75/100 · Elevated
Manufactured by Air Source Industries Inc
High Serious Reaction Rate for Oxygen Therapy
129,410 FDA adverse event reports analyzed
Last updated: 2026-05-12
0XYGEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Air Source Industries Inc. Based on analysis of 129,410 FDA adverse event reports, 0XYGEN 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 0XYGEN 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 0XYGEN.
0xygen 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 129,410 adverse event reports for this medication, which is primarily manufactured by Air Source Industries 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 reactions are non-serious, but the serious reaction rate is high at 68.7%.
Reactions such as dyspnea, pneumonia, and respiratory failure are common and can be life-threatening. The reaction diversity is high, indicating a wide range of potential adverse effects. Report volume is substantial, with over 129,000 reports, providing a comprehensive dataset.
Patients taking 0xygen 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 medications and may exacerbate underlying conditions such as chronic obstructive pulmonary disease (COPD) and heart failure. Warnings should be followed closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
0xygen received a safety concern score of 75/100 (elevated concern). This is based on a 68.7% serious event ratio across 44,827 classified reports. The score accounts for 129,410 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: 27,492, Male: 14,888, 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 44,827 classified reports for 0XYGEN:
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 medications and may exacerbate underlying conditions such as chronic obstructive pulmonary disease (COPD) and heart failure. Warnings should be followed closely.
If you are taking 0xygen, 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. Patients should closely follow prescribed oxygen therapy schedules and report any unusual symptoms to their healthcare provider. Ensure that oxygen equipment is properly maintained and used as directed to prevent complications. 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 oxygen therapy for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 129,410 adverse event reports associated with 0xygen. 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 0xygen 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 0xygen.
Out of 44,827 classified reports, 30,811 (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 0xygen break down by patient sex as follows: Female: 27,492, Male: 14,888, 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 0xygen 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 0xygen adverse event reports is Air Source Industries 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 0xygen 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 0xygen 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.
0xygen 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 reactions are non-serious, but the serious reaction rate is high at 68.7%.
Key safety signals identified in 0xygen's adverse event data include: High rate of serious reactions (30,811 out of 44,827, 68.7%). Common reactions include dyspnea, pneumonia, and respiratory failure. A wide range of reactions reported, indicating potential for various adverse effects. 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 medications and may exacerbate underlying conditions such as chronic obstructive pulmonary disease (COPD) and heart failure. Warnings should be followed closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting 0xygen.
Patients should closely follow prescribed oxygen therapy schedules and report any unusual symptoms to their healthcare provider. Ensure that oxygen equipment is properly maintained and used as directed to prevent complications.
0xygen has 129,410 adverse event reports on file with the FDA. Reactions such as dyspnea, pneumonia, and respiratory failure are common and can be life-threatening. The volume of reports for 0xygen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor oxygen therapy for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program. 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 0XYGEN:
Drugs related to 0XYGEN based on therapeutic use, drug class, or shared indications: