Note: This document contains side effect information about aripiprazole. Some of the dosage forms listed on this page may not apply to the brand name Abilify.

In Summary

More frequent side effects include: dizziness, drowsiness, lethargy, sedated state, urinary incontinence, and salivation. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to aripiprazole: oral solution, oral tablet, oral tablet disintegrating

Other dosage forms:

• intramuscular powder for suspension extended release
• intramuscular suspension extended release

Along with its needed effects, aripiprazole (the active ingredient contained in Abilify) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aripiprazole:

More common

• Difficulty with speaking
• drooling
• loss of balance control
• muscle trembling, jerking, or stiffness
• restlessness
• shuffling walk
• stiffness of the limbs
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

Less common

• Blurred vision
• dizziness
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sticking out the tongue
• trouble with breathing or swallowing
• unusual facial expressions

Rare

• High fever
• high or low blood pressure
• increased sweating
• lip smacking or puckering
• loss of bladder control
• muscle spasm or jerking of all extremities
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• seizures
• severe muscle stiffness
• sudden loss of consciousness
• tiredness
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• unusually pale skin

Incidence not known

• Hives or welts, itching, or skin rash
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking aripiprazole:

Symptoms of overdose

• Bigger, dilated, or enlarged pupils (black part of the eye)
• diarrhea
• fast, pounding, or irregular heartbeat or pulse
• increased sensitivity of the eyes to light
• lack or loss of strength
• nausea
• sleepiness or unusual drowsiness
• vomiting

Some side effects of aripiprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Anxiety
• belching
• blurred vision
• difficulty having a bowel movement
• dry mouth
• fear
• fever
• heartburn
• hyperventilation
• inability to sit still
• indigestion
• irritability
• lightheadedness
• need to keep moving
• nervousness
• rash
• runny nose
• shaking
• sore throat
• stomach discomfort, upset, or pain
• trouble sleeping
• weight gain

Less common

• Accidental injury
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• congestion
• coughing
• difficulty with moving
• dryness or soreness of the throat
• hoarseness
• increased appetite
• increased salivation
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• rapid weight gain
• sneezing
• stuffy nose
• swollen joints
• tender, swollen glands in the neck
• tingling of the hands or feet
• tremor
• unusual weight gain or loss
• voice changes

For Healthcare Professionals

Applies to aripiprazole: intramuscular powder for injection extended release, intramuscular solution, intramuscular suspension extended release, oral solution, oral tablet, oral tablet disintegrating

General

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension: The most commonly reported side effects included akathisia, headache, injection site reactions, and insomnia.

Aripiprazole Extended/Prolonged-Release IM Suspension: The most commonly reported side effects included increased weight, headache, akathisia, and insomnia.

Immediate-Release IM Injection: The most commonly reported side effects included extrapyramidal symptoms, headache, nausea, and dizziness.

Oral Formulations: The most commonly reported side effects included extrapyramidal disorder, headache, and somnolence.

Psychiatric

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Common (1% to 10%): Insomnia, restlessness

Frequency not reported: Anxiety, other compulsive behaviors, suicide

Postmarketing reports: Pathological gambling

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): Insomnia (up to 10.9%)

Common (1% to 10%): Agitation, anxiety, depression, psychotic disorder, restlessness, schizophrenia

Uncommon (0.1% to 1%): Affect lability, apathy, bruxism, decreased libido, delusion, dysphoria, hallucination, hypersexuality, irritability, mood altered, panic reaction, psychotic behavior, sleep disorder, suicidal ideation

Rare (0.01% to 0.1%): Aggression, panic attack

Frequency not reported: Abnormal dreams, bulimia nervosa, completed suicide, hallucination auditory, hyposomnia, middle insomnia, neonatal drug withdrawal syndrome, nervousness, nightmare, other compulsive behaviors, poor quality sleep, suicide attempt, tension

Postmarketing reports: Eating disorder, impulse-control disorders, obsessive-compulsive disorder, pathological gambling

Immediate-Release IM Injection:

Common (1% to 10%): Anxiety, insomnia, restlessness

Uncommon (0.1% to 1%): Depression, hypersexuality

Frequency not reported: Aggression, agitation, anorgasmia, catatonia, completed suicide, delirium, homicidal ideation, libido increased, loss of libido, neonatal drug withdrawal syndrome, nervousness, pathological gambling, sleep talking, sleep walking, suicide attempt, suicidal ideation, tic

Oral Formulations:

Very common (10% or more): Agitation (up to 19%), insomnia (up to 18%), anxiety (up to 17%), restlessness (up to 12%)

Common (1% to 10%): Irritability, suicidal ideation

Uncommon (0.1% to 1%): Abnormal dreams, aggression, anger, anorgasmia, apathy, bruxism, completed suicide, confusional state, delirium, depression, hallucination, hallucination auditory, homicidal ideation, hostility, hypersexuality, intentional self-injury, libido increased, loss of libido, mania, nervousness, nightmare, self-mutilation, suicide attempt, thinking abnormal, tic

Rare (0.01% to 0.1%): Asthenia, blunted affect, bradyphrenia, catatonia, cognitive deterioration, delirium, delusional perception, depressed mood, disorientation, eating disorder, emotional distress, euphoric mood, impulsive behavior, logorrhea, mental status changes, mood altered, mood swings, panic attack, psychomotor retardation, sleep disorder, sleep walking, somatoform disorder

Frequency not reported: Drug withdrawal syndrome neonatal, sleep talking

Postmarketing reports: Impulse-control disorders, obsessive-compulsive disorders, pathological gambling

Nervous system

Elderly patients (mean = 84 years old) enrolled in placebo-controlled studies examining the use of aripiprazole (the active ingredient contained in Abilify) for the treatment of dementia-related psychosis showed an increased incidence of cerebrovascular side effects, e.g. stroke and transient ischemia attacks, including fatalities. The incidence of these effects may be dose related.

In a dose response analysis, somnolence including sedation was the only adverse reaction determined to have a dose response relationship in adult patients. Somnolence was reported in 12.6% of adult patients with schizophrenia receiving the 30 mg dose.

In pediatric patients 13 to 17 years of age, extrapyramidal disorder, somnolence, and tremor displayed possible dose response relationship in patients with schizophrenia, while extrapyramidal disorder, somnolence, and akathisia displayed possible dose response relationship in pediatric patients with bipolar mania.

Extrapyramidal symptoms were more prevalent with use of the extended-release IM injection compared with oral formulations (18.4% versus 11.7%). Akathisia was the most frequently observed adverse event with the extended-release IM injection; it typically starts around day 10 and lasts a median of 56 days.

Aripiprazole lauroxil Extended-Release IM Suspension:

Very common (10% or more): Akathisia (up to 11%)

Common (1% to 10%): Dystonia, extrapyramidal symptoms (EPS), headache, other EPS-related events, parkinsonism

Frequency not reported: Cerebrovascular adverse reactions, cognitive/motor impairment, dizziness, increased mortality in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, seizures, stroke, tardive dyskinesia

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): EPS (up to 18.4%), headache (up to 14.4%), akathisia (up to 11.5%)

Common (1% to 10%): Dizziness, dyskinesia, extrapyramidal disorder, parkinsonism, sedation, somnolence, tremor

Uncommon (0.1% to 1%): Bradykinesia, cogwheel rigidity, drooling, dysgeusia, dystonia, gait disturbance, hypersomnia, hypertonia, lethargy, movement disorder, parosmia, psychomotor hyperactivity, restless legs syndrome, tardive dyskinesia

Rare (0.01% to 0.1%): Convulsion, memory impairment, oromandibular dystonia

Frequency not reported: Cerebrovascular adverse reaction, cognitive/motor impairment, diabetic hyperosmolar coma, disturbance in attention, grand mal convulsion, hypoesthesia, increased mortality in elderly patients with dementia-related psychosis, migraine, neuroleptic malignant syndrome, seizures, serotonin syndrome, sinus headache, speech disorder, stroke, syncope, tension headache, vertigo

Immediate-Release IM Injection:

Very common (10% or more): EPS (up to 25.8%), headache (up to 12%)

Common (1% to 10%): Akathisia, dizziness, extrapyramidal disorder, sedation, somnolence, tremor

Uncommon (0.1% to 1%): Dystonia, tardive dyskinesia

Frequency not reported: Akinesia, bradykinesia, choreoathetosis, cogwheel rigidity, coordination abnormal, diabetic hyperosmolar coma, grand mal convulsion, hypokinesia, memory impairment, myoclonus, neuroleptic malignant syndrome, parkinsonism, serotonin syndrome, speech disorder, syncope

Oral Formulations:

Very common (10% or more): Extrapyramidal disorder (up to 27.3), headache (up to 27%), somnolence (up to 26.3%), EPS (up to 25.8%), akathisia (up to 25%), sedation (up to 21%), tremor (up to 11.8%)

Common (1% to 10%): Coordination abnormal, disturbance in attention, dizziness, drooling, dystonia, lethargy

Uncommon (0.1% to 1%): Akinesia, bradykinesia, cerebrovascular accident, cogwheel rigidity, dysarthria, gait disturbance, hypertonia, hypoesthesia, hypokinesia, hypotonia, memory impairment, myoclonus, paresthesia, parkinsonism, postural hypotension, psychomotor hyperactivity, speech disorder, tardive dyskinesia

Rare (0.01% to 0.1%): Akinesthesia, ataxia, burning sensation, choreoathetosis, coma, convulsion, depressed level of consciousness, difficulty in walking, dysgeusia, dysphagia, facial palsy, grand mal convulsion, judgement impaired, loss of consciousness, migraine, neuroleptic malignant syndrome, phase sleep rhythm disturbance, positional vertigo, serotonin syndrome, unresponsive to verbal stimuli

Frequency not reported: Diabetic hyperosmolar coma, syncope

Metabolic

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Common (1% to 10%): Increased weight

Frequency not reported: Metabolic changes

Postmarketing reports: Blood glucose fluctuation

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): Increased weight (up to 21.5%)

Common (1% to 10%): Decreased weight, decreased appetite, diabetes mellitus, waist circumference increased

Uncommon (0.1% to 1%): Appetite disorder, blood cholesterol decreased, blood glucose decreased/increased, blood triglycerides decreased, glycosylated hemoglobin increased, hypercholesterolemia, hyperglycemia, hyperinsulinemia, hyperlipidemia, hypertriglyceridemia, obesity, thirst, waist circumference increased

Frequency not reported: Anorexia, blood insulin increased, diabetic ketoacidosis, gout, hyperuricemia, hypoglycemia, hyponatremia, increased appetite, lactate dehydrogenase increased, metabolic changes, overweight, type 2 diabetes mellitus

Postmarketing reports: Blood glucose fluctuation

Immediate-Release IM Injection:

Common (1% to 10%): Diabetes mellitus

Uncommon (0.1% to 1%): Hyperglycemia

Frequency not reported: Anorexia, blood glucose fluctuated, blood glucose increased, blood insulin increased, blood lactate dehydrogenase increased, diabetic ketoacidosis, glycosylated hemoglobin increased, hypoglycemia, hypokalemia, hyponatremia, weight gain/loss

Oral Formulations:

Common (1% to 10%): Decreased appetite, increased appetite, weight decreased, weight increased

Uncommon (0.1% to 1%): Anorexia, blood glucose increased, carbohydrate tolerance decreased, blood insulin increased, blood lactate dehydrogenase increased, dehydration, diabetes mellitus, diabetes mellitus non-insulin-dependent, glucose tolerance impaired, glycosuria, glycosylated hemoglobin increased, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, hyponatremia, increased appetite, polydipsia

Rare (0.01% to 0.1%): Thirst

Frequency not reported: Diabetic ketoacidosis, hyponatremia

Postmarketing reports: Blood glucose fluctuation

Reports of diabetes mellitus included increases in blood insulin, decreases in carbohydrate tolerance, non-insulin dependent diabetes mellitus, impaired glucose tolerance, and glycosuria.

Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean increase in fasting blood glucose of 4.4 mg/dL with a median exposure of 25 days. This was not significantly different from placebo (+2.5 mg/dL, median exposure 22 days). A pooled analysis in pediatric patients revealed a mean change in fasting glucose of 2.4 mg/dL compared with 0.1 mg/dL in placebo treated patients following 12 weeks of therapy. In long-term, open label schizophrenia studies with aripiprazole lauroxil, 14% of patients with HbA1c less than 5.7% at baseline developed levels of 5.7% or higher post-baseline.

Undesirable alterations in lipids have been observed in patients receiving atypical antipsychotics. Analyses of patients receiving this drug are limited due to the small number of patients who received this drug for extended periods in the clinical trials. In long-term, open label schizophrenia studies with aripiprazole lauroxil, shifts in fasting total cholesterol, LDL, and triglycerides from normal to high were reported in 1%, 1%, and 8% of patients.

Weight gain has been observed in patients receiving atypical antipsychotics. Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean change in weight of +0.3 kg (n=1673) with a median exposure of 21 to 25 days compared with a decrease of 0.1 kg in placebo treated patients (n=1100). A pooled analysis in pediatric patients (10 to 17 years) revealed a mean change in weight of +5.8 kg (n=62) compared with +1.4 kg (n=13) in placebo treated patients following 12 weeks of therapy. In a 12-week, fixed dose schizophrenia study in patients receiving with aripiprazole lauroxil, IM weight gain of 7% or greater from baseline was observed in 10% (n=207) and 9% (n=208) of patients receiving 441 mg and 882 mg IM, respectively.

During clinical trials, the percentage of pediatric and adolescent patients by indication with weight gain of 7% or more of body weight compared to placebo was (5.2% vs 1.6%), (26.3% vs 7.1%), and (20% vs 7.6%), respectively for schizophrenia/bipolar mania, irritability associated with autistic disorder, and Tourette's disorder, respectively. Treatment durations were 4 to 6 weeks, 8 weeks, and 8 to 10 weeks, respectively.

Hypersensitivity

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Postmarketing reports: Allergic reaction, anaphylactic reaction, angioedema

Aripiprazole Extended/Prolonged-Release IM Suspension:

Uncommon (0.1% to 1%): Hypersensitivity

Rare (0.01% to 0.1%): Drug hypersensitivity

Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema

Immediate-Release IM Injection:

Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema, hypersensitivity

Oral Formulations:

Uncommon (0.1% to 1%): Angioedema

Rare (0.01% to 0.1%): Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactic reaction

Gastrointestinal

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Frequency not reported: Constipation, difficulty swallowing, dry mouth, dysphagia, tongue protrusion

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Abdominal discomfort, constipation, diarrhea, dry mouth, dyspepsia, nausea, toothache, vomiting

Uncommon (0.1% to 1%): Frequent bowel movement, gastroesophageal reflux disease, salivary hypersecretion, upper abdominal pain

Rare (0.01% to 0.1%): Swollen tongue

Frequency not reported: Abdominal pain, anal abscess, anorectal discomfort, aphthous stomatitis, appendicitis perforated, colitis, dental caries, difficulty swallowing, diverticulum, dysphagia, gastritis, gastroenteritis, gastroenteritis viral, gingival edema, gingival pain, gingivitis, hemorrhoids, inguinal hernia, loose tooth, oral candidiasis, pancreatitis, periodontitis, poor dental condition, tongue disorder, tongue edema, tongue protrusion, tooth abscess, tooth fracture, tooth impacted, tooth infection, tooth loss

Immediate-Release IM Injection:

Common (1% to 10%): Constipation, dyspepsia, nausea, salivary hypersecretion, vomiting

Uncommon (0.1% to 1%): Dry mouth

Frequency not reported: Abdominal discomfort, diarrhea, dysphagia, gastroesophageal reflux disease, pancreatitis, swollen tongue, stomach discomfort, tongue dry, tongue edema, tongue spasm

Oral Formulations:

Very common (10% or more): Nausea (up to 15%), vomiting (up to 14%), constipation (up to 11%)

Common (1% to 10%): Abdominal discomfort, abdominal pain upper, diarrhea, dry mouth, dyspepsia, salivary hypersecretion, stomach discomfort, toothache

Uncommon (0.1% to 1%): Dysphagia, esophagitis, gastritis, gastroesophageal reflux disease, hypoesthesia oral, swollen tongue

Rare (0.01% to 0.1%): Abdominal distention, abnormal feces, eructation, feces discolored, gastroenteritis, gastroenteritis viral, gastrointestinal disorder, gastrointestinal pain, glossitis, lip dry, mouth injury, oral candidiasis, pancreatitis, paresthesia circumoral, parotid gland enlargement, parotitis, pruritus ani, tongue discoloration

Frequency not reported: Tongue dry, tongue edema, tongue spasm

Dermatologic

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Postmarketing reports: Pruritus, urticaria

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Erythema, induration/skin induration, pruritus, rash

Uncommon (0.1% to 1%): Acne, alopecia, eczema, folliculitis, fungal skin infection, rosacea

Frequency not reported: Acarodermatitis, blister, cellulitis, dry skin, excoriation, face edema, furuncle, herpes zoster, hyperhidrosis, hyperkeratosis, impetigo, lice infestation, photosensitivity reaction, pilonidal cyst, psoriasis, rash macula, skin laceration, skin lesion, skin striae, subcutaneous abscess, tinea pedis, urticaria, varicella

Immediate-Release IM Injection:

Frequency not reported: Alopecia, face edema, hirsutism, hyperhidrosis, photosensitivity reaction, pruritus, rash, urticaria

Oral Formulations:

Common (1% to 10%): Acneiform rash, allergic contact rash, drug eruption rash, erythematous rash, exfoliative rash, exfoliative seborrheic dermatitis, generalized rash, hyperhidrosis, macular rash, maculopapular rash, neurodermatitis, papular rah, rash

Uncommon (0.1% to 1%): Alopecia, face edema, photosensitivity reaction, pruritus, urticaria

Rare (0.01% to 0.1%): Body tinea, decubitus ulcer, dry skin, herpes simplex, pemphigus, psoriasis

Frequency not reported: Hirsutism

Reports of rash included erythematous, exfoliative, generalized, macular, maculopapular, papular rash; acneiform, allergic, contact, exfoliative, seborrheic dermatitis, neurodermatitis, and drug eruption.

Cardiovascular

Collective data from 17 placebo-controlled clinical studies involving the use of atypical antipsychotic agents in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although aripiprazole (the active ingredient contained in Abilify) was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Aripiprazole is not indicated for use in the treatment of behavioral disorders in elderly patients with dementia.

Aripiprazole lauroxil Extended-Release IM Suspension:

Frequency not reported: Angina pectoris, orthostatic hypotension, palpitations, tachycardia

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Hemorrhage, hypertension

Uncommon (0.1% to 1%): Abnormal electrocardiogram, bradycardia, chest discomfort, decreased blood pressure, electrocardiogram QT prolonged, electrocardiogram T-wave abnormal/amplitude decreased/inversion, increased blood pressure, orthostatic hypotension, peripheral edema, tachycardia, ventricular extrasystole

Rare (0.01% to 0.1%): Sinus tachycardia

Frequency not reported: Acute myocardial infarction, cardiac arrest, chest pain, congestive cardiac failure, contusion, decreased heart rate, deep vein thrombosis, first-degree atrioventricular block, orthostatic hypertension, Torsade de pointes, venous thromboembolism, ventricular arrhythmias

Immediate-Release IM Injection:

Common (1% to 10%): Tachycardia

Uncommon (0.1% to 1%): Increased diastolic blood pressure, orthostatic hypotension

Frequency not reported: Angina pectoris, atrial fibrillation, atrial flutter, atrioventricular block, bradycardia, cardiac arrest, cardiopulmonary failure, cardiorespiratory arrest, chest pain, deep vein thrombosis, electrocardiogram QT prolonged, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, peripheral edema, QT prolongation, Torsade de pointes, venous thromboembolism, ventricular arrhythmia

Oral Formulations:

Common (1% to 10%): Chest pain, hypertension, peripheral edema

Uncommon (0.1% to 1%): Angina pectoris, atrial fibrillation, atrioventricular block, bradycardia, cardiopulmonary failure, cardiorespiratory arrest, chest discomfort, edema, electrocardiogram QT prolonged, extrasystole, generalized edema, heart rate increased, hot flush, hypotension, myocardial infarction, myocardial ischemia, orthostatic hypotension, sinus tachycardia, tachycardia

Rare (0.01% to 0.1%): Atrial flutter, electrocardiogram abnormal, electrocardiogram PR prolongation, electrocardiogram T wave inversion, flushing, heart rate irregular, hyperemia, supraventricular tachycardia, ventricular tachycardia

Frequency not reported: Cardiac arrest, deep vein thrombosis, hypotension, palpitations, Torsade de pointes, venous thromboembolism, ventricular arrhythmias

Hematologic

Neutropenia has been reported with the extended/prolonged-release IM injection; it typically starts around day 16 and lasts a median of 18 days.

Aripiprazole lauroxil Extended-Release IM Suspension:

Frequency not reported: Agranulocytosis, leukopenia, neutropenia

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Neutropenia

Uncommon (0.1% to 1%): Anemia, neutrophil count decreased, thrombocytopenia, white blood cell count decreased

Frequency not reported: Agranulocytosis, bicytopenia, leukopenia, lymphadenopathy

Immediate-Release IM Injection:

Frequency not reported: Leukopenia, neutropenia, thrombocytopenia

Oral Formulations:

Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocytopenia

Rare (0.01% to 0.1%): Eosinophil count increased, eosinophilia, lymphadenopathy, white blood cell count increased

Endocrine

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Prolactin levels greater than 1 times the upper limit of normal

Uncommon (0.1% to 1%): Blood prolactin decreased, gynecomastia, hyperprolactinemia

Rare (0.01% to 0.1%): Hypoprolactinemia

Immediate-Release IM Injection:

Uncommon (0.1% to 1%): Hyperprolactinemia

Frequency not reported: Blood prolactin increased, gynecomastia

Oral Formulations:

Very common (10% or more): Serum prolactin levels less than 2 ng/mL (up to 53.3%), serum prolactin levels less than 3 ng/mL (up to 29.5%)

Uncommon (0.1% to 1%): Blood prolactin increased, hyperprolactinemia

Rare (0.01% to 0.1%): Early menarche, gynecomastia

Musculoskeletal

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Common (1% to 10%): Increased blood creatine phosphokinase

Frequency not reported: Abnormal/prolonged muscle contractions, muscular weakness, neck muscle spasms

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Arthralgia, back pain, increased blood creatine phosphokinase, musculoskeletal pain, musculoskeletal stiffness, myalgia, pain in extremity

Uncommon (0.1% to 1%): Joint range of motion decreased, joint stiffness, muscle rigidity, muscle spasms, muscle tightness, muscle twitching, nuchal rigidity, trismus

Rare (0.01% to 0.1%): Rhabdomyolysis, thrombocytopenia

Frequency not reported: Abnormal/prolonged muscle contractions, ankle fracture, arthritis, foot fracture, joint dislocation, joint sprain, joint swelling, muscle injury, muscle strain, neck muscle spasms, radius fracture, rotator cuff syndrome, skeletal injury, stiffness

Immediate-Release IM Injection:

Frequency not reported: Increased creatine phosphokinase, mobility decreased, muscle tightness, muscular weakness, myalgia, rhabdomyolysis, stiffness

Oral Formulations:

Common (1% to 10%): Arthralgia, blood creatinine phosphokinase increased/creatine phosphokinase increase, muscle rigidity, muscle spasms, musculoskeletal stiffness, myalgia, pain in extremity

Uncommon (0.1% to 1%): mobility decreased, muscle tightness, musculoskeletal rigidity

Rare (0.01% to 0.1%): Bone pain, clavicle fracture, femoral neck fracture, flank pain, hip fracture, humerus fracture, jaw disorder, kyphosis, muscle strain, nuchal rigidity, osteoarthritis, rhabdomyolysis

Frequency not reported: Muscular weakness, stiffness

Other

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Frequency not reported: Asthenia, body temperature regulation, falls

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Fatigue, inflammation, swelling

Frequency not reported: Accident, body temperature regulation, carbon monoxide poisoning, deafness, drug toxicity, ear infection, face injury, falls, fungal infection, gunshot wound, herpes virus infection, hypothermia, injury, multiple injuries, pain, procedural pain, sudden unexplained death, temperature regulation disorder, thermal burn, wound

Immediate-Release IM Injection:

Common (1% to 10%): Fatigue

Frequency not reported: Asthenia, fall, heat stroke, hypothermia, pyrexia, sudden unexplained death, temperature regulation disorder

Oral Formulations:

Very common (10% or more): Fatigue (up to 18.5%)

Common (1% to 10%): Asthenia, fall, feeling jittery, pain, pyrexia

Uncommon (0.1% to 1%): Adverse event, chills, discomfort, feeling abnormal

Rare (0.01% to 0.1%): Ear canal erythema, energy increased, facial pain, feeling cold, head lag abnormal, heat stroke, hypoacusis, hypothermia, injury, malaise, open wound, physical examination, sensation of heaviness, smoker, swelling, tenderness, tinnitus, xerosis

Frequency not reported: Sudden unexplained death, temperature regulation disorder

In a dose response analysis, fatigue was determined to have a dose response relationship in pediatric patients with incidences of fatigue reported at 3.8%, 22%, and 18.5% in those receiving 5 mg, 10 mg, and 15 mg respectively.

Respiratory

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Frequency not reported: Difficulty breathing, throat tightness

Postmarketing reports: Hiccups, laryngospasm, oropharyngeal spasm

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Bronchitis, cough, nasal congestion, nasopharyngitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Hiccups, pharyngitis

Frequency not reported: Acute respiratory distress syndrome, allergic rhinitis, aspiration pneumonia, difficulty breathing, dysphonia, dyspnea, epistaxis, laryngospasm, nasal septum deviation, oropharyngeal spasm, paranasal sinus hypersecretion, pulmonary embolism, respiratory tract congestion, rhinalgia, sinus congestion, throat tightness, wheezing

Immediate-Release IM Injection:

Uncommon (0.1% to 1%): Hiccups

Frequency not reported: Aspiration pneumonia, dyspnea, laryngospasm, nasal congestion, oropharyngeal spasm, pulmonary embolism

Oral Formulations:

Common (1% to 10%): Cough, dyspnea, epistaxis, nasal congestion, nasopharyngitis, pharyngolaryngeal pain, pneumonia aspiration, upper respiratory tract infection

Uncommon (0.1% to 1%): Hiccups

Rare (0.01% to 0.1%): Dry throat, hoarseness, lower respiratory tract infection, nasal dryness, painful respiration, paranasal sinus hypersecretion, rhinorrhea, sinus congestion, sinusitis

Frequency not reported: Laryngospasm, oropharyngeal spasm pulmonary embolism

Ocular

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:

Uncommon (0.1% to 1%): Blurred vision, diplopia, eye pain, oculogyric crisis

Frequency not reported: Allergic conjunctivitis, eye irritation, eyelid ptosis, hordeolum

Immediate-Release IM Injection:

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Diplopia

Frequency not reported: Oculogyric crisis, photophobia

Oral Formulations:

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Diplopia, dry eye, eyelid edema, photophobia, photopsia

Rare (0.01% to 0.1%): Chromotopsia, conjunctivitis, eye disorder, eye movement disorder, eye redness, gaze palsy, lacrimation increased

Frequency not reported: Oculogyric crisis

Genitourinary

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Erectile dysfunction

Uncommon (0.1% to 1%): Breast tenderness, ejaculation delayed, galactorrhea, vulvovaginal dryness

Rare (0.01% to 0.1%): Glycosuria, pollakiuria, urinary incontinence

Frequency not reported: Adnexa uteri pain, breast mass, Escherichia urinary tract infection (UTI), mastitis, micturition urgency, ovarian cyst, priapism, protein urine, suprapubic pain, urinary retention, UTIs, vaginal infections, vulvovaginal mycotic infection, white blood cells urine

Immediate-Release IM Injection:

Frequency not reported: Amenorrhea, breast pain, enuresis, erectile dysfunction, priapism, menstruation irregular, nocturia, urinary incontinence, urinary retention

Oral Formulations:

Uncommon (0.1% to 1%): Amenorrhea, breast pain, erectile dysfunction, glucose urine/glucose urine present, incontinence/urinary incontinence, menstruation irregular, nocturia, pollakiuria, polyuria, urinary retention

Rare (0.01% to 0.1%): Bladder discomfort, blood urine present, breast discharge, chromaturia, enuresis, genital pruritus female, micturition urgency, pelvic pain, priapism, proteinuria, sexual dysfunction, urethral discharge, urinary hesitation, urinary tract infection, urine ketone body present, urine output increased, vulvovaginal discomfort

Hepatic

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:

Uncommon (0.1% to 1%): Abnormal liver function test, ALT increased, AST increased, blood bilirubin increased, gamma-glutamyl transferase increased, increased hepatic enzymes

Rare (0.01% to 0.1%): Drug induced liver injury

Frequency not reported: Alkaline phosphatase increased, cholecystitis chronic, cholelithiasis, hepatic cirrhosis, hepatic failure, hepatic steatosis, hepatitis, hepatosplenomegaly, jaundice

Immediate-Release IM Injection:

Frequency not reported: Blood bilirubin increased, hepatic enzyme increased, hepatic failure, hepatitis, increased alkaline phosphatase, increased ALT, increased AST, increased gamma glutamyl transferase, jaundice

Oral Formulations:

Uncommon (0.1% to 1%): Blood bilirubin increased, hepatic enzyme increased

Rare (0.01% to 0.1%): Gamma glutamyl transferase increased, hepatitis, jaundice

Frequency not reported: Hepatic failure, increased alkaline phosphatase, increased ALT, increased AST

Local

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:

Common (1% to 10%): Injection site pain

Frequency not reported: Induration, redness, swelling

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Injection site induration, injection site pain, injection site reactions

Uncommon (0.1% to 1%): Injection site discomfort, injection site erythema, injection site pruritus, injection site swelling

Frequency not reported: Infusion site hematoma, infusion site swelling, localized infection, vessel puncture site hematoma, vessel puncture site pain

Immediate-Release IM Injection:

Frequency not reported: Injection site reaction, venipuncture site bruise

Oral Formulations:

Rare (0.01% to 0.1%): Local swelling, localized infection

Injection site reactions reported with the aripiprazole extended-release IM suspension included pain, erythema, induration, pruritus, swelling, rash, inflammation, and hemorrhage. The mean intensity of injection pain reported with the first injection was 7.1 (visual analog scale 0=no pain to 100=unbearably painful) and 4.8 with the second injection. Injection site reactions with aripiprazole lauroxil extended-release IM suspension were mostly associated with the first injection and decreased with each subsequent injection.

Renal

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:

Uncommon (0.1% to 1%): Glycosuria, nephrolithiasis

Frequency not reported: Cystitis, glucose urine present

Immediate-Release IM Injection:

Frequency not reported: Blood creatinine increased, blood urea increased

Oral Formulations:

Uncommon (0.1% to 1%): Blood creatinine increased, blood urea increased

Rare (0.01% to 0.1%): Oliguria

Oncologic

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:

Frequency not reported: Basal cell carcinoma, breast fibroma, pancreatic carcinoma

Oral Formulations:

Rare (0.01% to 0.1%): Cyst, oral neoplasm, skin papilloma

Immunologic

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Influenza

Frequency not reported: Influenza-like illness, viral infection

Oral Formulations:

Rare (0.01% to 0.1%): Decreased immune responsiveness