Important Safety Notice: Ranitidine Withdrawal from Market
Ranitidine should NOT be prescribed as it has been withdrawn from the market by the FDA due to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen. While the evidence provided contains historical prescribing information, this medication is no longer available for clinical use.
Historical Prescribing Information (For Reference Only)
FDA-Approved Indications
Ranitidine was indicated for 1:
- Duodenal ulcer: 150 mg twice daily or 300 mg at bedtime for 4-8 weeks acute treatment
- Maintenance therapy: Reduced dosage after ulcer healing
- Gastric ulcer: 150 mg twice daily for up to 6 weeks
- GERD: 150 mg twice daily for symptomatic relief
- Erosive esophagitis: 150 mg four times daily for treatment; maintenance dosing after healing
- Pathological hypersecretory conditions (Zollinger-Ellison syndrome): Individualized higher doses
Dosing Considerations
Adult Dosing
- Standard peptic ulcer disease: 150 mg orally twice daily or 300 mg once daily at bedtime 1, 2
- Maintenance therapy: 150 mg at bedtime 2, 3
- Hypersecretory states: Up to 1200 mg daily in divided doses 4
Pediatric Dosing
- Gastric hypersecretion in short bowel syndrome: 10-15 mg/kg/day via continuous infusion (more effective than intermittent dosing) 5
- Ranitidine demonstrated 7 times more potency than cimetidine with longer duration of action 5
Anaphylaxis (Adjunctive Therapy)
- Adults: 50 mg IV diluted in 5% dextrose over 5 minutes 5
- Children: 12.5-50 mg (1 mg/kg) IV over 5 minutes 5
- Post-discharge: Twice daily for 2-3 days 5
- Maximum dose: 75-150 mg 5
Contraindications
- Known hypersensitivity to ranitidine or any ingredient 1
Safety Profile
- Adverse events occurred in 20% of ranitidine patients vs. 27% on placebo in controlled trials 4
- Most common: headaches, tiredness, dizziness, mild GI disturbance (diarrhea, constipation, nausea) 6
- Cardiovascular effects extremely rare (1 in 1 million), mainly bradycardia/AV block with rapid IV administration 6
- Hepatotoxicity: transient LFT changes in 1 in 100-1000 patients; acute hepatitis <1 in 100,000 6
- Neuropsychiatric complications <1%, primarily in critically ill patients or those with renal/hepatic failure 6
Drug Interactions
Ranitidine has minimal drug interaction potential compared to cimetidine 7, 3:
- Does not inhibit hepatic cytochrome P450 enzymes 3
- No antiandrogenic effects 2, 3
- Safe coadministration with most medications 7
Current Clinical Alternatives
Prescribe alternative acid suppression therapy instead:
- Proton pump inhibitors (omeprazole 20 mg daily, pantoprazole 40 mg daily, etc.) 5
- Other H2 antagonists if still available: famotidine 20 mg twice daily, nizatidine 150 mg twice daily 5
Common Pitfall
The most critical error would be attempting to prescribe ranitidine at all, given its market withdrawal. Always verify current medication availability and safety alerts before prescribing any H2 antagonist.