ArticlePloS one2025
Sex-stratified pharmacovigilance of gastrointestinal events associated with first-line smoking-cessation medicines: Insights from the FAERS database.
Article in PloS one, 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
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
- Adverse events associated with tirzepatide: a focus on subgroup-specific differences.BMC pharmacology & toxicology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTobacco smoking is a major global health threat. Pharmacological aids, including nicotine-replacement therapy (NRT), varenicline, and bupropion, improve quit rates but are associated with gastrointestinal (GI) adverse events (AEs) that can compromise adherence. The real-world reporting profiles of these GI AEs, particularly the differences between sexes, have not been comprehensively characterized.
methodsWe analyzed the FDA Adverse Event Reporting System (FAERS) database from 2004 Q1 to 2024 Q2. After deduplication, reports designating NRT, varenicline, or bupropion as the primary suspect drug were extracted. Disproportionality analyses, including the Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), were conducted to quantify drug-event associations. The Breslow-Day test was used to assess the homogeneity of RORs between male and female strata.
resultsVarenicline was associated with the highest proportion of GI reports (36.0% of its total reports). The disproportionality signal was significantly stronger in women than in men (ROR 6.41 vs. 5.10 for nausea, p < 0.001). NRT was linked to 24.3% of GI reports, with hiccups (PRR = 60.1) being the most prominent signal. In contrast to varenicline, several key GI AE signals for NRT were significantly stronger in men (e.g., nausea, ROR 3.09 in men vs. 2.45 in women, p < 0.001). Bupropion had the lowest proportion of GI reports (2.1%) but still generated significant disproportionality signals (overall ROR 4.50), particularly for anorexia (PRR = 4.80) and dry mouth (PRR = 4.42), with most signals being stronger in women.
conclusionNRT, varenicline, and bupropion exhibit distinct and statistically significant sex-specific GI AE reporting profiles in a real-world setting. These hypothesis-generating findings underscore the importance of considering sex as a variable in pharmacovigilance studies and may inform future research aimed at personalizing smoking cessation therapy.
Indexed as
Identifiers
What OpenQuestion holds
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.