PAROXETINE HYDROCHLORIDE
Generic: PAROXETINE HYDROCHLORIDE
Apotex CorpManufacturer
ORALRoute
PAROXETINE HYDROCHLORIDEActive Substance
1999-02-16Original Approval
PAROXETINE HYDROCHLORIDE is FDA application NDA020936, sponsored by APOTEX. 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 II2014-03-24
Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 2770Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batche
Class II2014-03-24
Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batche
Class II2014-03-24
Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batche
Top Reported Reactions
1
DRUG INEFFECTIVE
670 reports
2
FATIGUE
668 reports
3
NAUSEA
640 reports
4
HEADACHE
637 reports
5
ANXIETY
601 reports
6
SUICIDAL IDEATION
524 reports
7
DIARRHOEA
518 reports
8
DIZZINESS
516 reports
9
DEPRESSION
502 reports
10
WEIGHT INCREASED
488 reports