Ranitidine
Ranitidine (ranitidine) is a small molecule pharmaceutical. Ranitidine was first approved as Zantac 150 on 1983-06-09. It is used to treat duodenal ulcer, gastroesophageal reflux, peptic esophagitis, stomach ulcer, and zollinger-ellison syndrome in the USA. The pharmaceutical is active against histamine H2 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ranitidine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZANTAC 75 | Sanofi | N-020520 DISCN | 1995-12-19 | 1 products, RLD |
| ZANTAC 75 | Sanofi | N-020745 DISCN | 1998-02-26 | 1 products, RLD |
| ZANTAC 150 | Sanofi | N-021698 DISCN | 2004-08-31 | 2 products, RLD |
| ZANTAC 300 | GSK | N-018703 DISCN | 1985-12-09 | 1 products, RLD |
| ZANTAC 150 | GSK | N-018703 DISCN | 1983-06-09 | 1 products, RLD |
| ZANTAC | GSK | N-019675 DISCN | 1988-12-30 | 1 products, RLD |
| ZANTAC 25 | GSK | N-020251 DISCN | 2004-04-01 | 1 products |
| ZANTAC 150 | GSK | N-020251 DISCN | 1994-03-31 | 2 products |
| ZANTAC 150 | GSK | N-020095 DISCN | 1994-03-08 | 1 products, RLD |
| ZANTAC 300 | GSK | N-020095 DISCN | 1994-03-08 | 1 products, RLD |
| ZANTAC | PAI Pharma | N-019090 DISCN | 1984-10-19 | 1 products, RLD |
| ZANTAC IN PLASTIC CONTAINER | PAI Pharma | N-019593 DISCN | 1986-12-17 | 2 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| deramsilkrx anodynexa pak | ANDA | 2015-07-13 |
| dermasilkrx diclopak | ANDA | 2015-08-05 |
| gabitidine | unapproved drug other | 2011-08-01 |
| inflammation reduction pack | ANDA | 2015-11-18 |
| sentradine | unapproved drug other | 2011-08-01 |
| zantac 360 | ANDA | 2024-01-29 |
| zantac 360 1 per blister 6 blisters | ANDA | 2022-08-12 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J2780 | Injection, ranitidine hydrochloride, 25 mg |
Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 3 | 2 | 5 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | 1 | — | 4 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | — | 1 | — | 3 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 2 | — | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | 1 | — | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 2 | — | 2 |
| Drug interactions | D004347 | — | — | 1 | — | — | 1 | — | 2 |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | — | — | 1 | — | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | — | — | 1 | — | 1 |
| Intestinal pseudo-obstruction | D007418 | EFO_1000988 | K56.0 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 4 | 1 | — | 1 | 5 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | 1 | 3 | — | 1 | 5 |
| Stomach ulcer | D013276 | — | K25 | — | — | 3 | — | — | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 1 | — | 1 | 2 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | 1 | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | — | 1 | — | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | 1 | 1 | — | — | 1 |
| Cough | D003371 | HP_0012735 | R05 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | 1 | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 3 | — | — | — | 3 |
| Peritoneal neoplasms | D010534 | — | — | 1 | 3 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 2 | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 2 | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | — | — | — | 2 |
| Circulating neoplastic cells | D009360 | — | — | — | 1 | — | — | — | 1 |
| Immune system diseases | D007154 | — | D89.9 | 1 | 1 | — | — | — | 1 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | — | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Covid-19 | D000086382 | — | U07.1 | 1 | — | — | — | 1 | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | — | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Respiratory sounds | D012135 | HP_0010307 | R06.1 | — | — | — | — | 1 | 1 |
| Laryngomalacia | D055092 | HP_0001601 | — | — | — | — | — | 1 | 1 |
| Eosinophilia | D004802 | HP_0001880 | D72.1 | — | — | — | — | 1 | 1 |
| Poisoning | D011041 | EFO_0008546 | T65.91 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ranitidine |
| INN | ranitidine |
| Description | Ranitidine is a member of the class of furans used to treat peptic ulcer disease (PUD) and gastroesophageal reflux disease. It has a role as an anti-ulcer drug, a H2-receptor antagonist, an environmental contaminant, a xenobiotic and a drug allergen. It is a member of furans, a tertiary amino compound, a C-nitro compound and an organic sulfide. |
| Classification | Small molecule |
| Drug class | H2-receptor antagonists (cimetidine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNC(=C[N+](=O)[O-])NCCSCc1ccc(CN(C)C)o1 |
Identifiers
| PDB | — |
| CAS-ID | 66357-35-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1790041 |
| ChEBI ID | — |
| PubChem CID | 3001055 |
| DrugBank | DB00863 |
| UNII ID | 884KT10YB7 (ChemIDplus, GSRS) |
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Ranitidine – Amneal Pharmaceuticals
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Estimated US medical usage
Ranitidine
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Trends
PubMed Central
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Additional graphs summarizing 12,913 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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268,446 adverse events reported
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