Drugs › Peroxisome proliferator receptor alpha agonist
Brand name · Fenofibrate
Tricor: adverse event reports filed with FDA
2,471 reports list it as a suspect or interacting product, 2004–2026. Class: Peroxisome proliferator receptor alpha agonist. Also reported as Tricor /00499301/, Tricor /00090101/, Tricor Tablets.
- 2,471
- reports as suspect product
- 0% of all reports · about 110 a year
- 5
- reports, 12 months to June 2026
- 14 in the 12 months before
- 39.3%
- marked serious by the reporter
- 85.1% across the class
- 3.8%
- record death among outcomes, as reported
- 93 reports · not verified by FDA
2,471 adverse event reports received by FDA list the brand name Tricor (fenofibrate) as a suspect or interacting product, from January 2004 to March 2026. A further 12,787 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 5 reports listed it, down 64% from 14 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 110 reports a year and 0% of the 20,646,523 reports in the database, and 8.3% of the reports for the peroxisome proliferator receptor alpha agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded myalgia (10.5%), arthralgia (5%) and drug hypersensitivity (4.9%). A report can list several reactions, so shares add to more than 100%; 417 different terms appear across these reports. Myalgia is recorded in 10.5% of these reports, a larger share than in the median peroxisome proliferator receptor alpha agonist drug (7.2%).
39.3% of the reports are marked serious by the reporter (85.1% across the class); 3.8% record death among the outcomes and 17.2% record hospitalisation, as reported. 44.1% of the reports came from consumers, and the largest patient age group is 45 to 64 (18.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Tricor reports recording the termmedian drug in peroxisome proliferator receptor alpha agonist
- Myalgiamuscle pain10.5%259
- Arthralgiajoint pain5%123
- Drug hypersensitivityan allergic-type reaction to a medicine4.9%122
- Muscle spasmsmuscle cramps4.9%122
- Pain in extremitypain in an arm or leg4.8%119
- Nauseafeeling sick4.5%110
- Fatiguetiredness4.4%108
- Drug ineffectivethe medicine did not work as expected4%99
- Astheniaweakness or lack of energy3.9%96
- Headachehead pain3.7%92
- Muscular weaknessmuscle weakness3.7%92
- Rhabdomyolysismuscle breakdown3.5%87
- Painpain, site not specified3.4%84
- Blood creatinine increasedraised creatinine, a kidney test3.3%82
- Drug interactionan interaction between medicines3.3%82
- Hepatic enzyme increasedraised liver enzymes3%75
- Dizzinesslight-headedness or unsteadiness2.8%69
- Back painback pain2.7%67
- Diarrhoealoose or frequent stools2.4%60
- Pancreatitisinflammation of the pancreas2.4%59
- Pruritusitching2.4%59
- Rashskin rash2.3%56
- Abdominal painstomach or belly pain2.2%55
- Abdominal pain upperupper stomach pain2.2%54
- Constipationconstipation2%49
- Gait disturbancedifficulty walking1.9%48
- Chest painchest pain1.9%47
- Insomniadifficulty sleeping1.9%47
Top 30 of 417 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the peroxisome proliferator receptor alpha agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 29,908 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 86.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Blood triglycerides increased | 454 | 18.4% |
| Blood cholesterol increased | 373 | 15.1% |
| Hyperlipidaemia | 135 | 5.5% |
| Hypertriglyceridaemia | 55 | 2.2% |
| Hypercholesterolaemia | 46 | 1.9% |
| Blood cholesterol | 44 | 1.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,471 reports.
In context
| Measure | Tricor | Peroxisome proliferator receptor alpha agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 2,471 | 29,908 | 20,646,523 |
| Share of that pool | — | 8.3% | 0% |
| Reports, latest 12 months | 5 | — | 1,332,454 |
| Marked serious | 39.3% | 85.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 38 | 134 | 91 |
| Hospitalisation recorded, per 1,000 reports | 172 | 265 | 213 |
| Consumer-filed share | 44.1% | 24% | 45.8% |
| Top term, share of reports | Myalgia 10.5% | median 7.2% | 0.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the peroxisome proliferator receptor alpha agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Actos | brand | 15,128 | 29 | 91.9% |
| Fenofibrate | generic | 6,355 | 526 | 89.1% |
| Pioglitazone | generic | 2,659 | 109 | 88.9% |
| Gemfibrozil | generic | 1,807 | 43 | 79% |
| Pioglitazone hydrochloride | generic | 776 | 36 | 91.8% |
| Lopid | brand | 712 | 2 | 57.9% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Tricor reports
How many adverse event reports has FDA received for Tricor?
2,471 reports list Tricor as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 5 of them arrived in the latest 12 months. Another 12,787 list it only as a concomitant medication.
What reactions are recorded in Tricor reports?
myalgia (10.5%), arthralgia (5%), drug hypersensitivity (4.9%), muscle spasms (4.9%) and pain in extremity (4.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Tricor was responsible.
How serious are the reports?
39.3% are marked serious by the reporter. Among the outcomes recorded, 3.8% of reports include death and 17.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (44.1%), physician (32.3%) and not given (9.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Tricor rising?
5 reports in the 12 months to June 2026, down 64% from 14 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Tricor was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Tricor?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Tricor as a suspect or interacting product; reports listing it only as a concomitant medication (12,787) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.