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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.

PAROXETINE\PAROXETINE: 1,064 Adverse Event Reports & Safety Profile

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1,064
Total FAERS Reports
284 (26.7%)
Deaths Reported
373
Hospitalizations
1,064
As Primary/Secondary Suspect
70
Life-Threatening
34
Disabilities

Active Ingredient: PAROXETINE\PAROXETINE HYDROCHLORIDE ·

First Report: 19960817 · Latest Report: 20160315

What Are the Most Common PAROXETINE\PAROXETINE Side Effects?

#1 Most Reported
Drug abuse
131 reports (12.3%)
#2 Most Reported
Toxicity to various agents
119 reports (11.2%)
#3 Most Reported
Completed suicide
105 reports (9.9%)

All PAROXETINE\PAROXETINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug abuse 131 12.3% 57 55
Toxicity to various agents 119 11.2% 93 40
Completed suicide 105 9.9% 105 13
Death 60 5.6% 60 7
Suicide attempt 59 5.6% 0 44
Overdose 56 5.3% 17 40
Drug ineffective 54 5.1% 0 9
Hypotension 47 4.4% 1 42
Depression 46 4.3% 0 9
Drug interaction 46 4.3% 4 15
Anxiety 45 4.2% 0 7
Confusional state 44 4.1% 4 25
Foetal exposure during pregnancy 44 4.1% 8 16
Drug withdrawal syndrome 43 4.0% 4 8
Dizziness 41 3.9% 1 9
Sopor 41 3.9% 1 32
Intentional overdose 38 3.6% 4 28
Fatigue 36 3.4% 0 13
Somnolence 36 3.4% 2 27
Nausea 35 3.3% 0 13

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

Gender: 56.8% female, 43.2% male. Average age: 48.4 years. Most reports from: US. View detailed demographics →

Is PAROXETINE\PAROXETINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 1 0 1
2002 2 0 0
2003 3 0 2
2004 5 0 2
2005 2 0 1
2006 1 0 1
2007 2 0 1
2008 1 0 1
2009 4 1 2
2010 5 0 0
2011 11 0 5
2012 14 10 2
2013 61 39 14
2014 219 33 111
2015 132 6 86
2016 12 1 4

View full timeline →

What Is PAROXETINE\PAROXETINE Used For?

IndicationReports
Product used for unknown indication 404
Depression 218
Anxiety 61
Major depression 35
Panic disorder 23
Intentional self-injury 20
Suicide attempt 19
Obsessive-compulsive disorder 18
Anxiety disorder 12
Drug abuse 11

PAROXETINE\PAROXETINE vs Alternatives: Which Is Safer?

PAROXETINE\PAROXETINE vs PAROXETINE\PAROXETINE ANHYDROUS PAROXETINE\PAROXETINE vs PASIREOTIDE PAROXETINE\PAROXETINE vs PASIREOTIDE DIASPARTATE PAROXETINE\PAROXETINE vs PATIROMER PAROXETINE\PAROXETINE vs PATISIRAN PAROXETINE\PAROXETINE vs PAXIL PAROXETINE\PAROXETINE vs PAZOPANIB PAROXETINE\PAROXETINE vs PEANUT PAROXETINE\PAROXETINE vs PEG INTERFERON PAROXETINE\PAROXETINE vs PEG-INTERFERON ALFA 2A

Official FDA Label for PAROXETINE\PAROXETINE

Official prescribing information from the FDA-approved drug label.