What the label lists and what reports show
Fenofibrate side effects
Fenofibrate's FDA label lists its adverse reactions in its own words. FAERS holds 35,248 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 (2,173 reports).
- Generic listed
Check it at the source: the fenofibrate FDA label on DailyMed (effective April 29, 2024, A-S Medication Solutions); 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 ) ] Pancreatitis [see Warnings and Precautions ( 5.7 ) ] Hypersensitivity reactions [see Warnings and Precautions ( 5.9 ) ] Venothromboembolic disease [see Warnings and Precautions ( 5.10 ) ] Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
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
| BODY SYSTEM Adverse Reaction | Fenofibrate* (N=439) | Placebo (N=365) |
|---|---|---|
| Abdominal Pain | 4.6% | 4.4% |
| Back Pain | 3.4% | 2.5% |
| Headache | 3.2% | 2.7% |
| Nausea | 2.3% | 1.9% |
| Constipation | 2.1% | 1.4% |
| Increased ALT | 3.0% | 1.6% |
| Increased CPK | 3.0% | 1.4% |
| Respiratory Disorder | 6.2% | 5.5% |
| Rhinitis | 2.3% | 1.1% |
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, NDA021656 (Abbvie), as published by A-S Medication Solutions, effective April 29, 2024 (SPL set 84b2af1b-365e-4723-ac5f-bc826ec47772), via openFDA; the full label on DailyMed
What do FAERS reports show?
35,248 reports list fenofibrate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,766 are coded as a death and 12,310 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, 8 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?
- Fenofibrate: 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