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Aripiprazole Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 7, 2024.

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

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, disintegrating; solution)

Warning: Increased Mortality In Elderly Patients With Dementia-Related Psychosis And Suicidal Thoughts And Behaviors With Antidepressant Drugs. Increased Mortality in Elderly Patients with Dementia-Related Psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.Suicidal Thoughts and Behaviors. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.

These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

Advise families and caregivers of the need for close observation and communication with the prescriber.The safety and efficacy of aripiprazole have not been established in pediatric patients.

Serious side effects of aripiprazole

Along with its needed effects, aripiprazole 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 side effects

  • 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 side effects

  • 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 side effects

  • 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

Other side effects of aripiprazole

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 side effects

  • 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 side effects

  • 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 adverse events

Aripiprazole 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 lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Nervous system

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

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

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

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.[Ref]

Hypersensitivity

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Gastrointestinal

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Dermatologic

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

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

Cardiovascular

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

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

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

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]

Endocrine

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

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 lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Other

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

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]

Respiratory

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Ocular

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Genitourinary

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Hepatic

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Local

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Skin irritation localized to patch placement included rashes and occurred in 12.4% of patients (n=61) receiving aripiprazole 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]

Renal

Aripiprazole lauroxil Extended-Release IM Suspension:

Aripiprazole Extended/Prolonged-Release IM Suspension:

Immediate-Release IM Injection:

Oral Formulations:

Oncologic

Aripiprazole Extended/Prolonged-Release IM Suspension:

Oral Formulations:

Immunologic

Aripiprazole Extended/Prolonged-Release IM Suspension:

Oral Formulations:

References

1. (2002) "Product Information. Abilify (aripiprazole)." Bristol-Myers Squibb

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

4. (2013) "Product Information. Abilify Maintena (aripiprazole)." Otsuka American Pharmaceuticals Inc

5. (2015) "Product Information. Aristada (aripiprazole)." Alkermes, Inc

Frequently asked questions

Further information

Aripiprazole side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.