Famotidine Pregnancy and Breastfeeding Warnings
Brand names: Acid Control, Acid Controller Maximum Strength, Acid Controller Original Strength, Acid Reducer Maximum Strength, Acid Reducer Original Strength, Acid Reducer-Famotidine, Fluxid, Heartburn Relief, Heartburn Relief Maximum Strength, Mylanta AR, Pepcid, Pepcid AC, Pepcid AC Chewable Tablets, Pepcid AC Maximum Strength, Pepcid AC Maximum Strength Tablets, Pepcid Oral Suspension, Pepcid RPD, Zantac 360
Famotidine Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: B
Animal models have failed to reveal evidence of teratogenicity or changes in fertility. This drug crosses the placenta. Sporadic abortions occurred in an animal model at maternotoxic doses. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Famotidine Breastfeeding Warnings
Animal models have revealed transient growth depression when mothers were given maternally toxic doses (at least 600 times the usual human dose).
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
Comment:
-Some experts state that use is contraindicated during breastfeeding.
See also
References for pregnancy information
- Product Information. Pepcid (famotidine). Merck & Co., Inc. 2002;PROD.
- Product Information. Pepcid AC (famotidine). Johnson and Johnson/Merck. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Product Information. Pepcid (famotidine). Merck & Co., Inc. 2002;PROD.
- Product Information. Pepcid AC (famotidine). Johnson and Johnson/Merck. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
