Drugs › Partial cholinergic nicotinic agonist
Generic name
Varenicline tartrate: adverse event reports filed with FDA
2,247 reports list it as a suspect or interacting product, 2007–2026. Class: Partial cholinergic nicotinic agonist.
- 2,247
- reports as suspect product
- 0% of all reports · about 119 a year
- 80
- reports, 12 months to June 2026
- 58 in the 12 months before
- 90.2%
- marked serious by the reporter
- 39.5% across the class
- 4.6%
- record death among outcomes, as reported
- 103 reports · not verified by FDA
Between August 2007 and June 2026, 2,247 adverse event reports received by FDA list varenicline tartrate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (456) are left out of every figure here.
In the 12 months to June 2026, 80 reports listed it, up 38% from 58 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 119 reports a year and 0% of the 20,646,523 reports in the database, and 3.1% of the reports for the partial cholinergic nicotinic agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are nausea (9.2%), drug ineffective (8.4%) and depression (6.9%). A report can list several reactions, so shares add to more than 100%; 538 different terms appear across these reports. Nausea is recorded in 9.2% of these reports, a smaller share than in the median partial cholinergic nicotinic agonist drug (14.3%).
90.2% of the reports are marked serious by the reporter (39.5% across the class); 4.6% record death among the outcomes and 22.5% record hospitalisation, as reported. 37.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (38.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Varenicline tartrate reports recording the termmedian drug in partial cholinergic nicotinic agonist
- Nauseafeeling sick9.2%207
- Drug ineffectivethe medicine did not work as expected8.4%189
- Depressionlow mood6.9%154
- Insomniadifficulty sleeping5.3%119
- Anxietyanxiety5%112
- Dyspnoeashortness of breath4.9%111
- Headachehead pain4.7%106
- Suicidal ideationthoughts of suicide4.4%99
- Dizzinesslight-headedness or unsteadiness4.2%95
- Vomitingbeing sick4.2%95
- Feeling abnormalfeeling odd or not right3.8%85
- Drug hypersensitivityan allergic-type reaction to a medicine3.6%81
- Drug intolerancethe medicine was not tolerated3.6%81
- Aggressionaggressive behaviour3.5%78
- Depressed moodlow mood3.1%70
- Drug interactionan interaction between medicines2.9%65
- Agitationrestlessness2.8%64
- Malaisegeneral feeling of being unwell2.7%61
- Abnormal dreamsunusual dreams2.6%59
- Irritabilityirritability2.6%58
- Hypertensionhigh blood pressure2.5%57
- Mental disorder2.4%54
- Asthmaasthma2.3%52
- Weight decreasedweight loss2.3%52
- Cardiac disorder2.2%50
- Hypersensitivityan allergic-type reaction2.2%50
- Decreased appetitereduced appetite2.1%48
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease2.1%48
- Nightmarenightmares2.1%47
Top 30 of 538 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the partial cholinergic nicotinic agonist class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 71,811 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 14.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Smoking cessation therapy | 988 | 44% |
| Ex-tobacco user | 99 | 4.4% |
| Tobacco user | 64 | 2.8% |
| Nicotine dependence | 29 | 1.3% |
| Tobacco abuse | 9 | 0.4% |
| Adverse drug reaction | 3 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,247 reports.
In context
| Measure | Varenicline tartrate | Partial cholinergic nicotinic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 2,247 | 71,811 | 20,646,523 |
| Share of that pool | — | 3.1% | 0% |
| Reports, latest 12 months | 80 | — | 1,332,454 |
| Marked serious | 90.2% | 39.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 46 | 19 | 91 |
| Hospitalisation recorded, per 1,000 reports | 225 | 79 | 213 |
| Consumer-filed share | 37.3% | 68.5% | 45.8% |
| Top term, share of reports | Nausea 9.2% | median 14.3% | 3.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the partial cholinergic nicotinic agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Chantix | brand | 69,564 | 26 | 37.9% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Varenicline tartrate reports
How many adverse event reports has FDA received for Varenicline tartrate?
2,247 reports list Varenicline tartrate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 80 of them arrived in the latest 12 months. Another 456 list it only as a concomitant medication.
What reactions are recorded in Varenicline tartrate reports?
nausea (9.2%), drug ineffective (8.4%), depression (6.9%), insomnia (5.3%) and anxiety (5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Varenicline tartrate was responsible.
How serious are the reports?
90.2% are marked serious by the reporter. Among the outcomes recorded, 4.6% of reports include death and 22.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (37.3%), physician (27.5%) and other health professional (25.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Varenicline tartrate rising?
80 reports in the 12 months to June 2026, up 38% from 58 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Varenicline tartrate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Varenicline tartrate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Varenicline tartrate as a suspect or interacting product; reports listing it only as a concomitant medication (456) are excluded. 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.