VARENICLINE TARTRATE

Generic: VARENICLINE TARTRATE

Indoco Remedies LimitedManufacturer
ORALRoute
VARENICLINE TARTRATEActive Substance
2024-10-29Original Approval

VARENICLINE TARTRATE is FDA application ANDA219106, sponsored by REGCON HOLDINGS. 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 III2025-11-11
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot w

Top Reported Reactions

1
NAUSEA
786 reports
2
DEPRESSION
522 reports
3
VOMITING
494 reports
4
DRUG INEFFECTIVE
324 reports
5
SUICIDAL IDEATION
314 reports
6
DIZZINESS
300 reports
7
INSOMNIA
293 reports
8
HEADACHE
288 reports
9
ANXIETY
275 reports
10
ABNORMAL DREAMS
257 reports