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Obeticholic Side Effects

The most commonly reported side effects of obeticholic include pruritus, fatigue, and nausea, based on 6,928 FDA adverse event reports from 2016 to 2025. 4.4% of reports found the drug to be ineffective.

Obeticholic side effects

Percentages show how often each reaction appears relative to total reports for obeticholic.

1
Pruritus34.3%2,378
2
Fatigue12.8%886
3
Nausea5.5%380
4
Death5.3%370
5
Drug Ineffective4.4%306
6
Arthralgia4.4%303
7
Hospitalisation4.2%294
8
Constipation4.1%281
9
Rash4.0%274
10
Therapy Interrupted3.8%263
11
Blood Alkaline Phosphatase Increased3.8%261
12
Dizziness3.7%257
13
Diarrhoea3.3%231
14
Abdominal Pain Upper3.2%223
15
Therapy Cessation2.8%194

These are voluntary reports and do not establish that obeticholic caused these reactions.

Report severity

44.9%Serious3,112 reports
21.1%Hospitalizations1,459 reports
7.7%Fatal533 reports

Seriousness is determined by the reporter, not by OpenClaim.

Obeticholic drug interactions

Other drugs that appear in adverse event reports alongside obeticholic. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ursodiol2.2%154
2
Elafibranor0.7%48
3
Taurursodiol0.4%26
4
Deoxycholic-acid0.4%25
5
Cholestyramine0.3%19
6
Hydroxychloroquine-sulfate0.2%16
7
Fenofibrate0.2%15
8
Prednisone0.2%14
9
Azathioprine0.2%14
10
Apixaban0.2%13
11
Amoxicillin0.2%12
12
Rifampin0.2%12
13
Hydroxyzine0.2%12
14
Rosuvastatin0.2%12
15
Dupilumab0.2%11

Taken alongside

1
Ursodiol29.5%2,042
2
Ergocalciferol10.6%736
3
Levothyroxine-sodium9.1%628
4
Omeprazole6.7%466
5
Atorvastatin-calcium5.2%358
6
Calcium4.6%322
7
Aspirin4.6%321
8
Pantoprazole-sodium4.5%309
9
Gabapentin4.2%290
10
Metformin3.7%259
11
Hydroxyzine3.6%249
12
Furosemide3.6%248
13
Acetaminophen3.5%240
14
Taurursodiol3.4%234
15
Amlodipine3.3%232

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports obeticholic side effects

57.4% of obeticholic adverse event reports involve female patients and 6.5% involve male patients. The largest age group is adult at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female57.4%
Male6.5%
Unknown36.1%

Age group

< 2<0.1%
2–11<0.1%
12–170.0%
18–6458.3%
65+41.6%

What is obeticholic used for

Conditions and purposes for which patients were taking obeticholic when the adverse event was reported.

Antimitochondrial AntibodyAsthmaAutoimmune HepatitisAutoimmune HepatitisBile Duct ObstructionBile Duct StoneBiliary CirrhosisBiliary Cirrhosis PrimaryBiliary CystBlood Alkaline Phosphatase IncreasedBlood Lactate Dehydrogenase IncreasedBronchiectasisBile Acid MalabsorptionBiliary CirrhosisCardiac Disorder

Showing 15 of 73 indications

Obeticholic brand names and reporting trend

Obeticholic is sold under the brand name Obeticholic Acid.

Brand names

Obeticholic Acid198

Quarterly reports (20162025)

2016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking obeticholic with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.