Aromasin: adverse event reports filed with FDA

6,407

reports as suspect product

0% of all reports · about 285 a year

112

reports, 12 months to June 2026

131 in the 12 months before

67.6%

marked serious by the reporter

82.2% across the class

10.4%

record death among outcomes, as reported

667 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 Aromasin reports recording the termmedian drug in aromatase inhibitor

1. Arthralgiajoint pain9.5%610
2. Fatiguetiredness7.7%493
3. Disease progressionthe disease advanced5.8%373
4. Deaththe patient died; cause not stated by this term5.5%355
5. Malaisegeneral feeling of being unwell5.4%349
6. Nauseafeeling sick5.1%327
7. Neoplasm progression4.9%311
8. Diarrhoealoose or frequent stools4.4%279
9. Painpain, site not specified4.2%266
10. Breast cancerbreast cancer3.8%242
11. Hot flusha hot flush3.8%241
12. Headachehead pain3.7%240
13. Pain in extremitypain in an arm or leg3.5%222
14. Alopeciahair loss3.4%221
15. Dyspnoeashortness of breath3.3%212
16. Bone painbone pain3.2%202
17. Malignant neoplasm progression3.1%200
18. Astheniaweakness or lack of energy3.1%197
19. Insomniadifficulty sleeping3%191
20. Dizzinesslight-headedness or unsteadiness2.8%179
21. Vomitingbeing sick2.6%168
22. Weight decreasedweight loss2.6%168
23. Myalgiamuscle pain2.5%157
24. Coughcough2.4%155
25. Breast cancer metastatic2.3%150
26. Back painback pain2.3%149
27. Rashskin rash2.3%145
28. Weight increasedweight gain2.2%143
29. Condition aggravatedthe condition being treated got worse2.1%134
30. Falla fall2.1%134

Top 30 of 910 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. 58.9% 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 6,407 reports.

Drugs most often listed in the same reports

Other products listed in reports where Aromasin 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 Aromasin as a suspect or interacting product; reports listing it only as a concomitant medication (2,855) 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.