Urotex Adverse Reactions

Adverse reactions of silodosin (capsule) were reported in 391 (44.8%) of a total of 873 patients with lower urinary tract symptoms in a clinical study conducted up to the time of approval. The most common adverse reactions included abnormal ejaculation (e.g., retrograde ejaculation) in 150 (17.2%) patients, thirst in 50 (5.7%) patients, diarrhea in 35 (4.0%) patients, loose stools in 34 (3.9%) patients, dizziness on standing up in 31 (3.6%) patients, nasal congestion in 29 (3.3%) patients, dizziness in 23 (2.6%) patients, light-headed feeling in 22 (2.5%) patients, and headache in 19 (2.2%) patients. Abnormal laboratory data were reported in 185 (21.7%) of a total of 853 patients. The most common events included increased triglycerides in 62 (7.4%) patients, increased CRP in 21 (3.9%) patients, increased ALT (GPT) in 20 (2.3%) patients, increased AST (GOT) in 19 (2.2%) patients, and increased Ɣ-GTP in 19 (2.2%) patients.
It should be noted that, in the phase III double-blind comparative study, abnormal ejaculation (e.g., retrograde ejaculation) was reported in 39 (22.3%) of 175 patients.
Clinically significant adverse reactions: Syncope, unconsciousness (Incidence unknown): Since a transient unconsciousness associated with hypotension etc. may occur, patients should be carefully monitored and, in the event of any abnormalities, treatment with UROTEX should be discontinued and appropriate therapeutic action taken.
Impaired hepatic function, jaundice (Both incidence unknown): Impaired hepatic function associated with increased AST (GOT), increased ALT (GPT) etc. or jaundice may occur, patients should be carefully monitored and, in the event of any abnormalities, appropriate measures, such as discontinuation of UROTEX should be taken.
Other adverse reactions: The following adverse reactions may occur. Therefore, if any abnormalities are observed, appropriate therapeutic measures such as dosage reduction or discontinuation of treatment should be taken. (See Table 8.)

Click on icon to see table/diagram/image