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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.

OXYCODONE\OXYCODONE TEREPHTHALATE: 72 Adverse Event Reports & Safety Profile

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72
Total FAERS Reports
12 (16.7%)
Deaths Reported
26
Hospitalizations
72
As Primary/Secondary Suspect
16
Life-Threatening
23
Disabilities

Active Ingredient: OXYCODONE HYDROCHLORIDE\OXYCODONE TEREPHTHALATE ·

First Report: 201801 · Latest Report: 20250831

What Are the Most Common OXYCODONE\OXYCODONE TEREPHTHALATE Side Effects?

#1 Most Reported
Drug ineffective
28 reports (38.9%)
#2 Most Reported
Pruritus
23 reports (31.9%)
#3 Most Reported
Pain
23 reports (31.9%)

All OXYCODONE\OXYCODONE TEREPHTHALATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 28 38.9% 5 10
Pain 23 31.9% 5 8
Pruritus 23 31.9% 3 6
Blister 22 30.6% 4 8
Irritable bowel syndrome 22 30.6% 3 5
Peripheral swelling 22 30.6% 4 6
Swelling 22 30.6% 4 7
Infection 21 29.2% 5 7
Pericarditis 21 29.2% 5 8
Rash 21 29.2% 3 7
Contusion 20 27.8% 3 6
Folliculitis 20 27.8% 4 6
Gastrointestinal disorder 20 27.8% 4 6
Lower respiratory tract infection 20 27.8% 3 4
Abdominal discomfort 19 26.4% 3 7
Arthropathy 19 26.4% 2 6
Discomfort 19 26.4% 4 8
Fatigue 19 26.4% 3 5
Hepatic enzyme increased 19 26.4% 4 8
Hypersensitivity 19 26.4% 3 6

Who Reports OXYCODONE\OXYCODONE TEREPHTHALATE Side Effects? Age & Gender Data

Gender: 85.6% female, 14.4% male. Average age: 45.6 years. Most reports from: CA. View detailed demographics →

Is OXYCODONE\OXYCODONE TEREPHTHALATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 3 0 0
2023 1 0 0
2024 2 0 2
2025 1 0 0

View full timeline →

What Is OXYCODONE\OXYCODONE TEREPHTHALATE Used For?

IndicationReports
Product used for unknown indication 47
Pain 8

Official FDA Label for OXYCODONE\OXYCODONE TEREPHTHALATE

Official prescribing information from the FDA-approved drug label.