SEROQUEL: 729 Adverse Event Reports & Safety Profile
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729
Total FAERS Reports
59 (8.1%)
Deaths Reported
262
Hospitalizations
729
As Primary/Secondary Suspect
68
Life-Threatening
24
Disabilities
First Report: 1981 · Latest Report: 20140616
What Are the Most Common SEROQUEL Side Effects?
#1 Most Reported
Off label use
95 reports (13.0%)
#2 Most Reported
Drug dose omission
85 reports (11.7%)
#3 Most Reported
Insomnia
83 reports (11.4%)
All SEROQUEL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 95 | 13.0% | 3 | 36 |
| Drug dose omission | 85 | 11.7% | 1 | 23 |
| Insomnia | 83 | 11.4% | 1 | 25 |
| Somnolence | 61 | 8.4% | 1 | 25 |
| Drug abuse | 52 | 7.1% | 2 | 37 |
| Weight increased | 51 | 7.0% | 1 | 20 |
| Sopor | 49 | 6.7% | 0 | 40 |
| Intentional product misuse | 45 | 6.2% | 0 | 11 |
| Drug ineffective | 44 | 6.0% | 2 | 13 |
| Depression | 43 | 5.9% | 0 | 13 |
| Fatigue | 42 | 5.8% | 2 | 18 |
| Feeling abnormal | 41 | 5.6% | 2 | 11 |
| Anxiety | 40 | 5.5% | 1 | 13 |
| Agitation | 38 | 5.2% | 2 | 14 |
| Tremor | 34 | 4.7% | 0 | 18 |
| Suicidal ideation | 33 | 4.5% | 2 | 10 |
| Intentional drug misuse | 32 | 4.4% | 2 | 9 |
| Malaise | 32 | 4.4% | 1 | 12 |
| Dizziness | 30 | 4.1% | 1 | 12 |
| Vomiting | 30 | 4.1% | 2 | 17 |
Who Reports SEROQUEL Side Effects? Age & Gender Data
Average age: 49.7 years. Most reports from: US. View detailed demographics →
Is SEROQUEL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 1 |
| 2002 | 3 | 0 | 1 |
| 2004 | 2 | 0 | 0 |
| 2005 | 5 | 0 | 3 |
| 2006 | 10 | 1 | 7 |
| 2007 | 6 | 0 | 3 |
| 2008 | 7 | 0 | 1 |
| 2009 | 23 | 2 | 11 |
| 2010 | 22 | 0 | 10 |
| 2011 | 18 | 1 | 6 |
| 2012 | 45 | 6 | 13 |
| 2013 | 164 | 15 | 75 |
| 2014 | 152 | 9 | 75 |
What Is SEROQUEL Used For?
| Indication | Reports |
|---|---|
| Bipolar disorder | 110 |
| Depression | 74 |
| Product used for unknown indication | 74 |
| Sleep disorder | 41 |
| Insomnia | 25 |
| Bipolar i disorder | 24 |
| Schizophrenia | 23 |
| Anxiety | 20 |
| Psychotic disorder | 17 |
| Affective disorder | 15 |
SEROQUEL vs Alternatives: Which Is Safer?
SEROQUEL vs SERTRALINE
SEROQUEL vs SETMELANOTIDE
SEROQUEL vs SEVELAMER
SEROQUEL vs SEVOFLURANE
SEROQUEL vs SIBUTRAMINE
SEROQUEL vs SILDENAFIL
SEROQUEL vs SILODOSIN
SEROQUEL vs SILTUXIMAB
SEROQUEL vs SILVER SULFADIAZINE
SEROQUEL vs SIMEPREVIR
Official FDA Label for SEROQUEL
Official prescribing information from the FDA-approved drug label.