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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

MIANSERIN: 2,554 Adverse Event Reports & Safety Profile

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2,554
Total FAERS Reports
488 (19.1%)
Deaths Reported
1,473
Hospitalizations
2,554
As Primary/Secondary Suspect
290
Life-Threatening
74
Disabilities

Active Ingredient: MIANSERIN HYDROCHLORIDE ·

First Report: 199108 · Latest Report: 20250806

What Are the Most Common MIANSERIN Side Effects?

#1 Most Reported
Toxicity to various agents
246 reports (9.6%)
#2 Most Reported
Fall
201 reports (7.9%)
#3 Most Reported
Coma
177 reports (6.9%)

All MIANSERIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 246 9.6% 126 82
Fall 201 7.9% 34 163
Coma 177 6.9% 41 99
Somnolence 163 6.4% 27 98
Off label use 141 5.5% 42 79
Drug abuse 132 5.2% 60 40
Confusional state 126 4.9% 19 89
Hyponatraemia 122 4.8% 11 112
Hypotension 113 4.4% 10 82
Poisoning deliberate 107 4.2% 11 68
Agranulocytosis 102 4.0% 18 66
Nausea 102 4.0% 54 79
Overdose 88 3.5% 44 45
Hepatocellular injury 85 3.3% 6 70
Drug ineffective 81 3.2% 2 49
Hepatic cytolysis 74 2.9% 36 33
Acute kidney injury 73 2.9% 27 45
Cholestasis 72 2.8% 7 48
Ischaemic stroke 69 2.7% 45 57
Drug reaction with eosinophilia and systemic symptoms 68 2.7% 23 41

Who Reports MIANSERIN Side Effects? Age & Gender Data

Gender: 60.6% female, 39.4% male. Average age: 63.9 years. Most reports from: FR. View detailed demographics →

Is MIANSERIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2007 1 0 1
2008 2 0 1
2009 4 1 4
2010 3 0 1
2011 15 1 11
2012 12 0 7
2013 19 4 10
2014 95 3 58
2015 82 4 73
2016 121 34 99
2017 178 31 134
2018 263 53 181
2019 236 40 131
2020 272 12 188
2021 190 12 116
2022 180 32 79
2023 159 34 79
2024 122 21 73
2025 74 13 41

View full timeline →

What Is MIANSERIN Used For?

IndicationReports
Product used for unknown indication 921
Depression 744
Bipolar disorder 79
Anxiety 59
Mixed anxiety and depressive disorder 59
Major depression 49
Insomnia 43
Sleep disorder 36
Intentional overdose 35
Poisoning deliberate 35

MIANSERIN vs Alternatives: Which Is Safer?

MIANSERIN vs MICAFUNGIN MIANSERIN vs MICARDIS MIANSERIN vs MICONAZOLE MIANSERIN vs MIDAZOLAM MIANSERIN vs MIDAZOLAM\MIDAZOLAM MIANSERIN vs MIDODRINE MIANSERIN vs MIDOMAFETAMINE MIANSERIN vs MIDOSTAURIN MIANSERIN vs MIFEPRISTONE MIANSERIN vs MIGALASTAT

Official FDA Label for MIANSERIN

Official prescribing information from the FDA-approved drug label.