Aripiprazole During Pregnancy

Schizophrenia is a serious mental disorder that most commonly appears in young adults in their 20s. Medications, such as aripiprazole, also known as Abilify can help improve the well-being of individuals experiencing this condition.  However, when schizophrenia presents itself during the childbearing years, it is common to question the safety of aripiprazole during pregnancy. It is important to discuss with your healthcare provider the best ways to maintain mental health without compromising the health of your developing baby

Aripiprazole and Pregnancy

  • Brand name: Abilify
  • Manufacturer: Bristol-Myers Squibb

Therapeutic Effect:
Abilify is used to:

  • Treat schizophrenia.
  • Treat manic and mixed episodes in individuals with bipolar I disorder.
  • Treat manic and mixed episodes in individuals with bipolar I disorder, in adjunction to treatment with either lithium or valproate.
  • Treat major depressive disorder, in adjunction to treatment with antidepressants.
  • Treat irritability in individuals with autistic disorder.

Pregnancy Safety Rating: Category: C
Pregnancy Recommendation: There is limited human data available on aripiprazole. Animal data suggest risk.

Side Effects:

  • Occasional: (4%-3%) Nausea, light-headedness, drowsiness, akathisia.
  • Rare: (2% or less) Blurred vision, anxiety, constipation, fever, orthostatic hypotension, rash, cough, asthenia (loss of energy/strength), rhinitis.

Pregnancy/Lactation Considerations: It is unknown if aripiprazole crosses the placenta. It may be distributed in breast milk. Breastfeeding is not recommended for individuals taking aripiprazole.

Pregnancy Summaries:

The following summaries are cited directly from the sources of Briggs, Freeman, & Yaffe, the Physicians’ Desk Reference, and the Reprotox Toxicology Center.

Briggs, Freeman, & Yaffe – Only three reports have described the use of aripiprazole in human pregnancy. No developmental toxicity was observed in these cases. The animal data suggest a risk of developmental toxicity and possibly teratogenicity, but the very limited human pregnancy experience prevents a complete assessment of the embryo-fetal risk.

Until such data are available, the safest course is to avoid the drug in pregnancy.

However, if the mother’s condition requires treatment with aripiprazole, the lowest effective dose, avoiding the 1st trimester if possible, should be used. In addition, long-term evaluation of the infant is warranted.

Physicians’ Desk Reference – There are no adequate and well-controlled studies in pregnant women. It is not known whether aripiprazole can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Aripiprazole should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. For further information, please refer to the Physicians’ Desk Reference or contact your Healthcare Provider.

Reprotox Toxicology Center – In rats, aripiprazole caused a diaphragmatic hernia at maternal levels 10 times the recommended human dose. There are two case reports of use in human pregnancy without adverse consequences.
There are no data on human lactation. Aripiprazole, like other antipsychotics, may cause hyperprolactinemia which is associated with galactorrhea, menstrual irregularities, and infertility.

Next Steps:

If you are pregnant and have questions related to medication use during pregnancy, the Reprotox Toxicology Center is the most comprehensive resource on medication use during pregnancy.

The American Pregnancy Association does not prescribe medication, nor do we serve as a consult for medication use during pregnancy. It is imperative that you discuss the use of any medication during pregnancy with your healthcare provider. The purpose of this document is to provide you with information to support discussions with your healthcare provider.

Hodgson, Barbara, and Kizior, Robert, Saunders Nursing Drug Handbook 2012, Elsevier, St. Louis, MO. ISBN: 978-1-4377-2334-2.
Briggs, Gerald, Freeman, Roger and Yaffe, Sumner, Drugs in Pregnancy and Lactation, 9th Ed., Wolters Kluwer/Lippincott Williams & 3. Wilkins, Philadelphia, PA. ISBN: 978-1-60831-708-0, 2011.
Physicians’ Desk Reference (PDR), PDR Network, LLC, Montvale, NJ 07645 ISBN: 978-1-56363-780-3
Reproductive Toxicology Center,, agent # 4246