Urief

Urief Adverse Reactions

silodosin

Manufacturer:

Synmosa

Distributor:

Synmosa
Full Prescribing Info
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 γ-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. (At the time of capsule approval) Adverse reactions were reported in 887 (11.3%) of a total of 7851 patients in drug-use survey and specified drug-use survey (long term) carried out after approval. The most common adverse reactions included abnormal ejaculation (e.g. retrograde ejaculation) in 255 (3.2%) patients, diarrhea and loose stools in 207 (2.6%) patients, dizziness and light-headed feeling in 85 (1.1%) patients, nasal congestion in 81 (1.0%) patients, thirst in 64 (0.8%) patients, dizziness on standing up in 60 (0.8%) patients. (At the end of the reexamination period).
Clinically significant adverse reactions: Syncope, unconsciousness (less than 0.1%note): Since a transient unconsciousness associated with hypotension etc. may occur, patients should be carefully monitored and, in the event of any abnormalities, treatment with URIEF Cap. should be discontinued and appropriate therapeutic action taken.
Impaired hepatic function, jaundice (less than 0.1%note): 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 URIEF Cap. should be taken.
note): Based on the results of post-marketing surveillance after approval.
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
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in