Pharmacologic class (EPC) · 8 drug pages

Cholinergic nicotinic agonist: adverse event reports filed with FDA

54,214 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.

54,214
reports across the class: 0.3% of all reports; 1,330
reports, 12 months to June 2026: 1,392 in the 12 months before; 22.1%
marked serious by the reporter: 57.4% across all reports; 8
drugs with a page: brand and generic names counted separately

Cholinergic nicotinic agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 54,214 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

1,330 reports arrived in the 12 months to June 2026, close to the 1,392 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 22.1% of the class's reports are marked serious, 1.9% record death among the outcomes and 6% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (16.7%), nicotine dependence (11.5%) and nausea (8.4%). 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
Nicoderm CqNicotine	brand	15,396	173	10.8%	Application site erythema
NicoretteNicotine polacrilex	brand	12,495	121	18.1%	Intentional drug misuse
Nicotine	generic	9,015	368	62.8%	Drug ineffective
Nicotine polacrilex	generic	7,798	392	12.9%	Drug ineffective
Nicotine transdermal system patch	generic	4,462	105	10.2%	Product adhesion issue
NicotrolNicotine	brand	2,281	6	32.4%	Drug ineffective
Equate NicotineNicotine polacrilex	brand	1,691	0	1.3%	Application site erythema
Nicotine transdermal system	generic	1,076	165	13.7%	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 expected16.7%9,062
Nicotine dependence11.5%6,253
Nauseafeeling sick8.4%4,538
Intentional drug misuse7.3%3,977
Application site erythemaredness where the product was applied6.8%3,704
Application site pruritusitching where the product was applied6.7%3,642
Malaisegeneral feeling of being unwell4.8%2,596
Product quality issuea problem with the product itself4.7%2,547
Dizzinesslight-headedness or unsteadiness4.2%2,289
Product adhesion issue4.1%2,227
Headachehead pain3.9%2,111
Macular degenerationa disease of the central retina3.7%2,004
Wrong technique in product usage processthe product was used in the wrong way3.1%1,681
Drug administration errora mistake in giving the medicine3%1,621
Overdosea dose above the recommended amount2.9%1,564
Treatment noncompliancethe treatment was not taken as directed2.9%1,549
Application site rash2.6%1,416
Vomitingbeing sick2.6%1,405
Application site pain2.4%1,295
Hypersensitivityan allergic-type reaction2.4%1,291
Application site irritation2.3%1,264
Dyspepsiaindigestion2.3%1,248
Abnormal dreamsunusual dreams2.2%1,171
Insomniadifficulty sleeping2.1%1,132
Rashskin rash1.9%1,022

Solid bar: share of all class reports. Hollow bar: the median share across the 8 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death1.9%1,010

Life-threatening0.5%262

Hospitalisation (initial or prolonged)6%3,248

Disability0.4%214

Congenital anomaly0.3%188

Other serious18.5%10,031

Not serious77.9%42,252

Patient age

Under 20.4%229

2 to 110.1%52

12 to 170.3%156

18 to 4415.3%8,313

45 to 6423.2%12,553

65 to 749.6%5,192

75 and over2.8%1,521

Age not given48.3%26,198

Who reported

Physician3.1%1,663

Pharmacist1.5%824

Other health professional6.5%3,516

Lawyer0.1%57

Consumer or non-health professional88%47,689

Not given0.9%465

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 Cholinergic nicotinic agonist reports

Which drugs are in the Cholinergic nicotinic agonist class on this site?

Nicoderm Cq, Nicorette, Nicotine, Nicotine polacrilex, Nicotine transdermal system patch and Nicotrol and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

54,214 reports through June 2026, 1,330 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 (16.7%), nicotine dependence (11.5%), nausea (8.4%), intentional drug misuse (7.3%) and application site erythema (6.8%).

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.