TOPIRAMATE

Generic: TOPIRAMATE

Zydus Lifesciences LimitedManufacturer

ORALRoute

TOPIRAMATEActive Substance

2009-10-14Original Approval

TOPIRAMATE is FDA application ANDA078877, sponsored by ZYDUS PHARMS USA INC. 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 II2014-09-15

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distribut

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Class III2021-10-25

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut

Discoloration

Class III2013-04-05

Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Lt

Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - o

Top Reported Reactions

1

DRUG INEFFECTIVE

6,858 reports

2

OFF LABEL USE

5,521 reports

3

HEADACHE

3,602 reports

4

NAUSEA

3,233 reports

5

FATIGUE

3,098 reports

6

PRODUCT USE IN UNAPPROVED INDICATION

2,549 reports

7

PAIN

2,509 reports

8

MIGRAINE

2,492 reports

9

DIZZINESS

2,346 reports

10

SEIZURE

2,230 reports