Famotidine
/ Famotidine /, Famotidine, Famotidine /, Pepcid (famotidine) is a small molecule pharmaceutical. Famotidine was first approved as Pepcid on 1986-10-15. It is used to treat duodenal ulcer, dyspepsia, gastroesophageal reflux, heartburn, and helicobacter infections amongst others in the USA. The pharmaceutical is active against histamine H2 receptor.
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Commercial
Trade Name
FDA
EMA
Famotidine, Pepcid ac (discontinued: Famotidine, Fluxid, Pepcid, Pepcid ac, Pepcid rpd)
CombinationsFamotidine, carbonate, magnesium hydroxide, Ibuprofen famotidine, Pepcid complete (discontinued: Duexis, Famotidine, carbonate, magnesium hydroxide, Ibuprofen famotidine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Famotidine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PEPCID AC | Johnson & Johnson | N-020325 OTC | 1995-04-28 | 2 products, RLD |
| PEPCID AC | Johnson & Johnson | N-020801 OTC | 2007-12-17 | 1 products, RLD, RS |
| FAMOTIDINE | Sagent Pharmaceuticals | N-219935 RX | 2025-07-16 | 3 products, RLD, RS |
Show 9 discontinued
Calcium carbonate
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Famotidine
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Magnesium hydroxide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PEPCID COMPLETE | Johnson & Johnson | N-020958 OTC | 2000-10-16 | 1 products, RLD, RS |
Famotidine
+
Ibuprofen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUEXIS | Horizon Therapeutics Public | N-022519 DISCN | 2011-04-23 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acid controller | ANDA | 2025-08-13 |
| acid reducer | ANDA | 2025-07-17 |
| acid reducer complete | ANDA | 2025-08-27 |
| acid reducer plus antacid | ANDA | 2025-08-11 |
| acid relief | ANDA | 2025-03-27 |
| amazon basic care acid reducer | ANDA | 2025-04-22 |
| basic care acid reducer | ANDA | 2025-02-10 |
| basic care dual action complete | ANDA | 2022-07-11 |
| basic care famotidine | ANDA | 2020-02-19 |
| basic care heartburn prevention | ANDA | 2023-01-01 |
Show 64 more
Indications
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EMA
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Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| S0028 | Injection, famotidine, 20 mg |
Clinical
Clinical Trials
8049 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 396 | 938 | 292 | 33 | 912 | 2360 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 44 | 36 | 34 | 41 | 605 | 742 |
| Adenocarcinoma | D000230 | — | — | 105 | 330 | 68 | 4 | 114 | 561 |
| Neoplasms | D009369 | — | C80 | 292 | 185 | 26 | 6 | 132 | 549 |
| Esophageal neoplasms | D004938 | — | C15 | 87 | 180 | 27 | 8 | 152 | 418 |
| Morbid obesity | D009767 | EFO_0001074 | — | 7 | 10 | 10 | 16 | 306 | 343 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 11 | 8 | 16 | 20 | 206 | 259 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 24 | 31 | 23 | 15 | 159 | 241 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 28 | 27 | 19 | 16 | 161 | 240 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 89 | 43 | 4 | 2 | 102 | 218 |
Show 267 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 58 | 33 | 5 | — | 16 | 94 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 29 | 21 | 2 | — | 12 | 55 |
| Prostatic neoplasms | D011471 | — | C61 | 26 | 18 | 5 | — | 12 | 54 |
| Peritoneal neoplasms | D010534 | — | — | 14 | 24 | 7 | — | 11 | 51 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 28 | 17 | 1 | — | 8 | 43 |
| Lymphoma | D008223 | — | C85.9 | 13 | 16 | 2 | — | 13 | 43 |
| Squamous cell carcinoma | D002294 | — | — | 16 | 16 | 4 | — | 10 | 42 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 10 | 23 | 3 | — | 10 | 42 |
| Colonic neoplasms | D003110 | — | C18 | 13 | 9 | 2 | — | 20 | 42 |
| Triple negative breast neoplasms | D064726 | — | — | 29 | 18 | 2 | — | 1 | 41 |
Show 166 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | 3 | 7 | — | — | 50 | 60 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 39 | 19 | — | — | 5 | 52 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 29 | 18 | — | — | 12 | 47 |
| Melanoma | D008545 | — | — | 30 | 19 | — | — | 8 | 47 |
| Small cell lung carcinoma | D055752 | — | — | 22 | 15 | — | — | 6 | 36 |
| Intestinal neoplasms | D007414 | — | C26.0 | 6 | 5 | — | — | 22 | 31 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 15 | 16 | — | — | 4 | 27 |
| Urologic neoplasms | D014571 | — | C64-C68 | 17 | 11 | — | — | 3 | 23 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | 11 | 4 | — | — | 8 | 22 |
| Fistula | D005402 | — | — | 2 | 3 | — | — | 17 | 22 |
Show 272 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anastomotic leak | D057868 | — | — | 2 | — | — | — | 26 | 28 |
| Gastrointestinal motility | D005769 | — | — | 4 | — | — | — | 8 | 12 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 1 | — | — | — | 11 | 12 |
| Feeding behavior | D005247 | — | — | 1 | — | — | — | 7 | 8 |
| Unknown primary neoplasms | D009382 | — | — | 5 | — | — | — | 2 | 7 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | 5 | 6 |
| Brain diseases | D001927 | — | G93.40 | 1 | — | — | — | 5 | 6 |
| Duodenal neoplasms | D004379 | — | — | 1 | — | — | — | 5 | 6 |
| Food diet and nutrition | D000066888 | — | — | 1 | — | — | — | 5 | 6 |
| Thymus neoplasms | D013953 | — | C37 | 3 | — | — | — | 2 | 5 |
Show 84 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Emergencies | D004630 | — | — | — | — | — | — | 17 | 17 |
| Endoscopy | D004724 | — | — | — | — | — | — | 16 | 16 |
| Gastrostomy | D005774 | — | — | — | — | — | — | 15 | 15 |
| Ultrasonography | D014463 | — | — | — | — | — | — | 15 | 15 |
| Carcinoma in situ | D002278 | — | D09.9 | — | — | — | — | 15 | 15 |
| Artificial intelligence | D001185 | — | — | — | — | — | — | 14 | 14 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 10 | 10 |
| Dyslipidemias | D050171 | — | — | — | — | — | — | 9 | 9 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 9 | 9 |
| Roux-en-y anastomosis | D000713 | — | — | — | — | — | — | 9 | 9 |
Show 612 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Famotidine |
| INN | famotidine |
| Description | Famotidine, sold under the brand name Pepcid among others, is a histamine H2 receptor antagonist medication that decreases stomach acid production. It is used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. It is taken by mouth or by injection into a vein. It begins working within an hour.
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| Classification | Small molecule |
| Drug class | H2-receptor antagonists (cimetidine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC(N)=Nc1nc(CSCC/C(N)=N/S(N)(=O)=O)cs1 |
Identifiers
| PDB | — |
| CAS-ID | 76824-35-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL902 |
| ChEBI ID | 4975 |
| PubChem CID | 5702160 |
| DrugBank | DB00927 |
| UNII ID | 5QZO15J2Z8 (ChemIDplus, GSRS) |
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Duexis – Horizon Therapeutics Public
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Famotidine
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Famotidine
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Ibuprofen
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
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Additional graphs summarizing 10,003 documents
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Safety
Black-box Warning
Black-box warning for: Ibuprofen and famotidine
Adverse Events
Top Adverse Reactions
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15,473 adverse events reported
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