Adverse Drug Reactions

Adverse reactions of silodosin 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 y-GTP in 19 (2.2%) patients. It should be noted that, in the phase Ill 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 Silodosin (Urief®) 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 this drug 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.

Unknown
Frequency
≥5% 1-5% 0.1-1%
Genito-urinary Abnormal ejaculation
(e.g., retrograde ejaculation)
Impotence, urinary incontinence
Gastrointestinal Stomatitis Thirst Stomach discomfort, diarrhea, loose stools, constipation Vomiting, nausea, anorexia, stomachache, abdominal pain, enlarged feeling of abdomen, epigastric discomfort, lower abdominal pain, gastric ulcer, gastritis, atrophic gastritis, heartburn, heavy stomach feeling, duodenal ulcer, increased flatus, increased defecation, feeling of residual stool, anal discomfort
Nervous system/ Psychiatric Numbness Dizziness, dizziness on standing up,
light-headed feeling, headache
Shoulder stiffness, numbness of fingers, twilight state, sleepiness, decreased libido, dull headache
Respiratory Epistaxis, nasal congestion Nasal discharge, coughing
Cardiovascular Atrial fibrillation, palpitations, tachycardia, arrhythmia, supraventricular extrasystole, orthostatic
hypotension, hypotension, hypertension
Hypersensitivity Lip swelling, swollen tongue, pharygeal edema, facial swelling, eyelid edema Rash, eruption, eczema, urticaria, itching
Ocular Intra-operative floppy iris syndrome (IFIS), filmy vision Ocular hyperemia, ocular pruritus, conjunctival
bleeding
Hepatic AST(GOT) increased, ALT(GPT increased, y-GTP increased, total bilirubin increased,
Al-P increased, LDH increased
Renal BUN increased, creatinine increased
Hematologic WBC decreased, RBC decreased,
hemoglobin decreased,
hematocrit decreased
Leukocytosis, thrombocytopenia
Others Edema, gynecomastia Increased triglyceride Malaise, CRP increased, total cholesterol increased, urine sugar increased, urinary sediment increased Facial hot flushes, tinnitus, bitter taste, chest pain, lumbar pain, weakness of lower extremities, sweating, hot flush, mood disorder, serum potassium increased, total protein decreased, prostate specific antigen increased, uric acid increased, urinary protein increased

Reporting of suspected adverse drug reactions
Please contact:
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: www.fda.gov.ph