Note: This document contains side effect information about cholic acid. Some dosage forms listed on this page may not apply to the brand name Cholbam.
Applies to cholic acid: oral capsule.
Serious side effects of Cholbam
Along with its needed effects, cholic acid (the active ingredient contained in Cholbam) 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
Other side effects of Cholbam
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
Common (1% to 10%): Exacerbation of hepatic impairment including deaths, jaundice
Uncommon (0.1% to 1%): Cholelithiasis
Frequency not reported: Transaminase increased, gallstones[Ref]
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]
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
Common (1% to 10%): Skin lesion
Frequency not reported: Pruritus[Ref]
Pruritus and/or persistent diarrhea may be signs of a potential overdose and should be investigated as such.[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]
