CANDESARTAN CILEXETIL

Generic: CANDESARTAN CILEXETIL

Alembic Pharmaceuticals LimitedManufacturer
ORALRoute
CANDESARTAN CILEXETILActive Substance
2018-12-04Original Approval

CANDESARTAN CILEXETIL is FDA application ANDA210302, sponsored by ALEMBIC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2021-09-13
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV

Failed Impurities/Degradation Specifications; out of specification for Related Compound

Class III2020-10-02
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002

Out-of-specification organic impurity results obtained during routine stability testing.

Top Reported Reactions

1
DYSPNOEA
997 reports
2
FATIGUE
903 reports
3
HEADACHE
851 reports
4
NAUSEA
849 reports
5
OFF LABEL USE
840 reports
6
DIZZINESS
788 reports
7
DIARRHOEA
756 reports
8
DRUG INEFFECTIVE
733 reports
9
VOMITING
716 reports
10
FALL
692 reports