temper Famotidine Pregnancy and Breastfeeding Warnings Famotidine is also known as: 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 Overview Side Effects Dosage Professional Tips More Interactions Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Compare Alternatives Pricing & Coupons 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. See references 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 references References for pregnancy information "Product Information. Pepcid (famotidine)." Merck & Co, Inc, West Point, PA. "Product Information. Pepcid AC (famotidine)." Johnson and Johnson/Merck, Fort Washington, PA. Cerner Multum, Inc. "Australian Product Information." O 0 Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 References for breastfeeding information "Product Information. Pepcid AC (famotidine)." Johnson and Johnson/Merck, Fort Washington, PA. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]): "Product Information. Pepcid (famotidine)." Merck & Co, Inc, West Point, PA. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 Cerner Multum, Inc. "Australian Product Information." O 0 Print this page See Also... Famotidine use while Breastfeeding (in more detail) Famotidine Consumer Information Pregnancy Support Group FDA Pregnancy Categories Medicine use during Pregnancy Medicine use while Breastfeeding Safe Medications during Breastfeeding Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist. Drug Status Rx OTC Availability Rx and/or OTC B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Famotidine Rating 21 User Reviews 7.1 /10 21 User Reviews 7.1 Rate it! 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