DOXEPIN

Generic: DOXEPIN

Aurobindo Pharma LimitedManufacturer
ORALRoute
DOXEPIN HYDROCHLORIDEActive Substance
2024-07-25Original Approval

DOXEPIN is FDA application ANDA216041, sponsored by AUROBINDO PHARMA LTD. 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 II2025-07-25
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Pan

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim

Top Reported Reactions

1
TOXICITY TO VARIOUS AGENTS
974 reports
2
DRUG INEFFECTIVE
917 reports
3
COMPLETED SUICIDE
826 reports
4
FATIGUE
751 reports
5
PAIN
718 reports
6
NAUSEA
652 reports
7
OFF LABEL USE
603 reports
8
HEADACHE
601 reports
9
PRURITUS
594 reports
10
INSOMNIA
582 reports