Exelon: adverse event reports filed with FDA

13,663

reports as suspect product

0.1% of all reports · about 607 a year

265

reports, 12 months to June 2026

210 in the 12 months before

92.6%

marked serious by the reporter

88.6% across the class

34%

record death among outcomes, as reported

4,649 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 Exelon reports recording the termmedian drug in cholinesterase inhibitor

1. Deaththe patient died; cause not stated by this term17.3%2,365
2. Falla fall7%957
3. Vomitingbeing sick5.8%788
4. Malaisegeneral feeling of being unwell5.5%756
5. Pneumonialung infection5.1%699
6. Confusional stateconfusion4.8%661
7. Nauseafeeling sick4.8%661
8. Cerebrovascular accidentstroke4.1%562
9. Memory impairmentmemory problems4.1%555
10. Dementia Alzheimer's type3.9%536
11. Dizzinesslight-headedness or unsteadiness3.9%529
12. Drug ineffectivethe medicine did not work as expected3.7%502
13. Weight decreasedweight loss3.5%475
14. Astheniaweakness or lack of energy3.4%466
15. Diarrhoealoose or frequent stools3.2%438
16. Hallucinationseeing or hearing things that are not there3.1%425
17. Dementiadementia3%405
18. Agitationrestlessness2.9%400
19. Application site erythemaredness where the product was applied2.9%394
20. Gait disturbancedifficulty walking2.8%389
21. Urinary tract infectionbladder or urinary infection2.8%382
22. Aggressionaggressive behaviour2.7%373
23. Somnolencedrowsiness2.5%348
24. Decreased appetitereduced appetite2.5%345
25. General physical health deteriorationgeneral decline in health2.4%327
26. Dyspnoeashortness of breath2.3%315
27. Condition aggravatedthe condition being treated got worse2.3%309
28. Tremorshaking2.2%295
29. Application site pruritusitching where the product was applied2.1%291
30. Dysphagiadifficulty swallowing2.1%289

Top 30 of 1,094 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 8 drugs in the cholinesterase 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 25,719 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. 22.1% 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 13,663 reports.

Drugs most often listed in the same reports

Other products listed in reports where Exelon 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 cholinesterase 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 Exelon as a suspect or interacting product; reports listing it only as a concomitant medication (4,022) 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.