85/100 · Critical
Manufactured by Upsher-Smith Laboratories, LLC
Warfarin Sodium Adverse Events: High Seriousness and Diverse Reactions
87,043 FDA adverse event reports analyzed
Last updated: 2026-05-12
WARFARIN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Upsher-Smith Laboratories, LLC. Based on analysis of 87,043 FDA adverse event reports, WARFARIN 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 WARFARIN SODIUM include INTERNATIONAL NORMALISED RATIO INCREASED, DRUG INTERACTION, DYSPNOEA, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for WARFARIN SODIUM.
Warfarin 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 87,043 adverse event reports for this medication, which is primarily manufactured by Upsher-Smith Laboratories, Llc.
The most commonly reported adverse events include International Normalised Ratio Increased, Drug Interaction, Dyspnoea. Of classified reports, 79.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Warfarin sodium has a high incidence of serious adverse events, particularly hemorrhage and thrombosis.
The drug is associated with a wide range of reactions, indicating a complex safety profile. Falls and dizziness are common, suggesting a risk of falls in elderly patients. Drug interactions are frequently reported, highlighting the need for careful monitoring. The most common reactions include nausea, diarrhea, and fatigue, which are generally non-serious.
Patients taking Warfarin Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Warfarin sodium interacts with many drugs, including NSAIDs, antibiotics, and antifungals, which can affect its efficacy and increase the risk of bleeding. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Warfarin Sodium received a safety concern score of 85/100 (high concern). This is based on a 79.2% serious event ratio across 45,582 classified reports. The score accounts for 87,043 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: 21,884, Female: 20,074, Unknown: 102. The most frequently reported age groups are age 80 (978 reports), age 75 (976 reports), age 76 (953 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 45,582 classified reports for WARFARIN 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.
Warfarin sodium interacts with many drugs, including NSAIDs, antibiotics, and antifungals, which can affect its efficacy and increase the risk of bleeding.
If you are taking Warfarin Sodium, here are important things to know. The most commonly reported side effects include international normalised ratio increased, drug interaction, dyspnoea, fatigue, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should avoid over-the-counter medications and supplements that can interact with warfarin without consulting a healthcare provider. Regular INR testing is crucial to maintain therapeutic levels and prevent complications. 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 closely monitors warfarin sodium due to its high risk of serious adverse events, particularly hemorrhage and thrombosis. Regular monitoring of INR is essential to prevent complications.
The FDA has received approximately 87,043 adverse event reports associated with Warfarin 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 Warfarin Sodium include International Normalised Ratio Increased, Drug Interaction, Dyspnoea, Fatigue, Nausea. By volume, the top reported reactions are: International Normalised Ratio Increased (5,065 reports), Drug Interaction (2,500 reports), Dyspnoea (2,486 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Warfarin Sodium.
Out of 45,582 classified reports, 36,098 (79.2%) were classified as serious and 9,484 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 Warfarin Sodium break down by patient sex as follows: Male: 21,884, Female: 20,074, Unknown: 102. 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 Warfarin Sodium adverse events are: age 80: 978 reports, age 75: 976 reports, age 76: 953 reports, age 79: 948 reports, age 74: 925 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 Warfarin Sodium adverse event reports is Upsher-Smith Laboratories, 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 Warfarin Sodium include: Diarrhoea, Dizziness, Fall, Asthenia, Anaemia. 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 Warfarin 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.
Warfarin 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. Warfarin sodium has a high incidence of serious adverse events, particularly hemorrhage and thrombosis.
Key safety signals identified in Warfarin Sodium's adverse event data include: Hemorrhage is the most serious and frequent adverse reaction, with 1,562 reports.. Drug interactions are a key safety signal, with 2,500 reports.. Atrial fibrillation and pulmonary embolism are significant cardiovascular risks.. Renal failure and acute kidney injury are reported in 762 and 482 cases, respectively.. Cerebral hemorrhage and myocardial infarction are critical neurological and cardiac events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Warfarin sodium interacts with many drugs, including NSAIDs, antibiotics, and antifungals, which can affect its efficacy and increase the risk of bleeding. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Warfarin Sodium.
Patients should avoid over-the-counter medications and supplements that can interact with warfarin without consulting a healthcare provider. Regular INR testing is crucial to maintain therapeutic levels and prevent complications.
Warfarin Sodium has 87,043 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating a complex safety profile. The volume of reports for Warfarin Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors warfarin sodium due to its high risk of serious adverse events, particularly hemorrhage and thrombosis. Regular monitoring of INR is essential to prevent complications. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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