Abilify Maintena

Abilify Maintena

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Questions & Answers

Side Effects & Adverse Reactions

ABILIFY MAINTENA may cause serious side effects, including:

  • Uncontrolled body movements (tardive dyskinesia). ABILIFY MAINTENA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY MAINTENA. Tardive dyskinesia may also start after you stop receiving ABILIFY MAINTENA.
  • Problems with your metabolism such as:
    • High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY MAINTENA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start receiving ABILIFY MAINTENA and during your treatment.
Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving ABILIFY MAINTENA:
  • feel very thirsty
  • need to urinate more than usual
  • feel very hungry
  • feel weak or tired
  • feel sick to your stomach
  • feel confused, or your breath smells fruity
  • Increased fat levels (cholesterol and triglycerides) in your blood.
  • Weight gain. You and your healthcare provider should check your weight regularly.
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Low white blood cell count
  • Seizures (convulsions)
  • Problems controlling your body temperature so that you feel too warm.
  • Difficulty swallowing
The most common side effect of ABILIFY MAINTENA includes feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia,) injection site pain, or sleepiness (sedation). Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ABILIFY MAINTENA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities)
  • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
  • Tardive Dyskinesia: Discontinue if clinically appropriate
  • Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain
    • Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with and at risk for diabetes
    • Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics
    • Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended
  • Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease
  • Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts in patients with a history of a clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC). Consider discontinuation if clinically significant decline in WBC/ANC in the absence of other causative factors
  • Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
  • Potential for Cognitive and Motor Impairment: Use caution when operating machinery

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


ABILIFY MAINTENA (aripiprazole) is indicated for the treatment of schizophrenia


There is currently no drug history available for this drug.

Other Information

Aripiprazole is an atypical antipsychotic which is present in ABILIFY MAINTENA as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C23H27Cl2N3O2•H2O and its molecular weight is 466.40. The chemical structure is:

Chemical Structure
ABILIFY MAINTENA (aripiprazole) is an extended-release injectable suspension available in 400-mg or 300-mg strength pre-filled dual chamber syringes and 400-mg or 300-mg strength vials. The labeled strengths are calculated based on the anhydrous form (aripiprazole). Inactive ingredients (per administered dose) for 400 mg and 300 mg strength products, respectively, include carboxymethyl cellulose sodium (16.64 mg and 12.48 mg), mannitol (83.2 mg and 62.4 mg), sodium phosphate monobasic monohydrate (1.48 mg and 1.11 mg) and sodium hydroxide (pH adjuster).

Abilify Maintena Manufacturers

  • Otsuka America Pharmaceutical, Inc.
    Abilify Maintena (Aripiprazole) Kit [Otsuka America Pharmaceutical, Inc.]

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