Skip to Content

Aristada Side Effects

Generic Name: aripiprazole

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 Aristada.

In Summary

Common side effects of Aristada include: akathisia, anxiety, constipation, dizziness, headache, insomnia, nausea, and vomiting. Other side effects include: basal ganglia disease, drowsiness, fatigue, limb pain, sedation, tremor, and restlessness. See below for a comprehensive list of adverse effects.

For the Consumer

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

Along with its needed effects, aripiprazole (the active ingredient contained in Aristada) 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
  • Convulsions
  • fast heartbeat
  • 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
  • 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
  • Acid or sour stomach
  • anxiety
  • belching
  • blurred vision
  • difficulty having a bowel movement (stool)
  • dry mouth
  • fear
  • fever
  • headache
  • 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


The most frequently reported adverse effects in adult clinical trials of the immediate-release products included nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness. The most common adverse reactions in pediatric clinical trials were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight gain.

The most commonly reported adverse reactions in clinical trials of the extended-release IM formulation included increased weight, akathisia, injection site pain, and sedation.[Ref]


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%): Insomnia, suicidal ideation
Uncommon (0.1% to 1%): Self-mutilation, aggression, loss of libido, suicide attempt, hostility, libido increased, anger, delirium, completed suicide, tic, homicidal ideation, sleep talking, bruxism, depression, psychotic disorder, hallucination, delusion, affect lability, apathy, dysphoria,
Rare (less than 0.1%): Catatonia, sleep walking, hypersexuality, panic attack
Postmarketing reports: Pathological gambling, impulse control disorders, obsessive-compulsive disorder, eating disorder[Ref]

Nervous system

Elderly patients (mean = 84 years old) enrolled in placebo-controlled studies examining the use of aripiprazole (the active ingredient contained in Aristada) 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.[Ref]

Very common (10% or more): Headache (up to 27%), akathisia (up to 25%), somnolence (up to 23%), extrapyramidal disorder (up to 20%)
Common (1% to 10%): Dizziness, sedation, tremor, drooling, dystonia, feeling jittery, disturbance in attention, abnormal coordination
Uncommon (0.1% to 1%): Speech disorder, parkinsonism, memory impairment, cogwheel rigidity, cerebrovascular accident, hypokinesia, tardive dyskinesia, hypotonia, myoclonus, hypertonia, akinesia, bradykinesia
Rare (less than 0.1%): Grand Mal convulsion, choreoathetosis, dysgeusia
Very rare (less than 0.01%): Oromandibular dystonia
Postmarketing reports: Neuroleptic malignant syndrome, serotonin syndrome, speech disorder[Ref]


Very common (10% or more): Increased weight (up to 17%); elevated glycosylated hemoglobin (up to 14%)
Common (1% to 10%): Decreased appetite, increased appetite, blood glucose elevations, weight gain
Uncommon (0.1% to 1%): Hyperlipidemia, anorexia, diabetes mellitus, hyperglycemia, hypokalemia, hyponatremia, hypoglycemia, hypertriglyceridemia, thirst
Rare (less than 0.1%): Blood triglycerides decreased, blood cholesterol decreased
Very rare (less than 0.01%): Diabetic ketoacidosis
Postmarketing reports: Blood glucose fluctuations, diabetic hyperosmolar coma[Ref]

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]


Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Allergic reactions including anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm[Ref]


Very common (10% or more): Nausea (up to 15%), constipation (up to 11%), vomiting (up to 11%)
Common (1% to 10%): Dyspepsia, dry mouth, toothache, abdominal discomfort, stomach discomfort, salivary hypersecretion
Uncommon (0.1% to 1%): Gastroesophageal reflux disease, swollen tongue, esophagitis, tongue spasm, dry tongue, gastritis, dysphagia
Rare (less than 0.1%): Pancreatitis, abnormal feces, feces discolored, glossitis, pruritus ani, tongue discoloration[Ref]


Common (1% to 10%): Rash, hyperhidrosis, seborrheic dermatitis, neurodermatitis
Uncommon (0.1% to 1%): Face edema, angioedema, pruritus, photosensitivity reaction, alopecia, acne, rosacea, eczema, skin induration, urticaria, hirsutism
Rare (less than 0.1%): Decubitus ulcer, pemphigus, psoriasis, dry skin[Ref]

Reports of rash included erythematous, exfoliative, generalized, macular, maculopapular, papular rash; acneiform, allergic, contact, exfoliative, seborrheic dermatitis, neurodermatitis, and drug eruption.[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 (the active ingredient contained in Aristada) 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]

Common (1% to 10%): Tachycardia, hypertension, chest pain, peripheral edema, ECG QT prolongation
Uncommon (0.1% to 1%): Bradycardia, hypotension, palpitations, cardiopulmonary failure, myocardial infarction, cardio-respiratory arrest, atrioventricular block, extrasystoles, sinus tachycardia, atrial fibrillation, angina pectoris, myocardial ischemia, orthostatic hypotension
Rare (less than 0.1%): Atrial flutter, supraventricular tachycardia, ventricular tachycardia, ECG T-wave abnormal
Postmarketing reports: Sudden unexplained death, cardiac arrest, Torsade de points, Ventricular arrhythmias, QT prolongation, Venous thromboembolism[Ref]


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

Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocytopenia, anemia[Ref]


Common (1% to 10%): Elevated blood prolactin
Uncommon (0.1% to 1%): Brest pain
Rare (less than 0.1%): Gynecomastia, early menarche[Ref]


Common (1% to 10%): Musculoskeletal stiffness, extremity pain, myalgia, muscle spasms, arthralgia, back pain, creatine phosphokinase elevations
Uncommon (0.1% to 1%): Muscle rigidity, muscular weakness, muscle tightness, decreased mobility, muscle twitching, joint range of motion decreased, nuchal rigidity, trismus
Rare (less than 0.1%): Rhabdomyolysis[Ref]


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]

Very common (10% or more): Fatigue (up to 17%)
Common (1% to 10%): Pain, pyrexia, asthenia
Uncommon (0.1% to 1%): Hypothermia, gait disturbance
Rare (less than 0.1%): Heat stroke, ear canal erythema, hypoacusis, vertigo positional, tinnitus
Frequency not reported: Deafness
Postmarketing reports: Drug withdrawal syndrome neonatal[Ref]


Common (1% to 10%): Pharyngolaryngeal pain, cough, nasopharyngitis, rhinorrhea, upper respiratory tract infection, nasal congestion, dyspnea, pneumonia aspiration
Postmarketing reports: Hiccups[Ref]


Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Photophobia, diplopia, eyelid edema, photopsia, oculogyric crisis, eye pain
Rare (less than 0.1%): eye redness, chromatopsia, conjunctivitis, eye disorder, eye movement disorder, gaze palsy, increased lacrimation[Ref]


Common (1% to 10%): Dysmenorrhea, erectile dysfunction
Uncommon (0.1% to 1%): Polydipsia, anorgasmia, urinary retention, polyuria, nocturia, irregular menstruation, amenorrhea, priapism, vulvovaginal dryness
Rare (less than 0.1%): Pollakiuria, urinary incontinence[Ref]


Uncommon (0.1% to 1%): Hepatic enzyme increased, bilirubin increased
Rare (less than 0.1%): Hepatitis, jaundice, elevated blood lactate dehydrogenase, increased gamma-glutamyl transferase
Postmarketing reports: Hepatic failure, alkaline phosphatase elevations[Ref]


Common (1% to 10%): Injection site reaction
Uncommon (0.1% to 1%): Venipuncture site bruise[Ref]

Injection site reactions reported with the aripiprazole extended-release IM formulation (Maintena(R)) 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 (Aristada(R)) were mostly associated with the first injection and decreased with each subsequent injection.[Ref]


Common (1% to 10%): Blood urea increased, nephrolithiasis[Ref]


Rare (less than 0.1%): Oral neoplasm, skin papilloma
Frequency not reported: Basal cell carcinoma, breast fibroma, pancreatic carcinoma[Ref]


1. "Product Information. Abilify (aripiprazole)." Bristol-Myers Squibb, Princeton, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Abilify Maintena (ARIPiprazole)." Otsuka American Pharmaceuticals Inc, Rockville, MD.

5. "Product Information. Aristada (ARIPiprazole)." Alkermes, Inc, Cambridge, MA.

Some side effects of Aristada may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.