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FAMOTIDINE
DIR Classification
Classification:Less-DIR concern
Severity Score:1
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
Rhabdomyolysis
273
42639
Other ADRs
7257
14110022
Odds Ratio = 12.449
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
CAS Number:76824-35-6
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 40.0 mg/day A02BA03
Chemical Structure: 
SMILE Code:
C1=C(N=C(S1)N=C(N)N)CSCCC(=NS(=O)(=O)N)N
C1=C(N=C(S1)N=C(N)N)CSCCC(=NS(=O)(=O)N)N
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: Rhabdomyolysis developing after transcatheter arterial chemoembolization for hepatocellular carcinoma.
[Matake Kunishige,Tajima Tsuyoshi,Yoshimitsu Kengo,Irie Hiroyuki,Aibe Hitoshi,Sugitani Atsushi,Honda Hiroshi]Cardiovasc Intervent Radiol.2009 Nov;32(6):1284-7. doi: 10.1007/s00270-009-9670-z. Epub 2009 Aug 13. PMID: 19680719
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