OpenClaim

Elafibranor Side Effects

The most commonly reported side effects of elafibranor include fatigue, pruritus, and nausea, based on 483 FDA adverse event reports from 2005 to 2025.

Elafibranor side effects

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

1
Fatigue11.2%54
2
Pruritus9.9%48
3
Nausea9.1%44
4
Constipation8.3%40
5
Weight Increased7.2%35
6
Product Dose Omission Issue7.2%35
7
Arthralgia7.0%34
8
Myalgia6.0%29
9
Diarrhoea6.0%29
10
Muscle Spasms4.8%23
11
Vomiting4.6%22
12
Headache4.3%21
13
Dizziness4.1%20
14
Abdominal Pain Upper3.7%18
15
Back Pain3.5%17

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

Report severity

24.8%Serious120 reports
6.4%Hospitalizations31 reports
2.3%Fatal11 reports

Seriousness is determined by the reporter, not by OpenClaim.

Elafibranor drug interactions

Other drugs that appear in adverse event reports alongside elafibranor. 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
Obeticholic-acid4.3%21
2
Ursodiol1.9%9
3
Atorvastatin-calcium0.6%3
4
Pregabalin0.6%3
5
Gabapentin0.4%2
6
Panobinostat-lactate0.4%2
7
Acetaminophen0.4%2
8
Duloxetine-hydrochloride0.4%2
9
Dupilumab0.4%2
10
Clozapine0.2%1
11
Gemfibrozil0.2%1
12
Niacin0.2%1
13
Fluvastatin-sodium0.2%1
14
Enoxaparin-sodium0.2%1
15
Warfarin0.2%1

Taken alongside

1
Ursodiol28.4%137
2
Ergocalciferol15.9%77
3
Levothyroxine-sodium9.7%47
4
Omeprazole9.3%45
5
Obeticholic-acid6.4%31
6
Aspirin5.8%28
7
Calcium5.6%27
8
Atorvastatin-calcium5.4%26
9
Gabapentin5.4%26
10
Ascorbic-acid5.2%25
11
Pantoprazole-sodium5.0%24
12
Metoprolol4.6%22
13
Acetaminophen4.6%22
14
Losartan-potassium4.1%20
15
Magnesium-acetate-tetrahydrate4.1%20

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 elafibranor side effects

90.5% of elafibranor adverse event reports involve female patients and 5.4% involve male patients. The largest age group is adult at 59%. These figures reflect who reports side effects, not underlying risk.

Sex

Female90.5%
Male5.4%
Unknown4.1%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6458.7%
65+41.3%

What is elafibranor used for

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

Adverse Drug ReactionAutoimmune HepatitisBiliary CirrhosisBlood Test AbnormalCholangitisDepressionDermatitis AtopicDysgeusiaEnzyme AbnormalityEnzyme Level AbnormalHepatic CirrhosisHepatic SteatosisHyperthyroidismIllnessLiver Disorder

Showing 15 of 23 indications

Elafibranor brand names and reporting trend

Elafibranor is sold under the brand name Iqirvo.

Brand names

Iqirvo35

Quarterly reports (20052025)

20052025

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

Taking elafibranor with another medication?

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