What the label lists and what reports show

Chenodiol side effects

Chenodiol's FDA label: “The most common adverse reactions (incidence > 14%) are diarrhea, headache, abdominal pain, constipation, hypertension, muscular weakness, and upper respiratory tract infection.” FAERS holds 352 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 (41 reports).

Generic listed

Check it at the source: the chenodiol FDA label on DailyMed (effective December 16, 2025, Mirum Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The most common adverse reactions (incidence > 14%) are diarrhea, headache, abdominal pain, constipation, hypertension, muscular weakness, and upper respiratory tract infection.

From the label: adverse reactions, continued
The following clinically significant adverse reaction is described elsewhere in the labeling: • Hepatotoxicity [see Warnings and Precautions ( 5.1 )] The most common adverse reactions (incidence > 14%) are diarrhea, headache, abdominal pain, constipation, hypertension, muscular weakness, and upper respiratory tract infection. ( 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. The safety of CTEXLI was evaluated in a randomized, double blind, placebo-controlled, 2-period, 2-treatment crossover trial in 14 patients (16 to 55 years of age) with CTX (Trial 1). CTEXLI is not approved for use in pediatric patients. The dosage of CTEXLI was 250 mg orally three times a day [see Clinical Studies ( 14 )]. The mean (SD) chenodiol exposure during Trial 1 was 139.1 (26.7) days. …

Source: FDA drug label, Mirum Pharmaceuticals Inc., effective December 16, 2025 (SPL set 015384e7-4ac5-4782-a309-e40cd1421c5b), via openFDA; the full label on DailyMed

What do FAERS reports show?

352 reports list chenodiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 21 are coded as a death and 28 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, 5 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

Diarrhoea (named in the label)41
Hepatic Enzyme Increased20
Vomiting20
Constipation (named in the label)19
Death (an outcome recorded in the report)13
Drug Ineffective (a use or a product term, not a reaction)13
Abdominal Discomfort9
Dehydration9
Headache (named in the label)9
Nausea9
Xanthoma (a use or a product term, not a reaction)8
Abdominal Pain Upper (named in the label)7
Gait Disturbance7
Abdominal Pain (named in the label)6
Decreased Appetite6
Dizziness6
Nasopharyngitis6
Weight Decreased6
Chest Pain5
Gastroenteritis Viral5
Muscle Spasms5
Off Label Use (a use or a product term, not a reaction)5
Pain5
Pyrexia5
Seizure5

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

What next?

Chenodiol: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions