What the label lists and what reports show
Fenofibric acid side effects
Fenofibric acid's FDA label lists its adverse reactions in its own words. FAERS holds 776 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 (67 reports).
- Generic listed
Check it at the source: the fenofibric acid FDA label on DailyMed (effective August 2, 2025, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1) ] Hepatoxicity [see Warnings and Precautions (5.2) ] Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3) ] Increases in Serum Creatinine [see Warnings and Precautions (5.4) ] Cholelithiasis [see Warnings and Precautions (5.5) ] Increased Bleeding Risk with Coumarin Anticoagulants [see Warnings and Precautions (5.6) ] Pancreatitis [see Warnings and Precautions (5.7) ] Hematologic Changes [see Warnings and Precautions (5.8) ] Hypersensitivity reactions [see Warnings and Precautions (5.9) ] Venothromboembolic disease [see Warnings and Precautions (5.10) ] Paradoxical Decreases in HDL Cholesterol Levels [see Warnings and Precautions (5.11) ] Adverse reactions (≥ 2% and greater than placebo): abnormal liver …
Table 1. Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
| Adverse Reaction | Placebo (N =365) | Fenofibrate (N = 439) |
|---|---|---|
| Abnormal Liver Tests | 1% | 8% |
| Abdominal Pain | 4% | 5% |
| Increased ALT | 2% | 3% |
| Increased AST | 1% | 3% |
| Increased Creatine Phosphokinase | 1% | 3% |
| Constipation | 1% | 2% |
| Rhinitis | 1% | 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.
Source: FDA drug label, Aurobindo Pharma Limited, effective August 2, 2025 (SPL set 9ad201de-fa62-4c49-bc61-ee09b9ba434c), via openFDA; the full label on DailyMed
What do FAERS reports show?
776 reports list fenofibric acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 76 are coded as a death and 200 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 20 reactions below, 9 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?
- Fenofibric acid: 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