MedeliX
Start asking

Silodosin

Silodyx, Urorec · ATC code G04CA04

Brand names: Silodyx, Urorec, Silbesan, Silodosin Al, Silodosin Amarox, Silodosin Aristo, Silodosin Heumann, Silodosin Ipca, Silodosin Vivanta, Silodosin Zentiva, Silodopin

Key facts
Active substance
Silodosin
ATC code
G04CA04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Silodyx 4 mg hard capsules / Silodyx 8 mg hard capsules · Urorec 4 mg hard capsules / Urorec 8 mg hard capsules
Marketing authorisation holder
Recordati Ireland Ltd
Information as of
2026-10-27

Key facts

Silodosin is a selective alpha-1A adrenoceptor blocker. It is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.

What it is used for

  • Signs and symptoms of benign prostatic hyperplasia (BPH) in adult men

Dosing

  • Recommended: one 8 mg capsule daily, taken with food, preferably at the same time each day
  • Moderate renal impairment: start with 4 mg once daily, may be increased to 8 mg after one week
  • Severe renal impairment (CLCR < 30 mL/min) and severe hepatic impairment: not recommended
  • No dose adjustment in the elderly, mild renal impairment or mild to moderate hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or excipients

Important warnings

  • Intraoperative floppy iris syndrome during cataract surgery; starting silodosin before scheduled cataract surgery is not recommended
  • Orthostatic effects: blood pressure reduction, rarely syncope; not recommended in orthostatic hypotension
  • Ejaculatory disorders that may temporarily affect male fertility

Side effects

  • Most frequent: ejaculatory disorders (retrograde ejaculation, anejaculation), reversible within a few days after stopping
  • Common: dizziness, orthostatic hypotension, nasal congestion, diarrhoea
  • Uncommon to rare: syncope, tachycardia, palpitations, abnormal liver function tests

Interactions

  • Metabolised via CYP3A4, alcohol dehydrogenase and UGT2B7; inhibitors (e.g. ketoconazole, itraconazole, ritonavir) and inducers (e.g. rifampicin, carbamazepine) affect levels
  • Other alpha-blockers: concomitant use not recommended

Pregnancy and breastfeeding

  • Not applicable, as intended for male patients only; reduced or absent ejaculation may temporarily affect male fertility

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Silodosin Recordati · genericRecordati Ireland Ltd · EMEA/H/C/004964
  • SilodyxRecordati Ireland Ltd · EMEA/H/C/001209
  • UrorecRecordati Ireland Ltd · EMEA/H/C/001092

Source: European Medicines Agency (EMA), product information

Germany

  • SilbesanTad Pharma Gmbh · 1 register entry
  • Silodosin AlAliud Pharma Gmbh · 1 register entry
  • Silodosin AmaroxAmarox Pharma Gmbh · 1 register entry
  • Silodosin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Silodosin HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Silodosin IpcaIpca Productos Farmaceuticos Unipessoal Lda · 1 register entry
  • Silodosin VivantaVivanta Generics S.R.O. · 1 register entry
  • Silodosin ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • SilodopinNOBEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • SilodyxRECOFARMA İLAÇ VE HAMMADDELERİ SAN.VE TİC. LTD. ŞTİ. · 1 register entry
  • UrorecRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 17 more European countries
Belgium
Silodosin Ab
Bulgaria
Пирсео, Сидарсо, Силодозин Мсн
Croatia
Niksol, Sidarso
France
Silodosine Arrow, Silodosine Biogaran, Silodosine Eg, Silodosine Sandoz, Silodosine Teva, Silodosine Viatris, Silodosine Zentiva
Hungary
Pirseo, Sidarso, Silodosin Aristo, Silodosin Krka, Silodosin Stada, Szilodoszin Zentiva
Iceland
Silodosin Recordati, Silodyx, Urorec
Italy
Silodosina Aristo, Silodosina Aurobindo, Silodosina Doc, Silodosina Eg, Silodosina Krka, Silodosina Mylan, Silodosina Sandoz, Silodosina Teva, Silodosina Vivanta, Silodosina Zentiva, Urisax, Virsil
Liechtenstein
Silodosin Recordati, Silodyx, Urorec
Lithuania
Sidarso
Netherlands
Silodosin Aurobindo, Silodosine Amarox, Silodosine Sandoz, Silodosine Teva
Norway
Silodosin Recordati, Silodyx, Urorec
Poland
Sidarso, Silodosin Aurovitas
Portugal
Silodosin Ipca, Silodosin Msn, Silodosin Vivanta, Silodosina Bluepharma, Silodosina Ciclum, Silodosina Generis, Silodosina Krka, Silodosina Mylan, Silodosina Ratiopharm, Silodosina Teva, Silodosina Tolife, Silodosina Viatris
Romania
Sidarso
Slovakia
Sidarso, Silodosin
Slovenia
Sidarso
Spain
Silodosina Abamed, Silodosina Alter, Silodosina Aristo, Silodosina Aurovitas, Silodosina Cinfa, Silodosina Krka, Silodosina Normon, Silodosina Noucor, Silodosina Pensa, Silodosina Ratiopharm, Silodosina Sandoz, Silodosina Stada, Silodosina Tarbis, Silodosina Tecnigen, Silodosina Tva-Ratiopharm, Silodosina Viatris, Silodosina Vivanta, Xilapro

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Silodyx – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/silodyx-epar-product-information_en.pdf
  2. European Medicines Agency. Urorec – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/urorec-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.