ArticleSAGE open medicine2018
Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004-2016.
Article in SAGE open medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 27 citations in OpenAlex.
- Psilocybin or Nicotine Patch for Smoking Cessation: A Pilot Randomized Clinical Trial.JAMA network open · 2026Trial
- Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial.Scientific reports · 2020Trial
- Platinum-based chemotherapies-induced nephrotoxicity: mechanisms, potential treatments, and management.International urology and nephrology · 2025Review
- Article
- Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups.Drug safety · 2025Article
- Exploring the association between melatonin and nicotine dependence (Review).International journal of molecular medicine · 2024Review
- Craving on the move: targeting smoking memories with a novel 3MDR-smoking cessation protocol.Frontiers in psychiatry · 2024Article
- Health Effects Associated With Electronic Cigarette Use: Automated Mining of Online Forums.Journal of medical Internet research · 2020Article
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesSeveral smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes are widely used. We evaluated the adverse events related to smoking cessation treatments and electronic cigarettes in the US Food and Drug Administration Adverse Event Reporting System database.
methodsWe analyzed reports of adverse events associated with smoking cessation treatment and electronic cigarettes terms dated between January 2004 and December 2016. We used the reporting odds ratio with 95% confidence intervals to detect a signal for each adverse event.
resultsIn total, 8,867,135 reports in the Food and Drug Administration Adverse Event Reporting System database were analyzed. The numbers of adverse events for nicotine replacement therapy (transdermal, buccal, oral, and respiratory administration) were 1673, 1016, 425, and 56, respectively. Nicotine replacement therapy (transdermal, buccal, and oral) demonstrated adverse events of nausea, nicotine dependence, and dizziness. For nicotine (transdermal) exposure, the top 5 adverse events reported were nausea (149 cases, reporting odds ratio: 2.28 (95% confidence interval: 1.92-2.69)), dizziness (132 cases, reporting odds ratio: 3.04 (95% confidence interval: 2.54-3.63)), application site erythema (108 cases, reporting odds ratio: 32.52 (95% confidence interval: 26.74-39.55)), headache (98 cases, reporting odds ratio: 1.84 (95% confidence interval: 1.50-2.25)), and dyspnea (94 cases, reporting odds ratio: 1.93 (95% confidence interval: 1.57-2.38)). Many cases of improper use of nicotine replacement therapies were reported. Nausea, depression, abnormal dreams, insomnia, and other adverse events were reported for varenicline. Insomnia, rash, anxiety, and dizziness were reported for bupropion. We observed electronic cigarettes-related adverse events such as dizziness, dyspnea, nausea, heart rate increased, and tremor.
conclusionOur findings suggest that an association exists between nicotine-related adverse events and nicotine replacement therapy. Healthcare professionals should closely monitor smokers trying to quit nicotine use for the misuse of nicotine replacement therapy. These findings may be informative to healthcare professionals in order to improve the management of smoking cessation treatment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.