Drug class · FAERS comparison

Cholinergic Nicotinic Agonist side effects compared: 6 drugs, 114,081 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)
Nicotine	40,197	36%	1,858	–	–	Application site erythema; Application site pruritus
Nicotine Polacrilex (Nicotine)	38,030	37%	1,709	–	–	Macular degeneration; Oral discomfort
Nicotine Polarilex (Nicotine)	14,919	70%	1,563	–	–	Macular degeneration; Chronic sinusitis
Nicotine Polacrilex Mini	14,919	70%	1,563	–	–	–
Nicotine Transdermal System Patch	4,583	12%	31	–	Abnormal dreams	Application site pruritus; Macular degeneration
Nicotine Transdermal System	1,433	28%	42	–	Abnormal dreams	Application site pruritus; Application site pain

Class-wide signals (flagged in at least 3 of 6 members)

Reaction	Members flagged	Median PRR	Reports (sum)	In label
Macular degeneration	5/6	66.2	2,921	0/5 members' labels
Vaginal flatulence	4/6	1,393.1	720	0/4 members' labels
Rhesus incompatibility	4/6	1,237.5	272	0/4 members' labels
Plethysmography	4/6	1,219.4	58	0/4 members' labels
Truncus arteriosus persistent	4/6	572.4	299	0/4 members' labels
Tobacco poisoning	4/6	533.1	166	0/4 members' labels
Myocardial stunning	4/6	212.4	97	0/4 members' labels
Nicotine dependence	4/6	211.2	8,336	0/4 members' labels
Tobacco interaction	4/6	163.2	65	0/4 members' labels
Lung diffusion disorder	4/6	126.0	73	0/4 members' labels
Female genital tract fistula	4/6	115.6	736	0/4 members' labels
Cardiac septal defect	4/6	78.9	219	0/4 members' labels
Tremor neonatal	4/6	74.9	129	0/4 members' labels
Multiple drug overdose accidental	4/6	72.5	128	0/4 members' labels
Radiculopathy	4/6	72.0	732	0/4 members' labels
Neutropenia neonatal	4/6	71.2	63	0/4 members' labels
Congenital cardiovascular anomaly	4/6	70.3	231	0/4 members' labels
Poor feeding infant	4/6	69.9	285	0/4 members' labels
Proctitis	4/6	68.5	742	0/4 members' labels
Chronic sinusitis	4/6	67.7	991	0/4 members' labels
Idiopathic interstitial pneumonia	3/6	77.5	54	0/3 members' labels
Jaundice neonatal	3/6	74.9	288	0/3 members' labels
Mediastinal mass	3/6	70.3	54	0/3 members' labels
Adenoidectomy	3/6	68.9	54	0/3 members' labels
Necrosis ischaemic	3/6	63.4	60	0/3 members' labels
Pulmonary eosinophilia	3/6	60.3	57	0/3 members' labels
Breech presentation	3/6	56.9	147	0/3 members' labels
Tooth erosion	3/6	51.1	142	0/3 members' labels
Application site pruritus	3/6	50.9	3,355	0/3 members' labels
Application site rash	3/6	42.4	1,209	0/3 members' labels

Member-specific signals (flagged in exactly one drug)

Reaction	Drug	Reports	PRR	Label screen
Application site dermatitis	Nicotine	248	187.3	Not in label — unassessed
Application site urticaria	Nicotine	445	127.7	Not in label — unassessed
Application site papules	Nicotine	183	109.5	Not in label — unassessed
Application site swelling	Nicotine	659	79.2	Not in label — unassessed
Application site reaction	Nicotine	903	76.0	Not in label — unassessed
Application site warmth	Nicotine	162	75.5	Not in label — unassessed
Application site paraesthesia	Nicotine	118	51.6	Not in label — unassessed
Hiccups	Nicotine Polacrilex	615	44.9	Not in label — unassessed
Vaginal discharge	Nicotine Transdermal System Patch	86	39.5	Not in label — unassessed
Oral discomfort	Nicotine Polacrilex	744	31.1	Not in label — unassessed
Paraesthesia oral	Nicotine Transdermal System Patch	96	30.8	Not in label — unassessed
Oral candidiasis	Nicotine Transdermal System Patch	86	30.4	Not in label — unassessed
Drug abuser	Nicotine Polacrilex	321	29.9	Not in label — unassessed
Tooth discolouration	Nicotine Polacrilex	152	29.8	Not in label — unassessed
Procedural pain	Nicotine Transdermal System Patch	94	15.6	Not in label — unassessed
Frequent bowel movements	Nicotine Transdermal System Patch	86	14.7	Not in label — unassessed
Colitis	Nicotine Transdermal System Patch	87	10.6	Not in label — unassessed
Rectal haemorrhage	Nicotine Transdermal System Patch	86	9.1	Not in label — unassessed
Colitis ulcerative	Nicotine Transdermal System Patch	85	8.7	Not in label — unassessed
Haematochezia	Nicotine Transdermal System Patch	89	7.4	Not in label — unassessed
Infusion related reaction	Nicotine Transdermal System Patch	96	6.7	Not in label — unassessed
Dyspepsia	Nicotine Transdermal System Patch	106	4.9	Not in label — unassessed

Common questions

Which cholinergic nicotinic agonist has the most FDA adverse event reports?

Nicotine has the most FAERS co-reports in this class (40,197), followed by Nicotine Polacrilex (38,030). 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 cholinergic nicotinic agonist drugs?

Reaction terms flagged in at least half of the 6 members include macular degeneration, vaginal flatulence, rhesus incompatibility, plethysmography, truncus arteriosus persistent. 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.