Overview
Ranitidine is a commonly used drug, classified as a histamine H2-receptor antagonist, and belongs to the same drug class as cimetidine and famotidine. This drug helps to prevent and treat gastric-acid associated conditions, including ulcers, because of its ability to decrease gastric acid secretion. Ranitidine is often referred to as Zantac, and is available in various forms, including tablet, injection, and effervescent tablet preparations. The prevalence of GERD is thought to be 10-20% in western countries. Ranitidine has proven to be an effective treatment for relieving uncomfortable symptoms of gastric acid associated conditions and is therefore widely used in GERD and other gastric-acid related conditions.
Indication
This drug is used alone or with concomitant antacids for the following conditions: short-term treatment of active duodenal ulcer, treating gastric acid hypersecretion due to Zollinger-Ellison syndrome, systemic mastocytosis, and other conditions that may pathologically raise gastric acid levels. It also used in the short term treatment of active benign gastric ulcers and maintenance therapy of gastric ulcers at a reduced dose. In addition to the above, ranitidine can be used for the treatment of GERD symptoms, treatment of erosive esophagitis (endoscopically diagnosed) and the maintenance of gastric or duodenal ulcer healing.
Associated Conditions
- Acid Aspiration Syndrome
- Ankylosing Spondylitis (AS)
- Duodenal Ulcer
- Erosive Esophagitis
- Gastric Ulcer
- Gastric hypersecretion
- Gastro-esophageal Reflux Disease (GERD)
- Healing
- Heartburn
- Osteoarthritis (OA)
- Peptic Ulcer Disease
- Rheumatoid Arthritis
- Stress Ulcers
- Zollinger-Ellison Syndrome
- Active Duodenal ulcer
- Benign gastric ulcer healing
- Benign gastric ulcers
- Duodenal ulcer healing
- Post-operative peptic ulcer
- Recurrent hemorrhage from bleeding ulcers
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/12/21 | Phase 2 | Terminated | |||
2016/11/17 | Phase 1 | Recruiting | Russell Richardson | ||
2016/11/02 | Phase 4 | UNKNOWN | Federal University of São Paulo | ||
2016/04/11 | Not Applicable | Completed | |||
2016/03/07 | Not Applicable | Withdrawn | |||
2015/09/22 | N/A | Completed | Canadian Network for Observational Drug Effect Studies, CNODES | ||
2015/05/12 | Phase 4 | Completed | |||
2015/05/12 | Phase 2 | UNKNOWN | Lagos State Health Service Commission | ||
2014/07/31 | Phase 4 | Completed | Genzyme, a Sanofi Company | ||
2014/07/22 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 43353-971 | ORAL | 150 mg in 1 1 | 10/1/2014 | |
| NuCare Pharmaceuticals,Inc. | 68071-2185 | ORAL | 150 mg in 1 1 | 2/23/2021 | |
| Ajanta Pharma USA Inc. | 27241-110 | ORAL | 300 mg in 1 1 | 11/24/2021 | |
| A-S Medication Solutions | 50090-2740 | ORAL | 150 mg in 1 1 | 12/7/2018 | |
| Ajanta Pharma USA Inc. | 27241-109 | ORAL | 150 mg in 1 1 | 11/24/2021 | |
| Atlantic Biologicals Corps | 17856-0664 | ORAL | 15 mg in 1 mL | 6/15/2010 | |
| State of Florida DOH Central Pharmacy | 53808-0775 | ORAL | 150 mg in 1 1 | 4/13/2010 | |
| Wockhardt USA LLC. | 64679-907 | ORAL | 300 mg in 1 1 | 11/26/2019 | |
| WOCKHARDT LIMITED | 55648-694 | ORAL | 15 mg in 1 mL | 1/19/2011 | |
| Rebel Distributors | 21695-110 | ORAL | 300 mg in 1 1 | 12/17/2009 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ranitidine Hydrochloride Tablets | 国药准字H36021554 | 化学药品 | 片剂 | 9/7/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H22021536 | 化学药品 | 片剂 | 10/21/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H15020587 | 化学药品 | 片剂(糖衣) | 5/14/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H31022998 | 化学药品 | 片剂(薄膜衣) | 1/10/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H23022364 | 化学药品 | 片剂 | 6/19/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H51023138 | 化学药品 | 片剂 (糖衣片) | 4/21/2021 | |
| Ranitidine Hydrochloride Tablets | 国药准字H31021250 | 化学药品 | 片剂 | 3/9/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H41023402 | 化学药品 | 片剂 | 4/7/2024 | |
| Ranitidine Hydrochloride Tablets | 国药准字H37020206 | 化学药品 | 片剂 | 4/17/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H32023691 | 化学药品 | 片剂 | 5/11/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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