Category- Allopathy
Medicine Highlights
| Uses | 1. To dissolve cholesterol gallstones in the gallbladder. 2. To prevent gallstone formation 3. To treat primary bile cholangitis (damage and closing of bile ducts) |
| Common Side Effects | 1. Back pain 2. Bleeding gums 3. Blurred vision 4. Chest pain, tightness, or discomfort 5. Confusion 6. Cough 7. Coughing up blood 8. Difficult or trouble breathing 9. Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position 11. Fast, slow, or irregular heartbeat 12. Headache 13. Increased menstrual flow or vaginal bleeding 14. Lightheadedness, dizziness, or fainting 15. Loss of consciousness 16. Nausea or vomiting 17. Nervousness 18. Nosebleeds 19. Paralysis 20. Pounding in the ears 21. Prolonged bleeding from cuts 22. Red or black, tarry stools 23. Red or dark brown urine 24. Sweating 25. Unusual bleeding or bruising 26. Unusual tiredness or weakness |
| Additional Information | 1. Take this medication after consuming food to help your body absorb it better and reduce stomach upset. 2. Take this medicine only after consulting a doctor. 3. Its off label uses include intrahepatic cholestasis of pregnancy (a condition in which pregnant women get itching all over the body due to accumulation of bile in the body) and nonalcoholic fatty liver disease |
| Storage | 1. The medicine should be stored at room temperature. 2. Keep away from sunlight and moisture. 3. Keep away from the reach of children |
| How to Take This Medicine | Swallow this medicine with water. |
Ursodiol Uses
Ursodiol 450 mg (SR) is an oral medicine belonging to the category of histamine inhibitors and is used for the following indications, which include:
- Gallstones
- Primary bile cholangitis (damage and closing of bile ducts)
- Intrahepatic cholestasis of pregnancy (a condition in which pregnant women get itching all over the body due to accumulation of bile in body)
- Nonalcoholic fatty liver disease.
Ursodiol side effects
More Common
- Upset stomach, nausea, vomiting
- Diarrhea, constipation
- Cough, sore throat
- Painful urination
- Hair loss
- Back pain.
Less Common
- Pain or burning when you urinate
- Stomach pain or discomfort, constipation, vomiting
- Liver problems nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
- Signs of a new infection sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, and trouble swallowing.
How Ursodiol works
Ursodiol works by acting like a gentle detergent in the body’s plumbing system: it replaces harsh bile acids with softer ones, thins the bile so it flows smoothly out of the body instead of forming stones, and protects the liver’s tiny veins from damage while also calming down the body’s immune attack on them.
Safety Measures and Warning
Pregnancy
Ursodiol is usually safe in pregnancy and used in intrahepatic cholestasis, but it should always be taken under medical supervision, at the lowest dose needed.
Breastfeeding
Ursodiol is considered safe to use while breastfeeding. Only very small amounts pass into breast milk, far less than doses sometimes directly given to newborns for stomach acid problems, so it is not expected to harm the baby.
Kidney and Liver Problems
Ursodiol is safe to use in kidney or liver disease.
Ursodiol Interaction with Food Product
Avoid consuming alcohol and smoking simultaneously, as it may affect the drug’s action and show effects like falling blood pressure, leading to severe drowsiness, sedation, and coma in severe cases.
Ursodiol Interaction with Other Medicines
Avoid taking Ursodiol 450 mg with the following medicines, as it may increase or decrease the desired effect, or in worse cases, it could be fatal:
Ursodiol Chemical Structure
IUPAC (International Union of Pure and Applied Chemistry)/ Chemical name
(3α,7β)-Dihydroxy-5β-cholan-24-oic acid.
Intake routine/cycle
Daily dose
Take Ursodiol exactly as your doctor recommends. The dose may change based on your condition and how well you respond. Do not take more than prescribed without consulting your doctor.
Missed Dose
If you forget to take your medicine, take the medication as soon as you remember. If it’s nearly time for your next dose, skip the missed one and continue with your regular schedule. Always consult the doctor before making any changes to your dosage.
Overdose
It is not recommended to take more than 950 mg of ursodiol per day, as it may cause severe overdosing effects like nausea, dizziness, kidney and liver damage, stomach irritation, and allergies. If you face any of the severe effects, consult a doctor.
Storage
- Store the medicine at room temperature
- Keep away from sunlight and moisture
- Keep out of reach of children
Directions for use
- Take ursodiol exactly as prescribed by your doctor, at the same time each day.
- Do not stop taking ursodiol without your doctor’s approval, even if you feel better.
- If you forget to take ursodiol, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose.
Ursodiol Summary
Ursodiol (ursodeoxycholic acid) is a naturally occurring bile acid drug used to dissolve and prevent cholesterol gallstones and to treat primary biliary cholangitis. It is also prescribed off‑label for conditions like intrahepatic cholestasis of pregnancy, biliary atresia, and fatty liver disease; it works like a gentle detergent in the body’s plumbing system by replacing harsh bile acids with softer ones, thinning bile so it flows smoothly, dissolving stones, protecting liver cells, and calming immune irritation, though common side effects include diarrhea, constipation, nausea, stomach pain, or mild rash; it should be taken with food for better absorption, not alongside aluminum antacids or bile‑acid binding drugs that block its effect, and stored at room temperature in a tightly closed container away from heat and moisture and this is a prescription medicine and should be used only by a doctor’s recommendation.
FAQ’s
What are the uses of Ursodiol 450 mg tablets?
Ursodiol is used to dissolve certain types of gallstones and prevent their formation in high-risk patients. It treats primary biliary cholangitis by improving bile flow and reducing liver inflammation. It’s also prescribed for some chronic liver diseases to reduce toxic bile acid buildup.
What are the side effects of Ursodiol tablets?
Ursodiol may cause mild side effects like diarrhea, nausea, or abdominal discomfort. Some people experience dizziness, rash, or hair thinning during treatment. Rarely, it can elevate liver enzymes, so regular liver function monitoring is advised.
What is the maximum daily dose of ursodiol per day?
It is not recommended to take more than 950 mg of ursodiol per day, as it may cause severe overdosing effects like nausea, dizziness, kidney and liver damage, stomach irritation, and allergies. If you face any of the severe effects, see the doctor.
What is the mechanism of action of ursodiol?
Ursodiol works by acting like a gentle detergent in the body’s plumbing system: it replaces harsh bile acids with softer ones, thins the bile so it flows smoothly instead of forming stones, and protects the liver’s tiny pipes from damage while also calming down the body’s immune attack on them.
Reference
- Ursodiol. In: Stat Pearls [Internet]. Treasure Island (FL): Stat Pearls Publishing; 2023 Jan–. Available from.
- Cleveland Clinic. Ursodiol: Uses & Side Effects [Internet]. Cleveland Clinic; [updated 2025; cited 2025 Sep 17]. Available from.
- Mayo Clinic. Ursodiol (oral route): Description, dosage & side effects [Internet]. Mayo Foundation for Medical Education and Research; [updated 2025 Jul 31; cited 2025 Sep 17]. Available from.
- Drugs.com. Ursodiol [Internet]. Cerner Multum, Inc.; 2024 Nov 20 [cited 2025 Sep 17]. Available from.
- Cho HJ. Ursodiol: Uses, Side Effects, and More [Internet]. WebMD; 2024 Jun 26 [cited 2025 Sep 17]. Available from.
Authors
Siva Krishna Adithya Bhumireddy completed a Bachelor of Pharmacy from GIET School of Pharmacy, affiliated with Andhra University, and from his 3rd year of graduation, he was working as a freelance medical and publication writer. Having expertise in systematic reviews and clinical research. With his keen interest and skills in research and documentation practices, he also reviewed more than 150 manuscripts from international journals like Elsevier, Springer Nature, and Sage Journals, and all the manuscripts were indexed and appeared in PubMed, Scopus, and Web of Science databases, and he received honorary recognition letters and certificates from all of them. Siva Krishna Adithya also published a few systematic, narrative reviews and a few chapters of international expertise.