BISOPROLOL FUMARATE

Generic: BISOPROLOL FUMARATE

Natco Pharma USA LLCManufacturer

ORALRoute

BISOPROLOL FUMARATEActive Substance

2005-12-14Original Approval

BISOPROLOL FUMARATE is FDA application ANDA075831, sponsored by NATCO PHARMA USA. 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 II2026-01-21

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UN

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Class II2017-10-02

Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind.

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was obse

Class II2021-03-15

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pha

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1

DYSPNOEA

2,340 reports

2

DIARRHOEA

1,954 reports

3

FATIGUE

1,905 reports

4

NAUSEA

1,872 reports

5

DIZZINESS

1,727 reports

6

DRUG INTERACTION

1,682 reports

7

MALAISE

1,591 reports

8

VOMITING

1,584 reports

9

OFF LABEL USE

1,524 reports

10

ACUTE KIDNEY INJURY

1,514 reports