Ursodiol (ursodeoxycholic acid)
اورسودیول (اورسوداکسیکولیک اسید)
🍽️ Alimentary Tract And MetabolismBile acid
Market / country: 🇺🇸 USA
Actigall (US)
🧮 Dose calculator
Gallstones · Regimen source: FDA Ursodiol · Dosage and Administration
Enter age and weight.
🛡️ Safety & information
Formulations
- 300 mg capsule — capsule 🇺🇸 USA FDA Ursodiol · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Ursodiol · Pregnancy
“Reproduction studies have been performed in rats and rabbits with ursodiol doses up to 200-fold the therapeutic dose and have revealed no evidence of impaired fertility or harm to the fetus at doses of 20- to 100-fold the human dose in rats and at 5-fold the human dose (highest dose tested) in rabbits.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Ursodiol · Nursing Mothers
“Because many drugs are excreted in human milk, caution should be exercised when ursodiol is administered to a nursing mother.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Ursodiol · Pediatric Use
“The safety and effectiveness of ursodiol in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Ursodiol · Geriatric Use
“Therefore, it is recommended that dosing proceed with caution in this population.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA019594
- DailyMed (FDA label)FDA Ursodiol
- MedlinePlus (NIH)Ursodiol
- WHO ATC/DDDA05AA02
- Darooyab (Iran)Ursodeoxycholic-Acid
🇮🇷 Registered in Iran Darooyab · G-4337/Ursodeoxycholic-Acid
Dosage forms with Iranian generic codes, per Darooyab.
- 09895 · URSODEOXYCHOLIC ACID 150MG TAB · قرص اورسودئوکسیکولیک اسید ۱۵۰ میلیگرم
- 01736 · URSODEOXYCHOLIC ACID 250MG CAP · کپسول اورسودئوکسیکولیک اسید ۲۵۰ میلیگرم
- 01273 · URSODEOXYCHOLIC ACID 250MG TAB · قرص اورسودئوکسیکولیک اسید ۲۵۰ میلیگرم
- 02497 · URSODEOXYCHOLIC ACID 300MG CAP · کپسول اورسودئوکسیکولیک اسید ۳۰۰ میلیگرم
- 12036 · URSODEOXYCHOLIC ACID 300MG TAB · قرص اورسودئوکسیکولیک اسید ۳۰۰ میلیگرم
- 17461 · URSODEOXYCHOLIC ACID 500MG TAB · قرص اورسودئوکسیکولیک اسید ۵۰۰ میلیگرم
- 52876 · URSODEOXYCHOLIC ACID SUSPENSION ORAL 250 mg/5mL 250 mL · سوسپانسیون خوراکی اورسودئوکسیکولیک اسید ۲۵۰ میلیگرم / ۵ میلیلیتر ۲۵۰ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Ursodiol · How SuppliedFDA Ursodiol · Dosage and AdministrationFDA Ursodiol · PregnancyFDA Ursodiol · Nursing MothersFDA Ursodiol · Pediatric UseFDA Ursodiol · Geriatric UseFDA Ursodiol · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4337/Ursodeoxycholic-Acid
- Clinical review⚠ Unverified