Ursacol: Presentations, Uses, Side Effects, Interactions and Precautions

Have you ever felt a strange pain in your upper abdomen?

Generally, digestive upset after a large meal is not something to worry about, but for others, it is a sign of a malfunctioning gallbladder.

Some people with gallstones never have symptoms, while others experience severe pain.

If you experience pain in the upper abdomen or right side of the body, you may have gallstones and want to seek treatment to avoid further complications.

In the United States at least, about 25 percent of newly diagnosed gallstone patients will need treatment.

The main function of the gallbladder is to store bile, a substance secreted by the liver that helps with digestion. Sometimes the bile contents crystallize and form gallstones .

Gallstones, which can be as small as a grain of salt or as large as a golf ball, can cause some serious problems. They can block the ducts within the organ, causing the gallbladder to become inflamed.

What’s worse, when a gallstone leaves the gallbladder duct and enters the main bile duct, it can lead to a bile duct infection that can ultimately cause inflammation of the pancreas.

Many patients undergo gallbladder surgery to relieve pain and avoid potentially serious conditions caused by gallstones.

In fact, surgery, in this case, a cholecystectomy or removal of the gallbladder, is the most common form of treatment for gallstones.

But the fact that surgical removal of gallstones requires the removal of an entire organ has sparked growing interest in non-surgical gallstone treatments, such as drugs like Ursacol.

Ursacol is used to dissolve gallstones in patients who do not need to have their gallbladders removed or in whom surgery should be avoided due to other medical problems.

However, Ursacol works only in those patients whose gallstones are made of cholesterol and works best when these stones are small and of the “floating” type.

It is also used to help prevent gallstones in patients who are on quick weight loss programs. Ursacol is also used to treat primary biliary cirrhosis (PBC).

Primary biliary cirrhosis is an autoimmune disorder that causes a patient’s liver to have problems and not work properly. This medicine is available only with a prescription from your doctor.


This product is available in the following dosage forms:

  • Capsule.
  • Tablet.

Why is treatment for gallstones with Ursacol necessary?

In addition to alleviating symptoms, treatment for gallstones is necessary to prevent a progression that can result in serious conditions, such as acute cholecystitis , the condition in which gallstones block the gallbladder ducts, causing the gallbladder to become inflamed and infected.

Patients with acute cholecystitis are usually hospitalized and receive antibiotics, pain relievers, and often surgery.

If you do not have symptoms, the most common treatment is “wait and see,” because the risks outweigh the benefits for both medical and surgical treatments.

If you have gallbladder symptoms, surgical treatments are preferred, unless you are at high risk, and then drug treatments can be used.

Gallbladder surgery is minimally invasive, so the risk of complications is low.

But if people cannot have surgery, if someone is really old or really sick, there are different treatment options, such as the use of Ursacol.

Medicines like Ursacol can dissolve gallstones

In some cases, gallstones can be treated with medications such as Ursacol.

This product has been shown to dissolve some gallstones, it is available in oral pills. This medicine works by thinning the bile, which allows gallstones to dissolve.

While these pills can be effective and are generally well tolerated by patients, medical treatment for gallstones is limited to people whose stones are small and made of cholesterol.

But this drug can take two years or more to work, and gallstones can return after treatment ends.

Lowering the cholesterol content of the bile can dissolve (certain gallstones), but is not effective enough not to refer patients for surgery.

Gallstone Dissolution Therapy with Ursacol

The balance between the synthesis of cholesterol and bile acids in the liver is a key factor in the formation of gallstones.

Cholesterol gallstone patients have been shown to have higher rates of hepatic cholesterol synthesis and lower rates of bile acid synthesis than control subjects, as measured by the activity of the enzymes that control the respective rate.

Treatment with Ursacol reduced the high levels of hydroxymethylglutaryl coenzyme. A reductase in gallstone patients treated for about a year. Such treatment did not appear to inhibit endogenous bile acid synthesis.

Ursacol is different from chenodeoxycholic acid, as no significant abnormalities of liver function have been reported during its use.

Bacterial 7-dehydroxylation is more active for chenodeoxycholic acid than Ursacol; thus less lithocholic acid is formed with Ursacol.

Patients receiving the highest dose of Ursacol have often been shown to have the lowest percentage of lithocholic acid in their bile.

During treatment with Ursacol for dissolution of gallstones, symptoms of biliary difficulty began to improve after three to six weeks.

Gallstones will recur in approximately 50% of patients, but there is no consensus on the management of patients after dissolution of their stones. In general, Ursacol is a safe and effective litholytic agent.

Before using Ursacol

When deciding to use a drug, the risks of taking the drug must be weighed against the good it will do. This is a decision that you and your doctor will make. For this drug, the following should be considered:


Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or other medicines.

Also tell your healthcare professional if you have any other allergies, such as foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.


Appropriate studies on the relationship between age and the effects of Ursacol in the pediatric population have not been performed. Safety and efficacy have not been established.


No information is available on the relationship between age and the effects of Ursacol in geriatric patients.

The pregnancy

Animal studies have not revealed evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have not shown a risk to the fetus.


There are no adequate studies in women to determine infant risk when using this drug while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Drug interactions

Ursacol can interact with cholestyramine, colestipol, estrogens (birth control pills or hormone replacement), or antacids that contain aluminum (such as Rolaids, Mylanta, or Maalox).

Tell your doctor about all the medicines you are taking. During pregnancy, Ursacol should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Although certain drugs should not be used together, in other cases two different drugs can be used together, even if an interaction occurs.

In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or non-prescription (over-the-counter [OTC]) medications.

Other interactions

Certain medications should not be used at the time of eating or around certain types of food, as interactions can occur.

Using alcohol or tobacco with certain medications can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems can affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

  • Ascites (accumulation of fluid in the abdominal or stomach cavity) or bleeding varicose veins (veins that enlarge and bleed) or hepatic encephalopathy (brain disease due to liver failure) or liver damage (from not having a certain chemical in the liver to break down a substance called lithocholate)
  • Liver transplant : use with caution. It can make these conditions worse.
  • Biliary tract obstruction : should not be used in patients with this condition. Biliary tract problems
  • Pancreatitis (swelling or inflammation of the pancreas) : These conditions may make it necessary to undergo surgery as treatment with Ursacol would take too long.

Proper use of Ursacol

Take this medicine exactly as directed by your doctor. Don’t take it more, don’t take it more often, and don’t take it for longer than your doctor ordered. Doing so can increase the chance of side effects.

It is best to take Ursacol with food, unless otherwise directed by your doctor.

Take this medicine for the entire time of treatment, even if you begin to feel better. If you stop taking this medicine too soon, the gallstones may not dissolve as quickly or may not dissolve at all.

It is thought that body weight and the type of diet a patient follows can affect how quickly the stones dissolve and whether new stones will form. However, check with your doctor before starting any diet.

If you are using Ursacol tablets

You can break the tablets into halves. To easily break the tablet, place it on a flat surface with the marked section at the top.

Hold the tablet with your thumbs placed near the slot, and then gently press until it breaks. Swallow each segment with water. Do not chew it.

Due to the bitter taste, store the half tablets or segments separately from the whole tablets. Half tablets can be used for up to 28 days when kept in the medicine bottle.

Ursacol dosage

The dose of this medicine will be different for different patients. Follow your doctor’s instructions or the directions on the label.

The information below includes only the average doses of this drug. If your dose is different, do not change it unless your doctor tells you to. The amount of medicine you take depends on the strength of the medicine.

Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem you are using the medicine for.

For oral dosage forms (capsules or tablets)

Ursacol is a bile acid used for patients with non-calcified radiolucent gallbladder stones <20 mm in larger diameter in whom elective cholecystectomy would be performed.

Except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia For those patients who refuse surgery.

Ursacol is also used to prevent gallstone formation in obese patients who experience rapid weight loss. Ursacol is available in generic form.

For gallstone disease

Adults and children 12 years of age and older : The dose is based on body weight and must be determined by your doctor. The dose is generally 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day, divided into two or three doses.

Children under 12 years : use and dosage must be determined by your doctor.

For the prevention of gallstones during rapid weight loss

Adults : 300 milligrams (mg) twice a day.

Children under 12 years : use and dosage must be determined by your doctor.

For primary biliary cirrhosis

Adults : the dose is based on body weight and must be determined by your doctor. The dose is usually 13 to 15 milligrams (mg) per kilogram (kg) of body weight per day, divided into two to four doses. Your doctor can adjust your dose as needed.

Children : use and dosage must be determined by your doctor.

Missed dose

Call your doctor or pharmacist for instructions. If you miss a dose of this medicine, take it as soon as possible or double your next dose.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children. Don’t keep outdated drugs or drugs that are no longer needed. Ask your healthcare professional how to dispose of any unused medicine.

Ursacol precautions

It is important for your doctor to check your progress at regular visits. You will need to have blood tests every few months while you are taking this medicine to make sure that the gallstones dissolve and that your liver is working properly.

Check with your doctor right away if you have severe abdominal or stomach pain, especially towards the upper right, or if you experience severe nausea and vomiting.

These symptoms may mean that you have other medical problems or that your gallstone problem needs your doctor’s attention.

Do not take other medications unless they have been discussed with your doctor. This includes prescription and non-prescription (over-the-counter) medicines and herbal or vitamin supplements.

Ursacol side effects

Along with its necessary effects, a drug can cause some unwanted effects. Although not all of these side effects can occur, if they do occur, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

The most common

  • Bladder pain
  • Bloody or cloudy urine.
  • Difficult, burning, or painful urination.
  • Dizziness.
  • Fast heartbeat
  • Frequent urge to urinate.
  • Indigestion.
  • Low back or side pain.
  • Severe nausea
  • Skin rash or itching all over the body.
  • Stomach ache.
  • Vomiting
  • Soft spot.

The least common

  • Black, tarry stools.
  • Chest pain.
  • Chills or fever
  • Tos.
  • Red spots on the skin.
  • Severe or ongoing stomach pain.
  • Sore throat or swollen glands.
  • Sores or white spots on the lips or in the mouth.
  • Unusual bleeding or bruising.
  • Unusual tiredness or weakness
  • Clay-colored stools.
  • Dark urine
  • Difficulty to swallow.
  • Headache.
  • Hives
  • Ronquera.
  • Large beehive-shaped swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sexual organs.
  • Loss of appetite
  • Sickness.
  • Redness of the skin.
  • Slow or irregular breathing
  • Chest tightness.
  • Unpleasant smell of breath.
  • Yellow skin or eyes.

Some side effects can occur that generally do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Also, your healthcare professional can educate you on ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

The most common

  • Back pain.
  • Body ache / muscle or bone pain.
  • Congestion.
  • Constipation .
  • General feeling of being unwell or ill.
  • Acidity.
  • Loss of voice
  • Joint pain, swelling, or redness.
  • Runny nose.
  • Perspiration.
  • Trouble sleeping

The least common

  • Diarrhea .
  • Worsening of psoriasis.
  • Heartburn or sour stomach.
  • Belching or swelling of the face, arms, hands, lower legs, or feet.
  • Difficulty moving.
  • Rapid unusual weight gain or loss.
  • Upset stomach or malaise.
  • Tingling in the hands or feet

Other side effects not mentioned can also occur in some patients. If you notice any other effects, check with your healthcare professional.

Clinical study experience

Because clinical trials are conducted under widely varying conditions, the rates of adverse reactions seen in clinical trials of one drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates seen in clinical practice.

In a randomized, crossover study in sixty patients with primary biliary cirrhosis, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients), and anorexia and esophagitis ( 1 patient each).

One patient on the twice daily regimen (total dose 1000 mg) withdrew due to nausea.

All of these nine adverse reactions, except esophagitis, were observed with the twice daily regimen at a total daily dose of 1000 mg or more. However, an adverse reaction can occur at any dose.

Post Marketing Experience

The following adverse reactions, listed by system organ class in alphabetical order, were identified during use after the use of Ursacol.

Because these reactions are reported voluntarily in a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship with drug exposure.

Gastrointestinal disorders : abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.

General disorders and administration site conditions : malaise, peripheral edema, pyrexia.

Hepatobiliary disorders : jaundice (or worsening of pre-existing jaundice).

Immune system disorders : hypersensitivity to medications to include facial edema, urticaria, angioedema, and laryngeal edema.

Abnormal laboratory tests : increased alanine transaminase, increased aspartate transaminase, increased alkaline phosphatase in the blood, increased bilirubin in the blood, increased γ-glutamyl transferase, increased liver enzyme, blood test abnormal liver function, increased transaminases.

Musculoskeletal and connective tissue disorders : myalgia .

Nervous system disorders : dizziness, headache .

Respiratory, thoracic and mediastinal disorders : cough.

Skin and subcutaneous tissue disorder : alopecia, pruritus, rash.