POST-MARKETING SAFETY PROFILE OF ANTIDEPRESSANTS IN 2012 TO 2025
Author(s)
Anoop Singh, Pharm D, Zhanghe Chen, MS, Xiaomo (Shawn) Xiong, MS, PhD, Arun Kumar, MS, PharmD, PhD, Marepalli B Rao, ., Ana L. Hincapie, PhD, Emma Claire Palmer, PharmD, Jeff Jianfei Guo, ..
James L Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
James L Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
OBJECTIVES: To analyze the reporting patterns of clinically relevant adverse events and serious outcomes across serotonin-norepinephrine reuptake inhibitors (SNRI’s) and N-methyl-D-aspartate (NMDA) receptor antagonists in the US FDA- Adverse Event reporting System (FAERS) using medication-focused disproportionality analysis and descriptiveseverity assessment.
METHODS: This retrospectiveFAERS disproportionality analysis (2012-2025) assessed literature-mappedclinically relevant adverse events and serious outcomes for SNRIs and NMDAreceptor modulators. Signals were evaluated using established ROR/PRR criteria,while serious outcomes were descriptively summarized across study drugs.
RESULTS: A total of 411,253 AEsreports from 381,282 case patients(age range from 1 to 87 years), withfemales accounting for 60.64% of reports. Significantsignals were observed for sexual dysfunction (ROR: 4.93, 95% CI: 2.55-9.51;PRR: 4.93), dry mouth (ROR: 3.90, 95% CI: 3.06-4.96), orthostatic hypotension(ROR: 3.55, 95% CI: 2.09-6.02), abnormal dreams (ROR: 2.91, 95% CI: 2.03-4.18),asthenia (ROR: 2.83, 95% CI: 2.51-3.19), and nervousness (ROR: 2.72, 95% CI:2.11-3.52). Total seriousoutcomes (n=374,513) comprised, other serious outcomes (OT; n=197,186, 52.6%), hospitalization(HO; n=115,773, 30.9%), death (DE; n=28,748, 7.6%), life-threateningevents (LT; n=18,103, 4.8%),disability (DS; n=10,905, 2.9%),congenital anomalies (CA; n=2,885, 0.8%),and required intervention (RI; n=913,0.2%). OT represented thepredominant severity outcome across Desvenlafaxine (60.6%), Duloxetine (54.2%),Esketamine (64.9%), Ketamine (45.1%), Levomilnacipran (36.8%), and Venlafaxine(50.5%). Duloxetine (n=1,68,462)and Venlafaxine (n=1,47,588) demonstrated the highest reporting burden, whileLevomilnacipran showed comparatively higher proportions of (DE, 15.2%), (DS,10.2%), (LT, 10.6%), and (CA, 8.9%). Ketamine demonstrated elevated HO (31.6%)and LT (13.2%).
CONCLUSIONS: Findings show numerous clinicallyrelevant AEs associated with duloxetine, venlafaxine, ketamine, and levomilnacipran, which can lead toother serious outcomes, including hospitalization. It is necessary tosystematically monitor the safety associated with antidepressants.
METHODS: This retrospectiveFAERS disproportionality analysis (2012-2025) assessed literature-mappedclinically relevant adverse events and serious outcomes for SNRIs and NMDAreceptor modulators. Signals were evaluated using established ROR/PRR criteria,while serious outcomes were descriptively summarized across study drugs.
RESULTS: A total of 411,253 AEsreports from 381,282 case patients(age range from 1 to 87 years), withfemales accounting for 60.64% of reports. Significantsignals were observed for sexual dysfunction (ROR: 4.93, 95% CI: 2.55-9.51;PRR: 4.93), dry mouth (ROR: 3.90, 95% CI: 3.06-4.96), orthostatic hypotension(ROR: 3.55, 95% CI: 2.09-6.02), abnormal dreams (ROR: 2.91, 95% CI: 2.03-4.18),asthenia (ROR: 2.83, 95% CI: 2.51-3.19), and nervousness (ROR: 2.72, 95% CI:2.11-3.52). Total seriousoutcomes (n=374,513) comprised, other serious outcomes (OT; n=197,186, 52.6%), hospitalization(HO; n=115,773, 30.9%), death (DE; n=28,748, 7.6%), life-threateningevents (LT; n=18,103, 4.8%),disability (DS; n=10,905, 2.9%),congenital anomalies (CA; n=2,885, 0.8%),and required intervention (RI; n=913,0.2%). OT represented thepredominant severity outcome across Desvenlafaxine (60.6%), Duloxetine (54.2%),Esketamine (64.9%), Ketamine (45.1%), Levomilnacipran (36.8%), and Venlafaxine(50.5%). Duloxetine (n=1,68,462)and Venlafaxine (n=1,47,588) demonstrated the highest reporting burden, whileLevomilnacipran showed comparatively higher proportions of (DE, 15.2%), (DS,10.2%), (LT, 10.6%), and (CA, 8.9%). Ketamine demonstrated elevated HO (31.6%)and LT (13.2%).
CONCLUSIONS: Findings show numerous clinicallyrelevant AEs associated with duloxetine, venlafaxine, ketamine, and levomilnacipran, which can lead toother serious outcomes, including hospitalization. It is necessary tosystematically monitor the safety associated with antidepressants.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD81
Topic
Real World Data & Information Systems
Disease
SDC: Neurological Disorders