ArticleFrontiers in pharmacology2025
Disproportionality analysis of safety signals for milnacipran and levomilnacipran: a pharmacovigilance study using the FDA adverse event reporting system.
Article in Frontiers in pharmacology, 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.
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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.
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Who cites it
1 citing paper in PubMed.
- Antidepressants and Road Safety: A Forensic Toxicological Perspective Based on Observational Data and Current Evidence.Pharmaceuticals (Basel, Switzerland) · 2026Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Major depressive disorder (MDD) is a global health concern, with serotonin-norepinephrine reuptake inhibitors (SNRIs) constituting a mainstay of the psychopharmacological approach to its clinical management. Milnacipran and levomilnacipran are SNRIs with distinct serotonin/norepinephrine reuptake ratios. Their real-world adverse event (AE) profiles and sex-specific patterns remain incompletely characterized owing to limitations of small-scale clinical trials. Methods: Utilizing the FAERS database, adverse event signals were identified for milnacipran (2,752 cases) and levomilnacipran (715 cases) through the methods of Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Sex-stratified analyses were also conducted, employing a modified ROR approach. Results: Female patients predominated in AE reports (milnacipran: 79.61%; levomilnacipran: 64.48%). At the level of System Organ Class, milnacipran exhibited significant signals in vascular disorders (EBGM05 = 2.16), while levomilnacipran demonstrated stronger signals in psychiatric (EBGM05 = 3.45), reproductive (EBGM05 = 8.65), and renal/urinary systems (EBGM05 = 2.39). Out of 26 shared Preferred Terms, painful ejaculation and urinary retention showed the largest disparities (levomilnacipran risk higher). Sex-specific signals included female-predominant nausea (milnacipran) and suicidal ideation (levomilnacipran), and male-predominant urinary retention (both agents). Conclusion: This real-world pharmacovigilance study has highlighted the distinct adverse event profiles of milnacipran and levomilnacipran, with a particular emphasis on sex-specific reactions. This differentiation supports the adoption of precision prescribing strategies and addresses the limitations often encountered in traditional clinical trial data.
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