NEBIVOLOL
Generic: NEBIVOLOL
Modavar Pharmaceuticals LLCManufacturer
ORALRoute
NEBIVOLOL HYDROCHLORIDEActive Substance
2021-12-17Original Approval
NEBIVOLOL is FDA application ANDA208717, sponsored by CADILA PHARMS LTD. 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 II2024-12-06
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-HightstCGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolo
Class III2025-11-18
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya PradCross Contamination with Other Products
Top Reported Reactions
1
ACUTE KIDNEY INJURY
996 reports
2
DYSPNOEA
892 reports
3
DIARRHOEA
828 reports
4
HYPOTENSION
701 reports
5
NAUSEA
682 reports
6
ANAEMIA
681 reports
7
DRUG INTERACTION
671 reports
8
DRUG INEFFECTIVE
668 reports
9
OFF LABEL USE
662 reports
10
FATIGUE
633 reports