Drug class · FAERS comparison

Acetylcholine Release Inhibitor side effects compared: 5 drugs, 98,714 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14

How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

Drug	FAERS reports	Serious	Death outcome	Boxed warning	Top labeled signals	Unlabeled (unassessed)
Onabotulinumtoxina (Botox)	76,722	19%	2,108	boxed	Eyelid ptosis; Multiple use of single-use product; Facial paresis	Poor quality product administered; Brow ptosis
Botulinum Toxin Type A (Dysport)	12,337	55%	1,874	boxed	Muscle injury; Peripheral venous disease; Facial asymmetry	Blepharospasm; Pemphigus
Incobotulinumtoxina (Xeomin)	5,628	14%	102	boxed	Injection site pain; Injection site swelling; Injection site erythema	Burning sensation; Influenza like illness
Prabotulinum Toxin Type A (Jeuveau)	3,775	2%	1	boxed	Injection site pain; Injection site swelling; Eyelid ptosis	–
Letibotulinumtoxina-Wlbg (Letybo)	252	11%	0	boxed	–	–

Class-wide signals (flagged in at least 3 of 5 members)

Reaction	Members flagged	Median PRR	Reports (sum)	In label
Eyelid ptosis	3/5	48.2	3,332	3/3 members' labels

Member-specific signals (flagged in exactly one drug)

Reaction	Drug	Reports	PRR	Label screen
Hepatic enzyme	Botulinum Toxin Type A	67	1,581.1	Not in label — unassessed
Neovascularisation	Botulinum Toxin Type A	59	509.6	Not in label — unassessed
Facet joint syndrome	Botulinum Toxin Type A	685	472.9	Not in label — unassessed
Hypocholesterolaemia	Botulinum Toxin Type A	58	395.0	Not in label — unassessed
Overlap syndrome	Botulinum Toxin Type A	103	298.6	Not in label — unassessed
Peripheral venous disease	Botulinum Toxin Type A	595	297.9	Labeled (related wording)
Multiple use of single-use product	Onabotulinumtoxina	2,857	292.0	Labeled (related wording)
Blepharospasm	Botulinum Toxin Type A	847	268.9	Not in label — unassessed
Onychomadesis	Botulinum Toxin Type A	502	233.7	Not in label — unassessed
Rheumatic fever	Botulinum Toxin Type A	512	225.7	Not in label — unassessed
Breast cancer stage iii	Botulinum Toxin Type A	742	221.6	Not in label — unassessed
Duodenal ulcer perforation	Botulinum Toxin Type A	738	190.0	Not in label — unassessed
Eyelid sensory disorder	Onabotulinumtoxina	73	164.8	Not in label — unassessed
Onychomycosis	Botulinum Toxin Type A	364	154.0	Not in label — unassessed
Infusion site reaction	Botulinum Toxin Type A	224	141.9	Not in label — unassessed
Muscle injury	Botulinum Toxin Type A	611	136.7	Labeled (related wording)
Lupus vulgaris	Botulinum Toxin Type A	86	132.3	Not in label — unassessed
Folliculitis	Botulinum Toxin Type A	745	132.1	Not in label — unassessed
Helicobacter infection	Botulinum Toxin Type A	720	129.1	Not in label — unassessed
Nail disorder	Botulinum Toxin Type A	604	126.9	Not in label — unassessed
Finger deformity	Botulinum Toxin Type A	330	124.1	Not in label — unassessed
Lip dry	Botulinum Toxin Type A	591	120.0	Not in label — unassessed
Hypercholesterolaemia	Botulinum Toxin Type A	602	114.1	Not in label — unassessed
Live birth	Botulinum Toxin Type A	519	112.9	Not in label — unassessed
Bursitis	Botulinum Toxin Type A	749	112.5	Not in label — unassessed

Common questions

Which acetylcholine release inhibitor has the most FDA adverse event reports?

Onabotulinumtoxina has the most FAERS co-reports in this class (76,722), followed by Botulinum Toxin Type A (12,337). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across acetylcholine release inhibitor drugs?

Reaction terms flagged in at least half of the 5 members include eyelid ptosis. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.