Silodosin
Regulatory sources consulted
- ema-epar-EMEA/H/C/001092
- aemps-cima-84633
- https://www.ema.europa.eu/es/documents/product-information/urorec-epar-product-information_es.pdf
- https://www.ema.europa.eu/en/documents/product-information/urorec-epar-product-information_en.pdf
- https://www.ema.europa.eu/fr/documents/product-information/urorec-epar-product-information_fr.pdf
- RxNorm rxcui 720825 ↗
Approved indications
- Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Major warning · Intraoperative Floppy Iris Syndrome (IFIS): IFIS has been observed during cataract surgery in some patients on or previously treated with α1-blockers. The ophthalmologist should be prepared for possible modifications to the surgical technique. — EMA SPC
- Orthostatic hypotension: Episodes of orthostatic hypotension may occur. If symptoms appear, the patient should sit or lie down until they have disappeared. Caution is advised in patients with symptomatic orthostatic hypotension. — EMA SPC
Drug interactions
- HighKetoconazoleJ02AB02
Mechanism: Potent inhibition of CYP3A4, the main metabolic pathway for silodosin, increasing its exposure (AUC) 3.7-fold.
Recommendation: Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir) is not recommended.
EMA SPC
- HighOther alpha-adrenergic receptor antagonistsG04CA
Mechanism: Additive pharmacodynamic effect. Increased risk of hypotension and other adverse effects.
Recommendation: Concomitant use is not recommended as adequate safety data are not available.
EMA SPC
Adverse events
Common (≥1%)
Retrograde ejaculation · Dizziness · Orthostatic hypotension · Nasal congestion · Diarrhoea
Rare but serious
Syncope · Loss of consciousness · Intraoperative Floppy Iris Syndrome (IFIS)
Pregnancy and lactation
FDA category: NA
Not applicable, as silodosin is only indicated for male patients.