85/100 · Critical
Manufactured by Sanofi-Aventis U.S. LLC
Clopidogrel Adverse Events: High Seriousness and Diverse Reactions
332,980 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLOPIDOGREL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sanofi-Aventis U.S. LLC. Based on analysis of 332,980 FDA adverse event reports, CLOPIDOGREL 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 CLOPIDOGREL include DYSPNOEA, MYOCARDIAL INFARCTION, FATIGUE, GASTROINTESTINAL HAEMORRHAGE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLOPIDOGREL.
Clopidogrel 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 332,980 adverse event reports for this medication, which is primarily manufactured by Sanofi-Aventis U.S. Llc.
The most commonly reported adverse events include Dyspnoea, Myocardial Infarction, Fatigue. Of classified reports, 81.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (81.4%) among total reports.
A wide range of reactions reported, including cardiovascular, gastrointestinal, and hematological issues. Significant number of reports involving death and myocardial infarction.
Patients taking Clopidogrel should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clopidogrel can interact with other medications, and patients should be aware of potential drug interactions and follow healthcare provider's instructions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clopidogrel received a safety concern score of 85/100 (high concern). This is based on a 81.4% serious event ratio across 192,894 classified reports. The score accounts for 332,980 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: 98,816, Female: 76,428, Unknown: 1,469. The most frequently reported age groups are age 75 (4,517 reports), age 77 (4,373 reports), age 74 (4,337 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 192,894 classified reports for CLOPIDOGREL:
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.
Clopidogrel can interact with other medications, and patients should be aware of potential drug interactions and follow healthcare provider's instructions.
If you are taking Clopidogrel, here are important things to know. The most commonly reported side effects include dyspnoea, myocardial infarction, fatigue, gastrointestinal haemorrhage, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult healthcare providers before starting or stopping clopidogrel to avoid potential drug interactions. Report any adverse reactions to the FDA's MedWatch program. 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 clopidogrel safety and may update labeling based on ongoing data.
The FDA has received approximately 332,980 adverse event reports associated with Clopidogrel. 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 Clopidogrel include Dyspnoea, Myocardial Infarction, Fatigue, Gastrointestinal Haemorrhage, Nausea. By volume, the top reported reactions are: Dyspnoea (9,916 reports), Myocardial Infarction (9,461 reports), Fatigue (8,478 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Clopidogrel.
Out of 192,894 classified reports, 156,924 (81.4%) were classified as serious and 35,970 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 Clopidogrel break down by patient sex as follows: Male: 98,816, Female: 76,428, Unknown: 1,469. 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 Clopidogrel adverse events are: age 75: 4,517 reports, age 77: 4,373 reports, age 74: 4,337 reports, age 71: 4,328 reports, age 72: 4,237 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 Clopidogrel adverse event reports is Sanofi-Aventis U.S. Llc. 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 Clopidogrel include: Dizziness, Diarrhoea, Drug Ineffective, Asthenia, 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 Clopidogrel 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.
Clopidogrel 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 percentage of serious adverse events (81.4%) among total reports.
Key safety signals identified in Clopidogrel's adverse event data include: High frequency of serious reactions like myocardial infarction and death.. Diverse range of reactions including gastrointestinal hemorrhage, dizziness, and fatigue.. Reports of drug interactions and ineffective drug performance.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clopidogrel can interact with other medications, and patients should be aware of potential drug interactions and follow healthcare provider's instructions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clopidogrel.
Consult healthcare providers before starting or stopping clopidogrel to avoid potential drug interactions. Report any adverse reactions to the FDA's MedWatch program.
Clopidogrel has 332,980 adverse event reports on file with the FDA. A wide range of reactions reported, including cardiovascular, gastrointestinal, and hematological issues. The volume of reports for Clopidogrel reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor clopidogrel safety and may update labeling based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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