MIRABEGRON

Generic: MIRABEGRON

Lupin PharmaceuticalsManufacturer
ORALRoute
MIRABEGRONActive Substance
2022-09-28Original Approval

MIRABEGRON is FDA application ANDA209485, sponsored by LUPIN. 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 II2026-08-05
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Top Reported Reactions

1
FALL
436 reports
2
DRUG INEFFECTIVE
375 reports
3
OFF LABEL USE
363 reports
4
FATIGUE
362 reports
5
DYSPNOEA
345 reports
6
DIZZINESS
311 reports
7
NAUSEA
296 reports
8
HEADACHE
290 reports
9
DIARRHOEA
284 reports
10
MALAISE
252 reports