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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.

SERTINDOLE: 61 Adverse Event Reports & Safety Profile

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61
Total FAERS Reports
5 (8.2%)
Deaths Reported
35
Hospitalizations
61
As Primary/Secondary Suspect
8
Life-Threatening
2
Disabilities

First Report: 20060101 · Latest Report: 20250207

What Are the Most Common SERTINDOLE Side Effects?

#1 Most Reported
Weight increased
16 reports (26.2%)
#2 Most Reported
Drug ineffective
16 reports (26.2%)
#3 Most Reported
Fatigue
13 reports (21.3%)

All SERTINDOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 16 26.2% 0 8
Weight increased 16 26.2% 2 10
Fatigue 13 21.3% 0 7
Anxiety 11 18.0% 0 5
Electrocardiogram qt prolonged 11 18.0% 0 6
Insomnia 11 18.0% 0 6
Hyperprolactinaemia 10 16.4% 0 9
Hallucination, auditory 9 14.8% 0 4
Tremor 8 13.1% 0 8
Hypotension 7 11.5% 0 7
Product use in unapproved indication 7 11.5% 0 7
Arrhythmia 6 9.8% 0 5
Depressed mood 6 9.8% 0 0
Depression 6 9.8% 0 6
Hallucination 6 9.8% 0 1
Lethargy 6 9.8% 0 6
Nausea 6 9.8% 0 0
Restlessness 6 9.8% 0 1
Sedation complication 6 9.8% 0 6
Sleep disorder 6 9.8% 1 1

Who Reports SERTINDOLE Side Effects? Age & Gender Data

Gender: 88.7% female, 11.3% male. Average age: 45.1 years. Most reports from: DE. View detailed demographics →

Is SERTINDOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 6 2 6
2007 1 0 1
2008 6 0 0
2009 7 0 7
2012 1 0 1
2014 1 0 1
2015 3 0 3
2017 5 0 5
2018 1 0 0
2023 1 0 0
2025 1 0 0

View full timeline →

What Is SERTINDOLE Used For?

IndicationReports
Schizophrenia 25
Product used for unknown indication 16
Psychotic disorder 7
Antipsychotic therapy 6
Mental disorder 6

Official FDA Label for SERTINDOLE

Official prescribing information from the FDA-approved drug label.