Pharmacologic class (EPC) · 2 drug pages

Partial cholinergic nicotinic agonist: adverse event reports filed with FDA

71,811 reports list a drug in this class as a suspect or interacting product, 2006–2026.

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.

71,811
reports across the class: 0.4% of all reports; 106
reports, 12 months to June 2026: 82 in the 12 months before; 39.5%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Partial cholinergic nicotinic agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 71,811 adverse event reports received by FDA, 0.4% of the database, from August 2006 to June 2026.

106 reports arrived in the 12 months to June 2026, up 29% from 82 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 39.5% of the class's reports are marked serious, 1.9% record death among the outcomes and 7.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are nausea (18.9%), depression (11.3%) and abnormal dreams (10.6%). 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
ChantixVarenicline tartrate	brand	69,564	26	37.9%	Nausea
Varenicline tartrate	generic	2,247	80	90.2%	Nausea

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

Nauseafeeling sick18.9%13,603
Depressionlow mood11.3%8,099
Abnormal dreamsunusual dreams10.6%7,605
Anxietyanxiety7.6%5,448
Insomniadifficulty sleeping7.3%5,269
Drug ineffectivethe medicine did not work as expected7.3%5,241
Vomitingbeing sick5.6%4,033
Suicidal ideationthoughts of suicide5.5%3,946
Feeling abnormalfeeling odd or not right5.3%3,839
Malaisegeneral feeling of being unwell5.3%3,816
Headachehead pain5.2%3,764
Nightmarenightmares4.3%3,119
Aggressionaggressive behaviour3.8%2,709
Fatiguetiredness3.8%2,694
Dizzinesslight-headedness or unsteadiness3.7%2,689
Suicide attempta suicide attempt3%2,178
Anger3%2,176
Irritabilityirritability3%2,126
Constipationconstipation2.9%2,054
Agitationrestlessness2.7%1,923
Weight increasedweight gain2.5%1,831
Abdominal discomfortstomach discomfort2.4%1,747
Dyspnoeashortness of breath2.4%1,735
Abdominal pain upperupper stomach pain2.4%1,698
Somnolencedrowsiness2.3%1,658

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death1.9%1,346

Life-threatening1.3%969

Hospitalisation (initial or prolonged)7.9%5,640

Disability1.6%1,181

Congenital anomaly0%26

Other serious35.3%25,349

Not serious60.5%43,454

Patient age

Under 20%6

2 to 110%10

12 to 170%12

18 to 447.2%5,158

45 to 6414.5%10,445

65 to 743.8%2,714

75 and over0.8%555

Age not given73.7%52,911

Who reported

Physician7.3%5,266

Pharmacist1.4%1,037

Other health professional13.9%9,950

Lawyer4.7%3,381

Consumer or non-health professional68.5%49,181

Not given4.2%2,996

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 Partial cholinergic nicotinic agonist reports

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

Chantix and Varenicline tartrate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

71,811 reports through June 2026, 106 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?

nausea (18.9%), depression (11.3%), abnormal dreams (10.6%), anxiety (7.6%) and insomnia (7.3%).

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.