72/100 · Elevated
Manufactured by Alvogen, Inc.
Moderate Safety Concerns with OxyCodone and Acetaminophen Tablets
55,737 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXYCODONE AND ACETAMINOPHEN TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alvogen, Inc.. Based on analysis of 55,737 FDA adverse event reports, OXYCODONE AND ACETAMINOPHEN TABLETS has a safety score of 72 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 AND ACETAMINOPHEN TABLETS include PAIN, FATIGUE, DRUG INEFFECTIVE, DYSPNOEA, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYCODONE AND ACETAMINOPHEN TABLETS.
Oxycodone And Acetaminophen Tablets has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 55,737 adverse event reports for this medication, which is primarily manufactured by Alvogen, Inc..
The most commonly reported adverse events include Pain, Fatigue, Drug Ineffective. Of classified reports, 69.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and respiratory issues are the most common reactions, indicating potential misuse and overdose risks.
Skin reactions and gastrointestinal issues are frequent, suggesting possible allergic or digestive side effects. Serious reactions, including infections and respiratory issues, account for nearly 70% of reports, highlighting significant safety concerns. The high volume of reports suggests a need for ongoing monitoring and patient education. Age distribution shows a higher incidence among middle-aged adults, with 44-66 years being the most affected.
Patients taking Oxycodone And Acetaminophen Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. OxyCodone and Acetaminophen tablets can interact with other drugs, potentially leading to 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 And Acetaminophen Tablets received a safety concern score of 72/100 (elevated concern). This is based on a 69.7% serious event ratio across 11,442 classified reports. The score accounts for 55,737 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 6,532, Male: 3,886, Unknown: 6. The most frequently reported age groups are age 44 (460 reports), age 66 (180 reports), age 61 (178 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 11,442 classified reports for OXYCODONE AND ACETAMINOPHEN TABLETS:
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.
OxyCodone and Acetaminophen tablets can interact with other drugs, potentially leading to respiratory depression and other adverse effects. Patients should avoid alcohol and other CNS depressants.
If you are taking Oxycodone And Acetaminophen Tablets, here are important things to know. The most commonly reported side effects include pain, fatigue, drug ineffective, dyspnoea, arthralgia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and do not exceed recommended limits to avoid overdose and respiratory issues. Report any unusual symptoms or side effects to your healthcare provider immediately. 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 continues to monitor the safety of OxyCodone and Acetaminophen tablets, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 55,737 adverse event reports associated with Oxycodone And Acetaminophen Tablets. 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 And Acetaminophen Tablets include Pain, Fatigue, Drug Ineffective, Dyspnoea, Arthralgia. By volume, the top reported reactions are: Pain (1,452 reports), Fatigue (1,409 reports), Drug Ineffective (1,390 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 And Acetaminophen Tablets.
Out of 11,442 classified reports, 7,977 (69.7%) were classified as serious and 3,465 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 And Acetaminophen Tablets break down by patient sex as follows: Female: 6,532, Male: 3,886, Unknown: 6. 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 And Acetaminophen Tablets adverse events are: age 44: 460 reports, age 66: 180 reports, age 61: 178 reports, age 58: 177 reports, age 57: 175 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 And Acetaminophen Tablets adverse event reports is Alvogen, 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 And Acetaminophen Tablets include: Nausea, Headache, Rash, Pruritus, Pyrexia. 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 And Acetaminophen Tablets 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 And Acetaminophen Tablets has a safety concern score of 72 out of 100 (elevated 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. Pain and respiratory issues are the most common reactions, indicating potential misuse and overdose risks.
Key safety signals identified in Oxycodone And Acetaminophen Tablets's adverse event data include: Respiratory issues like dyspnea and pneumonia are reported frequently, indicating potential misuse and overdose risks.. Skin reactions such as rash, pruritus, and urticaria are common, suggesting possible allergic reactions.. Infections, including lower respiratory tract infections and pneumonia, are significant safety signals.. Serious adverse events, including death and severe infections, are reported, indicating a need for caution.. Gastrointestinal issues like nausea, diarrhea, and abdominal pain are frequently reported, indicating potential digestive side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
OxyCodone and Acetaminophen tablets can interact with other drugs, potentially leading to 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 And Acetaminophen Tablets.
Follow prescribed dosages and do not exceed recommended limits to avoid overdose and respiratory issues. Report any unusual symptoms or side effects to your healthcare provider immediately.
Oxycodone And Acetaminophen Tablets has 55,737 adverse event reports on file with the FDA. Skin reactions and gastrointestinal issues are frequent, suggesting possible allergic or digestive side effects. The volume of reports for Oxycodone And Acetaminophen Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of OxyCodone and Acetaminophen tablets, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with OXYCODONE AND ACETAMINOPHEN TABLETS:
Drugs related to OXYCODONE AND ACETAMINOPHEN TABLETS based on therapeutic use, drug class, or shared indications: