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Cholic acid Side Effects

For the Consumer

Applies to cholic acid: oral capsule

Along with its needed effects, cholic acid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cholic acid:

More common
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • diarrhea
  • dizziness
  • fever
  • general feeling of tiredness or weakness
  • headache
  • itching or rash
  • light-colored stools
  • loss of appetite
  • nausea
  • stomach pain, continuing
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • yellow eyes or skin
Less common
  • Bladder pain
  • bloody or cloudy urine
  • clay-colored stools
  • dark urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
  • unpleasant breath odor

Some side effects of cholic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Burning, numbness, tingling, or painful sensations
  • chest pain
  • difficulty with swallowing
  • general feeling of discomfort or illness
  • heartburn
  • pain or burning in the throat
  • skin lesions
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet

For Healthcare Professionals

Applies to cholic acid: oral capsule

General

The most common adverse reactions have included diarrhea, reflux esophagitis, malaise, jaundice, skin lesions, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy.[Ref]

Hepatic

Ten patients, five with single enzyme defect (SED) and 5 with peroxisomal disorders (PD) experienced worsening transaminases, elevated bilirubin values, or worsening cholestasis on liver biopsy during treatment. Of these 10 patients, five (3 SED and 2 PD) had liver impairment at baseline while the other 5 did not have baseline cholestasis, but experienced exacerbation of liver disease while on treatment. Exacerbation by this drug could not be ruled out.

Deaths attributed to progression of underlying liver disease were reported in 5 patients aged 1 year or less in trial 1 (SED, n=50; PD, n=29); three patients had AKR1D1 deficiency, 1 had 3beta-HSD and 1 had CYP7A1 deficiency. Of the 29 patients in trial 1 with PDs including Zellweger spectrum disorders, 12 patients aged 7 months to 2.5 years died; 8 of the 12 deaths were attributed to progression of underlying liver disease or a worsening of their primary illness. Two additional deaths in trial 1 were both patients who had been off study medication for more than 1 year; their deaths were most likely due to a progression of their underlying liver disease.

In trial 2 (SED, n=31; PD, n=12) 2 patients with SED died; cause of death was unrelated to their primary treatment or progression of their underlying liver disease. Four patients between the ages of 4 and 8 years with PD died (1 new patient and 3 who rolled over from trial 1); cause of death in 3 of these 4 patients was attributed to progression of underlying liver disease or worsening of their primary illness.

One patient with 3 beta-HSD deficiency developed symptomatic cholelithiasis requiring cholecystectomy.

Gallstones have been reported after long-term therapy.[Ref]

Common (1% to 10%): Exacerbation of hepatic impairment including deaths, jaundice
Uncommon (0.1% to 1%): Cholelithiasis
Frequency not reported: Transaminase increased, gallstones[Ref]

Gastrointestinal

Pruritus and/or persistent diarrhea may be signs of a potential overdose and should be investigated as such.[Ref]

Common (1% to 10%): Diarrhea, reflux esophagitis, nausea, abdominal pain, intestinal polyp[Ref]

Dermatologic

Pruritus and/or persistent diarrhea may be signs of a potential overdose and should be investigated as such.[Ref]

Common (1% to 10%): Skin lesion
Frequency not reported: Pruritus[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Nervous system

Common (1% to 10%): Peripheral neuropathy[Ref]

Other

Common (1% to 10%): Malaise[Ref]

References

1. "Product Information. Cholbam (cholic acid)." Manchester Pharmaceutical, Fort Collins, CO.

Some side effects of cholic acid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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