RANOLAZINE
Generic: RANOLAZINE
Glenmark Pharmaceuticals Inc.Manufacturer
ORALRoute
RANOLAZINEActive Substance
2019-07-05Original Approval
RANOLAZINE is FDA application ANDA211082, sponsored by GLENMARK 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 II2025-03-13
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimiteCGMP Deviations
Class II2023-10-23
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimFailed Dissolution Specifications: Out of specification for dissolution.
Top Reported Reactions
1
DEATH
826 reports
2
MYOCARDIAL INFARCTION
646 reports
3
CHEST PAIN
614 reports
4
ANGINA PECTORIS
595 reports
5
STENT PLACEMENT
582 reports
6
DYSPNOEA
439 reports
7
DIZZINESS
427 reports
8
FALL
382 reports
9
CEREBROVASCULAR ACCIDENT
356 reports
10
CARDIAC DISORDER
307 reports