ursodiol

What is Ursodiol?

From the FDA label:Ursodiol capsules, USP are a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder practically insoluble in water; freely soluble in ethanol (96 percent), slightly soluble in acetone, practically insoluble in methylene chloride. The chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol USP has a molecular weight of 392.58. Its structure is shown below: Inactive Ingredients: Colloidal silicon dioxide, corn starch and magnesium stearate. The hard gelatin capsule shells contain gelatin, iron oxide red and titanium dioxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac. chemical structer

How to use

Ursodiol is sold in more than one form (Capsule and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA214849 — follow the label that came with the product you were actually prescribed.

Side effects

Warnings

Who should not take Ursodiol

Overdose — what happens if you take too much

Interactions

Frequently asked questions

What does Ursodiol treat?

Ursodiol (Ursodiol) may be used to treat cholelithiasis, biliary liver cirrhosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.

How is Ursodiol rated?

pharmaranks gives Ursodiol a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.

How much does Ursodiol cost?

Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $13.50 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.

Is there a coupon or discount for Ursodiol?

pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ursodiol. To pay less, Ursodiol is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.

Who makes Ursodiol?

Ursodiol is marketed by Aurobindo Pharma Ltd. You can see Aurobindo Pharma Ltd's full profile, rating, and other products on pharmaranks.

Is Ursodiol a brand-name or generic drug?

Ursodiol is a generic medication; its active ingredient is Ursodiol. Generics contain the same active ingredient as the brand-name original and are usually lower cost.

Is Ursodiol available over the counter?

No. Ursodiol is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.

What forms does Ursodiol come in?

Ursodiol is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory.

What class of drug is Ursodiol?

Ursodiol is classified as bile acid, per the FDA's Established Pharmacologic Class.

Is Ursodiol FDA-registered?

Ursodiol is on record with the U.S. FDA under application number ANDA214849. You can verify this on its official FDA label.

Has Ursodiol been recalled by the FDA?

Ursodiol has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.

Is Ursodiol safe?

There's no single safe-or-not verdict. pharmaranks gives Ursodiol a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

What are the side effects of Ursodiol?

Ursodiol's side effects are taken directly from its FDA label. From the label: The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level: GALLSTONE DISSOLUTION Ursodiol Placebo 8 to 10 mg/kg/day (N = 155) (N = 159) N (%) N (%) Bo… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.