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EPROSARTAN MESYLATE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • ADVERSE REACTIONS
  • Adverse Events Occurring at an Incidence of 1% or More Among Eprosartan-treated Patients
  • The following adverse events were also reported at a rate of 1% or greater in patients treated with eprosartan, but were as, or more, frequent in the placebo group: headache, myalgia, dizziness, sinusitis, diarrhea, bronchitis, dependent edema, dyspepsia, and chest pain.
  • Facial edema was reported in five patients receiving eprosartan. Angioedema has been reported with other angiotensin II antagonists. Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
2
42910
Other ADRs
1147
14116132

Odds Ratio = 0.574

Drug Property Information



ATC Code(s):
  • C09CA02 - eprosartan mesylate
    • C09CA - "Angiotensin II antagonists, plain"
    • C09C - "ANGIOTENSIN II ANTAGONISTS, PLAIN"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09DA02 - eprosartan mesylate
    • C09DA - Angiotensin II antagonists and diuretics
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
Active Ingredient:eprosartan mesylate
Active Ingredient UNII:8N2L1NX8S3
Drugbank ID:DB00876
PubChem Compound:5281037
CAS Number:133040-01-4
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 600.0 mg/day C09CA02
Chemical Structure:
SMILE Code:
CCCCC1=NC=C(N1CC2=CC=C(C=C2)C(=O)O)/C=C(\CC3=CC=CS3)/C(=O)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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