METHYLERGONOVINE MALEATE
Generic: METHYLERGONOVINE
Amneal Pharmaceuticals NY LLCManufacturer
ORALRoute
METHYLERGONOVINE MALEATEActive Substance
2018-09-10Original Approval
METHYLERGONOVINE MALEATE is FDA application ANDA211483, sponsored by AMNEAL 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 II2024-03-25
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, BriFailed Dissolution Specifications
Class II2026-06-16
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and DistributSubpotent Drug
Top Reported Reactions
1
DRUG INEFFECTIVE
16 reports
2
DYSPNOEA
11 reports
3
ACCIDENTAL EXPOSURE TO PRODUCT
8 reports
4
CHEST PAIN
8 reports
5
OFF LABEL USE
8 reports
6
ACUTE PULMONARY OEDEMA
7 reports
7
ARTERIOSPASM CORONARY
7 reports
8
CARDIAC ARREST
7 reports
9
MATERNAL EXPOSURE DURING PREGNANCY
7 reports
10
WRONG DRUG ADMINISTERED
7 reports