BENZTROPINE MESYLATE

Generic: BENZTROPINE MESYLATE

Chartwell RXManufacturer
ORALRoute
BENZTROPINE MESYLATEActive Substance
1992-01-23Original Approval

BENZTROPINE MESYLATE is FDA application ANDA081265, sponsored by CHARTWELL RX. 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 II2013-07-01
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured f

Presence of particulate matter: characterized as thin colorless flakes that are visually and chemic

Top Reported Reactions

1
DRUG INEFFECTIVE
461 reports
2
COMPLETED SUICIDE
438 reports
3
TOXICITY TO VARIOUS AGENTS
403 reports
4
OFF LABEL USE
372 reports
5
DRUG INTERACTION
344 reports
6
DEATH
331 reports
7
TREMOR
321 reports
8
FALL
252 reports
9
FATIGUE
242 reports
10
NAUSEA
242 reports