TRAZODONE HYDROCHLORIDE
Generic: TRAZODONE HYDROCHLORIDE
Rising Pharma HoldingsManufacturer
ORALRoute
TRAZODONE HYDROCHLORIDEActive Substance
2024-08-27Original Approval
TRAZODONE HYDROCHLORIDE is FDA application ANDA217740, sponsored by GRAVITI PHARMS. 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 III2025-12-19
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, DiFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the
Class II2026-08-24
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, ZagPresence of Foreign Tablets/Capsules
Class II2026-01-26
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 Presence of Foreign Tablets/Capsules
Class II2021-03-15
TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
DRUG INEFFECTIVE
1,212 reports
2
FATIGUE
1,157 reports
3
NAUSEA
1,123 reports
4
HEADACHE
924 reports
5
PAIN
823 reports
6
DIARRHOEA
817 reports
7
OFF LABEL USE
742 reports
8
VOMITING
704 reports
9
INSOMNIA
694 reports
10
DEPRESSION
674 reports