85/100 · Critical
Manufactured by Fresenius Kabi USA, LLC
High Safety Concerns with Methotrexate Sodium: Common and Serious Adverse Reactions
1,310,439 FDA adverse event reports analyzed
Last updated: 2026-05-12
METHOTREXATE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 1,310,439 FDA adverse event reports, METHOTREXATE 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 METHOTREXATE SODIUM include DRUG INEFFECTIVE, RHEUMATOID ARTHRITIS, ARTHRALGIA, PAIN, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METHOTREXATE SODIUM.
Methotrexate 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 1,310,439 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Drug Ineffective, Rheumatoid Arthritis, Arthralgia. Of classified reports, 73.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Methotrexate sodium is associated with a high number of serious adverse reactions, particularly infections and hematological issues.
Common side effects include pain, fatigue, and nausea, which are reported frequently. The drug is often used off-label, indicating potential misuse or unapproved therapeutic applications.
Patients taking Methotrexate Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Methotrexate sodium can interact with other drugs, such as sulfasalazine and methotrexate itself, leading to increased toxicity. Warnings include contraindications with certain medications and conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Methotrexate Sodium received a safety concern score of 85/100 (high concern). This is based on a 73.2% serious event ratio across 473,761 classified reports. The score accounts for 1,310,439 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: 302,592, Male: 123,885, Unknown: 1,402. The most frequently reported age groups are age 60 (8,254 reports), age 65 (7,845 reports), age 63 (7,842 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 473,761 classified reports for METHOTREXATE 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.
Methotrexate sodium can interact with other drugs, such as sulfasalazine and methotrexate itself, leading to increased toxicity. Warnings include contraindications with certain medications and conditions.
If you are taking Methotrexate Sodium, here are important things to know. The most commonly reported side effects include drug ineffective, rheumatoid arthritis, arthralgia, pain, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of infection, hematological issues, and other serious adverse reactions. Follow prescribed dosing and administration guidelines strictly to minimize the risk of toxicity. 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 Methotrexate sodium due to its high risk of serious adverse events, particularly in older adults and those with pre-existing conditions.
The FDA has received approximately 1,310,439 adverse event reports associated with Methotrexate 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 Methotrexate Sodium include Drug Ineffective, Rheumatoid Arthritis, Arthralgia, Pain, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (91,551 reports), Rheumatoid Arthritis (41,868 reports), Arthralgia (39,749 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Methotrexate Sodium.
Out of 473,761 classified reports, 346,680 (73.2%) were classified as serious and 127,081 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 Methotrexate Sodium break down by patient sex as follows: Female: 302,592, Male: 123,885, Unknown: 1,402. 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 Methotrexate Sodium adverse events are: age 60: 8,254 reports, age 65: 7,845 reports, age 63: 7,842 reports, age 59: 7,667 reports, age 61: 7,615 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 Methotrexate Sodium adverse event reports is Fresenius Kabi Usa, 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 Methotrexate Sodium include: Fatigue, Nausea, Joint Swelling, Drug Intolerance, Condition Aggravated. 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 Methotrexate 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.
Methotrexate 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. Methotrexate sodium is associated with a high number of serious adverse reactions, particularly infections and hematological issues.
Key safety signals identified in Methotrexate Sodium's adverse event data include: Serious adverse reactions such as pneumonia, sepsis, and death are reported frequently.. Hematological issues like anemia, pancytopenia, and neutropenia are common.. Infections, including respiratory tract infections and sepsis, are significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Methotrexate sodium can interact with other drugs, such as sulfasalazine and methotrexate itself, leading to increased toxicity. Warnings include contraindications with certain medications and conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Methotrexate Sodium.
Patients should be closely monitored for signs of infection, hematological issues, and other serious adverse reactions. Follow prescribed dosing and administration guidelines strictly to minimize the risk of toxicity.
Methotrexate Sodium has 1,310,439 adverse event reports on file with the FDA. Common side effects include pain, fatigue, and nausea, which are reported frequently. The volume of reports for Methotrexate Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Methotrexate sodium due to its high risk of serious adverse events, particularly in older adults and those with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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