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FAMOTIDINE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Postmarketing Experience
- The following adverse reactions have been reported during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
- Cardiovascular: arrhythmia, AV block, prolonged QT interval
- Gastrointestinal: cholestatic jaundice, hepatitis
- PATIENT COUNSELING INFORMATION
- QT Prolongation
- Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations (8.6)]. Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider.
- USE IN SPECIFIC POPULATIONS
- Renal Impairment
- CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [see Warnings and Precautions (5.1)]. The clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function [see Clinical Pharmacology (12.3)]. No dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute). Dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Dosage and Administration (2.2)].
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
50
24042
Other ADRs
8934
38372653
Odds Ratio = 8.933
Drug Property Information
ATC Code(s):
- A02BA03 - famotidine
- A02BA - H2-receptor antagonists
- A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- A02 - DRUGS FOR ACID RELATED DISORDERS
- A - ALIMENTARY TRACT AND METABOLISM
- A02BA53 - famotidine
- A02BA - H2-receptor antagonists
- A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- A02 - DRUGS FOR ACID RELATED DISORDERS
- A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:FAMOTIDINE
Active Ingredient UNII:5QZO15J2Z8
Drugbank ID:DB00927
PubChem Compound:3325
CTD ID:D015738
PharmGKB:PA449586
CAS Number:76824-35-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 40.0 mg/day A02BA03
Chemical Structure: 
SMILE Code:
NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1
NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1
Reference
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[Yun Jaesuk,Hwangbo Eun,Lee Jongpill,Chon Chong-Run,Kim Peol A,Jeong In-Hye,Park Manyoung,Park Raewoong,Kang Shin-Jung,Choi Donwoong]Cardiovasc Toxicol,2015 Apr;15(2):197-202. PMID: 25253561
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