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
256 reports
2
DRUG INEFFECTIVE
225 reports
3
DIZZINESS
175 reports
4
DEPRESSION
168 reports
5
HEADACHE
161 reports
6
DYSPNOEA
148 reports
7
ANXIETY
144 reports
8
INSOMNIA
144 reports
9
FATIGUE
134 reports
10
VOMITING
127 reports