Amoxapine Pregnancy and Breastfeeding Warnings
Brand names: Asendin
Medically reviewed by Drugs.com. Last updated on Jun 2, 2025.
Amoxapine Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not assigned
Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk
Animal studies have revealed evidence of fetotoxicity and embryotoxicity. There are no controlled data in human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Amoxapine Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies this drug as an agent whose effect on the nursing infant is unknown but may be of concern.
-Some experts state that exclusively breastfed infants should be monitored (e.g., drug serum levels).
See also
References for pregnancy information
- (2001) "Product Information. Asendin (amoxapine)." Lederle Laboratories
References for breastfeeding information
- (2001) "Product Information. Asendin (amoxapine)." Lederle Laboratories
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.