85/100 · Critical
Manufactured by Accord Healthcare Inc.
Gemcitabine Adverse Events: High Seriousness and Diverse Reactions
70,539 FDA adverse event reports analyzed
Last updated: 2026-05-12
GEMCITABINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 70,539 FDA adverse event reports, GEMCITABINE 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 GEMCITABINE include DISEASE PROGRESSION, THROMBOCYTOPENIA, OFF LABEL USE, NEUTROPENIA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GEMCITABINE.
Gemcitabine 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 70,539 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Disease Progression, Thrombocytopenia, Off Label Use. Of classified reports, 97.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gemcitabine is associated with a high number of serious adverse events, particularly thrombocytopenia and neutropenia.
The drug has a wide range of reactions, including disease progression and various hematological issues. Significant reports of infections and sepsis highlight the need for careful monitoring.
Patients taking Gemcitabine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Gemcitabine can cause severe hematological and infectious adverse events, and patients should be closely monitored for signs of these conditions. Drug interactions are not specifically highlighted in the data but should be considered in the context o This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Gemcitabine received a safety concern score of 85/100 (high concern). This is based on a 97.2% serious event ratio across 37,410 classified reports. The score accounts for 70,539 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: 15,603, Female: 15,079, Unknown: 182. The most frequently reported age groups are age 67 (937 reports), age 70 (912 reports), age 68 (901 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 37,410 classified reports for GEMCITABINE:
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.
Gemcitabine can cause severe hematological and infectious adverse events, and patients should be closely monitored for signs of these conditions. Drug interactions are not specifically highlighted in the data but should be considered in the context o
If you are taking Gemcitabine, here are important things to know. The most commonly reported side effects include disease progression, thrombocytopenia, off label use, neutropenia, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests are essential to monitor for hematological side effects. 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 continues to monitor the safety of gemcitabine, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information and guidelines.
The FDA has received approximately 70,539 adverse event reports associated with Gemcitabine. 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 Gemcitabine include Disease Progression, Thrombocytopenia, Off Label Use, Neutropenia, Drug Ineffective. By volume, the top reported reactions are: Disease Progression (4,353 reports), Thrombocytopenia (2,861 reports), Off Label Use (2,622 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Gemcitabine.
Out of 37,410 classified reports, 36,354 (97.2%) were classified as serious and 1,056 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 Gemcitabine break down by patient sex as follows: Male: 15,603, Female: 15,079, Unknown: 182. 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 Gemcitabine adverse events are: age 67: 937 reports, age 70: 912 reports, age 68: 901 reports, age 69: 851 reports, age 65: 850 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 Gemcitabine adverse event reports is Accord Healthcare 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 Gemcitabine include: Anaemia, Malignant Neoplasm Progression, Nausea, Pyrexia, 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 Gemcitabine 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.
Gemcitabine 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. Gemcitabine is associated with a high number of serious adverse events, particularly thrombocytopenia and neutropenia.
Key safety signals identified in Gemcitabine's adverse event data include: Thrombocytopenia and neutropenia are the most frequently reported hematological adverse events.. Disease progression and malignancy-related reactions are common, indicating potential efficacy but also risks.. Infections and sepsis are significant safety signals, especially in the context of immunosuppression.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Gemcitabine can cause severe hematological and infectious adverse events, and patients should be closely monitored for signs of these conditions. Drug interactions are not specifically highlighted in the data but should be considered in the context o Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Gemcitabine.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests are essential to monitor for hematological side effects.
Gemcitabine has 70,539 adverse event reports on file with the FDA. The drug has a wide range of reactions, including disease progression and various hematological issues. The volume of reports for Gemcitabine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of gemcitabine, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information and guidelines. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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