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Generic Ursodiol Information
Introduction
Ursodiol is a bile‑acid medication used primarily to dissolve cholesterol‑rich gallstones and to improve liver function in certain cholestatic liver diseases. In the United Kingdom it is classified under the Gastro Health and Cholesterol therapeutic groups. The active compound, ursodiol, is supplied by several manufacturers and is also available under well‑known brand names such as Actigall and Ursofalk. In addition to its main indications, clinicians sometimes prescribe ursodiol for secondary conditions such as primary biliary cholangitis and intra‑hepatic cholestasis of pregnancy, where modulation of bile‑acid composition is beneficial.
What is Ursodiol?
Ursodiol (also written as ursodeoxycholic acid, UDCA) is a naturally occurring secondary bile acid that can be obtained from bear bile or produced synthetically for pharmaceutical use. It belongs to the class of hydrophilic bile‑acid agents. The compound was first isolated in the 195s and later developed into a prescription medicine by pharmaceutical companies such as Schering‑Plough (now part of Merck) in the United States and by Actavis (now Allergan) for the European market.
Ursodiol is the generic version of Actigall (US) and Ursofalk (EU), containing the same active compound Ursodiol. Our online pharmacy provides this generic alternative as a cost‑effective treatment option.
How Ursodiol Works
Ursodiol is a hydrophilic bile‑acid that exerts several complementary actions:
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Cholesterol Solubilisation – It reduces the cholesterol content of bile by decreasing hepatic cholesterol secretion and by increasing the proportion of bile‑acid phospholipids, leading to a more soluble bile‑acid pool. This creates an environment in which cholesterol gallstones can gradually dissolve.
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Cytoprotective Effect – Ursodiol replaces more toxic, hydrophobic bile acids (such as deoxycholic acid) on the hepatocyte surface, protecting liver cells from detergent‑induced injury.
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Immunomodulation – In autoimmune cholestatic conditions, ursodiol dampens inflammatory cytokine production and reduces the recruitment of immune cells around the intra‑hepatic bile ducts.
The drug is absorbed from the small intestine, undergoes entero‑hepatic recirculation, and is mainly eliminated in the feces after conjugation with glycine or taurine. Therapeutic effects typically become evident after several weeks of continuous therapy, reflecting the time required for gallstone dissolution and for hepatic bile‑acid composition to remodel.
Conditions Treated with Ursodiol
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Cholesterol Gallstone Dissolution – Recommended for patients with radiolucent, cholesterol‑rich stones ≤ 2 cm in diameter who are unsuitable for surgery or who prefer a non‑invasive approach. In the UK, gallstone disease affects roughly 10 % of adults, making ursodiol a valuable alternative to cholecystectomy for selected cases.
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Primary Biliary Cholangitis (PBC) – Ursodiol is the first‑line therapy for PBC, a chronic autoimmune disease characterised by progressive destruction of intra‑hepatic bile ducts. Clinical trials have shown that a daily dose of 13–15 mg/kg improves liver biochemistry, delays disease progression, and enhances transplant‑free survival.
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Intra‑hepatic Cholestasis of Pregnancy (ICP) – By improving bile‑acid flow, ursodiol reduces maternal pruritus and decreases fetal exposure to toxic bile acids, thereby lowering the risk of pre‑term delivery.
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Primary Sclerosing Cholangitis (PSC) – Off‑label Use – Some specialists use ursodiol in PSC to modestly improve liver enzymes, although robust evidence of long‑term benefit is lacking.
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Drug‑Induced Cholestasis – When cholestasis results from medications such as oral contraceptives or anabolic steroids, ursodiol may be added to support bile‑acid clearance.
Who is Ursodiol For?
Ursodiol is appropriate for adult patients who meet any of the following criteria:
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Gallstone Patients – Individuals with radiolucent, cholesterol‑predominant gallstones ≤ 2 cm, who either decline surgery or carry surgical risk (e.g., severe cardiopulmonary disease).
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Primary Biliary Cholangitis – Newly diagnosed PBC patients, particularly those with early‑stage disease (ALP < 4 × ULN) and without advanced cirrhosis.
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Pregnant Women with ICP – Women experiencing severe pruritus and elevated serum bile acids (≥ 40 µmol/L) where symptom control and fetal protection are priorities.
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Patients with Mild Drug‑Induced Cholestasis – Those whose liver enzymes rise due to reversible medication effects and who need temporary bile‑acid support.
Ursodiol is not recommended for patients with:
- Large or calcified gallstones (> 2 cm) where dissolution is unlikely.
- Complete biliary obstruction or acute cholangitis, which require urgent decompression.
- Severe hepatic insufficiency (Child‑Pugh C) where the drug’s metabolism may be unpredictable.
- Known hypersensitivity to ursodiol or any excipients in the formulation.
Risks, Side Effects, and Interactions
Common
- Gastro‑intestinal discomfort – Diarrhoea, abdominal pain, and flatulence occur in up to 15 % of users.
- Nausea and vomiting – Typically mild and transient after initiating therapy.
- Rash or pruritus – Skin reactions are reported in 5–10 % of patients, often manageable with antihistamines.
Rare
- Hepatic enzyme elevation – Paradoxical rise in ALT/AST may be seen in < 2 % of patients; monitoring is advised.
- Alopecia – Hair thinning has been described in isolated case reports.
- Hypersensitivity reactions – Including urticaria and angio‑edema, occurring less than 1 % of the time.
Serious
- Severe cholestatic hepatitis – Rare (< .1 %) instances of worsening cholestasis have been documented, necessitating discontinuation.
- Pancreatitis – Extremely uncommon but reported in case series; patients presenting with severe abdominal pain should seek immediate care.
Drug‑Drug Interactions
- CYP3A4 substrates (e.g., statins, certain antifungals) – Ursodiol may modestly reduce plasma concentrations; dose adjustment of the co‑administered drug may be required.
- Bile‑acid sequestrants (e.g., cholestyramine) – These agents can bind ursodiol in the gut and lower its absorption; they should be taken at least 4 hours apart.
- Warfarin – Small reports suggest altered INR values; regular coagulation monitoring is prudent when both drugs are used concurrently.
Practical Use: Dosing, Missed Dose, Overdose
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Standard Dosing – For gallstone dissolution, the typical adult dose is 10–15 mg/kg divided into two daily doses taken with meals. For PBC, the recommended dose is 13–15 mg/kg once daily, usually in divided doses. Pregnant women with ICP generally receive 10–15 mg/kg divided twice daily.
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Missed Dose – If a dose is forgotten, take it as soon as it is remembered unless it is close to the time of the next scheduled dose; in that case, skip the missed dose and resume the regular schedule. Do not double‑dose to compensate.
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Overdose – Acute overdose is uncommon because the drug has a wide therapeutic window. Symptoms may include diarrhoea and abdominal cramping. Management is supportive, with hydration and observation. Seek medical attention if severe gastrointestinal symptoms or liver tenderness develop.
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Precautions –
- Take ursodiol with food to improve absorption.
- Avoid consuming excessive alcohol, which can aggravate liver stress.
- Patients with gallstone disease should have imaging follow‑up every 6–12 months to assess stone dissolution.
- Renal impairment does not significantly affect dosing, but hepatic dysfunction may necessitate dose reduction.
Buying Ursodiol from Our Online Pharmacy
Ursodiol can be purchased conveniently from our online pharmacy in the UK. We specialise in providing genuine generic medications at prices close to the manufacturer’s cost, without compromising quality.
- Affordable Pricing – By sourcing directly from licensed overseas manufacturers, we keep the cost of generic ursodiol lower than most high‑street pharmacies.
- Verified Quality – Every batch is supplied by reputable, GMP‑certified producers and undergoes independent laboratory testing before dispatch.
- Guaranteed Delivery – Discreet, tracked parcels are delivered within 7 days via express courier for premium orders, or within 2–3 weeks using standard airmail for cost‑effective options.
- Privacy‑Focused Service – As a pharmacy broker service, we collaborate with overseas licensed pharmacies to bring international medicines to the UK while respecting patient confidentiality.
For patients who struggle to obtain ursodiol through conventional NHS channels or who seek a more economical alternative, our platform offers a safe and reliable route to access this essential medication.
FAQ
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Is Ursodiol available in both brand‑name and generic forms in the UK?
Yes. The medication is sold under brand names such as Actigall and Ursofalk, as well as under its generic name Ursodiol. Generic versions contain the identical active compound and are typically less expensive. -
Can Ursodiol be stored at room temperature, or does it require refrigeration?
Ursodiol tablets should be kept at a controlled room temperature (15–30 °C). It must be protected from excess heat, moisture, and direct sunlight; refrigeration is not necessary. -
What does the packaging of Ursodiol look like when ordered online?
The medication is supplied in sealed, child‑resistant blister packs containing 30 or 60 tablets per pack, with the product name, strength, batch number, and expiry date clearly printed on the outer carton. -
Is it legal to import Ursodiol for personal use into the UK?
Personal import of a prescription medication for a valid personal need is permitted under the UK’s “personal importation scheme,” provided the quantity does not exceed a three‑month supply and the buyer possesses a valid prescription. Our pharmacy ensures compliance with all relevant regulations. -
Are there any specific warnings for Asian patients taking Ursodiol?
Some studies suggest that Asian populations may have a slightly higher incidence of benign liver enzyme elevation with ursodiol, but the overall safety profile remains comparable. Clinicians may monitor liver function more closely during the initial treatment phase. -
Does the formulation of Ursodiol differ between the EU and the US?
The active ingredient and strength are identical, but inactive excipients such as filler or binder may vary. For example, UK‑issued tablets often contain lactose, whereas some US formulations use corn‑starch. Patients with specific excipient allergies should verify the full ingredient list. -
Can I travel internationally with Ursodiol tablets?
Yes, provided you carry the medication in its original packaging with a copy of the prescription or a physician’s letter, especially when entering countries with strict drug‑import rules. Keeping the medication in your hand luggage reduces the risk of loss or temperature‑related degradation. -
What is the typical duration of therapy for gallstone dissolution?
Dissolution usually requires 6–12 months of continuous therapy, followed by imaging to confirm stone clearance. Some patients may need longer treatment if stones are larger or if bile composition normalises slowly. -
How does Ursodiol compare with surgical removal of the gallbladder?
Ursodiol offers a non‑invasive alternative that preserves the gallbladder, which can be advantageous for patients at high surgical risk. However, it is less effective for large or calcified stones, and adherence to a prolonged medication schedule is required, whereas cholecystectomy provides immediate resolution. -
Are there any drug‑testing implications for people taking Ursodiol?
Ursodiol is not a controlled substance and does not appear on standard occupational or sports drug‑screening panels. Its metabolites are natural bile acids, unlikely to trigger false‑positive results. -
What should I do if I experience persistent diarrhoea while on Ursodiol?
Mild diarrhoea is common, but if it is severe, prolonged, or accompanied by dehydration, you should contact a healthcare professional. Dose adjustment or a temporary pause in therapy may be recommended.
Glossary
- Bile‑Acid Pool
- The collection of primary and secondary bile acids circulating between the liver, gallbladder, and intestine, essential for digestion and cholesterol homeostasis.
- Cholesterol‑Rich Gallstone
- A stone formed primarily from cholesterol crystals that precipitate when bile becomes supersaturated with cholesterol, usually radiolucent on X‑ray.
- Entero‑hepatic Recirculation
- A physiological process where bile acids released into the intestine are reabsorbed in the terminal ileum and returned to the liver for reuse.
- Hydrophilic Bile Acid
- A bile acid with a high water‑solubility, such as ursodiol, that is less toxic to cell membranes compared with hydrophobic bile acids.
⚠️ Disclaimer
The information provided about Ursodiol is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Ursodiol for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.