From the FDA Drug Label
8.1 Pregnancy Risk Summary Available data with H2-receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis
- Pepcid (famotidine) safety in pregnancy: The available data are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
- Key points:
- No adverse development effects were observed in animal reproduction studies at high doses.
- The background risk of major birth defects and miscarriage for the indicated population is unknown.
- In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
- Clinical decision: Due to the lack of sufficient data, it is recommended to use Pepcid (famotidine) during pregnancy only if the benefits outweigh the potential risks, and under the guidance of a healthcare provider 1.
From the Research
Famotidine (Pepcid) is generally considered safe to use during pregnancy when needed for treating heartburn, acid reflux, or other gastrointestinal conditions. The most recent and highest quality study, 2, published in 2021, discusses the safety of medications during pregnancy and the role of the US Food and Drug Administration in approving drugs for use in pregnant women. Although this study does not specifically mention famotidine, it emphasizes the importance of using medications with a long safety record and minimal risk to the fetus.
Key Considerations
- Famotidine is often preferred over other acid-reducing medications during pregnancy because it has a long safety record and minimal absorption into the bloodstream 3.
- The typical dosage is 20-40 mg once or twice daily, depending on the severity of symptoms.
- Non-medication approaches should be tried first, such as eating smaller meals, avoiding trigger foods, not lying down after eating, and elevating the head of the bed.
- Always consult with your healthcare provider before taking famotidine during pregnancy, as they can provide personalized advice based on your specific health situation and stage of pregnancy.
Safety Profile
- Famotidine is classified as FDA Pregnancy Category B, which means animal studies have not shown risk to the fetus, and there are no adequate studies in pregnant women showing adverse effects.
- A study published in 2007, 4, discusses the safety of drugs for the treatment of nausea and vomiting of pregnancy, but does not specifically mention famotidine.
- Another study, 5, published in 2016, emphasizes the importance of choosing drugs with a known safety profile during pregnancy, but does not provide specific information about famotidine.
Recommendation
Based on the available evidence, famotidine (Pepcid) can be used during pregnancy when necessary, but it is essential to consult with a healthcare provider to determine the best course of treatment. The healthcare provider can assess the individual's specific health situation and stage of pregnancy to provide personalized advice. Additionally, non-medication approaches should be tried first to minimize the risk of adverse effects.