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ALISKIREN HEMIFUMARATE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

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

  • ADVERSE REACTIONS
  • Clinical Trials Experience
  • Aliskiren's effect on ECG intervals was studied in a randomized, double-blind, placebo and active-controlled (moxifloxacin), 7-day repeat dosing study with Holter-monitoring and 12 lead ECGs throughout the interdosing interval. No effect of aliskiren on QT interval was seen.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
18
42894
Other ADRs
8255
14109024

Odds Ratio = 0.718

Drug Property Information



ATC Code(s):
  • C09DX02 - aliskiren hemifumarate
    • C09DX -
    • C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09XA02 - aliskiren hemifumarate
    • C09XA - Renin-inhibitors
    • C09X - OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09XA52 - aliskiren hemifumarate
    • C09XA - Renin-inhibitors
    • C09X - OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09XA53 - aliskiren hemifumarate
    • C09XA - Renin-inhibitors
    • C09X - OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
  • C09XA54 - aliskiren hemifumarate
    • C09XA - Renin-inhibitors
    • C09X - OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
    • C - CARDIOVASCULAR SYSTEM
Active Ingredient:aliskiren hemifumarate
Active Ingredient UNII:C8A0P8G029
Drugbank ID:DB09026
PubChem Compound:5493444
CAS Number:173334-57-1
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 150.0 mg/day C09XA02
Chemical Structure:
SMILE Code:
CC(C)[[email protected]@H](CC1=CC(=C(C=C1)OC)OCCCOC)C[[email protected]@H]([[email protected]](C[[email protected]@H](C(C)C)C(=O)NCC(C)(C)C(=O)N)O)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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