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Label Changes for:

Abilify (aripiprazole) Tablets, Oral Solution, Orally Disintegrating Tablets, and Injectable Formulation

July 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

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


July 2013


Nursing Mothers
  • Aripiprazole is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


February 2012