Important Notice: Ranitidine (Zantac) Has Been Withdrawn from the Market
Ranitidine (Zantac) was removed from the U.S. market in 2020 by the FDA due to contamination with NDMA (N-Nitrosodimethylamine), a probable human carcinogen, and is no longer available for prescription or over-the-counter use.
Historical Dosing Information (For Reference Only)
While ranitidine is no longer available, the following represents the standard dosing that was used when it was on the market:
Duodenal Ulcer
- Active treatment: 150 mg twice daily OR 300 mg once daily at bedtime 1
- Maintenance: 150 mg at bedtime 1
Gastric Ulcer
GERD (Gastroesophageal Reflux Disease)
- Standard dosing: 150 mg twice daily 1, 3
- This dosing provided symptomatic relief in less than half of patients with reflux disease 3
Erosive Esophagitis
Pediatric Dosing (Ages 1 month to 16 years)
- Treatment of ulcers: 2-4 mg/kg twice daily (maximum 300 mg/day) 1
- Maintenance: 2-4 mg/kg once daily (maximum 150 mg/day) 1
- GERD/Erosive esophagitis: 5-10 mg/kg/day in 2 divided doses 1
Renal Impairment
- Creatinine clearance <50 mL/min: 150 mg every 24 hours 1
- Frequency may be increased to every 12 hours if clinically necessary 1
Current Recommended Alternatives
Proton pump inhibitors (PPIs) are now the preferred first-line therapy for GERD and peptic ulcer disease, as they are significantly more effective than H2-receptor antagonists. 4, 5, 6
Why PPIs Are Superior
- PPIs were proven superior to ranitidine in preventing NSAID ulcer recurrence and overall symptom control 4
- In patients who remained symptomatic after 6 weeks of ranitidine 150 mg twice daily, 70% achieved resolution with omeprazole 20 mg daily versus only 49% who continued ranitidine 6
- Complete heartburn resolution occurred in 46% of omeprazole-treated patients versus only 16% with ranitidine 6
- Even doubling the ranitidine dose to 300 mg twice daily provided complete heartburn resolution in less than 20% of poorly responsive patients 7
Alternative H2-Receptor Antagonist
- Famotidine remains available and can be used when H2-receptor antagonists are preferred over PPIs 5
- Famotidine is more effective than placebo but less effective than PPIs for GERD 5
- Unlike cimetidine, famotidine has not been linked to liver disease or gynecomastia 5
- Tachyphylaxis can develop within 6 weeks of H2-receptor antagonist therapy 5
Specific Clinical Scenarios for H2-Receptor Antagonists
- Patients taking dual antiplatelet therapy (particularly clopidogrel) may benefit from famotidine over PPIs due to potential drug interactions 5
- For stress ulcer prophylaxis in critically ill patients, low-dose famotidine (≤40 mg daily) is recommended 5
Key Clinical Pitfall
Do not attempt to prescribe ranitidine or seek alternative sources, as the contamination issue affects all ranitidine products regardless of manufacturer. The FDA withdrawal was comprehensive and applies to all formulations.