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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)[C@@H](CC1=CC(=C(C=C1)OC)OCCCOC)C[C@@H]([C@H](C[C@@H](C(C)C)C(=O)NCC(C)(C)C(=O)N)O)N
CC(C)[C@@H](CC1=CC(=C(C=C1)OC)OCCCOC)C[C@@H]([C@H](C[C@@H](C(C)C)C(=O)NCC(C)(C)C(=O)N)O)N
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
N/ADisclaimer:
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