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Famotidine
Duexis, 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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COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
digestive system diseasesD004066
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Pepcid ac (generic drugs available since 2001-04-16, discontinued: Fluxid, Pepcid, Pepcid rpd)
Combinations
Duexis, Pepcid complete (generic drugs available since 2001-04-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcium carbonate
+
Famotidine
+
Magnesium hydroxide
Tradename
Company
Number
Date
Products
PEPCID COMPLETEJohnson & JohnsonN-020958 OTC2000-10-16
1 products, RLD, RS
Famotidine
Tradename
Company
Number
Date
Products
PEPCID ACJohnson & JohnsonN-020325 OTC1995-04-28
2 products, RLD
PEPCID ACJohnson & JohnsonN-020801 OTC2007-12-17
1 products, RLD, RS
PEPCID ACJohnson & JohnsonN-020902 OTC1999-08-05
1 products
Show 8 discontinued
Famotidine
+
Ibuprofen
Tradename
Company
Number
Date
Products
DUEXISHorizon PharmaceuticalN-022519 RX2011-04-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
duexisNew Drug Application2021-06-08
maximum strength acid reducerANDA2023-06-15
pepcid acNew Drug Application2023-04-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
duodenal ulcerEFO_0004607D004381K26
dyspepsiaEFO_0008533D004415K30
gastroesophageal refluxEFO_0003948D005764K21
heartburn—D006356R12
helicobacter infectionsEFO_1000961D016481—
peptic esophagitisEFO_1001095D004942—
stomach ulcer—D013276K25
urticariaEFO_0005531D014581L50
zollinger-ellison syndrome—D015043E16.4
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Famotidine / Ibuprofen, Duexis, Horizon
80674512026-07-18DPU-1196
83091272026-07-18DP
83182022026-07-18DP
84499102026-07-18DP
85012282026-07-18U-1196
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BA: H2-receptor antagonists
— A02BA03: Famotidine
— A02BA53: Famotidine, combinations
HCPCS
Code
Description
S0028
Injection, famotidine, 20 mg
Clinical
Clinical Trials
90 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.11732214
Gastroesophageal refluxD005764EFO_0003948K21122115
Hiv infectionsD015658EFO_0000764B202——1—3
HeartburnD006356R122——1—3
Acute coronary syndromeD054058EFO_0005672———2—2
Inferior wall myocardial infarctionD056989EFO_1000983———2—2
SchizophreniaD012559EFO_0000692F20—111—2
Peptic ulcerD010437HP_0004398K27———2—2
UlcerD014456MPATH_579——11—2
AnesthesiaD000758———1—1
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—11—12
LymphomaD008223C85.9——1——1
EsophagitisD004941HP_0100633K20——1——1
Sickle cell anemiaD000755EFO_0000697D57—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LaryngomalaciaD055092HP_000160111——12
StrokeD020521EFO_0000712I63.9—1———1
Brain edemaD001929EFO_1000845G93.6—1———1
Stomach neoplasmsD013274EFO_0003897C16—1———1
Squamous cell carcinoma of head and neckD000077195—1———1
Eosinophilic esophagitisD057765EFO_0004232K20.0—1———1
Pulmonary arterial hypertensionD000081029—1———1
DyskinesiasD020820G24—1———1
Immunoglobulin g4-related diseaseD000077733—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—18———220
Drug interactionsD0043472————2
Biological availabilityD0016822————2
NeoplasmsD009369C802————2
Autonomic nervous system diseasesD001342EFO_0009532G901————1
FibrosisD0053551————1
PsoriasisD011565EFO_0000676L401————1
Colorectal neoplasmsD0151791————1
Non-small-cell lung carcinomaD0022891————1
MelanomaD0085451————1
Show 1 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RhytidoplastyD015361————11
VomitingD014839HP_0002013R11.1————11
ExerciseD015444EFO_0000483————11
Respiratory soundsD012135HP_0010307R06.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFAMOTIDINE
INNfamotidine
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.
Classification
Small molecule
Drug classH2-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-ID76824-35-6
RxCUI4278
ChEMBL IDCHEMBL902
ChEBI ID4975
PubChem CID5702160
DrugBankDB00927
UNII ID5QZO15J2Z8 (ChemIDplus, GSRS)
Target
Agency Approved
HRH2
HRH2
Organism
Homo sapiens
Gene name
HRH2
Gene synonyms
NCBI Gene ID
Protein name
histamine H2 receptor
Protein synonyms
gastric receptor 1, Gastric receptor I
Uniprot ID
Mouse ortholog
Hrh2 (15466)
histamine H2 receptor (Q9D282)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Duexis - Horizon Therapeutics Public
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,334 documents
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Safety
Black-box Warning
Black-box warning for: Duexis
Adverse Events
Top Adverse Reactions
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78,867 adverse events reported
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