Varenicline adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Varenicline
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Cholinergic receptor agonist
Also reported as: Varenicline Tablets, Varenicline 1mg

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2007 to June 2026, FDA received 2,680 adverse event reports that name Varenicline. In these reports the drug is a suspect or interacting product.

In the same period, 555 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 335 reports in the 12 months to June 2026 and 225 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 335 (under 0.1%) name Varenicline. Reports from pharmacists were 56.7% of the reports that name Varenicline and 6.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Varenicline is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 100 reports that name Varenicline.
In January to March 2026, FDA received 72.
In April to June 2025, FDA received 84.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 159 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 2,676 of the 2,680 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 159 terms.

Reaction terms in the reports that name Varenicline, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,680 reports
Nauseafeeling sick	502	18.7%
Depressionlow mood	352	13.1%
Vomitingbeing sick	331	12.4%
Suicidal ideationthoughts of suicide	214	8%
Nightmarenightmares	200	7.5%
Abnormal dreamsunusual dreams	198	7.4%
Agitationrestlessness	150	5.6%
Insomniadifficulty sleeping	139	5.2%
Headachehead pain	118	4.4%
Dizzinesslight-headedness or unsteadiness	108	4%
Anxiety	105	3.9%
Irritability	79	2.9%
Drug ineffectivethe medicine did not work as expected	71	2.6%
Drug interactionan interaction between medicines	69	2.6%
Mood swings	66	2.5%
Dyspnoeashortness of breath	63	2.4%
Rashskin rash	63	2.4%
Diarrhoealoose or frequent stools	61	2.3%
Fatiguetiredness	61	2.3%
Constipation	60	2.2%
Confusional stateconfusion	54	2%
Hallucinationseeing or hearing things that are not there	53	2%
Anger	52	1.9%
Aggressionaggressive behaviour	48	1.8%
Feeling abnormalfeeling odd or not right	48	1.8%
Abdominal discomfortstomach discomfort	43	1.6%
Somnolencedrowsiness	41	1.5%
Condition aggravatedthe condition being treated got worse	38	1.4%
Hepatotoxicityliver injury	35	1.3%
Pruritusitching	35	1.3%
Mood altereda change in mood	34	1.3%
Drug-induced liver injury	32	1.2%
Hepatic cirrhosis	31	1.2%
Palpitationsawareness of the heartbeat	31	1.2%
Depressed moodlow mood	30	1.1%
Dry mouth	29	1.1%
Hepatic encephalopathy	28	1%
Hepatic necrosis	28	1%
Suicide attempta suicide attempt	28	1%
Abdominal pain upperupper stomach pain	27	1%
Astheniaweakness or lack of energy	27	1%
Malaisegeneral feeling of being unwell	25	0.9%
Hyperhidrosisexcessive sweating	24	0.9%
Abdominal painstomach or belly pain	23	0.9%
Arthralgiajoint pain	23	0.9%
Chest pain	23	0.9%
Sleep disordera sleep problem	23	0.9%
Dysgeusiaaltered taste	22	0.8%
Abnormal behaviourunusual behaviour	21	0.8%
Sedationdrowsiness	21	0.8%

Download all 159 terms of Varenicline (CSV)

The counts add to more than 2,680 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Varenicline with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Varenicline (this page)	Generic name	2,680
Varenicline tartrate	Generic name	2,247
Chantix	Brand name	69,564
Tyrvaya	Brand name	2,608

Sum of the separately reported names: 77,099. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Varenicline, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2006	26	1	0	0	0	0	0	1	25
2007	243	137	3	2	13	5	0	122	106
2008	858	200	2	8	29	1	0	166	658
2009	468	71	1	4	20	0	0	51	397
2010	53	21	6	3	6	0	0	9	32
2011	39	22	0	6	9	2	0	13	17
2012	49	40	1	3	17	1	0	23	9
2013	23	21	3	1	6	0	2	10	2
2014	21	19	0	3	15	0	0	6	2
2015	35	25	6	2	13	1	0	11	10
2016	21	16	5	3	10	0	0	4	5
2017	25	17	0	6	11	0	0	6	8
2018	16	15	2	5	7	0	0	7	1
2019	21	11	1	0	2	0	0	9	10
2020	35	23	0	1	9	1	0	16	12
2021	20	15	4	0	11	0	0	6	5
2022	46	18	1	0	5	1	0	14	28
2023	73	47	2	1	21	2	0	39	26
2024	113	40	1	4	22	1	0	34	73
2025	320	144	0	10	24	5	0	132	176
2026	175	120	1	3	18	6	0	113	55

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Varenicline, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Varenicline, by the year in which FDA received them
Year	Reports
2007	159
2008	851
2009	468
2010	170
2011	39
2012	51
2013	22
2014	21
2015	38
2016	19
2017	23
2018	16
2019	21
2020	38
2021	24
2022	53
2023	81
2024	103
2025	311
2026	172

Reports that name Varenicline, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Varenicline
Age	Reports	Share
Under 2	0	0%
2 to 11	1	under 0.1%
12 to 17	5	0.2%
18 to 44	357	13.3%
45 to 64	1,300	48.5%
65 to 74	308	11.5%
75 and over	76	2.8%
Age not given	633	23.6%

Sex of the patient in the reports that name Varenicline
Sex	Reports	Share
Female	751	28%
Male	1,747	65.2%
Unknown or not given	182	6.8%

Type of reporter in the reports that name Varenicline
Reporter	Reports	Share
Physician	142	5.3%
Pharmacist	1,519	56.7%
Other health professional	660	24.6%
Lawyer	1	under 0.1%
Consumer or non-health professional	317	11.8%
Not given	41	1.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 70.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Varenicline record
Indication as recorded (MedDRA)	Reports	Share
Smoking cessation therapy	1,463	54.6%
Ex-tobacco user	111	4.1%
Tobacco abuse	47	1.8%
Nicotine dependence	36	1.3%
Tobacco user	21	0.8%
Ex-smoker	15	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,680 reports.

Pages near this one

Varenicline tartrate same ingredient
Chantix same ingredient
Tyrvaya same ingredient
Vizz same class
Pilocarpine hydrochloride same class
Evoxac same class
Vaniqa next in the A to Z list
Vanflyta next in the A to Z list
Vargatef next in the A to Z list
Vandetanib next in the A to Z list
Varithena next in the A to Z list
Vancomycine Sandoz next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for VareniclineThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Varenicline: adverse event reports that FDA received. https://reportedreactions.com/drug/varenicline/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Varenicline as a suspect or interacting product. The 555 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Varenicline was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Varenicline?

No. It is a count of what people reported to FDA: 2,680 reports from January 2007 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Pharmacist (56.7%), other health professional (24.6%) and consumer or non-health professional (11.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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