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Zantac (ranitidine)
Ranitidine (Zantac) was once the world\
At a glance
| Generic name | ranitidine |
|---|---|
| Also known as | Zantac |
| Sponsor | GSK (originally Glaxo) |
| Drug class | H2 receptor antagonist |
| Target | Multidrug and toxin extrusion protein 1, Acetylcholinesterase, Histamine H2 receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1983-06-01 (United States) |
Approved indications
- Duodenal Ulcer due to H. Pylori
- Duodenal ulcer disease
- Erosive esophagitis
- Gastric Hypersecretory Conditions
- Gastric ulcer
- Gastroesophageal reflux disease
- Heartburn
- Indigestion
- Maintenance of Healing Gastric Ulcer
- Zollinger-Ellison syndrome
Common side effects
- Headache
- Constipation
- Diarrhea
- Nausea/Vomiting
- Abdominal Discomfort/Pain
- Rash
Serious adverse events
- Hepatocellular, Cholestatic, or Mixed Hepatitis
- Hepatic Failure
- Agranulocytosis
- Aplastic Anemia
- Acquired Immune Hemolytic Anemia
- Anaphylaxis
- Acute Interstitial Nephritis
- Pancreatitis
- Arrhythmias (Tachycardia, Bradycardia, AV Block, PVBs)
- Mental Confusion, Agitation, Depression, Hallucinations
Key clinical trials
- Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Grou (Phase 1)
- A Phase 2 Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain (Phase 2)
- A Randomized, Double-blind, Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine, Esomeprazole, and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Sub (Phase 2)
- Pragmatic Clinical Trials in Scleroderma (NA)
- Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study. (Phase 4)
- Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer (Phase 4)
- A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects (Phase 1)
- Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |