85/100 · Critical
Manufactured by Allegiant Health
Aspirin 81 mg: High Serious Reaction Rate and Diverse Safety Profile
906,158 FDA adverse event reports analyzed
Last updated: 2026-05-12
ASPIRIN 81 MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allegiant Health. Based on analysis of 906,158 FDA adverse event reports, ASPIRIN 81 MG 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 ASPIRIN 81 MG include FATIGUE, DYSPNOEA, NAUSEA, DIARRHOEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ASPIRIN 81 MG.
Aspirin 81 Mg 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 906,158 adverse event reports for this medication, which is primarily manufactured by Allegiant Health.
The most commonly reported adverse events include Fatigue, Dyspnoea, Nausea. Of classified reports, 71.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High serious reaction rate (71.8%) with a significant number of reports involving cardiovascular and gastrointestinal issues.
Diverse range of reactions, including serious conditions like myocardial infarction and pneumonia. Significant number of drug interactions and warnings, particularly for those with pre-existing conditions.
Patients taking Aspirin 81 Mg should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Aspirin 81 mg can interact with other medications, particularly blood thinners and anticoagulants, and should be used with caution in patients with pre-existing conditions such as cardiovascular disease or gastrointestinal disorders. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Aspirin 81 Mg received a safety concern score of 85/100 (high concern). This is based on a 71.8% serious event ratio across 492,926 classified reports. The score accounts for 906,158 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: 236,159, Female: 226,408, Unknown: 1,279. The most frequently reported age groups are age 72 (10,434 reports), age 71 (10,422 reports), age 70 (10,415 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 492,926 classified reports for ASPIRIN 81 MG:
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.
Aspirin 81 mg can interact with other medications, particularly blood thinners and anticoagulants, and should be used with caution in patients with pre-existing conditions such as cardiovascular disease or gastrointestinal disorders.
If you are taking Aspirin 81 Mg, here are important things to know. The most commonly reported side effects include fatigue, dyspnoea, nausea, diarrhoea, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always inform your healthcare provider about all medications you are taking, including over-the-counter drugs and supplements. Do not stop taking aspirin 81 mg without consulting your doctor, as it may increase the risk of cardiovascular events. 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 aspirin 81 mg for safety, particularly in older adults and those with pre-existing conditions. Regular medical check-ups are recommended for patients taking this medication.
The FDA has received approximately 906,158 adverse event reports associated with Aspirin 81 Mg. 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 Aspirin 81 Mg include Fatigue, Dyspnoea, Nausea, Diarrhoea, Dizziness. By volume, the top reported reactions are: Fatigue (30,578 reports), Dyspnoea (26,203 reports), Nausea (25,465 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Aspirin 81 Mg.
Out of 492,926 classified reports, 354,078 (71.8%) were classified as serious and 138,848 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 Aspirin 81 Mg break down by patient sex as follows: Male: 236,159, Female: 226,408, Unknown: 1,279. 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 Aspirin 81 Mg adverse events are: age 72: 10,434 reports, age 71: 10,422 reports, age 70: 10,415 reports, age 69: 10,354 reports, age 74: 10,145 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 Aspirin 81 Mg adverse event reports is Allegiant Health. 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 Aspirin 81 Mg include: Drug Ineffective, Headache, Asthenia, Fall, Off Label Use. 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 Aspirin 81 Mg 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.
Aspirin 81 Mg 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. High serious reaction rate (71.8%) with a significant number of reports involving cardiovascular and gastrointestinal issues.
Key safety signals identified in Aspirin 81 Mg's adverse event data include: High rate of serious reactions (354,078 out of 492,926, or 71.8%). Cardiovascular issues (myocardial infarction, cardiac failure) are common and serious. Gastrointestinal issues (diarrhea, nausea, gastrointestinal hemorrhage) are frequent and can be severe. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Aspirin 81 mg can interact with other medications, particularly blood thinners and anticoagulants, and should be used with caution in patients with pre-existing conditions such as cardiovascular disease or gastrointestinal disorders. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Aspirin 81 Mg.
Always inform your healthcare provider about all medications you are taking, including over-the-counter drugs and supplements. Do not stop taking aspirin 81 mg without consulting your doctor, as it may increase the risk of cardiovascular events.
Aspirin 81 Mg has 906,158 adverse event reports on file with the FDA. Diverse range of reactions, including serious conditions like myocardial infarction and pneumonia. The volume of reports for Aspirin 81 Mg reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor aspirin 81 mg for safety, particularly in older adults and those with pre-existing conditions. Regular medical check-ups are recommended for patients taking this medication. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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