Zantac (Ranitidine) Availability Status
Zantac (ranitidine) is no longer available for use and was completely withdrawn from the market in April 2020 by the FDA due to unacceptable levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen. 1
Why Ranitidine Was Removed
The US Food and Drug Administration requested all manufacturers to immediately withdraw ranitidine from the market on April 1,2020, after discovering higher than acceptable levels of NDMA contamination in ranitidine products. 1
NDMA is a known potential carcinogen that was found to be present in ranitidine formulations at levels exceeding safety thresholds. 1, 2
The contamination issue was not limited to manufacturing defects—NDMA can be generated directly from ranitidine's chemical structure under certain conditions, making it an inherent stability problem with the drug itself. 2
Alternative H2-Receptor Antagonists Currently Available
You should switch patients to other H2-receptor antagonists (H2-blockers) that remain on the market:
Famotidine is the most commonly recommended alternative and does not have the NDMA contamination issue. 3
Nizatidine remains available and is metabolized differently (only 22% hepatic metabolism), making it less prone to drug interactions. 3
Cimetidine is available but has significant drug interaction potential as it inhibits multiple CYP450 enzymes (CYP1A2, 2C9, 2C19, 2D6, 2E1, and 3A4). 3
Reassurance About Past Ranitidine Use
Large-scale epidemiological studies conducted after the recall found no significant association between ranitidine use and increased cancer risk compared to other H2-blockers. 4
A multinational cohort study of 1,183,999 individuals found the calibrated hazard ratio for any cancer was 1.04 (95% CI: 0.97-1.12) when comparing ranitidine to other H2RAs—essentially no increased risk. 4
A Danish population-based study specifically examining bladder and kidney cancer found weighted hazard ratios of 1.11 (95% CI: 0.95-1.29) for bladder cancer and 0.89 (95% CI: 0.72-1.10) for kidney cancer when comparing ranitidine to other H2-blockers—no substantial increase. 5
Clinical Action Required
Immediately switch any patients still inquiring about ranitidine to famotidine or another available H2-blocker, using equivalent dosing (famotidine 20 mg is roughly equivalent to ranitidine 150 mg). The drug has been off the market for over 4 years and should not be available through any legitimate pharmacy channels.