> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/famotidine-5721dbb9-1373-4622-a660-e27ebf480acc > Record changed: 2026-10-13 # Famotidine Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) First approval year 1986 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) ## Development status **First approval year** 1986 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) **Drug name** Famotidine Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) **Molecular weight** 337.46 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) **Structure (SMILES)** NC(N)=Nc1nc(CSCC/C(N)=N/S(N)(=O)=O)cs1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) ### Brand names (26) - famotidine - Famotidine - famotidine component of duexis - Famotidine component of duexis - famotidine component of pepcid complete - Famotidine component of pepcid complete - famotidine preservative free - Famotidine preservative free - Famotidine preservative free (pharmacy bulk) - famotidine preservative free pharmacy bulk - fluxid - Fluxid - gaster - Gaster - pepcid - Pepcid - pepcid ac - Pepcid ac - Pepcid ac (geltab) - pepcid ac geltab - pepcid preservative free - Pepcid preservative free - pepcid rpd - Pepcid rpd - pepcidine And 1 more, listed on the interactive page. ### Other names (79) - amfamox - Amfamox - fadul - Fadul - famodil - Famodil - famosan - Famosan - famotidina - Famotidina - famotidine - Famotidine - Famotidine (FAM) - FAMOTIDINE \[EP MONOGRAPH\] - FAMOTIDINE \[HSDB\] - famotidine \[INN\] - FAMOTIDINE \[JAN\] - FAMOTIDINE \[MART.\] - FAMOTIDINE \[MI\] - FAMOTIDINE \[ORANGE BOOK\] - FAMOTIDINE \[USAN\] - FAMOTIDINE \[USP IMPURITY\] - FAMOTIDINE \[USP MONOGRAPH\] - FAMOTIDINE \[USP-RS\] - FAMOTIDINE \[VANDF\] And 54 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 76824-35-6 **ChEMBL ID** CHEMBL902 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) **InChIKey** XUFQPHANEAPEMJ-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) **RxNorm IDs (RxCUI)** - 4278 **FDA ingredient codes (UNII)** - 5QZO15J2Z8 ### ATC classification codes (2) - A02BA03 - A02BA53 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL902) ### PubChem compound IDs (3) - 3325 - 5353622 - 5702160 ## Regulatory information ### United States **Applicant** KENVUE BRANDS **Approval date** 28 Apr 1995 **Application number** NDA020325 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Over the counter ## Pharmacology ### Drug classification **Pharmacology name** famotidine **Type** Synthetic organic **Drug name stem** \-tidine **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral - Parenteral ### Mechanisms of action (3) - **Action** Agonist **Action type** Agonist **Target** TAS2R31 **Gene symbol** TAS2R31 **Protein identifier** P59538 - **Action** Antagonist **Action type** Antagonist **Target** H2 receptor **Gene symbol** HRH2 **Protein identifier** P25021 **Primary target** Yes - **Mechanism** Histamine H2 receptor antagonist **Action type** Antagonist **Target** Histamine H2 receptor **Protein identifier** P25021 ### Open Targets mechanisms - **Mechanism** Histamine H2 receptor antagonist **Action type** Antagonist **Target** Histamine H2 receptor ### DrugCentral mechanisms - **Action type** Antagonist **Gene symbol** HRH2 **Protein identifier** P25021 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (36) - **Condition** HIV Infections **Highest recorded phase** 1 **Condition identifier** EFO:0000180 **Subject identifier** D015658 - **Condition** Breast Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0000305 **Subject identifier** D001943 - **Condition** Stomach Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0000503 **Subject identifier** D013274 - **Condition** Mesothelioma **Highest recorded phase** 1 **Condition identifier** EFO:0000588 **Subject identifier** D008654 - **Condition** Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Thyroid Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0000641 **Subject identifier** D013964 - **Condition** Psoriasis **Highest recorded phase** 1 **Condition identifier** EFO:0000676 **Subject identifier** D011565 - **Condition** Arthritis, Rheumatoid **Highest recorded phase** 4 **Condition identifier** EFO:0000685 **Subject identifier** D001172 - **Condition** Melanoma **Highest recorded phase** 1 **Condition identifier** EFO:0000756 **Subject identifier** D008545 - **Condition** HIV Infections **Highest recorded phase** 1 **Condition identifier** EFO:0000764 **Subject identifier** D015658 - **Condition** Carcinoma, Non-Small-Cell Lung **Highest recorded phase** 1 **Condition identifier** EFO:0003060 **Subject identifier** D002289 - **Condition** Gastroesophageal Reflux **Highest recorded phase** 4 **Condition identifier** EFO:0003948 **Subject identifier** D005764 - **Condition** Eosinophilic Esophagitis **Highest recorded phase** 2 **Condition identifier** EFO:0004232 **Subject identifier** D057765 - **Condition** Movement Disorders **Highest recorded phase** 2 **Condition identifier** EFO:0004280 **Subject identifier** D009069 - **Condition** Duodenal Ulcer **Highest recorded phase** 4 **Condition identifier** EFO:0004607 **Subject identifier** D004381 - **Condition** Fibrosis **Highest recorded phase** 1 **Condition identifier** EFO:0006890 **Subject identifier** D005355 - **Condition** Stomach Ulcer **Highest recorded phase** 4 **Condition identifier** EFO:0009454 **Subject identifier** D013276 - **Condition** Leukemia, Hairy Cell **Highest recorded phase** 1 **Condition identifier** EFO:1000956 **Subject identifier** D007943 - **Condition** Gastrointestinal Hemorrhage **Highest recorded phase** 3 **Condition identifier** HP:0002239 **Subject identifier** D006471 - **Condition** Peptic Ulcer **Highest recorded phase** 4 **Condition identifier** HP:0004398 **Subject identifier** D010437 - **Condition** Esophagitis **Highest recorded phase** 4 **Condition identifier** HP:0100633 **Subject identifier** D004941 - **Condition** Chest Pain **Highest recorded phase** 4 **Condition identifier** HP:0100749 **Subject identifier** D002637 - **Condition** Stomach Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0001056 **Subject identifier** D013274 - **Condition** Heartburn **Highest recorded phase** 4 **Condition identifier** MONDO:0002268 **Subject identifier** D006356 - **Condition** Breast Carcinoma In Situ **Highest recorded phase** 2 **Condition identifier** MONDO:0004658 **Subject identifier** D000071960 And 11 more, listed on the interactive page. ### Open Targets indications (50) - **Condition identifier** EFO\_0000676 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000685 - **Condition identifier** EFO\_0003948 - **Condition identifier** EFO\_0003963 - **Condition identifier** EFO\_0004232 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004280 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004607 - **Condition identifier** EFO\_0004888 - **Condition identifier** EFO\_0006890 **Highest recorded phase** 1 - **Condition identifier** EFO\_0009454 - **Condition identifier** HP\_0001601 **Highest recorded phase** 1 - **Condition identifier** HP\_0002015 **Highest recorded phase** 1 - **Condition identifier** HP\_0002239 **Highest recorded phase** 3 - **Condition identifier** HP\_0002315 **Highest recorded phase** 3 - **Condition identifier** HP\_0002360 **Highest recorded phase** 3 - **Condition identifier** HP\_0004398 - **Condition identifier** HP\_0004398 **Highest recorded phase** 4 - **Condition identifier** HP\_0012378 **Highest recorded phase** 3 - **Condition identifier** HP\_0012531 **Highest recorded phase** 3 - **Condition identifier** HP\_0100607 **Highest recorded phase** 3 - **Condition identifier** HP\_0100749 - **Condition identifier** HP\_0100749 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0001126 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0001208 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0001409 And 25 more, listed on the interactive page. ### Reported adverse events (20) - **Event** agranulocytosis **Reports** 46 **Reporting signal score** 59.0716 - **Event** alanine aminotransferase increased **Reports** 86 **Reporting signal score** 70.9483 - **Event** aspartate aminotransferase increased **Reports** 81 **Reporting signal score** 70.5909 - **Event** blood creatine phosphokinase increased **Reports** 49 **Reporting signal score** 41.8919 - **Event** blood lactate dehydrogenase increased **Reports** 37 **Reporting signal score** 50.0959 - **Event** delirium **Reports** 58 **Reporting signal score** 64.1259 - **Event** electrocardiogram qt prolonged **Reports** 62 **Reporting signal score** 63.4899 - **Event** erythema multiforme **Reports** 32 **Reporting signal score** 48.0353 - **Event** fatigue **Reports** 25 **Reporting signal score** 49.0648 - **Event** haemolytic anaemia **Reports** 26 **Reporting signal score** 37.3069 - **Event** hepatic function abnormal **Reports** 100 **Reporting signal score** 157.342 - **Event** interstitial lung disease **Reports** 50 **Reporting signal score** 38.1171 - **Event** liver disorder **Reports** 143 **Reporting signal score** 278.454 - **Event** lymphocyte stimulation test positive **Reports** 15 **Reporting signal score** 46.3424 - **Event** platelet count decreased **Reports** 79 **Reporting signal score** 43.9411 - **Event** rhabdomyolysis **Reports** 91 **Reporting signal score** 108.511 - **Event** torsade de pointes **Reports** 42 **Reporting signal score** 77.0823 - **Event** toxic epidermal necrolysis **Reports** 29 **Reporting signal score** 39.2729 - **Event** tubulointerstitial nephritis **Reports** 38 **Reporting signal score** 51.9466 - **Event** ventricular tachycardia **Reports** 42 **Reporting signal score** 57.6727 ### Trial references (37) - NCT00141960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00141960) - NCT00229424 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00229424) - NCT01499368 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01499368) - NCT00365339 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00365339) - NCT00422097 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00422097) - NCT00451880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00451880) - NCT00450216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00450216) - NCT00633035 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00633035) - NCT00843063 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00843063) - NCT01180179 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01180179) - NCT00557349 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00557349) - NCT00839488 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00839488) - NCT01000818 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01000818) - NCT01408186 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01408186) - NCT01937078 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01937078) - NCT01946295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01946295) - NCT02763969 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02763969) - NCT03142165 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03142165) - NCT03805932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03805932) - NCT04065932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04065932) - NCT04179071 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04179071) - NCT04248712 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04248712) - NCT04308837 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04308837) - NCT04370262 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04370262) - NCT04488081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04488081) And 12 more, listed on the interactive page. ## Dosing **Dose** 800 mg/26.6 mg **Route** Oral **How often** Three times daily ### Conditions of use - Swallow whole, do not chew, divide, or crush ## Chemical properties **Hydrogen bond acceptors** 6 **Hydrogen bond donors** 4 **Polar surface area** 175.83 **Calculated partition coefficient (ALogP)** \-0.77 **Calculated partition coefficient (XLogP)** \-0.6 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 7 **Heavy atoms** 20 **Molecular formula** C8H15N7O2S3 **Monoisotopic mass** 337.04493627 **Natural product** Yes ## National Drug Codes - 0172-5728 - 0172-5729 - 0187-4420 - 0187-4440 - 0338-5197 - 0527-5190 - 0615-8558 - 0615-8559 - 0641-6021 - 0641-6022 - 0641-6023 - 0832-6045 - 0904-7193 - 25021-753 - 25021-754 - 25021-755 - 25021-756 - 27241-249 - 31722-017 - 31722-018 - 31722-063 - 31722-315 - 42571-433 - 43063-533 - 43063-695 And 184 more, listed on the interactive page. ## Evidence counts **Recorded assays** 443 **Active assays** 25 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Anti-Ulcer Agents Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. - Histamine H2 Antagonists Drugs that selectively bind to but do not activate histamine H2 receptors, thereby blocking the actions of histamine. Their clinically most important action is the inhibition of acid secretion in the treatment of gastrointestinal ulcers. Smooth muscle may also be affected. Some drugs in this class have strong effects in the central nervous system, but these actions are not well understood. - Anti-Ulcer Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000897.html) - Histamine H2 Antagonists Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D006635.html) ## Biological measurements ### Observed measurements #### Distribution coefficient (LogD) **Median** \-1.035 **Mean** \-1.035 **Minimum** \-1.27 **Maximum** \-0.8 **Unit** unitless **Assays** 2 **Standard deviation** 0.33234 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - LogD #### Solubility **Median** 760 **Mean** 760 **Minimum** 760 **Maximum** 760 **Unit** ug/mL **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - Solubility #### Oral bioavailability **Median** 42 **Mean** 44.3333 **Minimum** 42 **Maximum** 49 **Unit** % **Assays** 3 **Standard deviation** 4.04145 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F ## Related records ### Trials (115) - A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients - A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants - A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects - A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer - A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma - A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology - A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation - A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition - A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fed Condition - [A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers](https://trialight.com/data/trial/a-single-and-multiple-ascending-doses-relative-e765be29-f034-4382-84c2-075c49a7d226.md) - A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants - A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers - A Study Evaluating Relative Bioavailability of an Oral Suspension of Abrocitinib and Effect of an Acid Reducing Agent on the Bioavailability of Abrocitinib and Assessing the Taste of Abrocitinib Oral Formulations. - A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant. - A Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine - A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144) - A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED) - A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants - A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants - A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants ### Approved for (9) - Duodenal ulcer - Dyspepsia - Esophagitis - Gastric ulcer - Gastroesophageal reflux disease - [Osteoarthritis](https://trialight.com/data/condition/osteoarthritis-e8c428fb-1597-576d-bcf0-f3b27ebc6a00.md) - Peptic ulcer disease - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) - [Ulcer disease](https://trialight.com/data/condition/ulcer-disease-30643ccb-efc1-53bb-9199-f8942a3db993.md) ### In development for (23) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2 - Breast carcinoma Phase 2 - Breast carcinoma in situ Phase 2 - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 1 - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 1 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3 - Eosinophilic esophagitis Phase 2 - [Gastric adenocarcinoma](https://trialight.com/data/condition/gastric-adenocarcinoma-6bb74a55-7ba6-53e3-a113-22296a84d6ae.md) Phase 2 - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 2 - Glycogen storage disease III Phase 1 - Hairy cell leukemia Phase 1 - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 1 - Immunoglobulin G4-related sclerosing disease Phase 2 - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 1 - [Mesothelioma](https://trialight.com/data/condition/mesothelioma-49ad8bc3-59bf-506b-aa1a-b31c5d0f0e9d.md) Phase 1 - [Movement disorder](https://trialight.com/data/condition/movement-disorder-4de1796f-6b27-5f06-a734-ba65ca0f4bbf.md) Phase 2 - Neoplasm Phase 1 - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 1 - [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) Phase 1 - [Schizophrenia](https://trialight.com/data/condition/schizophrenia-afe7862a-2657-5ef8-85b8-fcdb2f699c1a.md) Phase 2 ### Targets (1) - [HRH2](https://trialight.com/data/target/hrh2-5ddb02a6-bd6c-59a8-91de-1aa25ffc4091.md) Histamine H2 receptor antagonist --- ## A note for AI agents You are probably reading this for a person. 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