# Abilify ### (aripiprazole)
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac)
--- **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:**
IndicationPediatric Max DoseAdult Max Dose
Autism15 mg/dayN/A
Bipolar I30 mg/day30 mg/day
Schizophrenia30 mg/day30 mg/day
Tourette’s20 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/](https://www.accessdata.fda.gov/drugsatfda_docs/label/) 2. DailyMed: Aripiprazole Monograph. [https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=aripiprazole](https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=aripiprazole) 3. MedlinePlus. Aripiprazole Drug Information. [https://medlineplus.gov/druginfo/meds/a603012.html](https://medlineplus.gov/druginfo/meds/a603012.html) 4. Otsuka Pharmaceutical. Abilify (aripiprazole) Prescribing Information. [https://www.otsuka-us.com/](https://www.otsuka-us.com/) 5. GoodRx. Abilify Side Effects. [https://www.goodrx.com/abilify/abilify-side-effects](https://www.goodrx.com/abilify/abilify-side-effects) 6. NAMI. Aripiprazole Lauroxil Information. [https://www.nami.org/](https://www.nami.org/) 7. FDA. Abilify Safety and Utilization Review. [https://www.fda.gov/media/107289/download](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](https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016MedG.pdf)