85/100 · Critical
Manufactured by Purdue Pharma LP
High Safety Concerns with OxyContin: Overdose and Dependence
594,683 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXYCODONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Purdue Pharma LP. Based on analysis of 594,683 FDA adverse event reports, OXYCODONE HYDROCHLORIDE 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 include DRUG DEPENDENCE, PAIN, OVERDOSE, EMOTIONAL DISTRESS, DRUG WITHDRAWAL SYNDROME. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYCODONE HYDROCHLORIDE.
Oxycodone Hydrochloride 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 594,683 adverse event reports for this medication, which is primarily manufactured by Purdue Pharma Lp.
The most commonly reported adverse events include Drug Dependence, Pain, Overdose. Of classified reports, 90.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Overdose and drug dependence are the most serious and frequent adverse reactions.
Emotional distress and mental disorders are also significant concerns. Neonatal withdrawal syndrome and maternal exposure during pregnancy are critical risks.
Patients taking Oxycodone Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. OxyContin can interact with other central nervous system depressants, increasing the risk of respiratory depression and overdose. It is contraindicated in patients with known severe respiratory depression, acute or severe bronchial asthma, or signifi This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oxycodone Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 90.7% serious event ratio across 213,249 classified reports. The score accounts for 594,683 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: Male: 98,961, Female: 81,131, Unknown: 178. The most frequently reported age groups are age 44 (1,750 reports), age 60 (1,391 reports), age 59 (1,355 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 213,249 classified reports for OXYCODONE HYDROCHLORIDE:
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 can interact with other central nervous system depressants, increasing the risk of respiratory depression and overdose. It is contraindicated in patients with known severe respiratory depression, acute or severe bronchial asthma, or signifi
If you are taking Oxycodone Hydrochloride, here are important things to know. The most commonly reported side effects include drug dependence, pain, overdose, emotional distress, drug withdrawal syndrome. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of respiratory depression, especially when starting or increasing the dose. Avoid driving or operating heavy machinery until the effects of the medication are known. 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 several warnings about the risks associated with OxyContin, including the risk of addiction, overdose, and death. Healthcare providers are advised to carefully assess the risks and benefits before prescribing this medication.
The FDA has received approximately 594,683 adverse event reports associated with Oxycodone Hydrochloride. 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 include Drug Dependence, Pain, Overdose, Emotional Distress, Drug Withdrawal Syndrome. By volume, the top reported reactions are: Drug Dependence (100,266 reports), Pain (56,025 reports), Overdose (48,931 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.
Out of 213,249 classified reports, 193,311 (90.7%) were classified as serious and 19,938 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 break down by patient sex as follows: Male: 98,961, Female: 81,131, Unknown: 178. 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 adverse events are: age 44: 1,750 reports, age 60: 1,391 reports, age 59: 1,355 reports, age 58: 1,344 reports, age 61: 1,293 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 adverse event reports is Purdue Pharma Lp. 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 include: Death, Toxicity To Various Agents, Drug Abuse, Anxiety, Depression. 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 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 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. Overdose and drug dependence are the most serious and frequent adverse reactions.
Key safety signals identified in Oxycodone Hydrochloride's adverse event data include: Over 48,000 reports of overdose, indicating a high risk of misuse and abuse.. More than 100,000 reports of drug dependence, highlighting the addictive nature.. Over 20,000 reports of death, emphasizing the severe consequences of misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
OxyContin can interact with other central nervous system depressants, increasing the risk of respiratory depression and overdose. It is contraindicated in patients with known severe respiratory depression, acute or severe bronchial asthma, or signifi Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oxycodone Hydrochloride.
Patients should be closely monitored for signs of respiratory depression, especially when starting or increasing the dose. Avoid driving or operating heavy machinery until the effects of the medication are known.
Oxycodone Hydrochloride has 594,683 adverse event reports on file with the FDA. Emotional distress and mental disorders are also significant concerns. The volume of reports for Oxycodone Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued several warnings about the risks associated with OxyContin, including the risk of addiction, overdose, and death. Healthcare providers are advised to carefully assess the risks and benefits before prescribing this medication. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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