Ureleve Adverse Reactions

Adverse Reactions observed in at least 2% of patients: The incidence of treatment-emergent adverse reaction listed in the following table were derived from two 12-week, multicenter, double-blind, placebo-controlled clinical studies of Silodosin 8 mg daily in BPH patients. Adverse reactions that occurred in at least 2% of patients treated with Silodosin and more frequently than with placebo are shown in Table 3. (See Table 3.)

Click on icon to see table/diagram/image

In the two 12-week, placebo-controlled clinical trials, the following adverse events were reported by between 1% and 2% of patients receiving Silodosin and occurred more frequently than with placebo: insomnia, increased PSA, sinusitis, abdominal pain, asthenia, and rhinorrhea. One case of syncope in a patient taking prazosin concomitantly and one case of priapism were reported in the Silodosin treatment group.
In a 9-month open-label safety study of Silodosin, one case of Intraoperative Floppy Iris Syndrome (IFIS) was reported.
Post Marketing Experience: The following adverse reactions have been identified during post approval use of Silodosin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: toxic skin eruption, purpura, skin rash, pruritus, and urticaria.
Hepatobiliary disorders: jaundice, impaired hepatic function associated with increased transaminase values.
Immune system disorders: allergic-type reactions, not limited to skin reactions including swollen tongue and pharyngeal edema resulting in serious outcomes.