85/100 · Critical
Manufactured by Medexus Pharma Inc.
High Safety Concerns with Methotrexate Due to Serious Reactions and Diverse Adverse Events
1,175,376 FDA adverse event reports analyzed
Last updated: 2026-05-12
METHOTREXATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Medexus Pharma Inc.. Based on analysis of 1,175,376 FDA adverse event reports, METHOTREXATE 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 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.
Methotrexate 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 1,175,376 adverse event reports for this medication, which is primarily manufactured by Medexus Pharma Inc..
The most commonly reported adverse events include Drug Ineffective, Rheumatoid Arthritis, Arthralgia. Of classified reports, 74.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Methotrexate has a high rate of serious adverse events, particularly infections and gastrointestinal disorders.
The drug shows a wide range of adverse reactions, indicating potential for diverse side effects. Report volume is substantial, with over 1.1 million reports, highlighting its widespread use and potential risks.
Patients taking Methotrexate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Methotrexate can interact with many drugs, including sulfasalazine, methotrexate, and azathioprine, potentially leading to increased toxicity. Warnings include contraindications with certain conditions and products. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Methotrexate received a safety concern score of 85/100 (high concern). This is based on a 74.5% serious event ratio across 410,012 classified reports. The score accounts for 1,175,376 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: 259,708, Male: 107,137, Unknown: 1,344. The most frequently reported age groups are age 60 (6,835 reports), age 59 (6,347 reports), age 63 (6,343 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 410,012 classified reports for METHOTREXATE:
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 can interact with many drugs, including sulfasalazine, methotrexate, and azathioprine, potentially leading to increased toxicity. Warnings include contraindications with certain conditions and products.
If you are taking Methotrexate, 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 strictly follow prescribed dosages and schedules to minimize risk. Regular monitoring of blood counts and liver function is essential. 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 due to its high risk of serious adverse events, particularly in older adults and those with pre-existing conditions.
The FDA has received approximately 1,175,376 adverse event reports associated with Methotrexate. 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 include Drug Ineffective, Rheumatoid Arthritis, Arthralgia, Pain, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (74,947 reports), Rheumatoid Arthritis (38,054 reports), Arthralgia (36,283 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.
Out of 410,012 classified reports, 305,513 (74.5%) were classified as serious and 104,499 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 break down by patient sex as follows: Female: 259,708, Male: 107,137, Unknown: 1,344. 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 adverse events are: age 60: 6,835 reports, age 59: 6,347 reports, age 63: 6,343 reports, age 61: 6,230 reports, age 65: 6,164 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 adverse event reports is Medexus Pharma Inc.. 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 include: Fatigue, Nausea, Joint Swelling, Headache, Rash. 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 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 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 has a high rate of serious adverse events, particularly infections and gastrointestinal disorders.
Key safety signals identified in Methotrexate's adverse event data include: Serious reactions such as pneumonia and sepsis are common.. Gastrointestinal issues like nausea and diarrhea are frequently reported.. There are multiple reports of hematological issues, including anemia and pancytopenia.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Methotrexate can interact with many drugs, including sulfasalazine, methotrexate, and azathioprine, potentially leading to increased toxicity. Warnings include contraindications with certain conditions and products. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Methotrexate.
Patients should strictly follow prescribed dosages and schedules to minimize risk. Regular monitoring of blood counts and liver function is essential.
Methotrexate has 1,175,376 adverse event reports on file with the FDA. The drug shows a wide range of adverse reactions, indicating potential for diverse side effects. The volume of reports for Methotrexate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Methotrexate 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.
The following drugs share commonly reported adverse reactions with METHOTREXATE:
Drugs related to METHOTREXATE based on therapeutic use, drug class, or shared indications: