CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

Generic: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

ANI PharmaceuticalsManufacturer
ORALRoute
CANDESARTAN CILEXETILActive Substance
2000-09-05Original Approval

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE is FDA application NDA021093, sponsored by ANI PHARMS. 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 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
72 reports
2
DIZZINESS
67 reports
3
GENERAL PHYSICAL HEALTH DETERIORATION
58 reports
4
HYPONATRAEMIA
56 reports
5
CONDITION AGGRAVATED
53 reports
6
ABDOMINAL PAIN
45 reports
7
NAUSEA
43 reports
8
ASTHMA
40 reports
9
FATIGUE
39 reports
10
FALL
38 reports