Side Effects of varenicline: A Synthesis of Findings from 27 Studies

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Original Abstract of the Article

Main Research Findings

Varenicline is used for smoking cessation. A study investigated the differences between standard 1 mg and 0.5 mg doses (both twice daily for 8 weeks) in (1) abstinence, (2) adherence, and (3) side effects. 12

Varenicline is an effective monotherapy for smoking cessation, but adherence is often suboptimal. A qualitative study explored the experiences of varenicline treatment among participants enrolled in a randomized controlled trial, who self-reported being adherent or nonadherent to varenicline treatment (n = 15). An environment of forced abstinence played a key role in motivating quit attempts. The main barriers to varenicline adherence were medicine-related side effects, relapse to smoking, and a belief that the medication was not working if abstinence was not achieved by the target quit date. Participants adherent to treatment adopted a reduce-to-quit approach and noticed a gradual reduction in cigarette cravings. 7

Varenicline is an effective drug for smoking cessation, but its use has decreased due to reports of depressogenic side effects. However, because smoking and smoking cessation themselves are associated with depression, it remains unclear whether reported depressogenic effects are attributable to varenicline, or to smoking, and/or smoking cessation themselves. 2

Reasons for Side Effects

Varenicline is a medication that binds to nicotine receptors and weakens the pleasure and dependence caused by nicotine, thereby suppressing smoking. This action is expected to reduce cravings for cigarettes. However, binding to nicotine receptors can also cause a variety of side effects.

Common Side Effects

Nausea

Varenicline can cause nausea. 4 21

Neuropsychiatric Side Effects

Varenicline may cause neuropsychiatric side effects such as depression, anxiety, insomnia, suicidal thoughts, delusions, hallucinations, and seizures. 15 24 3

Skin Reactions

Varenicline can cause skin reactions such as rash, itching, and hives. 26

Other Side Effects

Varenicline can cause dizziness, headache, constipation, loss of appetite, taste disturbances, heart abnormalities, high blood pressure, and blood clots. 15 14 24 9 20

Side Effects Management

Nausea

If nausea occurs, it may be alleviated by taking the medication after meals or on an empty stomach, or by eating small meals frequently. 4

Neuropsychiatric Side Effects

If neuropsychiatric side effects occur, it is important to consult a doctor. 15 24 3

Skin Reactions

If a skin reaction occurs, stop taking varenicline and consult a doctor. 26

Other Side Effects

If other side effects occur, consult your doctor. 15 14 24 9 20

Comparison Among Studies

Commonalities in Studies

Multiple studies have shown that varenicline is an effective drug for smoking cessation. However, it has also been pointed out that it may cause side effects such as neuropsychiatric side effects. 4 21

Differences in Studies

The frequency and severity of varenicline side effects may vary from study to study. 4 21

Considerations for Applying Research to Real Life

Varenicline is an effective drug for helping people quit smoking, but it is important to understand the risk of side effects. 15 4 24 3 26 14 9 20 21 13 6 1 22 16 17 27 25 2 5 11 8 4

Limitations of Current Research

Research on varenicline side effects is not yet comprehensive. Further research is needed, especially on long-term side effects and side effects in specific populations. 15 4 24 3 26 14 9 20 21 13 6 1 22 16 17 27 25 2 5 11 8 4

Future Research Directions

It is important to investigate varenicline side effects in more detail and develop methods to reduce side effects. Research is also needed to evaluate the long-term safety and efficacy of varenicline. 15 4 24 3 26 14 9 20 21 13 6 1 22 16 17 27 25 2 5 11 8 4

Conclusion

Varenicline is an effective medication to help people quit smoking, but it is important to understand the risk of side effects. 15 4 24 3 26 14 9 20 21 13 6 1 22 16 17 27 25 2 5 11 8 4

Literature analysis of 27 papers
Positive Content
21
Neutral Content
1
Negative Content
5
Article Type
10
2
1
3
27
1.

Effect of varenicline on individual nicotine withdrawal symptoms: a combined analysis of eight randomized, placebo-controlled trials.

Author: FouldsJonathan, RussCristina, YuChing-Ray, ZouKelly H, GalaznikAaron, FranzonMikael, BergArthur, HughesJohn R

Neuropsychiatric side effects

Varenicline had no significant effect on neuropsychiatric symptoms or other symptoms as measured by the Minnesota Nicotine Withdrawal Scale.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Effects of short-term varenicline administration on cortisol in healthy, non-smoking adults: a randomized, double-blind, study.

Author: MockingRoel J T, WeverStephany A, PflanzC Patrick, PringleAbbie, ParsonsElizabeth, McTavishSarah F, CowenPhil J, HarmerCatherine J, ScheneAart H

Effective smoking cessation
Depressogenic side effects

Varenicline is a highly effective drug for smoking cessation, but it has been linked to depression in some users. It remains unclear whether this is due to varenicline itself, or to smoking and/or smoking cessation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Varenicline induced auditory hallucinations in a young female with bipolar disorder: a case report.

Author: TsangVivian W L, BhanotSaundarai, JiaLingsa

abstinence
smoking cessation
caution needed

Treating patients with concurrent mental health and substance use disorders presents challenges. Varenicline is a medication found to be most effective for smoking cessation compared to placebo, nicotine patches, and bupropion. However, caution is necessary when prescribing varenicline due to potential complications. With the high prevalence of concurrent disorders in vulnerable populations, research and guidance on treating these complex conditions are crucial.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Adverse Effects Cause Varenicline Discontinuation: A Meta-Analysis.

Author: DrovandiAaron D, ChenCarla C, GlassBeverley D

Smoking cessation
Discontinuation

Varenicline is a smoking cessation drug that is effective in providing prolonged smoking abstinence. However, its adverse effect profile may cause discontinuation, potentially reducing smoking abstinence rates.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

6.

A Genome-Wide Association Study of Nausea Incidence in Varenicline-Treated Cigarette Smokers.

Author: ChenowethMeghan J, LermanCaryn, KnightJo, TyndaleRachel F

Smoking cessation
Nausea

Varenicline is an effective smoking cessation treatment, but long-term cessation rates are less than 25%. Nausea, the most common side effect of varenicline, affects approximately 28% of patients, is most common at the start of treatment, and can reduce cessation success. Genetic variation influences treatment response, but genetic contributors to individual differences in side effects are less understood.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Experiences of hospitalized smokers initiated on varenicline as part of a pragmatic smoking cessation trial.

Author: GobaraniRukshar K, WeeksGregory R, AbramsonMichael J, BonevskiBillie, LiauShin J, GeorgeJohnson

Reduce-to-quit approach
Smoking cessation
Side effects

This study investigated the experiences of varenicline, a medication for smoking cessation, among participants in a clinical trial. The main barriers to adherence were side effects, relapse to smoking, and the belief that the medication wasn't working. Participants who adhered to treatment reported a gradual reduction in cravings.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Precision nicotine metabolism-informed care for smoking cessation in Crohn's disease: A pilot study.

Author: ScovilleElizabeth A, TindleHilary A, WellsQuinn S, PeytonShannon C, GurwaraShelly, PointerStephanie O, HorstSara N, SchwartzDavid A, AdamsDawn W, FreibergMatthew S, GatskieVanessa, KingStephen, AbneyLesa R, BeaulieuDawn B

Smoking cessation

Smoking is a strong risk factor for Crohn's disease severity, and cessation improves outcomes. This study explores the use of nicotine metabolite ratio (NMR) to optimize cessation pharmacotherapy in patients with Crohn's disease. Varenicline doubles cessation rates over nicotine replacement therapy (NRT) for 'normal' metabolizers, but not 'slow' metabolizers.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Extended varenicline treatment in a severe cardiopathic cigarette smoker: a case report.

Author: MunariniElena, MarabelliChiara, PozziPaolo, BoffiRoberto

Smoking cessation

This case report describes a patient with cardiovascular disease who successfully received varenicline, a smoking cessation medication, for 9 months without any side effects. This highlights the safety of varenicline in heart patients.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

[Hypomania following the use of varenicline in two patients with bipolar disorder].

Author: SluysM L, RemmersA, BeerthuisR J

Smoking cessation
Neuropsychiatric side effects

Varenicline, a drug used to help people stop smoking, can have neuropsychiatric side effects, particularly in patients with mental illnesses. Two cases of patients with bipolar disorder who developed manic symptoms while using varenicline are discussed.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Dutch

12.

Effect of 0.5 mg versus 1 mg varenicline for smoking cessation: a randomized controlled trial.

Author: Fouz-RosónNatalia, Montemayor-RubioTeodoro, Almadana-PachecoVirginia, Montserrat-GarcíaSoledad, Gómez-BasteroAna Paulina, Romero-MuñozConcepción, Polo-PadilloJuan

Side effects

This open-label randomized trial compared the effectiveness of 1 mg and 0.5 mg varenicline in smoking cessation. The study found that both doses were equally effective in achieving abstinence at 1 year, with similar rates of adherence and side effects. This suggests that a lower dose of varenicline may be just as effective as a higher dose for smoking cessation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

13.

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial.

Author: EbbertJon, Jimenez-RuizCarlos, DutroMichael P, FisherMatt, LiJing, HaysJ Taylor

Comparable AE profiles
Well-tolerated
Insomnia
Nausea

Varenicline, bupropion, and nicotine patch were well-tolerated for smoking cessation. The most common adverse events were nausea, insomnia, abnormal dreams, anxiety, irritability, dry mouth, fatigue, and application site pruritus.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Treatment With Bupropion and Varenicline for Smoking Cessation and the Risk of Acute Cardiovascular Events and Injuries: a Swedish Case-Crossover Study.

Author: Monárrez-EspinoJoel, GalantiMaria Rosaria, HanssonJenny, JanszkyImre, Söderberg-LöfdalKarin, MöllerJette

Reduced craving
Smoking cessation
Withdrawal symptom relief
Falls
Myocardial infarction
Stroke
Suicide
Suicide attempt
Traffic crash

Bupropion and varenicline are non-nicotine medications used for smoking cessation. This study found no consistent higher risks for acute adverse outcomes such as myocardial infarction, stroke, suicide, suicide attempt, fall injury, or road traffic crash.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone on body weight in quitters: results of a randomised controlled trial.

Author: LycettDeborah, AveyardPaul, FarmerAndrew, LewisAmanda, MunafòMarcus

Quitting aid
Weight gain prevention

The study investigated the effects of a weight management program on weight gain, cravings, and quit rates in obese smokers. The study found that the weight management program was associated with less weight gain, lower craving scores, and higher quit rates compared to a control group. However, the study was not powered to detect superiority in cravings and quit rates.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

17.

The safety of treatments for tobacco use disorder.

Author: LittleMelissa A, EbbertJon O

Nicotine replacement therapy, bupropion sustained-release, and varenicline are the first-line pharmacotherapies for tobacco use disorder. This abstract reviews current evidence on the safety of these medications.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Use of the nicotine metabolite ratio as a genetically informed biomarker of response to nicotine patch or varenicline for smoking cessation: a randomised, double-blind placebo-controlled trial.

Author: LermanCaryn, SchnollRobert A, HawkLarry W, CinciripiniPaul, GeorgeTony P, WileytoE Paul, SwanGary E, BenowitzNeal L, HeitjanDaniel F, TyndaleRachel F,

Smoking cessation

This study examined the predictive power of a genetically informed biomarker, the nicotine metabolite ratio (NMR), for response to nicotine patch or varenicline treatment for smoking cessation. The study aimed to identify biomarkers that can optimize treatment choice for individual smokers, potentially improving outcomes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Effect of varenicline on individual nicotine withdrawal symptoms: a combined analysis of eight randomized, placebo-controlled trials.

Author: FouldsJonathan, RussCristina, YuChing-Ray, ZouKelly H, GalaznikAaron, FranzonMikael, BergArthur, HughesJohn R

Neuropsychiatric side effects

Varenicline had no significant effect on neuropsychiatric symptoms or other symptoms as measured by the Minnesota Nicotine Withdrawal Scale.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Trends in Incident Varenicline Prescribing Among Veterans Following the US Food and Drug Administration Drug Safety Warnings.

Author: GerlachLauren B, VanTony, KimHyungjin Myra, ChangMing-Un Myron, BohnertKipling M, ZivinKara

Unknown
Neuropsychiatric side effects

Prescribing of varenicline and nicotine replacement therapy (NRT) for smoking cessation among Department of Veterans Affairs (VA) beneficiaries was evaluated before and after US Food and Drug Administration (FDA) warnings regarding neuropsychiatric side effects with varenicline. There was a significant decrease in the rate of varenicline prescriptions after the warnings, while NRT prescriptions remained stable.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

21.

Varenicline for smoking cessation in people with schizophrenia: systematic review and meta-analysis.

Author: KishiTaro, IwataNakao

Smoking cessation
Abnormal dreams
Nausea

Varenicline adjuvant therapy for smoking cessation in people with schizophrenia was not superior to placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

22.

Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study.

Author: ChengappaK N Roy, PerkinsKenneth A, BrarJaspreet S, SchlichtPatricia J, TurkinScott R, HetrickMichelle L, LevineMichele D, GeorgeTony P

Smoking cessation
Neuropsychiatric events

Varenicline, a medication for smoking cessation, was assessed in euthymic bipolar subjects motivated to quit smoking.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

Effects of short-term varenicline administration on cortisol in healthy, non-smoking adults: a randomized, double-blind, study.

Author: MockingRoel J T, WeverStephany A, PflanzC Patrick, PringleAbbie, ParsonsElizabeth, McTavishSarah F, CowenPhil J, HarmerCatherine J, ScheneAart H

Effective smoking cessation
Depressogenic side effects

Varenicline is a highly effective drug for smoking cessation, but it has been linked to depression in some users. It remains unclear whether this is due to varenicline itself, or to smoking and/or smoking cessation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

[Pharmacovigilance update].

Author: DaoKim, ChtiouiHaithem, RothuizenLaura E, DieziLéonore, Prod'homSylvain, WinterfeldUrsula, BuclinThierry, LivioFrançoise

Improved benefit-risk ratio
Abuse potential
Addiction potential
Alcohol potentiation
Bone fracture
Bradycardia
Diabetic acidosis
Erythrodermia
Leucoencephalopathy
Pregnancy risks
QT prolongation

This review highlights important pharmacovigilance updates from 2015, including new information on drug interactions, side effects, and risks associated with various medications.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : French

25.

Paradoxical adverse drug reactions: descriptive analysis of French reports.

Author: HakimiYan, PetitpainNadine, PinzaniVéronique, MontastrucJean-Louis, BagheriHaleh

Paradoxical ADRs

Paradoxical adverse drug reactions (ADRs) are unexpected and opposite reactions to the intended effects of a drug. This study aimed to describe paradoxical ADRs using the French PharmacoVigilance Database.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

26.

Varenicline-induced drug eruption: case and review of the literature.

Author: CorreiaCatarina, FernandesSonia, CorreiaTeresa, Soares-de-AlmeidaLuis, FilipePaulo

Smoking cessation
Skin reaction

This case report describes an atypical and rapid onset of a varenicline-induced drug eruption. Clinicians should be aware of this potential adverse cutaneous reaction in patients taking varenicline for smoking cessation.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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