85/100 · Critical
Manufactured by Rising Pharma Holdings, Inc.
Aspirin Adverse Events: High Serious Reaction Rate
945,345 FDA adverse event reports analyzed
Last updated: 2026-05-12
ASPIRIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rising Pharma Holdings, Inc.. Based on analysis of 945,345 FDA adverse event reports, ASPIRIN 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 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.
Aspirin 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 945,345 adverse event reports for this medication, which is primarily manufactured by Rising Pharma Holdings, Inc..
The most commonly reported adverse events include Fatigue, Dyspnoea, Nausea. Of classified reports, 71.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High rate of serious reactions, including myocardial infarction and death.
Common gastrointestinal issues like diarrhea and nausea reported. Significant number of drug interactions and warnings noted.
Patients taking Aspirin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Aspirin can interact with other medications, potentially leading to adverse effects. Patients should consult healthcare providers before combining aspirin with other drugs. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Aspirin received a safety concern score of 85/100 (high concern). This is based on a 71.5% serious event ratio across 518,281 classified reports. The score accounts for 945,345 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: 247,344, Female: 239,377, Unknown: 1,283. The most frequently reported age groups are age 71 (11,016 reports), age 72 (10,983 reports), age 70 (10,978 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 518,281 classified reports for ASPIRIN:
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 can interact with other medications, potentially leading to adverse effects. Patients should consult healthcare providers before combining aspirin with other drugs.
If you are taking Aspirin, 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 follow prescribed dosages and consult a healthcare provider before starting or stopping aspirin use. Be aware of potential interactions with other medications and report any unusual symptoms to a healthcare provider promptly. 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 safety, particularly in elderly populations and those with pre-existing conditions. Regular medical check-ups are recommended for patients taking aspirin.
The FDA has received approximately 945,345 adverse event reports associated with Aspirin. 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 include Fatigue, Dyspnoea, Nausea, Diarrhoea, Dizziness. By volume, the top reported reactions are: Fatigue (31,972 reports), Dyspnoea (27,177 reports), Nausea (26,586 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.
Out of 518,281 classified reports, 370,740 (71.5%) were classified as serious and 147,541 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 break down by patient sex as follows: Male: 247,344, Female: 239,377, Unknown: 1,283. 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 adverse events are: age 71: 11,016 reports, age 72: 10,983 reports, age 70: 10,978 reports, age 69: 10,924 reports, age 74: 10,694 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 adverse event reports is Rising Pharma Holdings, 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 Aspirin include: Drug Ineffective, Headache, Asthenia, Off Label Use, Fall. 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 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 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 rate of serious reactions, including myocardial infarction and death.
Key safety signals identified in Aspirin's adverse event data include: High percentage of serious reactions (71.5%). Multiple cardiovascular events reported, including myocardial infarction and stroke. Significant number of reports of gastrointestinal bleeding and hemorrhage. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Aspirin can interact with other medications, potentially leading to adverse effects. Patients should consult healthcare providers before combining aspirin with other drugs. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Aspirin.
Always follow prescribed dosages and consult a healthcare provider before starting or stopping aspirin use. Be aware of potential interactions with other medications and report any unusual symptoms to a healthcare provider promptly.
Aspirin has 945,345 adverse event reports on file with the FDA. Common gastrointestinal issues like diarrhea and nausea reported. The volume of reports for Aspirin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor aspirin safety, particularly in elderly populations and those with pre-existing conditions. Regular medical check-ups are recommended for patients taking aspirin. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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