Dysport: adverse event reports filed with FDA

6,545

reports as suspect product

0% of all reports · about 294 a year

367

reports, 12 months to June 2026

433 in the 12 months before

29.5%

marked serious by the reporter

20.1% across the class

2.1%

record death among outcomes, as reported

135 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 Dysport reports recording the termmedian drug in acetylcholine release inhibitor

1. Off label useused for a purpose or in a way not on the label36.6%2,397
2. Drug ineffectivethe medicine did not work as expected26.2%1,712
3. Product preparation error11.4%749
4. Headachehead pain7%456
5. Muscular weaknessmuscle weakness5.7%371
6. Eyelid ptosis5.5%360
7. Overdosea dose above the recommended amount5.5%359
8. Dysphagiadifficulty swallowing5.4%351
9. Therapeutic response shortened4.9%323
10. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times4.9%321
11. Injection site painpain where the injection was given4.4%289
12. Vision blurredblurred vision4.3%280
13. Intentional product misusedeliberate use not as intended4%261
14. Dyspnoeashortness of breath4%259
15. Dizzinesslight-headedness or unsteadiness3.7%243
16. Fatiguetiredness3.7%241
17. Astheniaweakness or lack of energy3.6%235
18. Nauseafeeling sick3.1%201
19. Painpain, site not specified2.9%190
20. Wrong technique in product usage processthe product was used in the wrong way2.8%183
21. Prescribed overdose2.6%169
22. Swelling facea swollen face2.5%164
23. Diplopiadouble vision2.4%159
24. Injection site swellingswelling where the injection was given2.4%154
25. Anxietyanxiety2.2%146
26. Neuromuscular toxicity2.2%146
27. Drug effect decreasedthe medicine had less effect2.2%143
28. Eye swellinga swollen eye2.2%143
29. Hypoaesthesianumbness2.1%137
30. Influenza like illnessflu-like symptoms2%130

Top 30 of 585 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. 81.7% 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 6,545 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dysport 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 Dysport as a suspect or interacting product; reports listing it only as a concomitant medication (241) 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.