famotidine indications/contra

Stem definitionDrug idCAS RN
histamine-H2-receptor antagonists, cimetidine derivatives 1129 76824-35-6

Description:

MoleculeDescription

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

Drug dosage:

DoseUnitRoute
40 mg O
40 mg P

Approvals:

DateAgencyCompanyOrphan
Oct. 15, 1986 FDA VALEANT PHARMS NORTH

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Liver disorder 286.42 29.51 88 2773 10135 3372863
Torsade de pointes 244.51 29.51 60 2801 2969 3380029
Hepatic function abnormal 241.33 29.51 79 2782 11148 3371850
Completed suicide 236.10 29.51 102 2759 31012 3351986
Toxicity to various agents 210.38 29.51 107 2754 46947 3336051
Urticaria 204.22 29.51 90 2771 28637 3354361
Drug hypersensitivity 176.53 29.51 87 2774 35593 3347405
Rhabdomyolysis 175.22 29.51 68 2793 15661 3367337
Electrocardiogram QT prolonged 161.64 29.51 58 2803 10737 3372261
Somnolence 157.66 29.51 78 2783 32126 3350872
Cardiac arrest 154.32 29.51 73 2788 27246 3355752
Alanine aminotransferase increased 151.65 29.51 69 2792 23571 3359427
Aspartate aminotransferase increased 149.36 29.51 66 2795 21047 3361951
Tubulointerstitial nephritis 140.78 29.51 42 2819 4344 3378654
Angioedema 139.15 29.51 57 2804 15078 3367920
Drug ineffective 138.64 29.51 115 2746 115975 3267023
Overdose 130.70 29.51 70 2791 33908 3349090
Blood creatine phosphokinase increased 119.54 29.51 49 2812 12964 3370034
Platelet count decreased 118.12 29.51 61 2800 27407 3355591
Drug interaction 112.35 29.51 71 2790 46741 3336257
Pneumonia aspiration 105.69 29.51 38 2823 7050 3375948
Intentional overdose 102.45 29.51 46 2815 15179 3367819
Pyrexia 99.94 29.51 82 2779 81033 3301965
Thrombocytopenia 98.59 29.51 59 2802 35209 3347789
Delirium 97.84 29.51 39 2822 9589 3373409
Depressed level of consciousness 94.58 29.51 40 2821 11425 3371573
Renal impairment 91.46 29.51 45 2816 18216 3364782
Disseminated intravascular coagulation 87.70 29.51 32 2829 6185 3376813
Suicide attempt 85.20 29.51 41 2820 15806 3367192
Gastrooesophageal reflux disease 84.00 29.51 37 2824 11654 3371344

Pharmacologic Action:

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SourceCodeDescription
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 antagonist
CHEBI has role CHEBI:49201 anti-ulcer drug
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006635 Histamine H2 Antagonists
MeSH PA D018377 Neurotransmitter Agents
FDA MoA N0000000151 Histamine H2 Receptor Antagonists
FDA EPC N0000175784 Histamine-2 Receptor Antagonist

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
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 DOID:13976
Indigestion indication 162031009 DOID:2321
Gastroesophageal reflux disease indication 235595009 DOID:8534
Gastric ulcer indication 397825006 DOID:10808
Dyspepsia Prevention indication
Maintenance of Healing Duodenal Ulcer indication
Heartburn Prevention indication
Constipation contraindication 14760008 DOID:2089
Sarcoidosis contraindication 31541009 DOID:13404
Dehydration contraindication 34095006
Diarrhea contraindication 62315008
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Kidney disease contraindication 90708001 DOID:2527
Kidney stone contraindication 95570007
Impaired renal function disorder contraindication 197663003
Osteolysis contraindication 203522001
Disease of liver contraindication 235856003 DOID:409
Malignant tumor of stomach contraindication 363349007 DOID:10534
Upper gastrointestinal hemorrhage off-label use 37372002
Prevention of Stress Ulcer off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.84 acidic
pKa2 12.0 acidic
pKa3 6.97 Basic
pKa4 6.37 Basic
pKa5 2.56 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
26.6MG DUEXIS HORIZON PHARMA 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 DUEXIS HORIZON PHARMA 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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H2 receptor GPCR ANTAGONIST Kd 7.93 WOMBAT-PK CHEMBL
Heat shock protein HSP 90-alpha Cytosolic other IC50 5.30 WOMBAT-PK
Solute carrier family 22 member 3 Transporter IC50 4.97 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 4.44 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 4.44 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 6.12 CHEMBL
Histamine H2 receptor GPCR Kd 7 CHEMBL

External reference:

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IDSource
4017970 VUID
N0000146320 NUI
C0015620 UMLSCUI
7074 IUPHAR_LIGAND_ID
D00318 KEGG_DRUG
5QZO15J2Z8 UNII
5217 INN_ID
DB00927 DRUGBANK_ID
CHEMBL902 ChEMBL_ID
41331 MMSL
4278 RXNORM
387211002 SNOMEDCT_US
39128000 SNOMEDCT_US
4713 MMSL
d00141 MMSL
4017970 VANDF
N0000146320 NDFRT
N0000006373 NDFRT
003417 NDDF
5702160 PUBCHEM_CID
D015738 MESH_DESCRIPTOR_UI
CHEBI:4975 CHEBI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0069-0121 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0069-0125 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0069-0126 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 13 sections
Famotidine HUMAN OTC DRUG LABEL 1 0093-2748 TABLET, FILM COATED 10 mg ORAL ANDA 10 sections
Good Sense Dual Action Complete HUMAN OTC DRUG LABEL 3 0113-0032 TABLET, CHEWABLE 10 mg ORAL ANDA 9 sections
good sense acid reducer HUMAN OTC DRUG LABEL 1 0113-0141 TABLET 10 mg ORAL ANDA 9 sections
Good Sense Acid Reducer HUMAN OTC DRUG LABEL 1 0113-0194 TABLET 20 mg ORAL ANDA 9 sections
Good Sense Complete HUMAN OTC DRUG LABEL 3 0113-0321 TABLET, CHEWABLE 10 mg ORAL ANDA 9 sections
Acid Reducer HUMAN OTC DRUG LABEL 1 0113-2141 TABLET 10 mg ORAL ANDA 9 sections
Basic Care famotidine HUMAN OTC DRUG LABEL 1 0113-7194 TABLET 20 mg ORAL ANDA 9 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0172-5728 TABLET, FILM COATED 20 mg ORAL ANDA 10 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0172-5729 TABLET, FILM COATED 40 mg ORAL ANDA 10 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0179-1471 TABLET, FILM COATED 40 mg ORAL ANDA 10 sections
Pepcid HUMAN PRESCRIPTION DRUG LABEL 1 0187-4420 TABLET, FILM COATED 20 mg ORAL ANDA 11 sections
Pepcid HUMAN PRESCRIPTION DRUG LABEL 1 0187-4440 TABLET, FILM COATED 40 mg ORAL ANDA 11 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0338-5197 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 12 sections
Famotidine HUMAN OTC DRUG LABEL 1 0363-0036 TABLET, FILM COATED 20 mg ORAL ANDA 10 sections
Acid Controller HUMAN OTC DRUG LABEL 1 0363-0141 TABLET 10 mg ORAL ANDA 9 sections
Acid Controller Complete HUMAN OTC DRUG LABEL 3 0363-0321 TABLET, CHEWABLE 10 mg ORAL ANDA 9 sections
Acid Reducer Complete HUMAN OTC DRUG LABEL 3 0363-0511 TABLET, CHEWABLE 10 mg ORAL ANDA 9 sections
Acid Controller Complete HUMAN OTC DRUG LABEL 3 0363-0546 TABLET, CHEWABLE 10 mg ORAL ANDA 9 sections
Acid Controller HUMAN OTC DRUG LABEL 1 0363-0701 TABLET 20 mg ORAL ANDA 9 sections
Acid Reducer Complete HUMAN OTC DRUG LABEL 3 0363-0713 TABLET, CHEWABLE 10 mg ORAL ANDA 9 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3020 TABLET, FILM COATED 20 mg ORAL ANDA 9 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3040 TABLET, FILM COATED 40 mg ORAL ANDA 9 sections
DUO Fusion HUMAN OTC DRUG LABEL 3 0597-0315 TABLET, CHEWABLE 10 mg ORAL ANDA 13 sections
DUO Fusion HUMAN OTC DRUG LABEL 3 0597-0320 TABLET, CHEWABLE 10 mg ORAL ANDA 13 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0615-4582 TABLET, FILM COATED 20 mg ORAL ANDA 10 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0615-4594 TABLET, FILM COATED 40 mg ORAL ANDA 10 sections
Famotidine HUMAN PRESCRIPTION DRUG LABEL 1 0641-6021 INJECTION 10 mg INTRAVENOUS ANDA 12 sections