What the label lists and what reports show
Elafibranor side effects
Elafibranor's FDA label: “Most common adverse reactions with IQIRVO (reported in ≥ 5% and higher compared to placebo) are weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight …” FAERS holds 744 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 fatigue (87 reports).
- No generic listed
Check it at the source: the elafibranor FDA label on DailyMed (effective August 11, 2026, Ipsen Biopharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of IQIRVO?IQIRVO can cause serious side effects including: Muscle problems (myalgia, myopathy, rhabdomyolysis). IQIRVO can cause muscle problems that can be severe. Treatment with IQIRVO may cause muscle pain or worsen existing pain and can increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your healthcare provider should test for muscle weakness or pain before and during treatment. If there is new onset or worsening of muscle pain, your healthcare provider may temporarily stop your treatment. IQIRVO may be restarted if another cause for your symptoms has been identified and resolved. If your symptoms come back after restarting, your healthcare provider will stop IQIRVO permanently. […]
Source: FDA drug label, Ipsen Biopharmaceuticals, Inc., effective August 11, 2026 (SPL set d78aa14f-6ec1-4b1d-a4ae-e48658137a25), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions with IQIRVO (reported in ≥ 5% and higher compared to placebo) are weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.
Table 1: Common Adverse Reactions Occurring During the Double-Blind Period in Adult Patients with PBC (Study 1) Included 8 patients (5%) who were intolerant to UDCA and initiated treatment as monotherapy: 6 patients…
| Reaction | IQIRVO 80 mg Once Daily N = 108 % (n) | Placebo N = 53 % (n) |
|---|---|---|
| Weight gain Weight gain, abdominal pain, muscle pain, fracture, and rash include other… | 23% (25) | 21% (11) |
| Diarrhea | 11% (12) | 9% (5) |
| Abdominal pain | 11% (12) | 6% (3) |
| Nausea | 11% (12) | 6% (3) |
| Vomiting | 11% (12) | 2% (1) |
| Arthralgia | 8% (9) | 4% (2) |
| Constipation | 8% (9) | 2% (1) |
| Muscle pain | 7% (8) | 2% (1) |
| Fracture | 6% (7) | 0 |
| Gastroesophageal reflux disease | 6% (7) | 2% (1) |
| Dry mouth | 5% (5) | 2% (1) |
| Weight loss | 5% (5) | 0 |
| Rash | 5% (5) | 4% (2) |
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, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Myalgia, Myopathy, and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Fractures [see Warnings and Precautions (5.2) ] Drug-Induced Liver Injury [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions with IQIRVO (reported in ≥ 5% and higher compared to placebo) are weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 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 IQIRVO is based on Study 1 consisting of 161 patients who were randomized to receive IQIRVO 80 mg (n=108) or placebo (n=53) once daily with a median duration of exposure during the double-blind period of 62 weeks (inter quartile range: 52, 84) [see Clinical Studies (14) ]. …
Source: FDA drug label, Ipsen Biopharmaceuticals, Inc., effective August 11, 2026 (SPL set d78aa14f-6ec1-4b1d-a4ae-e48658137a25), via openFDA; the full label on DailyMed
What do FAERS reports show?
744 reports list elafibranor among the medicines taken, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 51 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 22 reactions below, 11 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.
Reports received each year
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?
- Elafibranor: 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