85/100 · Critical
Manufactured by Eagle Pharmaceuticals, Inc.
High Safety Concerns with Metastatic Cancer Treatment: Metformin
35,073 FDA adverse event reports analyzed
Last updated: 2026-05-12
PEMETREXED is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eagle Pharmaceuticals, Inc.. Based on analysis of 35,073 FDA adverse event reports, PEMETREXED 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 include MALIGNANT NEOPLASM PROGRESSION, ANAEMIA, DISEASE PROGRESSION, OFF LABEL USE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PEMETREXED.
Pemetrexed 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 35,073 adverse event reports for this medication, which is primarily manufactured by Eagle Pharmaceuticals, Inc..
The most commonly reported adverse events include Malignant Neoplasm Progression, Anaemia, Disease Progression. Of classified reports, 97.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe adverse events such as malignancy progression and death are common.
Significant hematological toxicity, including anemia and neutropenia, is frequently reported. Respiratory issues, including pneumonia and interstitial lung disease, are notable safety concerns.
Patients taking Pemetrexed 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 methotrexate, may increase toxicity. Warnings include monitoring for hematological and respiratory adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pemetrexed received a safety concern score of 85/100 (high concern). This is based on a 97.9% serious event ratio across 19,550 classified reports. The score accounts for 35,073 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: 9,905, Female: 7,359, Unknown: 56. The most frequently reported age groups are age 68 (617 reports), age 66 (602 reports), age 69 (597 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 19,550 classified reports for PEMETREXED:
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 methotrexate, may increase toxicity. Warnings include monitoring for hematological and respiratory adverse events.
If you are taking Pemetrexed, here are important things to know. The most commonly reported side effects include malignant neoplasm progression, anaemia, disease progression, off label use, 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 be closely monitored for signs of hematological and respiratory issues. Inform healthcare providers of all medications and supplements to avoid potential drug interactions. 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 these reports and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 35,073 adverse event reports associated with Pemetrexed. 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 include Malignant Neoplasm Progression, Anaemia, Disease Progression, Off Label Use, Nausea. By volume, the top reported reactions are: Malignant Neoplasm Progression (1,596 reports), Anaemia (1,170 reports), Disease Progression (1,066 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.
Out of 19,550 classified reports, 19,148 (97.9%) were classified as serious and 402 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 break down by patient sex as follows: Male: 9,905, Female: 7,359, Unknown: 56. 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 adverse events are: age 68: 617 reports, age 66: 602 reports, age 69: 597 reports, age 70: 577 reports, age 71: 574 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 adverse event reports is Eagle Pharmaceuticals, 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 Pemetrexed include: Neutropenia, Diarrhoea, Drug Ineffective, Thrombocytopenia, Pancytopenia. 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 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 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 events such as malignancy progression and death are common.
Key safety signals identified in Pemetrexed's adverse event data include: Malignant neoplasm progression and death are the most serious reactions.. Hematological toxicity, including anemia and neutropenia, is a key safety signal.. Respiratory issues, such as pneumonia and interstitial lung disease, are frequent.. 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 methotrexate, may increase toxicity. Warnings include monitoring for hematological and respiratory adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pemetrexed.
Patients should be closely monitored for signs of hematological and respiratory issues. Inform healthcare providers of all medications and supplements to avoid potential drug interactions.
Pemetrexed has 35,073 adverse event reports on file with the FDA. Significant hematological toxicity, including anemia and neutropenia, is frequently reported. The volume of reports for Pemetrexed reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these reports and may require additional safety studies or label changes based on ongoing data. 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 PEMETREXED:
Drugs related to PEMETREXED based on therapeutic use, drug class, or shared indications: