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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.

OXYBATE: 240 Adverse Event Reports & Safety Profile

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240
Total FAERS Reports
72 (30.0%)
Deaths Reported
77
Hospitalizations
240
As Primary/Secondary Suspect
44
Life-Threatening

First Report: 20060601 · Latest Report: 20250630

What Are the Most Common OXYBATE Side Effects?

#1 Most Reported
Drug abuse
77 reports (32.1%)
#2 Most Reported
Toxicity to various agents
44 reports (18.3%)
#3 Most Reported
Coma
44 reports (18.3%)

All OXYBATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug abuse 77 32.1% 26 30
Coma 44 18.3% 2 22
Toxicity to various agents 44 18.3% 36 11
Intentional product misuse 29 12.1% 17 9
Death 26 10.8% 26 3
Drug dependence 25 10.4% 1 12
Substance use disorder 25 10.4% 0 7
Miosis 23 9.6% 0 7
Overdose 22 9.2% 15 11
Agitation 19 7.9% 0 12
Drug use disorder 19 7.9% 0 6
Victim of chemical submission 16 6.7% 0 0
Completed suicide 15 6.3% 15 4
Cardio-respiratory arrest 14 5.8% 14 1
Loss of consciousness 14 5.8% 4 8
Pneumonia aspiration 14 5.8% 12 1
Poisoning 14 5.8% 1 4
Bradycardia 13 5.4% 0 0
Drug interaction 13 5.4% 11 2
Mydriasis 13 5.4% 1 7

Who Reports OXYBATE Side Effects? Age & Gender Data

Gender: 24.7% female, 75.3% male. Average age: 35.5 years. Most reports from: FR. View detailed demographics →

Is OXYBATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 1 0
2012 1 0 1
2013 1 1 0
2016 2 0 1
2020 11 0 11
2021 6 1 4
2022 6 0 5
2023 28 12 0
2024 28 3 10
2025 14 1 6

View full timeline →

What Is OXYBATE Used For?

IndicationReports
Product used for unknown indication 185
Foetal exposure during pregnancy 5

OXYBATE vs Alternatives: Which Is Safer?

OXYBATE vs OXYBUTYNIN OXYBATE vs OXYBUTYNIN\OXYBUTYNIN OXYBATE vs OXYCODONE OXYBATE vs OXYCODONE TEREPHTHALATE OXYBATE vs OXYCODONE\OXYCODONE OXYBATE vs OXYCONTIN OXYBATE vs OXYGEN OXYBATE vs OXYMETAZOLINE OXYBATE vs OXYMORPHONE OXYBATE vs OXYQUINOLINE

Official FDA Label for OXYBATE

Official prescribing information from the FDA-approved drug label.