85/100 · Critical
Manufactured by Armas Pharmaceuticals Inc.
High Safety Concerns with Gemcitabine Hydrochloride
92,220 FDA adverse event reports analyzed
Last updated: 2026-05-12
GEMCITABINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Armas Pharmaceuticals Inc.. Based on analysis of 92,220 FDA adverse event reports, GEMCITABINE HYDROCHLORIDE 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 HYDROCHLORIDE include DISEASE PROGRESSION, OFF LABEL USE, THROMBOCYTOPENIA, NEUTROPENIA, ANAEMIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GEMCITABINE HYDROCHLORIDE.
Gemcitabine Hydrochloride 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 92,220 adverse event reports for this medication, which is primarily manufactured by Armas Pharmaceuticals Inc..
The most commonly reported adverse events include Disease Progression, Off Label Use, Thrombocytopenia. Of classified reports, 97.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gemcitabine Hydrochloride is associated with a high frequency of serious adverse events, particularly hematological and gastrointestinal issues.
The drug is often used off-label, indicating potential misuse or unapproved therapeutic applications. Significant drug interactions and warnings are present, highlighting the need for careful monitoring.
Patients taking Gemcitabine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Gemcitabine Hydrochloride can cause severe hematological and gastrointestinal side effects, and its use should be closely monitored for potential drug interactions and signs of toxicity. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Gemcitabine Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 97.1% serious event ratio across 50,349 classified reports. The score accounts for 92,220 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: 21,047, Female: 20,105, Unknown: 374. The most frequently reported age groups are age 68 (1,272 reports), age 67 (1,263 reports), age 70 (1,200 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 50,349 classified reports for GEMCITABINE HYDROCHLORIDE:
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 Hydrochloride can cause severe hematological and gastrointestinal side effects, and its use should be closely monitored for potential drug interactions and signs of toxicity.
If you are taking Gemcitabine Hydrochloride, here are important things to know. The most commonly reported side effects include disease progression, off label use, thrombocytopenia, neutropenia, anaemia. 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 gastrointestinal side effects. Healthcare providers should be aware of potential drug interactions and follow guidelines for off-label use. 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 necessary to ensure proper use and monitoring of Gemcitabine Hydrochloride, given its high safety concerns and serious adverse event profile.
The FDA has received approximately 92,220 adverse event reports associated with Gemcitabine Hydrochloride. 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 Hydrochloride include Disease Progression, Off Label Use, Thrombocytopenia, Neutropenia, Anaemia. By volume, the top reported reactions are: Disease Progression (4,636 reports), Off Label Use (3,864 reports), Thrombocytopenia (3,564 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 Hydrochloride.
Out of 50,349 classified reports, 48,908 (97.1%) were classified as serious and 1,441 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 Hydrochloride break down by patient sex as follows: Male: 21,047, Female: 20,105, Unknown: 374. 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 Hydrochloride adverse events are: age 68: 1,272 reports, age 67: 1,263 reports, age 70: 1,200 reports, age 65: 1,173 reports, age 69: 1,159 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 Hydrochloride adverse event reports is Armas 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 Gemcitabine Hydrochloride include: Malignant Neoplasm Progression, Drug Ineffective, Pyrexia, Nausea, Diarrhoea. 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride is associated with a high frequency of serious adverse events, particularly hematological and gastrointestinal issues.
Key safety signals identified in Gemcitabine Hydrochloride's adverse event data include: High incidence of hematological adverse events such as thrombocytopenia, neutropenia, and anemia.. Frequent gastrointestinal issues like nausea, diarrhea, and vomiting.. Serious infections and sepsis are common, indicating a high risk of severe complications.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Gemcitabine Hydrochloride can cause severe hematological and gastrointestinal side effects, and its use should be closely monitored for potential drug interactions and signs of toxicity. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Gemcitabine Hydrochloride.
Patients should be closely monitored for signs of hematological and gastrointestinal side effects. Healthcare providers should be aware of potential drug interactions and follow guidelines for off-label use.
Gemcitabine Hydrochloride has 92,220 adverse event reports on file with the FDA. The drug is often used off-label, indicating potential misuse or unapproved therapeutic applications. The volume of reports for Gemcitabine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is necessary to ensure proper use and monitoring of Gemcitabine Hydrochloride, given its high safety concerns and serious adverse event profile. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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