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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.

ZOLOFT: 771 Adverse Event Reports & Safety Profile

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771
Total FAERS Reports
31 (4.0%)
Deaths Reported
90
Hospitalizations
771
As Primary/Secondary Suspect
51
Life-Threatening
13
Disabilities

First Report: 1992 · Latest Report: 20140621

What Are the Most Common ZOLOFT Side Effects?

#1 Most Reported
Maternal exposure during pregnancy
162 reports (21.0%)
#2 Most Reported
Drug hypersensitivity
116 reports (15.0%)
#3 Most Reported
Congenital anomaly
69 reports (8.9%)

All ZOLOFT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Maternal exposure during pregnancy 162 21.0% 5 7
Drug hypersensitivity 116 15.1% 0 0
Congenital anomaly 69 9.0% 2 4
Drug ineffective 61 7.9% 2 6
Atrial septal defect 41 5.3% 1 7
Anxiety 38 4.9% 0 10
Premature baby 36 4.7% 2 1
Ventricular septal defect 34 4.4% 2 7
Patent ductus arteriosus 30 3.9% 1 9
Depression 29 3.8% 0 6
Heart disease congenital 29 3.8% 1 6
Malaise 29 3.8% 1 4
Talipes 29 3.8% 0 3
Feeling abnormal 24 3.1% 1 6
Suicidal ideation 20 2.6% 0 3
Foetal exposure during pregnancy 19 2.5% 0 7
Insomnia 19 2.5% 0 2
Maternal exposure timing unspecified 19 2.5% 2 6
Dizziness 17 2.2% 0 1
Nausea 17 2.2% 0 2

Who Reports ZOLOFT Side Effects? Age & Gender Data

Average age: 48.2 years. Most reports from: US. View detailed demographics →

Is ZOLOFT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 9 0 1
2001 6 0 1
2002 8 0 0
2003 18 2 2
2004 21 1 4
2005 15 0 1
2006 17 0 2
2007 12 1 3
2008 16 0 1
2009 13 0 2
2010 22 1 0
2011 27 7 3
2012 19 3 5
2013 96 8 29
2014 75 4 15

View full timeline →

What Is ZOLOFT Used For?

IndicationReports
Depression 198
Anxiety 86
Affective disorder 26
Product used for unknown indication 20
Post-traumatic stress disorder 12
Panic attack 11
Bipolar disorder 9
Obsessive-compulsive disorder 8
Anxiety disorder 7
Major depression 6

ZOLOFT vs Alternatives: Which Is Safer?

ZOLOFT vs ZOLPIDEM ZOLOFT vs ZOLPIDEM\ZOLPIDEM ZOLOFT vs ZOMETA ZOLOFT vs ZONISAMIDE ZOLOFT vs ZOPICLONE ZOLOFT vs ZOTEPINE ZOLOFT vs ZUCLOPENTHIXOL ZOLOFT vs ZUCLOPENTHIXOL DECANOATE ZOLOFT vs ZURANOLONE ZOLOFT vs ZYPREXA

Official FDA Label for ZOLOFT

Official prescribing information from the FDA-approved drug label.