Long-term safety evaluation of mirtazapine: A real-world pharmacovigilance study based on the FAERS database - PubMed
4 days ago
- #pharmacovigilance
- #mirtazapine
- #FAERS
- Mirtazapine's long-term safety was evaluated using the FAERS database from 2004 to 2025.
- The study included 17,953 reports, with 54.1% from females and 37.7% from males.
- Known adverse events (AEs) like somnolence, QT interval prolongation, suicidal ideation, and rhabdomyolysis showed positive signals.
- Unexpected AEs such as restless legs syndrome, neuroleptic malignant syndrome, and nightmares also exhibited positive signals.
- 59.52% of AEs occurred within the first month of treatment.
- The study supports the need for continuous safety monitoring of mirtazapine.