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VALSARTAN


DIR Classification


Classification:Less-DIR concern
Severity Score:1

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

  • ADVERSE REACTIONS
  • Post-Marketing Experience
  • Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
138
42774
Other ADRs
21438
14095841

Odds Ratio = 2.122

Drug Property Information



ATC Code(s):
  • C09DX02 - valsartan
    • C09DX -
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09DB08 - valsartan
    • C09DB - Angiotensin II antagonists and calcium channel blockers
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C10BX10 - valsartan
    • C10BX - "HMG CoA reductase inhibitors, other combinations"
    • C10B - "LIPID MODIFYING AGENTS, COMBINATIONS"
    • C10 - LIPID MODIFYING AGENTS
    • C - CARDIOVASCULAR SYSTEM
  • C09DB01 - valsartan
    • C09DB - Angiotensin II antagonists and calcium channel blockers
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09DX01 - valsartan
    • C09DX -
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09DA03 - valsartan
    • C09DA - Angiotensin II antagonists and diuretics
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09DX04 - valsartan
    • C09DX -
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09CA03 - valsartan
    • C09CA - "Angiotensin II antagonists, plain"
    • C09C - "ANGIOTENSIN II ANTAGONISTS, PLAIN"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
Active Ingredient:valsartan
Active Ingredient UNII:80M03YXJ7I
Drugbank ID:DB00177
PubChem Compound:60846
CAS Number:137862-53-4
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
  • 80.0 mg/day C09CA03
Chemical Structure:
SMILE Code:
CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NNN=N3)[C@@H](C(C)C)C(=O)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Rhabdomyolysis After Coadministration of Atorvastatin and Sacubitril/Valsartan (Entresto™) in a 63-Year-Old Woman.

[Faber Eve S,Gavini Madhavi,Ramirez Ronald,Sadovsky Richard]
Drug Saf Case Rep.2016 Dec;3(1):14. PMID: 27804100

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