Ursodiol
Cholex, Proursan, Safrax, Surol · ATC code A05AA02
Also known as: Ursodeoxycholsäure, Acido ursodesossicolico, Acide ursodésoxycholique, Ácido ursodesoxicólico · Brand names: Reltone 200 mg, Reltone 400 mg, Urso 250, Urso Forte, Ursolign, Cholex, Proursan, Safrax, Surol, Ugefal, Ursabay, Ursactive, Ursilon Retard, Ursocolik, Ursodin …
- Key facts
- Active substance
- Ursodiol
- ATC code
- A05AA02
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Ursodiol (ursodeoxycholic acid) is a bile acid. Per the US label it is used to dissolve radiolucent gallbladder stones and to prevent gallstones during rapid weight loss.
What it is used for
- Radiolucent, noncalcified gallbladder stones < 20 mm in patients with increased surgical risk or who refuse surgery
- Prevention of gallstone formation in obese patients undergoing rapid weight loss
Dosing
- Gallstone dissolution: 8 - 10 mg/kg/day in 2 or 3 divided doses
- Gallbladder ultrasound at 6-month intervals in the first year; confirm apparent dissolution within 1 to 3 months
- If no partial dissolution by 12 months, success is much less likely
- Gallstone prevention during rapid weight loss: 600 mg/day (300 mg b.i.d.)
Contraindications
- Calcified cholesterol stones, radiopaque stones or radiolucent bile pigment stones (not dissolved)
- Compelling reasons for cholecystectomy (e.g. acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-gastrointestinal fistula)
- Allergy to bile acids
Important warnings
- Safety of use beyond 24 months is not established
- Monitor response by ultrasound at regular intervals
Side effects
- Frequently reported in trials: abdominal pain, diarrhoea, dyspepsia, nausea, headache
- Upper respiratory tract infection, sinusitis, viral infection
- Nature and frequency similar to placebo
Summary of the official product information, written with AI on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
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.
USA
- Reltone 200 mgIntra-Sana Laboratories · 1 register entry
- Reltone 400 mgIntra-Sana Laboratories · 1 register entry
- Urso 250Allergan, Inc. · 1 register entry
- Urso ForteAllergan, Inc. · 1 register entry
- UrsolignPangea Pharmaceuticals, LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Turkey
- CholexWİL İLAÇ SAN. İÇ VE DIŞ TİC. A.Ş. · 2 register entries
- ProursanVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- SafraxİLKO İLAÇ SAN.VE TİC. A.Ş. · 1 register entry
- SurolHELBA İLAÇ İÇ VE DIŞ SAN. TİC. A.Ş. · 2 register entries
- UgefalGENVEON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- UrsabayATABAY KİMYA SAN. VE TİC. A.Ş. · 1 register entry
- UrsactiveHUMANİS SAĞLIK A.Ş. · 3 register entries
- Ursilon RetardPLATİN KİMYA MÜMESSİLLİK VE DIŞ TİC. A.Ş. · 2 register entries
- UrsocolikKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
- UrsodinDİNÇSA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- UrsoductVEFARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 5 register entries
- UrsofalkALİ RAİF İLAÇ SAN. A.Ş. · 2 register entries
Show all 17 brand names
- UrsogepNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 1 register entry
- UrsokolPHARMER DANIŞMANLIK SAĞLIK VE KOZMETİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ. · 4 register entries
- UrsolvanBİLİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- UrsomedWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 7 register entries
- UrsovefVEFA İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. Ursodiol (AvKARE) – Prescribing Information, 2026-01-19. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=00c47258-aef0-53f6-e063-6294a90af96f
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- 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: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.