Japan - Tamsulosin was marketed in 1993 for dysuria due to prostatic hypertrophy. Based on reports received during the first phase of postmarketing surveillance, hypotension was added to the precautions section of the labelling in 1994. Cases of syncope/unconsciousness were also cited with reference to case reports from other countries.
Five cases of syncope/unconsciousness due to orthostatic hypotension associated with the use of tamsulosin have since been reported in Japan.
Reference: Pharmaceuticals and Medical Devices Safety Information, 159, 22 March 2000.