ARIFY 15/MG 30/TAB

Indications

Approved Uses

Schizophrenia; Bipolar I disorder (acute manic/mixed episodes and maintenance); Adjunctive treatment of major depressive disorder (MDD); Irritability associated with autistic disorder; Tourette’s disorder.

Off-Label Uses

Common off-label uses include behavioral/psychological symptoms of dementia (agitation/psychosis-boxed warning and caution), PTSD-related symptoms, anxiety disorders, and augmentation in other refractory mood disorders; other proposed uses (e.g., borderline personality disorder, eating disorders, substance use disorders) have variable/limited evidence.

Dosage & Administration

Dosing by Condition

Adults-Schizophrenia: start 10-15 mg once daily, target/maintenance 15 mg once daily, max 30 mg/day; Bipolar I mania (mono/adjunct): start 15 mg once daily, max 30 mg/day; Adjunctive MDD: start 2-5 mg once daily, usual range 2-15 mg/day (max 15 mg/day). Pediatrics (where approved): schizophrenia (13-17) and bipolar mania (10-17) typically start 2 mg/day and titrate to 10 mg/day; autism irritability (6-17) and Tourette’s (6-18) have weight/response-based titration with lower starting doses (often 2 mg/day) and condition-specific maximums.

Initial Dose

10-15 mg once daily for schizophrenia; 15 mg once daily for bipolar mania; 2-5 mg once daily as adjunct for MDD

Maintenance Dose

15 mg once daily (schizophrenia); 15-30 mg once daily (bipolar); 5-10 mg once daily (adjunct MDD)

Maximum Dose

30 mg per day.

Children's Dosage

Schizophrenia (13-17 years): Start 2mg/day, titrate to 10mg/day; Max 30mg/day. Bipolar I Disorder (10-17 years): Start 2mg/day, titrate to 10mg/day; Max 30mg/day. Irritability with Autism (6-17 years): Start 2mg/day, target 5-15mg/day; Max 15mg/day. Tourette's (6-18 years): Start 2mg/day, target 10-20mg/day; Max 20mg/day.

Dose Adjustment Notes

Adjust for CYP interactions: reduce aripiprazole dose with strong CYP2D6 inhibitors or strong CYP3A4 inhibitors; increase (often up to double) with strong CYP3A4 inducers; no renal adjustment; hepatic adjustment generally not required in mild-severe impairment, but use clinical judgment; consider lower starting doses in elderly/sensitive patients.

How to Take

Oral tablet: swallow whole with water; may be taken with or without food; take once daily at the same time each day.

Side Effects

Common Side Effects

Nausea, vomiting, constipation, headache, dizziness, akathisia, somnolence, insomnia, restlessness, tremor, blurred vision, weight gain, fatigue, anxiety

Side Effect Frequency

Very common (≥10%): akathisia, headache. Common (1-10%): insomnia, anxiety, nausea, vomiting, constipation, dizziness, somnolence, blurred vision, weight gain. Uncommon (<1%): orthostatic hypotension, tachycardia; rare/very rare but serious: neuroleptic malignant syndrome, seizures, tardive dyskinesia; impulse-control disorders (e.g., pathological gambling) have been reported.

Safety & Warnings

Contraindications

Known hypersensitivity to aripiprazole or to any component/excipient of the formulation.

Warnings & Precautions

Key warnings/precautions: increased mortality in elderly with dementia-related psychosis (not approved); suicidality risk in children/adolescents/young adults (monitor); NMS; tardive dyskinesia; metabolic monitoring (glucose/lipids/weight); orthostatic hypotension and cardiovascular/cerebrovascular caution; seizure risk; leukopenia/neutropenia monitoring in at-risk patients; impulse-control disorders; dysphagia/aspiration risk; CNS impairment (caution with driving/operating machinery).

Age Restriction

Pediatric use is indication-specific: approved from age 6 years for irritability associated with autistic disorder and for Tourette’s disorder; approved from age 10 years for bipolar I manic/mixed episodes; approved from age 13 years for schizophrenia; not established/approved under 6 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Clinically significant interactions: strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) and strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) increase aripiprazole exposure-dose reduction is typically required; strong CYP3A4 inducers (e.g., carbamazepine, rifampin) decrease exposure-dose increase is typically required; additive CNS depression with alcohol/benzodiazepines/opioids; additive hypotension with antihypertensives.

Interaction Severity

MAJOR/clinically significant: strong CYP3A4 inducers (e.g., carbamazepine, rifampin) ↓ aripiprazole levels; strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) ↑ levels-dose adjustment required. MODERATE: additive CNS depression with alcohol/benzodiazepines/opioids; enhanced orthostatic hypotension with antihypertensives. Other: antacids have minimal clinically relevant effect.

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Not assigned a pregnancy category (Risk Summary: Neonates exposed to antipsychotics during the third trimester have increased risk of extrapyramidal symptoms; use during pregnancy only if potential benefit justifies potential risk

Breastfeeding

Caution

Children

Schizophrenia (13-17 years): Start 2mg/day, titrate to 10mg/day; Max 30mg/day. Bipolar I Disorder (10-17 years): Start 2mg/day, titrate to 10mg/day; Max 30mg/day. Irritability with Autism (6-17 years): Start 2mg/day, target 5-15mg/day; Max 15mg/day. Tourette's (6-18 years): Start 2mg/day, target 10-20mg/day; Max 20mg/day.

Elderly

Start at lower doses, titrate slowly, monitor for orthostatic hypotension and CNS effects. Not approved for dementia-related psychosis.

Kidney Impairment

No adjustment needed.

Liver Impairment

No dosage adjustment is required for hepatic impairment (including severe), but use clinical caution and monitor tolerability.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop abruptly unless medically necessary; taper gradually under medical supervision to reduce relapse and withdrawal/rebound symptoms.

Overdose

Overdose may cause somnolence/sedation, vomiting, tremor, agitation, tachycardia or bradycardia, hypotension, and altered mental status; manage with immediate emergency evaluation, airway/ventilation support, activated charcoal if appropriate, ECG/cardiovascular monitoring, and supportive care (no specific antidote).

Patient Counseling

Take once daily as prescribed (with or without food) and do not stop abruptly without medical advice; may cause dizziness/orthostatic hypotension and somnolence-use caution driving until effects are known and avoid alcohol; report new/worsening mood or suicidal thoughts, extrapyramidal symptoms (restlessness, tremor, abnormal movements), signs of hyperglycemia, and impulse-control problems (e.g., gambling/compulsive behaviors); seek urgent care for suspected neuroleptic malignant syndrome (fever, rigidity, confusion).

Monitoring Requirements

Monitor weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, and fasting lipids at baseline and periodically; assess for extrapyramidal symptoms/tardive dyskinesia, akathisia, sedation/orthostasis, and suicidality/mood changes; consider CBC if history of leukopenia/neutropenia.

Pharmacology

Mechanism of Action

Partial agonist at dopamine D2 (and D3) receptors and serotonin 5‑HT1A receptors; antagonist at serotonin 5‑HT2A receptors.

Onset of Action

Some symptom improvement may be seen within 1-2 weeks; full therapeutic benefit often requires 4-6 weeks. Pharmacologic activity begins within hours of a dose.

Duration of Effect

Pharmacologic effect from a single dose persists for several days due to the long elimination half-life (aripiprazole ~75 hours; active metabolite ~94 hours); once-daily dosing maintains therapeutic levels. Clinical symptom control is maintained with continued daily dosing.

Half-Life

Aripiprazole: ~75 hours. Dehydro-aripiprazole (active metabolite): ~94 hours.

Bioavailability

Approximately 87% (oral).

Metabolism

Extensive hepatic metabolism primarily via CYP2D6 and CYP3A4, producing the active metabolite dehydro-aripiprazole.

Excretion

Eliminated mainly as metabolites: approximately 55% recovered in feces and ~25% in urine (with minimal unchanged drug).

Protein Binding

>99%, primarily to albumin.

Product Information

Available Dosage Forms

Immediate‑release oral tablet; orally disintegrating tablet; oral solution; immediate‑release intramuscular injection; long‑acting injectable intramuscular formulations (extended‑release).

Composition per Dose

Each tablet: 15 mg aripiprazole

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 05-08-2026