Withdrawn from the market (safety)

Ranitidine

ZANTAC

What it isHistamine H2 antagonist suppressing parietal-cell acid secretion; GERD and peptic ulcer disease.

Why this oneThe reformulated tablet controls the storage-related nitrosamine problem that forced older products off the market.

What limits itUse only the current reformulation. Renal impairment requires adjustment, and confusion can occur in older adults.

FDA label

FDA dosing	Population	Start	Target	Max
Active duodenal ulcer	Adults	150 mg BID (or 300 mg QHS/after evening meal)	150 mg BID	300 mg/day
Maintenance of healing, duodenal ulcer	Adults	150 mg QHS	150 mg QHS	150 mg QHS
Pathological hypersecretory conditions (e.g., Zollinger-Ellison)	Adults	150 mg BID	Adjust to individual need; continue as long as indicated	Up to 6 g/day used in severe disease
Benign gastric ulcer	Adults	150 mg BID	150 mg BID	300 mg/day
Maintenance of healing, gastric ulcer	Adults	150 mg QHS	150 mg QHS	150 mg QHS
GERD	Adults	150 mg BID	150 mg BID	300 mg/day
Erosive esophagitis	Adults	150 mg QID	150 mg QID	600 mg/day
Maintenance of healing, erosive esophagitis	Adults	150 mg BID	150 mg BID	300 mg/day
Active duodenal/gastric ulcer	Peds 1 mo-16 y	2-4 mg/kg BID	2-4 mg/kg BID	300 mg/day
Maintenance of healing, duodenal/gastric ulcer	Peds 1 mo-16 y	2-4 mg/kg QD	2-4 mg/kg QD	150 mg/day
GERD / erosive esophagitis	Peds 1 mo-16 y (limited data)	5-10 mg/kg/day, usually divided BID	5-10 mg/kg/day divided BID	10 mg/kg/day

Renal CrCl <50 mL/min: 150 mg q24h; may cautiously increase to q12h or further if needed; schedule dose to follow end of hemodialysis

Hepatic Undefined

Antacid may be given as needed for ulcer pain relief
Elderly: more likely to have decreased renal function — use caution in dose selection; consider monitoring renal function

Hepatitis (hepatocellular, cholestatic, or mixed, with or without jaundice) reported — discontinue immediately if occurs; rarely fatal, rare hepatic failure
Reversible mental confusion, agitation, depression, hallucinations reported, predominantly in severely ill elderly patients
Insufficient pharmacokinetic data in neonates (<1 month) for dosing recommendations

Headache, sometimes severe
Rare: malaise, dizziness, somnolence, insomnia, vertigo; reversible confusion/hallucinations (elderly, severely ill)
Rare arrhythmias: tachycardia, bradycardia, AV block, PVCs
Constipation, diarrhea, nausea/vomiting, abdominal discomfort; rare pancreatitis
Hepatitis (reversible; rare deaths and hepatic failure)
Blood count changes: leukopenia, granulocytopenia, thrombocytopenia; rare agranulocytosis, pancytopenia, aplastic anemia
Rash incl. rare erythema multiforme; rare alopecia, vasculitis
Rare hypersensitivity: bronchospasm, anaphylaxis, angioneurotic edema, acute interstitial nephritis

Pregnancy Undefined

Lactation Undefined

NO BOXED WARNINGS

Principal riskNo FDA boxed warning (withdrawn from the US market in 2020 over NDMA contamination).

Direct muscarinic antagonism0 / 4