ArticleInternational journal of chronic obstructive pulmonary disease2025
Pharmacovigilance Study on Adverse Events of Nicotine Replacement Therapy, Bupropion, and Varenicline in Patients with Chronic Obstructive Pulmonary Disease.
Article in International journal of chronic obstructive pulmonary disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- A Pharmacological Update and Safety Analysis of Medications for Smoking Cessation: Which Ones to Use?Current pharmaceutical design · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
Purpose: Chronic obstructive pulmonary disease (COPD) is one of the most prevalent respiratory disorders, with smoking being a major risk factor. Smoking cessation is therefore crucial in the management of COPD. This study aimed to comprehensively evaluate the safety profiles of common cessation therapies, including nicotine replacement therapy, bupropion, and varenicline. Patients and Methods: Using the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q2 2024, we analyzed adverse events (AEs) associated with bupropion, nicotine, and varenicline in COPD patients. Disproportionality analysis, case-by-case evaluation, and co-medication analysis were performed to identify positive safety signals. Results: Eighty-eight positive safety signals were identified, primarily involving psychiatric, nervous system, and gastrointestinal disorders. Notable AEs included depression, nausea, anxiety, abnormal dreams, and insomnia. Critically, eight PTs indicated serious AEs associated with psychiatric disorders that were not present in the labeling but required Important Medical Event (IME) surveillance. Experiencing severe neuropsychiatric symptoms (eg, suicidal thoughts and suicide attempts) was the major reason for limiting the use of these drugs, especially varenicline, for which the FDA issued a black box warning in 2009. Nicotine combined with varenicline showed higher risks for skin reactions and gastrointestinal issues. Most AEs occurred within the first 30 days of therapy, with some persisting beyond a year. Conclusion: This study highlights significant psychiatric, neurological, and gastrointestinal AEs associated with smoking cessation therapies in patients with COPD. Clinicians are advised to be particularly cautious of these risks, especially when using combination therapies or treating patients with a predisposition to psychiatric disorders.
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Registered trials
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