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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.

DOCONEXENT: 241 Adverse Event Reports & Safety Profile

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241
Total FAERS Reports
3 (1.2%)
Deaths Reported
215
Hospitalizations
241
As Primary/Secondary Suspect
3
Life-Threatening
3
Disabilities

First Report: 20120822 · Latest Report: 20220201

What Are the Most Common DOCONEXENT Side Effects?

#1 Most Reported
Somnolence
122 reports (50.6%)
#2 Most Reported
Pneumonia aspiration
120 reports (49.8%)
#3 Most Reported
Gastrooesophageal reflux disease
120 reports (49.8%)

All DOCONEXENT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Somnolence 122 50.6% 1 119
Coma 120 49.8% 0 118
Gastrooesophageal reflux disease 120 49.8% 0 118
Pneumonia aspiration 120 49.8% 0 118
Off label use 52 21.6% 1 48
Drug dependence 50 20.8% 0 50
Respiratory depression 50 20.8% 0 50
Drug ineffective 48 19.9% 1 46
Product prescribing error 48 19.9% 0 48
Product use issue 43 17.8% 0 43
Drug abuse 42 17.4% 0 42
Epidural lipomatosis 41 17.0% 0 41
Juvenile idiopathic arthritis 41 17.0% 0 41
Obesity 41 17.0% 0 41
Child abuse 40 16.6% 0 40
Intentional product misuse 37 15.4% 1 37
Hepatotoxicity 36 14.9% 0 33
Underdose 35 14.5% 0 35
Product use in unapproved indication 34 14.1% 1 34
Drug-induced liver injury 33 13.7% 0 33

Who Reports DOCONEXENT Side Effects? Age & Gender Data

Gender: 69.8% female, 30.2% male. Average age: 47.5 years. Most reports from: CA. View detailed demographics →

Is DOCONEXENT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 2 0 2
2013 1 0 0
2015 2 0 0
2018 1 0 0
2022 1 0 0

View full timeline →

What Is DOCONEXENT Used For?

IndicationReports
Product used for unknown indication 208

DOCONEXENT vs Alternatives: Which Is Safer?

DOCONEXENT vs DOCONEXENT\ICOSAPENT DOCONEXENT vs DOCONEXENT\ICOSAPENT\PHOSPHATIDYL SERINE DOCONEXENT vs DOCOSANOL DOCONEXENT vs DOCUSATE DOCONEXENT vs DOCUSATE\SENNOSIDES DOCONEXENT vs DOCUSATE\SENNOSIDES A AND B DOCONEXENT vs DOFETILIDE DOCONEXENT vs DOLUTEGRAVIR DOCONEXENT vs DOLUTEGRAVIR\LAMIVUDINE DOCONEXENT vs DOLUTEGRAVIR\LAMIVUDINE\TENOFOVIR DISOPROXIL

Official FDA Label for DOCONEXENT

Official prescribing information from the FDA-approved drug label.