Cholbam is a bile acid. Bile acids are produced naturally in the body to aid in digestion of fats and certain nutrients.

People with bile acid disorders are unable to produce Cholbam normally. This can make it harder for the body to absorb nutrients important for health, growth, and body functioning. Abnormal bile acids can also build up in the body and become toxic to the liver.

Cholbam is used in people with bile acid disorders. Cholbam works by normalizing bile acid production in the body.

Cholbam may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Swallow the capsule whole and do not crush or chew it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of soft food. If you are giving Cholbam to a young child, mix the medicine with a small amount of baby formula or breast milk. Stir the mixture for 30 seconds and use it right away. Do not save the mixture for later use.

Cholbam comes in different capsule sizes. Your dose may require that you take only 1 capsule per day or up to 8 capsules per day. This medicine doses are based on weight and you may need to use two different capsule sizes to make up your entire dose. Follow your doctor's dosing instructions very carefully.

The recommended dose of cholic acid increases with every few pounds gained as you grow from infancy to adulthood. Tell your doctor if you have any changes in weight.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Tell your doctor if you have ever had:

• liver disease; or

• if you also use cyclosporine.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cholic acid on the baby.

Do not give Cholbam to a child without medical advice. Cholbam is not approved for use by anyone younger than 3 weeks old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

When you take your Cholbam dose, avoid taking other medicines by mouth at the same time. Since this medicine aids in digestion, it can affect how well your body absorbs any other medicines you need to take. Take this medicine at least 1 hour before or 4 to 6 hours after you take:

• cholestyramine;

• colesevelam;

• colestipol; or

• an antacid that contains aluminum--Acid Gone, Di-Gel, Gaviscon, Gelusil, Maalox, Mylagen, Mylanta, Rulox, and others.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cholbam may cause serious side effects. Call your doctor at once if you have:

• blood in your stools, changes in your bowel habits (such as diarrhea or constipation);

• pain or burning when you urinate; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Cholbam may include:

• heartburn, acid reflux;

• nausea, diarrhea, stomach pain;

• painful urination;

• general ill feeling;

• jaundice;

• skin sores; or

• numbness, tingling, or burning pain in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect Cholbam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.