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What the label lists and what reports show

Cholic acid side effects

Cholic acid's FDA label: “Most common adverse reactions (≥1%) are diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy.” FAERS holds 397 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (56 reports).

  • No generic listed

Check it at the source: the cholic acid FDA label on DailyMed (effective January 26, 2026, Mirum Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥1%) are diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy.

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

Adverse ReactionsTrial 1Trial 2*Overall n (%)
Diarrhea12*3 (2)
Reflux Esophagitis101 (1)
Malaise101 (1)
Jaundice101 (1)
Skin lesion101 (1)
Nausea01*1 (1)
Abdominal Pain01*1 (1)
Intestinal Polyp01*1 (1)
Urinary Tract Infection01*1 (1)
Peripheral Neuropathy011 (1)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following clinically significant adverse reaction is described elsewhere in the labeling: • Exacerbation of Liver Impairment [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥1%) are diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mirum Pharmaceuticals at 1-855-MRM-4YOU or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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, single-arm 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. …

Source: FDA drug label, Mirum Pharmaceuticals Inc., effective January 26, 2026 (SPL set 5c6e4c9d-b85e-493f-9420-ab2fd0ff3723), via openFDA; the full label on DailyMed

What do FAERS reports show?

397 reports list cholic acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 72 are coded as a death and 89 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Cholic acid: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions