85/100 · Critical
Manufactured by Fresenius Kabi USA, LLC
High Safety Concerns with Metastatic Cancer Treatment
62,980 FDA adverse event reports analyzed
Last updated: 2026-05-12
PEMETREXED DISODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 62,980 FDA adverse event reports, PEMETREXED DISODIUM 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 PEMETREXED DISODIUM include MALIGNANT NEOPLASM PROGRESSION, OFF LABEL USE, ANAEMIA, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PEMETREXED DISODIUM.
Pemetrexed Disodium 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 62,980 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Malignant Neoplasm Progression, Off Label Use, Anaemia. Of classified reports, 95.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe adverse reactions such as death, malignancy progression, and renal failure are common.
Significant hematological toxicity, including anemia and neutropenia, is frequently reported. Drug interactions and warnings are necessary due to the high incidence of serious adverse events.
Patients taking Pemetrexed Disodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs, such as those affecting renal function, are a concern. Warnings are issued for concurrent use with certain medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pemetrexed Disodium received a safety concern score of 85/100 (high concern). This is based on a 95.0% serious event ratio across 35,690 classified reports. The score accounts for 62,980 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: 19,208, Female: 13,144, Unknown: 84. The most frequently reported age groups are age 68 (1,100 reports), age 70 (1,074 reports), age 66 (1,064 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,690 classified reports for PEMETREXED DISODIUM:
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.
Interactions with other drugs, such as those affecting renal function, are a concern. Warnings are issued for concurrent use with certain medications.
If you are taking Pemetrexed Disodium, here are important things to know. The most commonly reported side effects include malignant neoplasm progression, off label use, anaemia, nausea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of severe hematological and renal toxicity. Inform patients about the potential for serious adverse events and the importance of adherence to prescribed dosing and monitoring schedules. 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.
Regulatory oversight is stringent, with ongoing monitoring and updates to the drug’s labeling to address safety concerns.
The FDA has received approximately 62,980 adverse event reports associated with Pemetrexed Disodium. 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 Pemetrexed Disodium include Malignant Neoplasm Progression, Off Label Use, Anaemia, Nausea, Diarrhoea. By volume, the top reported reactions are: Malignant Neoplasm Progression (2,979 reports), Off Label Use (2,209 reports), Anaemia (2,011 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pemetrexed Disodium.
Out of 35,690 classified reports, 33,890 (95.0%) were classified as serious and 1,800 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 Pemetrexed Disodium break down by patient sex as follows: Male: 19,208, Female: 13,144, Unknown: 84. 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 Pemetrexed Disodium adverse events are: age 68: 1,100 reports, age 70: 1,074 reports, age 66: 1,064 reports, age 65: 1,037 reports, age 63: 974 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 Pemetrexed Disodium 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 Pemetrexed Disodium include: Neutropenia, Pancytopenia, Death, Thrombocytopenia, Fatigue. 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 Pemetrexed Disodium 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.
Pemetrexed Disodium 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. Severe adverse reactions such as death, malignancy progression, and renal failure are common.
Key safety signals identified in Pemetrexed Disodium's adverse event data include: High incidence of death and malignancy progression.. Severe hematological toxicity, including anemia and neutropenia.. Renal impairment and failure are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs, such as those affecting renal function, are a concern. Warnings are issued for concurrent use with certain medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pemetrexed Disodium.
Monitor patients closely for signs of severe hematological and renal toxicity. Inform patients about the potential for serious adverse events and the importance of adherence to prescribed dosing and monitoring schedules.
Pemetrexed Disodium has 62,980 adverse event reports on file with the FDA. Significant hematological toxicity, including anemia and neutropenia, is frequently reported. The volume of reports for Pemetrexed Disodium reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is stringent, with ongoing monitoring and updates to the drug’s labeling to address safety concerns. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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