TAMSULOSIN HYDROCHLORIDE

Generic: TAMSULOSIN HYDROCHLORIDE

Sun Pharmaceutical IndustriesManufacturer
ORALRoute
TAMSULOSIN HYDROCHLORIDEActive Substance
2010-07-15Original Approval

TAMSULOSIN HYDROCHLORIDE is FDA application ANDA090931, sponsored by SUN PHARM INDS 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 II2019-07-17
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15)

Failed Dissolution Specifications

Class II2019-02-22
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mu

Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed durin

Top Reported Reactions

1
FATIGUE
1,513 reports
2
DYSPNOEA
1,442 reports
3
DIZZINESS
1,242 reports
4
DIARRHOEA
1,230 reports
5
OFF LABEL USE
1,049 reports
6
DRUG INEFFECTIVE
979 reports
7
HEADACHE
966 reports
8
FALL
907 reports
9
ASTHENIA
900 reports
10
NAUSEA
875 reports