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Abilify (aripiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
Abilify is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression). It is not known if aripiprazole is safe or effective in children younger than 13 with schizophrenia, or children younger than 10 with bipolar disorder.
Abilify is also used together with other medicines to treat major depressive disorder in adults.
Abilify is also used in children 6 years or older who have Tourette's disorder, or symptoms of autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).
Abilify is not approved for use in psychotic conditions related to dementia. Abilify may increase the risk of death in older adults with dementia-related conditions.
Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor will need to check your progress at regular visits while you are using Abilify. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.
You should not take Abilify if you are allergic to aripiprazole.
Abilify is not approved for use in psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related conditions.
To make sure Abilify is safe for you, tell your doctor if you have ever had:
liver or kidney disease;
heart disease, high or low blood pressure, heart rhythm problems;
high cholesterol or triglycerides (a type of fat in the blood);
low white blood cell (WBC) counts;
a heart attack or stroke;
seizures or epilepsy;
trouble swallowing;
a personal or family history of diabetes; or
an obsessive-compulsive disorder, impulse-control disorder, or addictive behaviors.
Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
The liquid form (oral solution) of this medication may contain up to 15 grams of sugar per dose. Before taking Abilify oral solution, tell your doctor if you have diabetes.
Abilify may cause you to have high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking this medicine.
The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.
Taking antipsychotic medicine in the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant, do not stop taking Abilify without your doctor's advice.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of aripiprazole on the baby.
Aripiprazole can pass into breast milk. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not take Abilify for longer than 6 weeks unless your doctor has told you to.
Abilify can be taken with or without food.
Swallow the regular tablet whole and do not crush, chew, or break the tablet.
Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
To take the orally disintegrating tablet (Discmelt):
Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
Use dry hands to remove the tablet and place it in your mouth.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.
Use Abilify regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
You should not stop using Abilify suddenly. Stopping suddenly may make your condition worse.
Your doctor will need to check your progress while you are using this medicine.
Store at room temperature away from moisture and heat. Abilify liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), trouble breathing, or fainting.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.
Avoid drinking alcohol. Dangerous side effects could occur.
Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.
Get emergency medical help if you have signs of an allergic reaction to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe agitation, distress, or restless feeling;
twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
mask-like appearance of the face, trouble swallowing, problems with speech;
seizure (convulsions);
thoughts about suicide or hurting yourself;
severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
low blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, red or swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or
high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, weight loss.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.
Common Abilify side effects may include:
weight gain;
blurred vision;
nausea, vomiting, changes in appetite, constipation;
drooling;
headache, dizziness, drowsiness, feeling tired;
anxiety, feeling restless;
sleep problems (insomnia); or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Taking Abilify with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Many other drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Abilify.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Abilify only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Abilify (www.drugs.com/abilify.html).
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 SummaryMore frequent side effects include: dizziness, drowsiness, lethargy, sedated state, urinary incontinence, and salivation. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to aripiprazole: oral solution, oral tablet, oral tablet disintegrating
Other dosage forms:
Oral route (Tablet; Tablet, Disintegrating; Solution)
Warning: Increased Mortality In Elderly Patients With Dementia-Related Psychosis And Suicidal Thoughts And Behaviors With Antidepressant DrugsElderly 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.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.In patients of all ages who are started on antidepressant therapy, monitor closely for 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.
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
Less common
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking aripiprazole:
Symptoms of overdose
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
Less common
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
GeneralAripiprazole (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.
PsychiatricAripiprazole (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 systemElderly 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
MetabolicAripiprazole (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.
HypersensitivityAripiprazole (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
GastrointestinalAripiprazole (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
DermatologicAripiprazole (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.
CardiovascularCollective 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
HematologicNeutropenia 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
EndocrineAripiprazole (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
MusculoskeletalAripiprazole (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
OtherAripiprazole (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.
RespiratoryAripiprazole (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
OcularAripiprazole (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
GenitourinaryAripiprazole (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
HepaticAripiprazole (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
LocalAripiprazole (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.
RenalAripiprazole (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
OncologicAripiprazole (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
ImmunologicAripiprazole (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
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Abilify (www.drugs.com/abilify.html).
September 17, 2015
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