Botox: adverse event reports filed with FDA

29,345

reports as suspect product

0.1% of all reports · about 1,305 a year

2,936

reports, 12 months to June 2026

3,287 in the 12 months before

34.3%

marked serious by the reporter

20.1% across the class

6.5%

record death among outcomes, as reported

1,920 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 Botox reports recording the termmedian drug in acetylcholine release inhibitor

1. Off label useused for a purpose or in a way not on the label17.7%5,207
2. Drug ineffectivethe medicine did not work as expected17.6%5,172
3. Headachehead pain6.2%1,814
4. Deaththe patient died; cause not stated by this term5%1,454
5. Muscular weaknessmuscle weakness4.6%1,358
6. Migrainemigraine4.5%1,311
7. Dysphagiadifficulty swallowing4.2%1,230
8. Eyelid ptosis4.1%1,199
9. Injection site painpain where the injection was given3.6%1,051
10. Nauseafeeling sick3.5%1,031
11. Painpain, site not specified3.5%1,031
12. Dyspnoeashortness of breath2.9%859
13. Neck painneck pain2.8%832
14. Dizzinesslight-headedness or unsteadiness2.8%809
15. Fatiguetiredness2.7%787
16. Astheniaweakness or lack of energy2.6%771
17. Therapeutic response decreasedthe medicine worked less well2.4%692
18. Vision blurredblurred vision2.1%613
19. Product use in unapproved indicationused for a purpose not on the label1.9%559
20. Hypoaesthesianumbness1.8%537
21. Rashskin rash1.7%510
22. Malaisegeneral feeling of being unwell1.7%492
23. Therapeutic response shortened1.7%485
24. Product storage errorthe product was stored wrongly1.6%461
25. Hyperhidrosisexcessive sweating1.6%460
26. Vomitingbeing sick1.6%456
27. Paraesthesiatingling or pins and needles1.5%440
28. Influenza like illnessflu-like symptoms1.5%428
29. Anxietyanxiety1.4%419
30. Swelling facea swollen face1.4%402

Top 30 of 1,636 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 acetylcholine release 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 88,564 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. 81.3% 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 29,345 reports.

Drugs most often listed in the same reports

Other products listed in reports where Botox 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 acetylcholine release 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 Botox as a suspect or interacting product; reports listing it only as a concomitant medication (8,312) 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.