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CANDESARTAN CILEXETIL
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 were identified during post-approval use of candesartan cilexetil. 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.
- The following have been very rarely reported in post-marketing experience:
- Digestive
- Abnormal hepatic function and hepatitis.
- Hematologic
- Neutropenia, leukopenia, and agranulocytosis.
- Immunologic
- Angioedema.
- Metabolic and Nutritional Disorders
- Hyperkalemia, hyponatremia.
- Respiratory System Disorders
- Cough.
- Skin and Appendages Disorders
- Pruritus, rash and urticaria.
- Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
213
42699
Other ADRs
10141
14107138
Odds Ratio = 6.94
Drug Property Information
ATC Code(s):
- C09CA06 - candesartan cilexetil
- C09CA - "Angiotensin II antagonists, plain"
- C09C - "ANGIOTENSIN II ANTAGONISTS, PLAIN"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
- C09DB07 - candesartan cilexetil
- C09DB - Angiotensin II antagonists and calcium channel blockers
- C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
- C09DA06 - candesartan cilexetil
- C09DA - Angiotensin II antagonists and diuretics
- C09D - "ANGIOTENSIN II ANTAGONISTS, COMBINATIONS"
- C09 - AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C - CARDIOVASCULAR SYSTEM
Active Ingredient:candesartan cilexetil
Active Ingredient UNII:R85M2X0D68
Drugbank ID:DB00796
PubChem Compound:2540
CAS Number:145040-37-5
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 8.0 mg/day C09CA06
Chemical Structure: 
SMILE Code:
CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NNN=N5)C(=O)OC(C)OC(=O)OC6CCCCC6
CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NNN=N5)C(=O)OC(C)OC(=O)OC6CCCCC6
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
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