FINGOLIMOD

Generic: FINGOLIMOD

Teva PharmaceuticalsManufacturer
ORALRoute
FINGOLIMOD HYDROCHLORIDEActive Substance
2020-07-02Original Approval

FINGOLIMOD is FDA application ANDA208008, sponsored by TEVA PHARMS USA. 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 II2023-07-11
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by:

Failed Dissolution Specifications

Top Reported Reactions

1
MULTIPLE SCLEROSIS RELAPSE
600 reports
2
LYMPHOPENIA
475 reports
3
MULTIPLE SCLEROSIS
330 reports
4
FATIGUE
300 reports
5
DRUG INEFFECTIVE
268 reports
6
HEADACHE
212 reports
7
LYMPHOCYTE COUNT DECREASED
196 reports
8
COVID-19
172 reports
9
DIZZINESS
165 reports
10
GAIT DISTURBANCE
161 reports