75/100 · Elevated
Manufactured by Keen Compressed Gas Co. Inc.
High Serious Event Rate for Oxygen Therapy
129,417 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXYGEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Keen Compressed Gas Co. Inc.. Based on analysis of 129,417 FDA adverse event reports, OXYGEN has a safety score of 75 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 OXYGEN include DYSPNOEA, COUGH, HEADACHE, DIARRHOEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYGEN.
Oxygen has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 129,417 adverse event reports for this medication, which is primarily manufactured by Keen Compressed Gas Co. Inc..
The most commonly reported adverse events include Dyspnoea, Cough, Headache. Of classified reports, 68.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but serious events such as death and respiratory failure are common.
Diverse reactions include cardiovascular, respiratory, and gastrointestinal issues, indicating a broad safety profile. Report volume is high, with over 129,000 reports, suggesting extensive monitoring and potential for rare but severe events. The serious event rate is 68.7%, indicating a significant proportion of reports involve severe outcomes.
Patients taking Oxygen should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Oxygen therapy can interact with other respiratory medications and may exacerbate conditions like chronic obstructive pulmonary disease (COPD) and pulmonary hypertension. Warnings should be followed closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oxygen received a safety concern score of 75/100 (elevated concern). This is based on a 68.7% serious event ratio across 44,830 classified reports. The score accounts for 129,417 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: 27,493, Male: 14,889, Unknown: 52. The most frequently reported age groups are age 71 (877 reports), age 74 (836 reports), age 75 (821 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 44,830 classified reports for OXYGEN:
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.
Oxygen therapy can interact with other respiratory medications and may exacerbate conditions like chronic obstructive pulmonary disease (COPD) and pulmonary hypertension. Warnings should be followed closely.
If you are taking Oxygen, here are important things to know. The most commonly reported side effects include dyspnoea, cough, headache, diarrhoea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Ensure oxygen therapy is administered only as prescribed by a healthcare provider. Monitor for any signs of respiratory distress or changes in condition and report to a 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.
Regulatory oversight is ongoing, with a focus on monitoring serious events and ensuring proper administration to prevent adverse reactions.
The FDA has received approximately 129,417 adverse event reports associated with Oxygen. 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 Oxygen include Dyspnoea, Cough, Headache, Diarrhoea, Fatigue. By volume, the top reported reactions are: Dyspnoea (8,985 reports), Cough (4,252 reports), Headache (4,192 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Oxygen.
Out of 44,830 classified reports, 30,814 (68.7%) were classified as serious and 14,016 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 Oxygen break down by patient sex as follows: Female: 27,493, Male: 14,889, Unknown: 52. 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 Oxygen adverse events are: age 71: 877 reports, age 74: 836 reports, age 75: 821 reports, age 69: 818 reports, age 73: 813 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 Oxygen adverse event reports is Keen Compressed Gas Co. 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 Oxygen include: Pneumonia, Nausea, Dizziness, Oxygen Saturation Decreased, Death. 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 Oxygen 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.
Oxygen has a safety concern score of 75 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. The majority of adverse events are non-serious, but serious events such as death and respiratory failure are common.
Key safety signals identified in Oxygen's adverse event data include: Death. Respiratory failure. Cardiac failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Oxygen therapy can interact with other respiratory medications and may exacerbate conditions like chronic obstructive pulmonary disease (COPD) and pulmonary hypertension. Warnings should be followed closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oxygen.
Ensure oxygen therapy is administered only as prescribed by a healthcare provider. Monitor for any signs of respiratory distress or changes in condition and report to a healthcare provider immediately.
Oxygen has 129,417 adverse event reports on file with the FDA. Diverse reactions include cardiovascular, respiratory, and gastrointestinal issues, indicating a broad safety profile. The volume of reports for Oxygen reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious events and ensuring proper administration to prevent adverse reactions. 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 OXYGEN:
Drugs related to OXYGEN based on therapeutic use, drug class, or shared indications: