Pharmacologic class (EPC) · 6 drug pages

Acetylcholine release inhibitor: adverse event reports filed with FDA

88,564 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

88,564
reports across the class: 0.4% of all reports; 6,817
reports, 12 months to June 2026: 7,304 in the 12 months before; 20.1%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Acetylcholine release inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 88,564 adverse event reports received by FDA, 0.4% of the database, from January 2004 to June 2026.

6,817 reports arrived in the 12 months to June 2026, close to the 7,304 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 20.1% of the class's reports are marked serious, 4.3% record death among the outcomes and 6.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (36.2%), off label use (20.2%) and therapeutic response decreased (5.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
BOTOX CosmeticOnabotulinumtoxina	brand	38,760	1,409	2.4%	Drug ineffective
BotoxOnabotulinumtoxina	brand	29,345	2,936	34.3%	Off label use
DysportBotulinum toxin type a	brand	6,545	367	29.5%	Off label use
XeominIncobotulinumtoxina	brand	5,438	637	12.2%	Drug ineffective
Botulinum toxin type a	generic	4,736	972	87.1%	Off label use
JeuveauPrabotulinum toxin type a	brand	3,740	496	1.4%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected36.2%32,093
Off label useused for a purpose or in a way not on the label20.2%17,885
Therapeutic response decreasedthe medicine worked less well5.9%5,215
Headachehead pain5.7%5,004
Product preparation error5%4,396
Injection site painpain where the injection was given4.4%3,879
Eyelid ptosis4.3%3,767
Multiple use of single-use product3.2%2,858
Muscular weaknessmuscle weakness3%2,694
Nauseafeeling sick3%2,620
Painpain, site not specified2.9%2,544
Dizzinesslight-headedness or unsteadiness2.8%2,478
Migrainemigraine2.8%2,472
Dysphagiadifficulty swallowing2.5%2,230
Fatiguetiredness2.4%2,167
Dyspnoeashortness of breath2.3%2,045
Astheniaweakness or lack of energy2.3%1,993
Product use in unapproved indicationused for a purpose not on the label2.2%1,935
Hypoaesthesianumbness2.2%1,921
Neck painneck pain1.9%1,700
Vision blurredblurred vision1.9%1,694
Wrong technique in product usage processthe product was used in the wrong way1.9%1,677
Rashskin rash1.9%1,671
Paraesthesiatingling or pins and needles1.9%1,665
Wrong technique in drug usage processthe medicine was used in the wrong way1.8%1,638

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death4.3%3,781

Life-threatening2.2%1,940

Hospitalisation (initial or prolonged)6.7%5,917

Disability3%2,636

Congenital anomaly1.7%1,500

Other serious13.7%12,104

Not serious79.9%70,799

Patient age

Under 20.1%88

2 to 110.6%521

12 to 170.4%333

18 to 4415.3%13,540

45 to 6417.1%15,109

65 to 743.4%3,025

75 and over1.9%1,639

Age not given61.3%54,309

Who reported

Physician26.9%23,809

Pharmacist1.5%1,372

Other health professional37.7%33,362

Lawyer0%39

Consumer or non-health professional31.3%27,725

Not given2.5%2,257

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Acetylcholine release inhibitor reports

Which drugs are in the Acetylcholine release inhibitor class on this site?

BOTOX Cosmetic, Botox, Dysport, Xeomin, Botulinum toxin type a and Jeuveau. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

88,564 reports through June 2026, 6,817 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (36.2%), off label use (20.2%), therapeutic response decreased (5.9%), headache (5.7%) and product preparation error (5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.