Actos: adverse event reports filed with FDA

15,128

reports as suspect product

0.1% of all reports · about 673 a year

29

reports, 12 months to June 2026

33 in the 12 months before

91.9%

marked serious by the reporter

85.1% across the class

16.4%

record death among outcomes, as reported

2,482 reports · not verified by FDA

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 Actos reports recording the termmedian drug in peroxisome proliferator receptor alpha agonist

1. Bladder cancer58.4%8,833
2. Deaththe patient died; cause not stated by this term6.5%981
3. Weight increasedweight gain3.7%561
4. Bladder transitional cell carcinoma3.5%524
5. Oedema peripheralswelling of the legs, ankles or hands2.7%410
6. Blood glucose increasedraised blood sugar reading2.6%396
7. Dyspnoeashortness of breath2.5%376
8. Cardiac failure congestivecongestive heart failure2.3%354
9. Myocardial infarctionheart attack1.7%258
10. Hypoglycaemialow blood sugar1.4%218
11. Haematuriablood in the urine1.4%210
12. Cardiac failureheart failure1.3%194
13. Nauseafeeling sick1.2%189
14. Falla fall1.2%183
15. Fluid retentionthe body holding extra fluid1.1%165
16. Dizzinesslight-headedness or unsteadiness1.1%163
17. Drug hypersensitivityan allergic-type reaction to a medicine1.1%163
18. Drug ineffectivethe medicine did not work as expected1.1%159
19. Weight decreasedweight loss1.1%159
20. Oedemaswelling from fluid1%155
21. Fatiguetiredness1%152
22. Bladder cancer recurrent1%147
23. Astheniaweakness or lack of energy0.9%141
24. Condition aggravatedthe condition being treated got worse0.9%136
25. Chest painchest pain0.9%133
26. Blood glucose decreasedlow blood sugar reading0.8%125
27. Diabetes mellitus inadequate controldiabetes not well controlled0.8%122
28. Glycosylated haemoglobin increaseda raised HbA1c, the long-term sugar measure0.8%122
29. Headachehead pain0.8%118
30. Urinary tract infectionbladder or urinary infection0.7%113

Top 30 of 999 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 80.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 15,128 reports.

Drugs most often listed in the same reports

Other products listed in reports where Actos is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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

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.

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 Actos as a suspect or interacting product; reports listing it only as a concomitant medication (19,026) 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.