85/100 · Critical
Manufactured by Endo USA, Inc.
High Safety Concerns with OxyContin and Acetaminophen
222,803 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Endo USA, Inc.. Based on analysis of 222,803 FDA adverse event reports, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN include DEPENDENCE, DEATH, OVERDOSE, TOXICITY TO VARIOUS AGENTS, ILL-DEFINED DISORDER. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN.
Oxycodone Hydrochloride And Acetaminophen has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 222,803 adverse event reports for this medication, which is primarily manufactured by Endo Usa, Inc..
The most commonly reported adverse events include Dependence, Death, Overdose. Of classified reports, 82.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Over 16,000 reports of death and over 14,000 reports of overdose highlight severe safety concerns.
Dependence and withdrawal symptoms are common, indicating significant risk of addiction. Serious adverse events such as respiratory depression and renal failure are reported.
Patients taking Oxycodone Hydrochloride And Acetaminophen should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. OxyContin and Acetaminophen can interact with other drugs, potentially leading to severe respiratory depression and other adverse effects. Patients should avoid alcohol and other CNS depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oxycodone Hydrochloride And Acetaminophen received a safety concern score of 85/100 (high concern). This is based on a 82.2% serious event ratio across 97,354 classified reports. The score accounts for 222,803 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 37,728, Male: 25,512, Unknown: 75. The most frequently reported age groups are age 44 (993 reports), age 59 (818 reports), age 60 (818 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 97,354 classified reports for OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
OxyContin and Acetaminophen can interact with other drugs, potentially leading to severe respiratory depression and other adverse effects. Patients should avoid alcohol and other CNS depressants.
If you are taking Oxycodone Hydrochloride And Acetaminophen, here are important things to know. The most commonly reported side effects include dependence, death, overdose, toxicity to various agents, ill-defined disorder. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Do not exceed the recommended dose and follow all instructions provided by your healthcare provider. Do not combine with other pain medications or CNS depressants without consulting your doctor. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has issued multiple warnings about the risks associated with OxyContin and Acetaminophen, including the risk of addiction and overdose. Healthcare providers should closely monitor patients and adjust dosages as necessary.
The FDA has received approximately 222,803 adverse event reports associated with Oxycodone Hydrochloride And Acetaminophen. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Oxycodone Hydrochloride And Acetaminophen include Dependence, Death, Overdose, Toxicity To Various Agents, Ill-Defined Disorder. By volume, the top reported reactions are: Dependence (18,807 reports), Death (16,246 reports), Overdose (14,234 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Oxycodone Hydrochloride And Acetaminophen.
Out of 97,354 classified reports, 79,981 (82.2%) were classified as serious and 17,373 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Oxycodone Hydrochloride And Acetaminophen break down by patient sex as follows: Female: 37,728, Male: 25,512, Unknown: 75. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Oxycodone Hydrochloride And Acetaminophen adverse events are: age 44: 993 reports, age 59: 818 reports, age 60: 818 reports, age 57: 792 reports, age 61: 786 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Oxycodone Hydrochloride And Acetaminophen adverse event reports is Endo Usa, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Oxycodone Hydrochloride And Acetaminophen include: Pain, Nausea, Drug Dependence, Fatigue, Drug Ineffective. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Oxycodone Hydrochloride And Acetaminophen to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Oxycodone Hydrochloride And Acetaminophen has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Over 16,000 reports of death and over 14,000 reports of overdose highlight severe safety concerns.
Key safety signals identified in Oxycodone Hydrochloride And Acetaminophen's adverse event data include: Over 16,000 reports of death, indicating a high risk of fatal outcomes.. More than 14,000 reports of overdose, suggesting a high risk of misuse and abuse.. Over 10,000 reports of dependence and withdrawal, indicating significant addiction potential.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
OxyContin and Acetaminophen can interact with other drugs, potentially leading to severe respiratory depression and other adverse effects. Patients should avoid alcohol and other CNS depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oxycodone Hydrochloride And Acetaminophen.
Do not exceed the recommended dose and follow all instructions provided by your healthcare provider. Do not combine with other pain medications or CNS depressants without consulting your doctor.
Oxycodone Hydrochloride And Acetaminophen has 222,803 adverse event reports on file with the FDA. Dependence and withdrawal symptoms are common, indicating significant risk of addiction. The volume of reports for Oxycodone Hydrochloride And Acetaminophen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued multiple warnings about the risks associated with OxyContin and Acetaminophen, including the risk of addiction and overdose. Healthcare providers should closely monitor patients and adjust dosages as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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