85/100 · Critical
Manufactured by Sanofi-Aventis U.S. LLC
Highly Reported Adverse Reactions for Enoxaparin Sodium
96,320 FDA adverse event reports analyzed
Last updated: 2026-05-12
ENOXAPARIN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sanofi-Aventis U.S. LLC. Based on analysis of 96,320 FDA adverse event reports, ENOXAPARIN SODIUM 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 ENOXAPARIN SODIUM include DYSPNOEA, NAUSEA, OFF LABEL USE, DIARRHOEA, ANAEMIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENOXAPARIN SODIUM.
Enoxaparin Sodium 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 96,320 adverse event reports for this medication, which is primarily manufactured by Sanofi-Aventis U.S. Llc.
The most commonly reported adverse events include Dyspnoea, Nausea, Off Label Use. Of classified reports, 87.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include dyspnea, nausea, and thrombosis, indicating a significant risk of respiratory and cardiovascular issues.
Serious adverse events such as pulmonary embolism, death, and sepsis are frequently reported, highlighting the severity of potential complications. Drug interactions and hematological issues are also significant concerns, with reports of heparin-induced thrombocytopenia and thrombosis. The high volume of reports suggests a need for careful monitoring and management of patients on this medication.
Patients taking Enoxaparin Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Enoxaparin sodium can interact with other anticoagulants and may increase the risk of bleeding. Healthcare providers should monitor for signs of hemorrhage and adjust dosing accordingly. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Enoxaparin Sodium received a safety concern score of 85/100 (high concern). This is based on a 87.3% serious event ratio across 55,707 classified reports. The score accounts for 96,320 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: Female: 26,906, Male: 23,655, Unknown: 297. The most frequently reported age groups are age 74 (1,100 reports), age 72 (1,073 reports), age 65 (1,060 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,707 classified reports for ENOXAPARIN SODIUM:
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.
Enoxaparin sodium can interact with other anticoagulants and may increase the risk of bleeding. Healthcare providers should monitor for signs of hemorrhage and adjust dosing accordingly.
If you are taking Enoxaparin Sodium, here are important things to know. The most commonly reported side effects include dyspnoea, nausea, off label use, diarrhoea, anaemia. 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 unusual symptoms to their healthcare provider immediately. Regular monitoring of blood parameters, such as platelet count and international normalized ratio, is recommended. 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 the safety of enoxaparin sodium and has not issued any specific warnings or restrictions based on the current data.
The FDA has received approximately 96,320 adverse event reports associated with Enoxaparin Sodium. 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 Enoxaparin Sodium include Dyspnoea, Nausea, Off Label Use, Diarrhoea, Anaemia. By volume, the top reported reactions are: Dyspnoea (2,372 reports), Nausea (2,352 reports), Off Label Use (2,302 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Enoxaparin Sodium.
Out of 55,707 classified reports, 48,610 (87.3%) were classified as serious and 7,097 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 Enoxaparin Sodium break down by patient sex as follows: Female: 26,906, Male: 23,655, Unknown: 297. 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 Enoxaparin Sodium adverse events are: age 74: 1,100 reports, age 72: 1,073 reports, age 65: 1,060 reports, age 71: 1,058 reports, age 69: 1,055 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 Enoxaparin Sodium 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 Enoxaparin Sodium include: Thrombocytopenia, Pyrexia, Fatigue, Vomiting, Pulmonary Embolism. 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 Enoxaparin Sodium 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.
Enoxaparin Sodium 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. The most common reactions include dyspnea, nausea, and thrombosis, indicating a significant risk of respiratory and cardiovascular issues.
Key safety signals identified in Enoxaparin Sodium's adverse event data include: Pulmonary embolism and deep vein thrombosis are among the most serious reported reactions.. Hematological issues, including thrombocytopenia and anemia, are frequently reported.. Drug interactions, particularly with heparin, are a key safety signal.. Respiratory issues, such as pneumonia and respiratory failure, are also commonly reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Enoxaparin sodium can interact with other anticoagulants and may increase the risk of bleeding. Healthcare providers should monitor for signs of hemorrhage and adjust dosing accordingly. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Enoxaparin Sodium.
Patients should report any unusual symptoms to their healthcare provider immediately. Regular monitoring of blood parameters, such as platelet count and international normalized ratio, is recommended.
Enoxaparin Sodium has 96,320 adverse event reports on file with the FDA. Serious adverse events such as pulmonary embolism, death, and sepsis are frequently reported, highlighting the severity of potential complications. The volume of reports for Enoxaparin Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of enoxaparin sodium and has not issued any specific warnings or restrictions based on the current data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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