82/100 · Critical
Manufactured by Apotex Corp.
High Safety Concerns with CLOPIDOGREL BISULFATE, Particularly for Serious Reactions
168,674 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLOPIDOGREL BISULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Apotex Corp.. Based on analysis of 168,674 FDA adverse event reports, CLOPIDOGREL BISULFATE has a safety score of 82 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 BISULFATE include DYSPNOEA, FATIGUE, DIZZINESS, DRUG INEFFECTIVE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLOPIDOGREL BISULFATE.
Clopidogrel Bisulfate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 168,674 adverse event reports for this medication, which is primarily manufactured by Apotex Corp..
The most commonly reported adverse events include Dyspnoea, Fatigue, Dizziness. Of classified reports, 86.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but serious reactions account for 86.7% of all outcomes.
Drug interactions and falls are common, indicating potential risks in combination therapy and daily activities. The most frequent reactions include dyspnoea, fatigue, and dizziness, which can affect patient quality of life.
Patients taking Clopidogrel Bisulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. CLOPIDOGREL BISULFATE can interact with various medications, and patients should be monitored for signs of adverse reactions, particularly in combination with other cardiovascular drugs. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clopidogrel Bisulfate received a safety concern score of 82/100 (high concern). This is based on a 86.7% serious event ratio across 98,251 classified reports. The score accounts for 168,674 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: 50,647, Female: 36,242, Unknown: 240. The most frequently reported age groups are age 75 (2,556 reports), age 77 (2,536 reports), age 74 (2,434 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 98,251 classified reports for CLOPIDOGREL BISULFATE:
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 BISULFATE can interact with various medications, and patients should be monitored for signs of adverse reactions, particularly in combination with other cardiovascular drugs.
If you are taking Clopidogrel Bisulfate, here are important things to know. The most commonly reported side effects include dyspnoea, fatigue, dizziness, drug ineffective, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosages and avoid alcohol, as it can increase the risk of gastrointestinal bleeding. 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.
Regulators continue to monitor the safety profile of CLOPIDOGREL BISULFATE, with ongoing reviews to ensure patient safety.
The FDA has received approximately 168,674 adverse event reports associated with Clopidogrel Bisulfate. 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 Bisulfate include Dyspnoea, Fatigue, Dizziness, Drug Ineffective, Diarrhoea. By volume, the top reported reactions are: Dyspnoea (5,180 reports), Fatigue (4,581 reports), Dizziness (4,046 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 Bisulfate.
Out of 98,251 classified reports, 85,168 (86.7%) were classified as serious and 13,083 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 Bisulfate break down by patient sex as follows: Male: 50,647, Female: 36,242, Unknown: 240. 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 Bisulfate adverse events are: age 75: 2,556 reports, age 77: 2,536 reports, age 74: 2,434 reports, age 78: 2,420 reports, age 72: 2,409 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 Bisulfate adverse event reports is Apotex Corp.. 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 Bisulfate include: Nausea, Anaemia, Drug Interaction, Fall, Myocardial Infarction. 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 Bisulfate 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 Bisulfate has a safety concern score of 82 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. The majority of adverse events are non-serious, but serious reactions account for 86.7% of all outcomes.
Key safety signals identified in Clopidogrel Bisulfate's adverse event data include: Serious reactions such as myocardial infarction, acute kidney injury, and death are reported frequently.. Drug interactions are a significant safety signal, with 3589 reports of interactions.. Fall-related injuries are common, suggesting a need for caution, especially in elderly patients.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
CLOPIDOGREL BISULFATE can interact with various medications, and patients should be monitored for signs of adverse reactions, particularly in combination with other cardiovascular drugs. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clopidogrel Bisulfate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosages and avoid alcohol, as it can increase the risk of gastrointestinal bleeding.
Clopidogrel Bisulfate has 168,674 adverse event reports on file with the FDA. Drug interactions and falls are common, indicating potential risks in combination therapy and daily activities. The volume of reports for Clopidogrel Bisulfate reflects both the drug's usage level and the vigilance of the reporting community.
Regulators continue to monitor the safety profile of CLOPIDOGREL BISULFATE, with ongoing reviews to ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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