AMANTADINE HYDROCHLORIDE

Generic: AMANTADINE HYDROCHLORIDE

BAJAJ MEDICALManufacturer
ORALRoute
AMANTADINE HYDROCHLORIDEActive Substance
2002-09-11Original Approval

AMANTADINE HYDROCHLORIDE is FDA application ANDA075819, sponsored by ADAPTIS. 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 II2021-03-15
Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
FALL
161 reports
2
GAIT DISTURBANCE
145 reports
3
DRUG INEFFECTIVE
132 reports
4
HALLUCINATION
132 reports
5
OFF LABEL USE
132 reports
6
FATIGUE
129 reports
7
SPEECH DISORDER
115 reports
8
DYSKINESIA
109 reports
9
CONSTIPATION
96 reports
10
TREMOR
95 reports