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Long-term safety evaluation of mirtazapine: A real-world pharmacovigilance study based on the FAERS database
1Department of Dermatology, Xi'an Jiaotong University Second Affiliated Hospital, Xi'an, China.
Background:
Mirtazapine is widely used in the treatment of major depressive disorder (MDD), yet its real-world safety profile remains insufficiently evaluated.
Methods:
This study analyzed adverse event (AE, plural AEs) reports related to mirtazapine from the FDA Adverse Event Reporting System (FAERS) database between the first quarter of 2004 and the first quarter of 2025. Four disproportionality analysis methods were employed, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). Additional analyses included sensitivity analysis, time-to-onset (TTO) evaluation, and Weibull distribution modeling.
Results:
A total of 17,953 reports were included, with females accounting for 54.1% and males for 37.7%. In 48.4% of the reports, patients were aged between 18 and 65 years. Overall, 65.0% of the reports were submitted by healthcare professionals. Known AEs such as somnolence (n = 887, ROR = 4.57, PRR = 4.52, EBGM = 4.50, IC = 2.17), QT interval prolongation (n = 259, ROR = 7.35, PRR = 7.32, EBGM = 7.27, IC = 2.86), suicidal ideation (n = 601, ROR = 6.65, PRR = 6.59, EBGM = 6.55, IC = 2.71), and rhabdomyolysis (n = 146, ROR = 3.66, PRR = 3.65, EBGM = 3.64, IC = 1.87) showed positive signals. In addition, several unexpected AEs also exhibited positive signals, including restless legs syndrome (n = 305, ROR = 17.05, PRR = 16.97, EBGM = 16.65, IC = 4.06), neuroleptic malignant syndrome (n = 158, ROR = 13.77, PRR = 13.74, EBGM = 13.53, IC = 3.76), and nightmare (n = 279, ROR = 8.02, PRR = 7.99, EBGM = 7.93, IC = 2.99). TTO analysis showed that 59.52% of AEs occurred within the first month of treatment. The results of the sensitivity analyses further supported the robustness of these findings.
Conclusion:
This study systematically assessed the long-term safety profile of mirtazapine using 21 years of real-world pharmacovigilance data from the FAERS database. The findings provide important evidence to support safe clinical use of mirtazapine and emphasize the need for continuous safety monitoring.
Insights
This study analyzed 21 years of mirtazapine safety data, identifying known and unexpected adverse events (AEs) like restless legs syndrome. Findings support mirtazapine
Area of Science:
- Pharmacovigilance and Drug Safety
- Clinical Pharmacology
- Psychiatric Drug Research
Background:
- Mirtazapine is a common treatment for major depressive disorder (MDD).
- Real-world safety data for mirtazapine requires further evaluation.
- Understanding mirtazapine's safety profile is crucial for clinical practice.
Purpose of the Study:
- To systematically evaluate the long-term safety profile of mirtazapine.
- To identify potential adverse events (AEs) associated with mirtazapine use.
- To provide evidence for the safe clinical application of mirtazapine.
Main Methods:
- Analysis of adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS) database (2004-2025).
- Utilized four disproportionality analysis methods: ROR, PRR, BCPNN, and MGPS.
- Conducted sensitivity analyses, time-to-onset (TTO) evaluation, and Weibull distribution modeling.
Main Results:
- 17,953 AE reports were analyzed; 65.0% submitted by healthcare professionals.
- Positive safety signals identified for known AEs (somnolence, QT prolongation, suicidal ideation, rhabdomyolysis) and unexpected AEs (restless legs syndrome, neuroleptic malignant syndrome, nightmare).
- 59.52% of AEs occurred within the first month of mirtazapine treatment.
Conclusions:
- Real-world pharmacovigilance data over 21 years confirms mirtazapine's safety profile.
- Identified both expected and unexpected adverse events, highlighting the need for vigilance.
- Findings support the safe clinical use of mirtazapine and underscore the importance of ongoing safety monitoring.
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