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Abilify

(aripiprazole)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg
  • Orally Disintegrating Tablets (Abilify ODT): 10 mg, 15 mg
  • Oral Solution: 1 mg/mL

Dosing

  • Age: >6 y/o

    • Irritability Associated with Autistic Disorder: 6-17 years

    • Bipolar I Disorder (Acute Mania/Mixed): 10-17 years, adults

    • Schizophrenia: 13+ years, adults

    • Tourette’s Disorder: 6-17 years

  • Onset: Variable; clinical effect typically within days to weeks for mood/behavioral symptoms
  • Duration: ~75 hours (half-life); steady-state typically achieved within 1–2 weeks
  • Considerations: Monitor for EPS, metabolic and cardiovascular changes, assess behavioral shifts (especially in ADHD/mood dysregulation), and counsel families on potential side effects and gradual titration.
  • Initial Dose: 

    • Autism: 2 mg/day

    • Bipolar: 2-5 mg/day (pediatrics), 10-15 mg/day (adults)

    • Schizophrenia: 2 mg/day titrated to 10-15 mg/day

    • Tourette’s: 2 mg/day

  • Titration: Increase dose every 1–2 weeks
  • Max Dose:
    Indication Pediatric Max Dose Adult Max Dose
    Autism 15 mg/day N/A
    Bipolar I 30 mg/day 30 mg/day
    Schizophrenia 30 mg/day 30 mg/day
    Tourette’s 20 mg/day (6-12 y/o), 30 mg (13-17 y/o) N/A

Quick Facts

  • Partial agonist at dopamine D2 & serotonin 5-HT1A; antagonist at 5-HT2A receptors
  • Modulates neurotransmission to stabilize mood and reduce psychotic symptoms
  • Approved for reducing irritability and tantrums in children with autistic disorder
  • Effective as adjunctive therapy in major depressive disorder
  • Useful in controlling manic symptoms in bipolar I disorder and reducing motor/vocal tics in Tourette's Disorder
  • Off-label benefits include use in ADHD-related aggression, disruptive behavior, and impulsivity
  • Lower risk of EPS and metabolic burden compared to many first-generation and some second-generation antipsychotics (e.g., olanzapine, clozapine)
  • Common side effects: akathisia, restlessness, insomnia, nausea, headache, weight gain, constipation
  • Use with caution in patients with cardiovascular/metabolic risks

Indications

  • Irritability Associated with Autistic Disorder (ICD-10: F84.0): Reduces aggression and tantrums.
  • Major Depressive Disorder, Adjunctive Use (ICD-10: F32.x / F33.x): Enhances antidepressant effects.
  • Schizophrenia (ICD-10: F20.x): Reduces delusions and hallucinations.
  • Bipolar I Disorder (ICD-10: F31.x): Controls manic episodes and stabilizes mood.
  • Tourette’s Disorder (ICD-10: F95.2): Reduces motor and vocal tics.

Off-Label Uses

  • Generalized Anxiety Disorder (ICD-10: F41.1): Sometimes used adjunctively in refractory cases
  • Post-Traumatic Stress Disorder (ICD-10: F43.10): May benefit select patients not responding to first-line treatments
  • Borderline Personality Disorder (ICD-10: F60.3): May help reduce impulsivity and emotional dysregulation
  • Behavioral Control in ADHD/Disruptive Behavior: Although not FDA-approved for this use, aripiprazole is often considered in pediatric patients with significant aggression or impulsivity when first-line ADHD treatments are insufficient

How to Take

  • Administration:

    • Can be taken with or without food
    • Orally Disintegrating Tablets (ODT): Place on the tongue and allow to dissolve; do not chew or crush
    • Oral Solution: Measure accurately with a dosing syringe or cup
    • Take at the same time each day for consistency in drug levels

  • Missed Dose:

    • Take as soon as possible unless it is near the next scheduled dose; do not double up

  • Discontinuation:

    • Taper gradually when discontinuing to avoid withdrawal effects or rebound behavioral symptoms

Side Effects

    • Common:

      • Akathisia, restlessness
      • Fatigue, drowsiness
      • Nausea, vomiting
      • Dizziness, constipation

    • Serious:

      • Black Box Warnings: Increased mortality in elderly patients with dementia-related psychosis; increased suicidality in children/young adults with major depressive disorder
      • Tardive dyskinesia (involuntary facial, tongue, or body movements; risk increases with long-term use)
      • Neuroleptic malignant syndrome (high fever, muscle rigidity, confusion, altered consciousness, autonomic instability; rare but life-threatening)
      • Hyperglycemia and related complications (ketoacidosis, diabetic coma)
      • Orthostatic hypotension
      • Seizures/convulsions
      • Low white blood cell count
      • Laryngeal spasm and dystonic reactions (pharynx, hypopharynx, tongue)
      • Compulsive behaviors (gambling, binge eating, shopping, sexual urges)
      • Allergic reactions (rash, hives, swelling, difficulty breathing/swallowing)
      • Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis (stroke, TIA)

Monitoring / Labs

  • Metabolic Effects: Monitor weight, fasting glucose, and lipid profiles regularly.
  • Psychiatric Symptoms: Watch for worsening mood, suicidal thoughts, or unusual behavior.
  • Tardive Dyskinesia: Assess for abnormal involuntary movements periodically.
  • Blood Pressure: Monitor for orthostatic changes, especially in older adults.
  • Baseline and Routine Monitoring:
    • Fasting glucose and lipid profile.
    • CBC (if history of leukopenia/neutropenia).
  • Others: Monitor prolactin if symptoms of hyperprolactinemia occur.

Education

  • When to Call the Doctor:
    • Signs of allergic reaction (rash, swelling, difficulty breathing).
    • High fever, muscle stiffness, or confusion (possible Neuroleptic Malignant Syndrome).
    • Uncontrolled movements of face, tongue, arms, or legs (possible Tardive Dyskinesia).
    • Sudden mood changes, agitation, suicidal thoughts.
    • Severe dizziness or fainting.
    • Excessive thirst, frequent urination, unexplained weight loss (possible hyperglycemia).

  • Safety Tips:

    • Avoid alcohol and CNS depressants, as they may enhance sedation.
    • Caution with activities requiring alertness (e.g., driving) until individual response is known.
    • Slow positional changes to prevent orthostatic hypotension.
    • Maintain hydration and monitor for heat intolerance.
    • Tapering may be necessary before discontinuation to prevent withdrawal effects.

  • Parent Tips for Pediatric Patients:

    • Monitor for behavioral changes (e.g., aggression, restlessness, suicidal ideation).
    • Encourage nutrient-dense meals to counteract potential weight gain.
    • Watch for sedation-related school performance issues.
    • Communicate with teachers and caregivers regarding behavioral or academic changes.
    • Ensure adherence; skipping doses may reduce symptom control.

Additional Information

  • Contraindications:
    • Hypersensitivity to aripiprazole or any component of the formulation.
  • Pregnancy: May cause extrapyramidal/withdrawal symptoms in neonates; use if benefits > risks (limited data)
  • Lactation: Excreted in breast milk; not recommended.
  • Drug Interactions:
    • CYP3A4 and CYP2D6 inhibitors (e.g., fluoxetine, ketoconazole) may increase aripiprazole levels.
    • CYP3A4 inducers (e.g., carbamazepine, rifampin) may decrease efficacy.
    • May potentiate effects of antihypertensives, leading to hypotension.
    • Caution with dopamine agonists or antagonists due to possible pharmacodynamic interactions.

References

  1. FDA. Abilify (aripiprazole) Full Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/
  2. DailyMed: Aripiprazole Monograph. https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=aripiprazole
  3. MedlinePlus. Aripiprazole Drug Information. https://medlineplus.gov/druginfo/meds/a603012.html
  4. Otsuka Pharmaceutical. Abilify (aripiprazole) Prescribing Information. https://www.otsuka-us.com/
  5. GoodRx. Abilify Side Effects. https://www.goodrx.com/abilify/abilify-side-effects
  6. NAMI. Aripiprazole Lauroxil Information. https://www.nami.org/
  7. FDA. Abilify Safety and Utilization Review. https://www.fda.gov/media/107289/download
  8. FDA. Abilify Medication Guide. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016MedG.pdf




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