85/100 · Critical
Manufactured by Allegiant Health
Aspirin 325 mg: High Serious Reaction Rate and Diverse Safety Profile
905,741 FDA adverse event reports analyzed
Last updated: 2026-05-12
ASPIRIN 325 MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allegiant Health. Based on analysis of 905,741 FDA adverse event reports, ASPIRIN 325 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 325 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 325 MG.
Aspirin 325 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 905,741 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 rate of serious reactions, including myocardial infarction and pneumonia.
Diverse range of reactions, with gastrointestinal issues being common. Significant number of drug interactions and warnings, especially for older adults.
Patients taking Aspirin 325 Mg 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, and warnings are particularly important for older adults due to increased risk of adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Aspirin 325 Mg received a safety concern score of 85/100 (high concern). This is based on a 71.8% serious event ratio across 492,680 classified reports. The score accounts for 905,741 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: 236,062, Female: 226,273, Unknown: 1,279. The most frequently reported age groups are age 72 (10,429 reports), age 71 (10,419 reports), age 70 (10,414 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 492,680 classified reports for ASPIRIN 325 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 can interact with other medications, and warnings are particularly important for older adults due to increased risk of adverse effects.
If you are taking Aspirin 325 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. Consult a healthcare provider before starting aspirin therapy, especially if you have existing health conditions. Be aware of potential drug interactions and inform your doctor of all medications you are taking. 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 adverse events and drug interactions.
The FDA has received approximately 905,741 adverse event reports associated with Aspirin 325 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 325 Mg include Fatigue, Dyspnoea, Nausea, Diarrhoea, Dizziness. By volume, the top reported reactions are: Fatigue (30,559 reports), Dyspnoea (26,191 reports), Nausea (25,454 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 325 Mg.
Out of 492,680 classified reports, 353,915 (71.8%) were classified as serious and 138,765 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 325 Mg break down by patient sex as follows: Male: 236,062, Female: 226,273, 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 325 Mg adverse events are: age 72: 10,429 reports, age 71: 10,419 reports, age 70: 10,414 reports, age 69: 10,346 reports, age 74: 10,143 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 325 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 325 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 325 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 325 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 rate of serious reactions, including myocardial infarction and pneumonia.
Key safety signals identified in Aspirin 325 Mg's adverse event data include: High percentage of serious reactions (71.8%). Multiple cardiovascular and respiratory issues reported. Significant number of gastrointestinal and neurological reactions. 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, and warnings are particularly important for older adults due to increased risk of adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Aspirin 325 Mg.
Consult a healthcare provider before starting aspirin therapy, especially if you have existing health conditions. Be aware of potential drug interactions and inform your doctor of all medications you are taking.
Aspirin 325 Mg has 905,741 adverse event reports on file with the FDA. Diverse range of reactions, with gastrointestinal issues being common. The volume of reports for Aspirin 325 Mg reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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