Silodosin is an alpha-adrenergic blocker indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), among other approved uses. It is available as capsules for oral use. MedsAcross supplies Silodosin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsule is not indicated for the treatment of hypertension. Silodosin capsule, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Source: US FDA prescribing information
Silodosin is a selective antagonist of post-synaptic alpha-1 adrenoreceptors, which are located in the human prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. Blockade of these alpha-1 adrenoreceptors can cause smooth muscle in these tissues to relax, resulting in an improvement in urine flow and a reduction in BPH symptoms. An in vitro study examining binding affinity of silodosin to the three subtypes of the alpha-1 adrenoreceptors (alpha-1A, alpha-1B, and alpha-1D) was conducted. The results of the study demonstrated that silodosin binds with high affinity to the alpha-1A subtype.
Source: US FDA prescribing information
8 mg capsules taken orally once daily with a meal. 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30 to 50 mL/min].
Source: US FDA prescribing information
Severe renal impairment (CCr < 30 mL/min) Severe hepatic impairment (Child-Pugh score ≥ 10) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) Patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)]. Patients with severe hepatic impairment (Child-Pugh score >10). Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir).
Source: US FDA prescribing information
Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning silodosin treatment. In patients with moderate renal impairment, silodosin dose should be reduced to 4 mg once daily. Silodosin should not be used in combination with other alpha-blockers. Examine patients thought to have BPH prior to starting therapy with silodosin to rule out the presence of carcinoma of the prostate. Inform patients planning cataract surgery to notify their ophthalmologist that they are taking silodosin because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS).
Source: US FDA prescribing information
Most common adverse reactions (incidence > 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.
Source: US FDA prescribing information
Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. Alpha-blockers: Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. Concomitant use of PDE5 inhibitors with alpha-blockers including silodosin can potentially cause symptomatic hypotension.
Source: US FDA prescribing information
Storage Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F). Protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Silodosin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Silodosin 8 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Silodosin 4 mg capsuleOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Silodosin and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Silodosin on 8 October 2008, according to Drugs@FDA.
Yes. Silodosin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Silodosin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Silodosin is classified under ATC code G04CA04 (Silodosin).
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