Pharmacologic class (EPC) · 7 drug pages

Peroxisome proliferator receptor alpha agonist: adverse event reports filed with FDA

29,908 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

29,908
reports across the class: 0.1% of all reports; 750
reports, 12 months to June 2026: 824 in the 12 months before; 85.1%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Peroxisome proliferator receptor alpha agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 29,908 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

750 reports arrived in the 12 months to June 2026, close to the 824 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 85.1% of the class's reports are marked serious, 13.4% record death among the outcomes and 26.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are bladder cancer (30%), death (3.7%) and dyspnoea (3.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
ActosPioglitazone	brand	15,128	29	91.9%	Bladder cancer
Fenofibrate	generic	6,355	526	89.1%	Drug interaction
Pioglitazone	generic	2,659	109	88.9%	Drug ineffective
TricorFenofibrate	brand	2,471	5	39.3%	Myalgia
Gemfibrozil	generic	1,807	43	79%	Rhabdomyolysis
Pioglitazone hydrochloride	generic	776	36	91.8%	Dyspnoea
LopidGemfibrozil	brand	712	2	57.9%	Drug hypersensitivity

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Bladder cancer30%8,971
Deaththe patient died; cause not stated by this term3.7%1,112
Dyspnoeashortness of breath3.6%1,080
Drug interactionan interaction between medicines3.5%1,056
Myalgiamuscle pain3.5%1,048
Rhabdomyolysismuscle breakdown3.1%923
Drug ineffectivethe medicine did not work as expected2.9%874
Fatiguetiredness2.8%844
Nauseafeeling sick2.7%804
Astheniaweakness or lack of energy2.7%793
Drug hypersensitivityan allergic-type reaction to a medicine2.6%774
Weight increasedweight gain2.6%773
Falla fall2.4%728
Dizzinesslight-headedness or unsteadiness2.4%716
Diarrhoealoose or frequent stools2.3%675
Oedema peripheralswelling of the legs, ankles or hands2.3%674
Arthralgiajoint pain2.2%671
Headachehead pain2.1%637
Blood glucose increasedraised blood sugar reading1.9%566
Bladder transitional cell carcinoma1.9%559
Vomitingbeing sick1.8%552
Malaisegeneral feeling of being unwell1.8%551
Abdominal painstomach or belly pain1.8%548
Haematuriablood in the urine1.7%520
Pruritusitching1.7%504

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death13.4%4,010

Life-threatening5.1%1,534

Hospitalisation (initial or prolonged)26.5%7,937

Disability2.6%773

Congenital anomaly0.2%50

Other serious61.6%18,417

Not serious14.9%4,460

Patient age

Under 20.1%30

2 to 110.5%163

12 to 170.4%110

18 to 445.4%1,621

45 to 6419.9%5,939

65 to 7414%4,190

75 and over10.1%3,012

Age not given49.6%14,843

Who reported

Physician21.3%6,385

Pharmacist6.2%1,863

Other health professional19.6%5,855

Lawyer18.4%5,508

Consumer or non-health professional24%7,164

Not given10.5%3,133

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Peroxisome proliferator receptor alpha agonist reports

Which drugs are in the Peroxisome proliferator receptor alpha agonist class on this site?

Actos, Fenofibrate, Pioglitazone, Tricor, Gemfibrozil and Pioglitazone hydrochloride and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

29,908 reports through June 2026, 750 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

bladder cancer (30%), death (3.7%), dyspnoea (3.6%), drug interaction (3.5%) and myalgia (3.5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.