BOTOX Cosmetic: adverse event reports filed with FDA

38,760

reports as suspect product

0.2% of all reports · about 1,723 a year

1,409

reports, 12 months to June 2026

1,372 in the 12 months before

2.4%

marked serious by the reporter

20.1% across the class

0.1%

record death among outcomes, as reported

21 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 Cosmetic reports recording the termmedian drug in acetylcholine release inhibitor

1. Drug ineffectivethe medicine did not work as expected52.5%20,347
2. Off label useused for a purpose or in a way not on the label15%5,804
3. Therapeutic response decreasedthe medicine worked less well9.5%3,684
4. Product preparation error8.4%3,250
5. Multiple use of single-use product6.8%2,645
6. Injection site painpain where the injection was given5.3%2,041
7. Eyelid ptosis4.9%1,903
8. Wrong technique in drug usage processthe medicine was used in the wrong way3.8%1,458
9. Headachehead pain3.7%1,437
10. Wrong technique in product usage processthe product was used in the wrong way3.2%1,256
11. Injection site swellingswelling where the injection was given1.9%725
12. Swelling facea swollen face1.6%639
13. Facial paresis1.6%632
14. Vision blurredblurred vision1.6%619
15. Product preparation issuea problem preparing the product1.5%599
16. Dizzinesslight-headedness or unsteadiness1.5%570
17. Drug ineffective for unapproved indication1.4%561
18. Therapeutic response shortened1.3%515
19. Product storage errorthe product was stored wrongly1.3%510
20. Nauseafeeling sick1.2%476
21. Product quality issuea problem with the product itself1.1%427
22. Poor quality product administered1.1%422
23. Injection site erythemaredness where the injection was given1%406
24. Eye swellinga swollen eye1%397
25. Dysphagiadifficulty swallowing1%382
26. Rashskin rash1%371
27. Dyspnoeashortness of breath1%369
28. Fatiguetiredness0.9%360
29. Hypoaesthesianumbness0.9%351
30. Painpain, site not specified0.9%342

Top 30 of 679 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. 97.4% 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 38,760 reports.

Drugs most often listed in the same reports

Other products listed in reports where BOTOX Cosmetic 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 Cosmetic as a suspect or interacting product; reports listing it only as a concomitant medication (286) 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.