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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.

FLUOXETINE\FLUOXETINE: 1,584 Adverse Event Reports & Safety Profile

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1,584
Total FAERS Reports
510 (32.2%)
Deaths Reported
361
Hospitalizations
1,584
As Primary/Secondary Suspect
67
Life-Threatening
102
Disabilities

Active Ingredient: FLUOXETINE\FLUOXETINE HYDROCHLORIDE ·

First Report: 19910613 · Latest Report: 20150925

What Are the Most Common FLUOXETINE\FLUOXETINE Side Effects?

#1 Most Reported
Completed suicide
195 reports (12.3%)
#2 Most Reported
Drug abuse
170 reports (10.7%)
#3 Most Reported
Toxicity to various agents
130 reports (8.2%)

All FLUOXETINE\FLUOXETINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Completed suicide 195 12.3% 194 14
Drug abuse 170 10.7% 151 14
Toxicity to various agents 130 8.2% 100 30
Death 116 7.3% 116 0
Anxiety 83 5.2% 11 13
Depression 83 5.2% 14 16
Agitation 75 4.7% 17 29
Dizziness 71 4.5% 13 23
Confusional state 66 4.2% 4 41
Intentional overdose 61 3.9% 10 48
Drug interaction 60 3.8% 7 28
Nausea 59 3.7% 0 6
Drug ineffective 56 3.5% 1 2
Suicidal ideation 55 3.5% 3 14
Foetal exposure during pregnancy 52 3.3% 3 10
Insomnia 50 3.2% 8 5
Serotonin syndrome 50 3.2% 0 22
Headache 49 3.1% 0 6
Vomiting 44 2.8% 3 18
Palpitations 42 2.7% 0 29

Who Reports FLUOXETINE\FLUOXETINE Side Effects? Age & Gender Data

Gender: 60.3% female, 39.7% male. Average age: 40.8 years. Most reports from: US. View detailed demographics →

Is FLUOXETINE\FLUOXETINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2002 1 0 0
2003 2 0 0
2004 3 1 1
2005 8 0 5
2006 3 0 1
2007 1 0 0
2008 4 0 1
2009 20 1 11
2010 5 0 2
2011 7 1 1
2012 46 29 9
2013 183 131 5
2014 196 15 91
2015 182 3 75

View full timeline →

What Is FLUOXETINE\FLUOXETINE Used For?

IndicationReports
Product used for unknown indication 623
Depression 377
Anxiety 78
Major depression 28
Obsessive-compulsive disorder 26
Anxiety disorder 14
Suicide attempt 14
Affective disorder 9
Depressed mood 9
Schizophrenia, paranoid type 9

FLUOXETINE\FLUOXETINE vs Alternatives: Which Is Safer?

FLUOXETINE\FLUOXETINE vs FLUOXETINE\OLANZAPINE FLUOXETINE\FLUOXETINE vs FLUPENTIXOL FLUOXETINE\FLUOXETINE vs FLUPENTIXOL DECANOATE FLUOXETINE\FLUOXETINE vs FLUPHENAZINE FLUOXETINE\FLUOXETINE vs FLUPHENAZINE DECANOATE FLUOXETINE\FLUOXETINE vs FLUPIRTINE FLUOXETINE\FLUOXETINE vs FLURAZEPAM FLUOXETINE\FLUOXETINE vs FLURAZEPAM MONOHYDROCHLORIDE FLUOXETINE\FLUOXETINE vs FLURAZEPAM\FLURAZEPAM FLUOXETINE\FLUOXETINE vs FLURBIPROFEN

Official FDA Label for FLUOXETINE\FLUOXETINE

Official prescribing information from the FDA-approved drug label.