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

Applies to aripiprazole: oral solution, oral tablet, oral tablet disintegrating. Other dosage forms:

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

Serious side effects of Aristada Initio

Along with its needed effects, aripiprazole (the active ingredient contained in Aristada Initio) 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

Other side effects of Aristada Initio

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 with sensor, oral tablet disintegrating.

General

Aripiprazole (the active ingredient contained in Aristada Initio) 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.^[Ref]

Psychiatric

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

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

Frequency not reported: Aggression, anorgasmia, anxiety, catatonia, delirium, homicidal ideation, libido increased, loss of libido, other compulsive behaviors, suicide, tic

Postmarketing reports: Pathological gambling

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): Insomnia (up to 13.7%), psychomotor hyperactivity (up to 12.8%)

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

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

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

Frequency not reported: Abnormal dreams, anger, anorgasmia, binge eating, catatonia, completed suicide, compulsive eating, compulsive shopping, delirium, disturbance in attention, dysphemia, dysphonia, hallucination auditory, homicidal ideation, hostility, hypomania, hyposomnia, impulse-control disorders, increased libido, intentional self-injury, initial insomnia, loss of libido, middle insomnia, neonatal drug withdrawal syndrome, nightmare, other compulsive behaviors, pathological gambling, poor quality sleep, psychomotor retardation, social avoidant behavior, suicide attempt, tension

Postmarketing reports: Eating disorder, obsessive-compulsive disorder

Immediate-Release IM Injection:

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

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

Frequency not reported: Aggression, agitation, anorgasmia, binge eating, catatonia, compulsive eating, completed suicide, compulsive shopping, delirium, homicidal ideation, impulse control disorders, loss of libido, neonatal drug withdrawal syndrome, other compulsive behaviors, pathological gambling, poriomania, sleep talking, sleep walking, suicidal ideation, suicidal thoughts and behaviors, suicide, suicide attempt

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, psychotic disorder, schizophrenia, 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, sleep talking, suicide attempt, thinking abnormal

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: Binge eating, compulsive shopping, drug withdrawal syndrome neonatal, impulse-control disorders, other compulsive behaviors, pathological gambling, poriomania, suicidal thoughts and behaviors, suicide^[Ref]

Nervous system

Aripiprazole (the active ingredient contained in Aristada Initio) 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: Abnormal coordination, akinesia, bradykinesia, cerebrovascular adverse reactions, choreoathetosis, cognitive/motor impairment, dizziness, hypokinesia, increased mortality in elderly patients with dementia-related psychosis, memory impairment, mobility decreased, myoclonus, neuroleptic malignant syndrome, seizures, sleep walking, speech disorder, stroke, tardive dyskinesia

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): Akathisia (up to 21.2%), EPS (up to 18.4%), headache (up to 14.4%)

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

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

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

Frequency not reported: Akinesia, cerebrovascular adverse reaction, choreoathetosis, cognitive/motor impairment, coordination abnormal, diabetic hyperosmolar coma, grand mal convulsion, hypoesthesia, hypokinesia, hypotonia, increased mortality in elderly patients with dementia-related psychosis, migraine, myoclonus, neuroleptic malignant syndrome, paresthesia, post-traumatic neck syndrome, seizures, serotonin syndrome, sinus headache, sleep walking/somnambulism, speech disorder, stroke, syncope, tension headache, tic, transient ischemic attack, vertigo

Immediate-Release IM Injection:

Very common (10% or more): EPS (up to 25.8%), somnolence (up to 12.6%), akathisia (up to 12.1%), headache (up to 12%)

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

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

Frequency not reported: Acute dystonia, akinesia, bradykinesia, brain injury, cerebrovascular adverse events, choreoathetosis, cognitive/motor impairment, cogwheel rigidity, coordination abnormal, diabetic hyperosmolar coma, dyskinesia, grand mal convulsion, hypokinesia, increased mortality in elderly patients with dementia-related psychosis, memory impairment, myoclonus, neuroleptic malignant syndrome, oculogyric crisis, parkinsonism, serotonin syndrome, sleep talking, speech disorder, stroke, syncope, tic

Oral Formulations:

Very common (10% or more): Dystonia (up to 57%), extrapyramidal disorder (up to 28.8%), 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, dyskinesia, lethargy, parkinsonism

Uncommon (0.1% to 1%): Akinesia, bradykinesia, cerebrovascular accident, cogwheel rigidity, dysarthria, gait disturbance, hypertonia, hypoesthesia, hypokinesia, hypotonia, memory impairment, mobility decreased, myoclonus, oculogyric crisis, paresthesia, postural dizziness, postural hypotension, psychomotor hyperactivity, sleep talking, speech disorder, tardive dyskinesia, tic

Rare (0.01% to 0.1%): Akinesthesia, ataxia, burning sensation, cerebrovascular adverse events, choreoathetosis, cognitive/motor impairment, coma, convulsion, depressed level of consciousness, difficulty in walking, dysgeusia, dysphagia, facial palsy, gaze palsy, grand mal convulsion, increased mortality in elderly patients with dementia-related psychosis, judgement impaired, loss of consciousness, migraine, neuroleptic malignant syndrome, paresthesia circumoral, positional vertigo, seizures, serotonin syndrome, sleep phase rhythm disturbance, stroke, unresponsive to verbal stimuli

Frequency not reported: Acute dystonia, spasmodic deviations of the eyes/upward spasmodic deviations of the eyes, syncope^[Ref]

Elderly patients (mean = 84 years old) enrolled in placebo-controlled studies examining the use of aripiprazole 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%). Extrapyramidal disorder occurred most frequently with 30 mg oral doses, while the disorder occurred in 9.1% of patients given 10 mg oral doses.

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.^[Ref]

Metabolic

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 (the active ingredient contained in Aristada Initio) 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.^[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:

Common (1% to 10%): Increased weight

Frequency not reported: Anorexia, blood glucose increased, blood lactate dehydrogenase increased, glycosylated hemoglobin increased, hypoglycemia, hypokalemia, hyponatremia, metabolic changes, weight decreased

Postmarketing reports: Blood glucose fluctuation

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): Increased weight (up to 23.5%), weight loss of at least 7% (up to 10.2%)

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

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 glucose fluctuation, blood insulin increased, bulimia nervosa, diabetic ketoacidosis, gout, hyperuricemia, hypoglycemia, hyponatremia, increased appetite, lactate dehydrogenase increased, overweight, triglycerides increased, type 2 diabetes mellitus

Immediate-Release IM Injection:

Common (1% to 10%): Diabetes mellitus

Uncommon (0.1% to 1%): Hyperglycemia

Frequency not reported: Anorexia, blood glucose fluctuation, blood glucose increased, blood insulin increased, blood lactate dehydrogenase increased, diabetic ketoacidosis, glycosylated hemoglobin increased, hypoglycemia, hypokalemia, hyponatremia, increased appetite, metabolic changes, polydipsia, weight gain/loss

Oral Formulations:

Very common (10% or more): Increased weight (up to 20%)

Common (1% to 10%): Anorexia, blood insulin increased, decreased appetite, diabetes mellitus, increased appetite, weight decreased, weight loss of at least 7%

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

Rare (0.01% to 0.1%): Diabetic ketoacidosis, hyperuricemia, thirst

Frequency not reported: Blood glucose fluctuation, diabetic hyperosmolar coma, metabolic changes^[Ref]

Hypersensitivity

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

Frequency not reported: Hypersensitivity

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:

Rare (0.01% to 0.1%): Hypersensitivity

Postmarketing reports: Allergic reaction, anaphylactic reaction, angioedema^[Ref]

Gastrointestinal

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

Frequency not reported: Constipation, difficulty swallowing, dry mouth, dysphagia, gastroesophageal reflux disease (GERD/GORD), tongue protrusion

Postmarketing reports: Hiccups

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): Constipation (up to 10%)

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

Uncommon (0.1% to 1%): Frequent bowel movement, GERD/GORD, upper abdominal pain

Rare (0.01% to 0.1%): Swollen tongue

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

Immediate-Release IM Injection:

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

Frequency not reported: Abdominal discomfort, diarrhea, difficulty swallowing, dysphagia, GERD/GORD, pancreatitis, swollen tongue, stomach discomfort, tongue dry, tongue edema, tongue protrusion, 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, upper abdominal pain

Uncommon (0.1% to 1%): Dysphagia, esophagitis, gastritis, GERD/GORD, hiccups, hypoesthesia oral, swollen tongue, tongue dry, tongue spasm

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, parotid gland enlargement, parotitis, pruritus ani, tongue discoloration

Frequency not reported: Difficulty swallowing, dysphagia, tongue edema, tongue protrusion^[Ref]

Dermatologic

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

Aripiprazole lauroxil Extended-Release IM Suspension:

Frequency not reported: Alopecia, hyperhidrosis, face edema, photosensitivity reaction, 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, rosacea

Frequency not reported: Acarodermatitis, acneiform dermatitis, allergic dermatitis, blister, breast cellulitis, cellulitis, contact dermatitis, dermatitis, drug eruption, dry skin, excoriation, exfoliative dermatitis, face edema, folliculitis, fungal skin infection, furuncle, hyperhidrosis, hyperkeratosis, impetigo, laceration, lice infestation, neurodermatitis, papular rash, photosensitivity reaction, pilonidal cyst, pityriasis, psoriasis, rash erythematous, rash exfoliative, rash generalized, rash macular, rash maculopapular, seborrheic dermatitis, skin laceration, skin lesion, skin striae, subcutaneous abscess, tinea pedis, urticaria

Immediate-Release IM Injection:

Frequency not reported: Alopecia, face edema, 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 rash, 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, pemphigus, psoriasis^[Ref]

Cardiovascular

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

Frequency not reported: Angina pectoris, atrial fibrillation, atrial flutter, atrioventricular block, bradycardia, cardiopulmonary failure, cardiorespiratory arrest, chest pain, electrocardiogram QT prolonged, heat stroke, hypertension, hypotension, myocardial infarction, myocardial ischemia, orthostatic hypotension, palpitations, peripheral edema, tachycardia, thrombocytopenia

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Blood pressure increased, 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, orthostatic hypotension, peripheral edema, tachycardia, ventricular extrasystole

Rare (0.01% to 0.1%): Sinus tachycardia

Frequency not reported: Acute myocardial infarction, angina pectoris, atrial fibrillation, atrial flutter, cardiac arrest, cardiorespiratory arrest, chest injury, chest pain, congestive cardiac failure, contusion, decreased heart rate, deep vein thrombosis, electrocardiogram ST segment depression, extrasystoles, first-degree atrioventricular block, muscle hemorrhage, heat stroke, myocardial ischemia, orthostatic hypertension, QT prolongation, supraventricular tachycardia, Torsade de pointes, venous thromboembolism, ventricular arrhythmias, ventricular tachycardia

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, heat stroke, 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, epistaxis, 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/QT prolongation, extrasystoles, generalized edema, heart rate increased, hot flush, hypotension, myocardial infarction, myocardial ischemia, orthostatic hypotension, palpitations, 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, Torsade de pointes, venous thromboembolism, ventricular arrhythmias

Postmarketing reports: Heat stroke^[Ref]

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 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.^[Ref]

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.^[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:

Frequency not reported: Agranulocytosis, leukopenia, neutropenia

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Anemia, neutropenia

Uncommon (0.1% to 1%): Neutrophil count decreased, thrombocytopenia, white blood cell (WBC) 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, WBC count increased

Frequency not reported: Agranulocytosis^[Ref]

Endocrine

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

Frequency not reported: Blood prolactin increased, gynecomastia

Aripiprazole 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

Frequency not reported: Blood prolactin increased

Immediate-Release IM Injection:

Uncommon (0.1% to 1%): Hyperprolactinemia

Frequency not reported: Blood prolactin decreased/increased, gynecomastia, hirsutism

Oral Formulations:

Very common (10% or more): Serum prolactin levels less than 2 ng/mL (up to 59.4%), serum prolactin levels less than 3 ng/mL (up to 37%)

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

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

Frequency not reported: Blood prolactin decreased^[Ref]

Serum prolactin levels less than 2 ng/mL occurred in up to 59.4% of male patients aged 13 to 17 years with schizophrenia and bipolar disorder receiving this drug over 2 years.

Serum prolactin levels less than 3 ng/mL occurred in up to 37% of female patients aged 13 to 17 years with schizophrenia and typical bipolar disorder receiving this drug over 2 years.^[Ref]

Musculoskeletal

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

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

Frequency not reported: Abnormal/prolonged muscle contractions, cogwheel rigidity, muscle tightness, muscular weakness, neck muscle spasms, rhabdomyolysis

Aripiprazole Extended/Prolonged-Release IM Suspension:

Very common (10% or more): Back pain (up to 11.5%)

Common (1% to 10%): Arthralgia, 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

Frequency not reported: Ankle fracture, arthritis, foot fracture, joint dislocation, joint sprain, joint swelling, mobility decreased, muscle edema, muscle injury, muscle strain, muscular weakness, neck muscle spasms, neck pain, radius fracture, rotator cuff syndrome, sciatica, skeletal injury, stiffness

Immediate-Release IM Injection:

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

Frequency not reported: Mobility decreased, muscle tightness, muscular weakness, myalgia, neck muscle spasms, prolonged abnormal contractions of muscle groups, rhabdomyolysis, stiffness

Oral Formulations:

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

Uncommon (0.1% to 1%): Mobility decreased, muscle tightness, muscular weakness, musculoskeletal rigidity

Rare (0.01% to 0.1%): Abnormal blood creatine phosphokinase, bone pain, clavicle fracture, flank pain, hip fracture, humerus fracture, jaw disorder, kyphosis, muscle strain, nuchal rigidity, osteoarthritis, rhabdomyolysis

Frequency not reported: Neck muscle spasms, prolonged abnormal contractions of muscle groups, stiffness^[Ref]

Other

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.^[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:

Frequency not reported: Asthenia, body temperature dysregulation, falls

Aripiprazole Extended/Prolonged-Release IM Suspension:

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

Uncommon (0.1% to 1%): Asthenia, pyrexia, sluggishness

Frequency not reported: Accident, arthropod bite, body temperature regulation, carbon monoxide poisoning, deafness, drug toxicity, ear infection, face injury, falls, gunshot wound, hypothermia, injury, multiple injuries, night sweats, otitis externa, otitis media, pain, poor personal hygiene, procedural pain, spinal column injury, sudden unexplained death, suprapubic pain, temperature regulation disorder, thermal burn, tinnitus, wound

Immediate-Release IM Injection:

Common (1% to 10%): Fatigue

Frequency not reported: Asthenia, body temperature regulation, drug withdrawal syndrome neonatal, fall, 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, swelling

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

Frequency not reported: Body temperature regulation, sudden unexplained death, temperature regulation disorder^[Ref]

Respiratory

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

Frequency not reported: Difficulty breathing, dyspnea, nasal congestion, throat tightness

Postmarketing reports: Laryngospasm, oropharyngeal spasm

Aripiprazole Extended/Prolonged-Release IM Suspension:

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

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

Frequency not reported: Acute respiratory distress syndrome, allergic rhinitis, allergic sinusitis, aspiration pneumonia, asthma, difficulty breathing, dyspnea, epistaxis, fungal oropharyngitis, laryngitis, laryngospasm, nasal septum deviation, noncardiac chest pain, oropharyngeal pain, oropharyngeal spasm, respiratory failure, paranasal sinus hypersecretion, pharyngitis streptococcal, pharyngolaryngeal pain, pneumonia, pulmonary embolism, respiratory tract congestion, respiratory tract infection, rhinalgia, sinus congestion, throat tightness, viral rhinitis, viral upper respiratory tract infection, wheezing

Immediate-Release IM Injection:

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

Frequency not reported: Difficulty breathing, dyspnea, laryngospasm, nasal congestion, oropharyngeal spasm, pulmonary embolism, throat tightness

Oral Formulations:

Common (1% to 10%): Bronchitis, cough, dyspnea, 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: Difficulty breathing, laryngospasm, oropharyngeal spasm pulmonary embolism, throat tightness^[Ref]

Ocular

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

Frequency not reported: Diplopia, photophobia

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Diplopia, eye pain

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

Immediate-Release IM Injection:

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Diplopia

Frequency not reported: 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, lacrimation increased^[Ref]

Genitourinary

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

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

Aripiprazole Extended/Prolonged-Release IM Suspension:

Common (1% to 10%): Erectile dysfunction

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

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

Frequency not reported: Adnexa uteri pain, amenorrhea, asymptomatic bacteriuria, breast mass, breast pain, Escherichia UTI, hypertonic bladder, mastitis, menorrhagia, menstruation irregular, micturition urgency, nocturia, ovarian cyst, polyuria, priapism, protein urine, sexual dysfunction, urinary retention, vaginal infections, vulvovaginal mycotic infection, white blood cells urine

Immediate-Release IM Injection:

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

Oral Formulations:

Common (1% to 10%): Enuresis

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

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

Hepatic

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

Frequency not reported: Blood bilirubin increased, gamma glutamyl transferase (GGT) increased, hepatic enzyme increased, hepatitis, jaundice

Aripiprazole Extended/Prolonged-Release IM Suspension:

Uncommon (0.1% to 1%): Abnormal liver function test, ALT increased, AST increased, blood bilirubin increased, GGT 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 GGT, jaundice

Oral Formulations:

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

Rare (0.01% to 0.1%): Hepatitis, jaundice

Frequency not reported: Hepatic failure, increased alkaline phosphatase, increased ALT, increased AST^[Ref]

Local

Skin irritation localized to patch placement included rashes and occurred in 12.4% of patients (n=61) receiving aripiprazole (the active ingredient contained in Aristada Initio) IR tablets with sensors.

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.^[Ref]

Aripiprazole 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 erythema, injection site hemorrhage, injection site induration, injection site inflammation, injection site pain, injection site pruritus, injection site rash, injection site reactions, injection site swelling

Uncommon (0.1% to 1%): Injection site discomfort

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

Immediate-Release IM Injection:

Frequency not reported: Injection site reaction, venipuncture site bruise

Oral Formulations:

Very common (10% or more): Skin irritation (up to 12.4%)

Rare (0.01% to 0.1%): Local swelling, localized infection^[Ref]

Renal

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

Frequency not reported: Blood creatinine increased, blood urea increased

Aripiprazole Extended/Prolonged-Release IM Suspension:

Uncommon (0.1% to 1%): Nephrolithiasis

Frequency not reported: Blood creatinine increased, blood urea increased, cystitis, glycosuria/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, glycosuria/glucose urine/glucose urine present

Rare (0.01% to 0.1%): Oliguria^[Ref]

Oncologic

Aripiprazole (the active ingredient contained in Aristada Initio) 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^[Ref]

Immunologic

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

Common (1% to 10%): Influenza

Frequency not reported: Chlamydial infection, fungal infection, herpes virus infection, herpes zoster, influenza-like illness, localized infection, sycosis barbae, trichomoniasis, varicella, viral infection

Oral Formulations:

Rare (0.01% to 0.1%): Decreased immune responsiveness, herpes simplex^[Ref]