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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.

AGOMELATINE: 913 Adverse Event Reports & Safety Profile

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913
Total FAERS Reports
300 (32.9%)
Deaths Reported
270
Hospitalizations
913
As Primary/Secondary Suspect
60
Life-Threatening
31
Disabilities

First Report: 2001 · Latest Report: 20250316

What Are the Most Common AGOMELATINE Side Effects?

#1 Most Reported
Fall
229 reports (25.1%)
#2 Most Reported
Insomnia
215 reports (23.5%)
#3 Most Reported
Coma
207 reports (22.7%)

All AGOMELATINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fall 229 25.1% 206 32
Insomnia 215 23.6% 181 8
Coma 207 22.7% 187 15
Tachycardia 206 22.6% 183 10
Arthralgia 204 22.3% 182 4
Diarrhoea 204 22.3% 190 4
Dizziness 204 22.3% 183 5
Fatigue 204 22.3% 163 19
Pruritus 203 22.2% 189 1
Dyspnoea 202 22.1% 184 3
Somnolence 202 22.1% 164 16
Head discomfort 199 21.8% 188 0
Altered state of consciousness 197 21.6% 192 3
Chills 197 21.6% 188 0
Cardio-respiratory arrest 195 21.4% 194 0
Headache 193 21.1% 166 6
Haematemesis 192 21.0% 187 0
Haemorrhagic stroke 192 21.0% 192 0
Sepsis 192 21.0% 192 0
Amaurosis fugax 191 20.9% 189 0

Who Reports AGOMELATINE Side Effects? Age & Gender Data

Gender: 75.5% female, 24.5% male. Average age: 49.1 years. Most reports from: DE. View detailed demographics →

Is AGOMELATINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 3 0 3
2009 7 0 2
2010 1 0 0
2011 17 0 5
2012 1 0 0
2013 26 5 5
2014 38 5 19
2015 27 1 24
2016 39 3 10
2017 42 14 17
2018 47 4 24
2019 31 2 19
2020 7 0 5
2021 25 0 17
2022 9 0 6
2023 2 0 0
2024 7 0 5
2025 5 0 0

View full timeline →

What Is AGOMELATINE Used For?

IndicationReports
Product used for unknown indication 442
Depression 161
Bipolar disorder 33
Major depression 33
Antidepressant therapy 28
Sleep disorder 23
Insomnia 22
Depressive symptom 13
Schizophrenia 11
Affective disorder 10

AGOMELATINE vs Alternatives: Which Is Safer?

AGOMELATINE vs ALAWAY AGOMELATINE vs ALBENDAZOLE AGOMELATINE vs ALBIGLUTIDE AGOMELATINE vs ALBUMIN AGOMELATINE vs ALBUMIN HUMAN AGOMELATINE vs ALBUTEROL AGOMELATINE vs ALBUTEROL\BUDESONIDE AGOMELATINE vs ALBUTEROL\IPRATROPIUM AGOMELATINE vs ALCAFTADINE AGOMELATINE vs ALCOHOL

Official FDA Label for AGOMELATINE

Official prescribing information from the FDA-approved drug label.