DOXEPIN HYDROCHLORIDE

Generic: DOXEPIN HYDROCHLORIDE

Novadoz Pharmaceuticals LLCManufacturer
ORALRoute
DOXEPIN HYDROCHLORIDEActive Substance
2023-04-03Original Approval

DOXEPIN HYDROCHLORIDE is FDA application ANDA214823, sponsored by MSN. 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
PAIN
193 reports
2
COMPLETED SUICIDE
188 reports
3
DRUG INEFFECTIVE
177 reports
4
DIZZINESS
162 reports
5
INSOMNIA
159 reports
6
TOXICITY TO VARIOUS AGENTS
153 reports
7
FALL
150 reports
8
FATIGUE
145 reports
9
ANXIETY
140 reports
10
OFF LABEL USE
126 reports