(s):
Abilify



Possible Abilify side effects / adverse reactions in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-02

Patient: 45 year old male weighing 86.0 kg (189.2 pounds)

Reactions: Pneumonia, Ileus, Respiratory Failure, Neuroleptic Malignant Syndrome

Adverse event resulted in: death

Suspect drug(s):
Cremin
    Dosage: granules
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 1996-10-01
    End date: 2011-07-19

Promethazine HCL
    Administration route: Oral
    Indication: Parkinsonism
    Start date: 1996-10-01
    End date: 2011-07-19

Fludecasin
    Indication: Schizophrenia
    Start date: 2004-05-25
    End date: 2011-06-20

Symmetrel
    Dosage: granules
    Administration route: Oral
    Indication: Parkinsonism
    Start date: 1996-10-01
    End date: 2011-07-19

Abilify
    Dosage: 3mg:05jul-07jul11, 6mg:08jul-11jul11, 9mg:12jul-19jul11.
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-07-05
    End date: 2011-07-19

Akineton
    Administration route: Oral
    Indication: Parkinsonism
    Start date: 1996-10-01
    End date: 2011-07-19

Pentona
    Administration route: Oral
    Indication: Parkinsonism
    Start date: 1996-10-01
    End date: 2011-07-19

Other drugs received by patient: Diazepam



Possible Abilify side effects / adverse reactions in 2 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 2 year old male

Reactions: Heart Rate Increased, Accidental Drug Intake by Child, Accidental Exposure

Adverse event resulted in: hospitalization

Suspect drug(s):
Abilify



See index of all Abilify side effect reports >>

Drug label data at the top of this Page last updated: 2007-02-14

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