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famotidine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
histamine-H2-receptor antagonists, cimetidine derivatives	1129	76824-35-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: famotidine agufam amfamox antodine apogastine bestidine brolin cepal digervin dispromil	A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion. Computer-aided, structure-based, virtual screening of libraries of compounds against SARS-CoV-2 proteins suggested potential for famotidine to interact with viral proteases in-volved in coronavirus replication. HOWEVER, there is no clinical trial evidence supporting efficacy or safety for treatment of COVID-19. Molecular weight: 337.44 Formula: C8H15N7O2S3 CLOGP: -0.86 LIPINSKI: 1 HAC: 9 HDO: 6 TPSA: 170.83 ALOGS: -3.48 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

famotidine
agufam
amfamox
antodine
apogastine
bestidine
brolin
cepal
digervin
dispromil

A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion. Computer-aided, structure-based, virtual screening of libraries of compounds against SARS-CoV-2 proteins suggested potential for famotidine to interact with viral proteases in-volved in coronavirus replication. HOWEVER, there is no clinical trial evidence supporting efficacy or safety for treatment of COVID-19.

Molecular weight: 337.44
Formula: C8H15N7O2S3
CLOGP: -0.86
LIPINSKI: 1
HAC: 9
HDO: 6
TPSA: 170.83
ALOGS: -3.48
ROTB: 6

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
40	mg	O
40	mg	P

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	67 %	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	6.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	42 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	2.80 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.98 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	1.20 L/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	1 mg/mL	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.84 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Oct. 15, 1986	FDA	VALEANT PHARMS NORTH

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective	440.09	9.41	1044	139050	1043721	62305207
Pemphigus	388.27	9.41	3	140091	183723	63165205
Contraindicated product administered	388.11	9.41	23	140071	217625	63131303
Synovitis	377.51	9.41	7	140087	186911	63162017
Drug intolerance	320.65	9.41	140	139954	308521	63040407
Hand deformity	310.28	9.41	9	140085	159448	63189480
Systemic lupus erythematosus	289.65	9.41	55	140039	208863	63140065
Glossodynia	282.78	9.41	32	140062	178844	63170084
Joint swelling	269.57	9.41	198	139896	327468	63021460
Arthropathy	264.29	9.41	94	140000	234698	63114230

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective	182.09	10.01	609	91574	456142	34408606
Drug abuse	177.95	10.01	25	92158	99071	34765677
Hepatic function abnormal	160.84	10.01	359	91824	44004	34820744
Toxicity to various agents	127.02	10.01	208	91975	200154	34664594
Off label use	112.31	10.01	649	91534	418875	34445873
Alanine aminotransferase increased	109.70	10.01	463	91720	80352	34784396
Aspartate aminotransferase increased	109.41	10.01	410	91773	67373	34797375
Platelet count decreased	97.58	10.01	594	91589	119123	34745625
Completed suicide	89.91	10.01	76	92107	98092	34766656
Liver disorder	85.61	10.01	235	91948	32762	34831986

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective	416.71	9.28	1225	184797	1079688	78478678
Synovitis	283.42	9.28	17	186005	150717	79407649
Hepatic function abnormal	262.61	9.28	548	185474	72559	79485807
Drug intolerance	257.63	9.28	148	185874	263971	79294395
Contraindicated product administered	248.15	9.28	36	185986	157502	79400864
Drug abuse	247.58	9.28	41	185981	162650	79395716
Joint swelling	236.06	9.28	196	185826	288450	79269916
Pemphigus	212.19	9.28	4	186018	99578	79458788
Arthropathy	210.49	9.28	75	185947	177036	79381330
Platelet count decreased	206.00	9.28	950	185072	193714	79364652

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A02BA03	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) H2-receptor antagonists
ATC	A02BA53	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) H2-receptor antagonists
CHEBI has role	CHEBI:37961	H2 receptor antagonists
CHEBI has role	CHEBI:49201	anti-ulcer drugs
CHEBI has role	CHEBI:50183	P450 inhibitors
FDA EPC	N0000175784	Histamine-2 Receptor Antagonist
FDA MoA	N0000000151	Histamine H2 Receptor Antagonists
MeSH PA	D000897	Anti-Ulcer Agents
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D018494	Histamine Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Heartburn	indication	16331000
Erosive esophagitis	indication	40719004
Duodenal ulcer disease	indication	51868009	DOID:1724
Zollinger-Ellison syndrome	indication	53132006	DOID:0050782
Peptic reflux disease	indication	57643001
Indigestion	indication	162031009
Gastroesophageal reflux disease	indication	235595009	DOID:8534
Gastric ulcer	indication	397825006	DOID:10808
Dyspepsia Prevention	indication
Maintenance of Healing Duodenal Ulcer	indication

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.84	acidic
pKa2	12.0	acidic
pKa3	6.97	Basic
pKa4	6.37	Basic
pKa5	2.56	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
26.6MG;800MG	DUEXIS	HORIZON	N022519	April 23, 2011	RX	TABLET	ORAL	8067451	July 18, 2026	RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
26.6MG;800MG	DUEXIS	HORIZON	N022519	April 23, 2011	RX	TABLET	ORAL	8501228	July 18, 2026	RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN	ANTAGONIST	Kd	7.93	WOMBAT-PK	CHEMBL
Carbonic anhydrase 2	Enzyme	P00918	CAH2_HUMAN		Ki	7.24	CHEMBL
Carbonic anhydrase 1	Enzyme	P00915	CAH1_HUMAN		Ki	6.04	CHEMBL
Carbonic anhydrase 4	Enzyme	P22748	CAH4_HUMAN		Ki	6.03	CHEMBL
Carbonic anhydrase 9	Enzyme	Q16790	CAH9_HUMAN		Ki	6.90	CHEMBL
Carbonic anhydrase 12	Enzyme	O43570	CAH12_HUMAN		Ki	7.34	CHEMBL
Carbonic anhydrase 5A, mitochondrial	Enzyme	P35218	CAH5A_HUMAN		Ki	5.84	CHEMBL
Carbonic anhydrase 5B, mitochondrial	Enzyme	Q9Y2D0	CAH5B_HUMAN		Ki	5.27	CHEMBL
Carbonic anhydrase 7	Enzyme	P43166	CAH7_HUMAN		Ki	8.52	CHEMBL
Carbonic anhydrase 6	Enzyme	P23280	CAH6_HUMAN		Ki	7.01	CHEMBL

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External reference:

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ID	Source
FO9	PDB_CHEM_ID
003417	NDDF
387211002	SNOMEDCT_US
39128000	SNOMEDCT_US
4017970	VUID
4017970	VANDF
41331	MMSL
4278	RXNORM
4713	MMSL
5217	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Acid Controller	HUMAN OTC DRUG LABEL	1	0363-0701	TABLET, FILM COATED	20 mg	ORAL	ANDA	15 sections
Acid Controller	HUMAN OTC DRUG LABEL	1	0363-0701	TABLET, FILM COATED	20 mg	ORAL	ANDA	15 sections
acid controller	HUMAN OTC DRUG LABEL	1	0363-1203	TABLET, FILM COATED	20 mg	ORAL	ANDA	15 sections
Acid ControllerOriginal Strength	HUMAN OTC DRUG LABEL	1	0363-0141	TABLET, FILM COATED	10 mg	ORAL	ANDA	15 sections
Acid ControllerOriginal Strength	HUMAN OTC DRUG LABEL	1	0363-0141	TABLET, FILM COATED	10 mg	ORAL	ANDA	15 sections
Acid Reducer Complete	HUMAN OTC DRUG LABEL	3	0363-0511	TABLET, CHEWABLE	10 mg	ORAL	ANDA	15 sections
Acid Reducer Complete	HUMAN OTC DRUG LABEL	3	0363-0511	TABLET, CHEWABLE	10 mg	ORAL	ANDA	15 sections
Acid Reducer Complete	HUMAN OTC DRUG LABEL	3	0363-0713	TABLET, CHEWABLE	10 mg	ORAL	ANDA	15 sections
Acid Reducer Complete	HUMAN OTC DRUG LABEL	3	0363-0713	TABLET, CHEWABLE	10 mg	ORAL	ANDA	15 sections
basic care acid reducer	HUMAN OTC DRUG LABEL	1	0113-7141	TABLET, FILM COATED	10 mg	ORAL	ANDA	15 sections

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