TRAMADOL HYDROCHLORIDE

Generic: TRAMADOL HYDROCHLORIDE

Macleods Pharmaceuticals LimitedManufacturer
ORALRoute
TRAMADOL HYDROCHLORIDEActive Substance
2025-01-31Original Approval

TRAMADOL HYDROCHLORIDE is FDA application ANDA209404, sponsored by MACLEODS 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 II2024-04-26
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plain

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tram

Top Reported Reactions

1
DEPENDENCE
7,827 reports
2
OVERDOSE
3,914 reports
3
VOMITING
3,467 reports
4
PAIN
3,129 reports
5
NAUSEA
2,975 reports
6
DRUG INEFFECTIVE
2,765 reports
7
DYSPNOEA
2,489 reports
8
OFF LABEL USE
2,481 reports
9
HEADACHE
2,469 reports
10
FATIGUE
2,436 reports