Is Ranitidine Safe in Pregnancy
Status
avoidReason
FDA requested removal of all ranitidine products due to NDMA impurity concerns.
Drug Information
Safe Amount
Dosage must be determined by your provider based on individual risk/benefit.
Effects
- Pregnancy
- Use is not recommended because of FDA market withdrawal; consult your prescriber for alternatives.
- Mother
- Can reduce stomach acid; product was removed from the U.S. market due to NDMA contamination concerns.
- Baby
- No adequate, well-controlled studies in pregnant women; animal studies did not show fetal harm in labeling.
Trimester Notes
- 1st Trimester
- No trimester-specific pregnancy dosing guidance found in official labeling; avoid use because FDA removed ranitidine products from the market.
- 2nd Trimester
- No trimester-specific pregnancy dosing guidance found in official labeling; avoid use because FDA removed ranitidine products from the market.
- 3rd Trimester
- No trimester-specific pregnancy dosing guidance found in official labeling; avoid use because FDA removed ranitidine products from the market.
Conditions & Warnings
- Consult OB/GYN or prescriber
- Do not start, stop, or switch medicines without medical advice
- If you are pregnant and need acid relief, ask about alternatives
Alternatives
- famotidine
- antacids such as calcium carbonate if approved by your OB/GYN or prescriber
References
- FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market - Zantac labeling (DailyMed/FDA accessdata archived label)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf