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Label Changes for:

Abilify (aripiprazole) Injection for Intramuscular Use Only

February 2008

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View


Sections Modified Summary of Changes to Contraindications and Warnings


  • Orthostatic Hypotension
  • Seizures/Convulsions
  • Potential for Cognitive and Motor Impairment


  • Clinical Studies Experience
    • Pediatric Patients (10 to 17 years) with Bipolar Mania
    • Commonly Observed Adverse Reactions
    • Table 7
  • Somnolence
  • Extrapyramidal Disorder
  • Fatigue
  • Nausea
  • Akathisia
  • Blurred Vision
  • Salivary Hypersecretion
  • Dizziness


  • Pediatric Use


Orthostatic Hypotension

Aripiprazole may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. The incidence of orthostatic hypotension-associated events from short-term, placebo-controlled trials...of pediatric patients 10 to 17 years of age (n=399) on oral Abilify included orthostatic hypotension (1.0%, 0%)...

The incidence of a significant orthostatic change in blood pressure...In pediatric oral aripiprazole-treated patients aged 10 to 17 years (0%, 0.5%), or in aripiprazole injection-treated patients (3%, 2%).


In short-term, placebo-controlled trials, seizures/convulsions occurred in 0.2% (3/1894) of adult patients treated with oral aripiprazole, in 0.3% (1/399) of pediatric patients (10 to 17 years), and in 0.2% (1/501) of adult aripiprazole injection-treated patients...

Potential for Cognitive and Motor Impairment

Abilify, like other antipsychotics, may have the potential to impair judgment, thinking, or motor skills...