Cholbam Side Effects Center

Last updated on RxList: 11/10/2021
Cholbam Side Effects Center

What Is Cholbam?

Cholbam (cholic acid) is a bile acid used to treat bile acid synthesis disorders due to single enzyme defects (SEDs). It is also used for adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat-soluble vitamin absorption.

What Are Side Effects of Cholbam?

Common side effects of Cholbam include:

Dosage for Cholbam

The recommended dosage of Cholbam is 10 to 15 mg/kg administered orally once daily, or in two divided doses, in pediatric patients and in adults.

What Drugs, Substances, or Supplements Interact with Cholbam?

Cholbam may interact with cyclosporine, cholestyramine, colestipol, colesevelam, or aluminum-based antacids. Tell your doctor all medications and supplements you use. During pregnancy, should be taken only if prescribed.

Cholbam During Pregnancy and Breastfeeding

There is a pregnancy surveillance program that monitors pregnancy outcomes in women exposed to Cholbam during pregnancy [COCOA Registry (ChOlbam: Child and mOther's heAlth)]. Women who become pregnant during treatment are encouraged to enroll. It is unknown if this drug passes into breast milk or if it will affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Cholbam (cholic acid) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Cholbam Consumer Information

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

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 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.

Read the entire detailed patient monograph for Cholbam (Cholic Acid Capsules)

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Cholbam Professional Information

SIDE EFFECTS

Clinical Trials Experience

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

Clinical safety experience with CHOLBAM consists of:

  • Trial 1: a non-randomized, open-label, uncontrolled trial of 50 patients with bile acid synthesis disorders due to SEDs and 29 patients with PDs including Zellweger spectrum disorders. Safety data are available over the 18 years of the trial.
  • Trial 2: an extension trial of 12 new patients (10 SED and 2 PD) along with 31 (21 SED and 10 PD) patients who rolled-over from Trial 1. Safety data are available for 3 years and 11 months of treatment.

Adverse events were not collected systematically in either of these trials. Most patients received an oral dose of 10 to 15 mg/kg/day of CHOLBAM.

Deaths

In Trial 1, among the 50 patients with SEDs, 5 patients aged 1 year or less died, which included three patients originally diagnosed with AKR1D1 deficiency, one with 3β-HSD deficiency and one with CYP7A1 deficiency. The cause of death was attributed to progression of underlying liver disease in every patient.

Of the 29 patients in Trial 1 with PDs including Zellweger spectrum disorders, 12 patients between the ages of 7 months and 2.5 years died. In the majority of these patients (8/12), the cause of death was attributed to progression of underlying liver disease or to a worsening of their primary illness.

Two additional patients in Trial 1 (1 SED and 1 PD) died who had been off study medication for more than one year with the cause of death most likely being a progression of their underlying liver disease. Of the patients who died with disease progression, laboratory testing showed abnormal serum transaminases, bilirubin, or cholestasis on liver biopsy suggesting worsening of their underlying cholestasis.

In Trial 2, among the 31 patients with SED, two patients (1 new patient and 1 who rolled over from Trial 1) died. The cause of death in both cases was unrelated to their primary treatment or progression of their underlying liver disease.

Of the 12 patients with PD in Trial 2, four patients died between the ages of 4 and 8 years (1 new patient and 3 who rolled over from Trial 1). The cause of death in three of these patients was attributed to progression of underlying liver disease or to a worsening of their primary illness.

Worsening Liver Impairment

Seven patients in Trial 1(4 SED and 3 PD) and 3 patients in Trial 2 (1 SED and 2 PD) experienced worsening serum transaminases, elevated bilirubin values, or worsening cholestasis on liver biopsy during treatment.

Common Adverse Reactions

There were 12 adverse reactions reported across 9 patients in the trials, with diarrhea being the most common reaction in approximately 2% of the patient population. All other adverse reactions represented 1% of the patient population. The breakdown by trial follows:

Table 3: Most Common Adverse Reactions in Trials 1 and 2

Adverse Reactions Trial 1 Trial 2* Overall (%)
Diarrhea 1 2* 3 (2%)
Reflux Esophagitis 1 0 1 (1%)
Malaise 1 0 1 (1%)
Jaundice 1 0 1 (1%)
Skin lesion 1 0 1 (1%)
Nausea 0 1* 1 (1%)
Abdominal Pain 0 1* 1 (1%)
Intestinal Polyp 0 1* 1 (1%)
Urinary Tract Infection 0 1* 1 (1%)
Peripheral Neuropathy 0 1 1 (1%)
*Adverse reactions that occurred in new patients

Only one of the reactions (peripheral neuropathy) resulted in discontinuation of medication for a patient in Trial 2. An additional five SED patients (3 from Trial 1 and 2 from Trial 2) and 1 PD patient (Trial 1) discontinued medication and withdrew from the study due to a worsening of their primary disease.

The development of symptomatic cholelithiasis requiring cholecystectomy has been reported in a single patient with 3β-HSD deficiency.

Read the entire FDA prescribing information for Cholbam (Cholic Acid Capsules)

© Cholbam Patient Information is supplied by Cerner Multum, Inc. and Cholbam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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