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Cholic acid Side Effects

For the Consumer

Applies to cholic acid: oral capsule

In addition to its needed effects, some unwanted effects may be caused by cholic acid. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

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

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.

Not all side effects for cholic acid may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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