Exemestane: adverse event reports filed with FDA

7,041

reports as suspect product

0% of all reports · about 314 a year

473

reports, 12 months to June 2026

516 in the 12 months before

85.5%

marked serious by the reporter

82.2% across the class

13.1%

record death among outcomes, as reported

925 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 Exemestane reports recording the termmedian drug in aromatase inhibitor

1. Malignant neoplasm progression12.6%889
2. Fatiguetiredness11.8%831
3. Diarrhoealoose or frequent stools11%774
4. Nauseafeeling sick10.3%723
5. Arthralgiajoint pain9.4%660
6. Dyspnoeashortness of breath7.9%553
7. Astheniaweakness or lack of energy6.8%480
8. Headachehead pain6.8%478
9. Breast cancer metastatic6.8%476
10. Coughcough6.4%452
11. Vomitingbeing sick6.4%451
12. Dizzinesslight-headedness or unsteadiness5.6%397
13. Metastases to liver5.6%397
14. Insomniadifficulty sleeping5.6%394
15. Metastases to bone5.6%393
16. Neoplasm progression5.4%381
17. Malaisegeneral feeling of being unwell5.4%380
18. Decreased appetitereduced appetite5.2%365
19. Disease progressionthe disease advanced5.2%365
20. Pyrexiafever5.2%365
21. Pruritusitching5%349
22. Myalgiamuscle pain4.8%337
23. Abdominal painstomach or belly pain4.6%325
24. Ascitesfluid in the abdomen4.4%312
25. Painpain, site not specified4.3%300
26. Falla fall4.1%288
27. Sepsisa severe body-wide response to infection3.9%277
28. Abdominal pain upperupper stomach pain3.8%271
29. Neutropenialow neutrophils, a type of white blood cell3.8%265
30. Breast cancerbreast cancer3.7%260

Top 30 of 1,151 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 6 drugs in the aromatase inhibitor 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 70,406 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. 27.6% 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 7,041 reports.

Drugs most often listed in the same reports

Other products listed in reports where Exemestane 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 aromatase inhibitor 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 Exemestane as a suspect or interacting product; reports listing it only as a concomitant medication (5,507) 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.