85/100 · Critical
Manufactured by Accord Healthcare Inc.
Cisplatin Adverse Events: High Seriousness and Diverse Reactions
137,577 FDA adverse event reports analyzed
Last updated: 2026-05-12
CISPLATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 137,577 FDA adverse event reports, CISPLATIN 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 CISPLATIN include OFF LABEL USE, NAUSEA, NEUTROPENIA, DISEASE PROGRESSION, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CISPLATIN.
Cisplatin 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 137,577 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Off Label Use, Nausea, Neutropenia. Of classified reports, 96.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Cisplatin is associated with a high number of serious adverse events, including death and severe infections.
The drug has a wide range of reactions, indicating potential for multiple side effects. Neutropenia and anemia are among the most frequently reported conditions, highlighting blood-related risks.
Patients taking Cisplatin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cisplatin can interact with other drugs, and patients should be monitored for potential adverse effects, especially when used in combination with other chemotherapy agents. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cisplatin received a safety concern score of 85/100 (high concern). This is based on a 96.8% serious event ratio across 74,819 classified reports. The score accounts for 137,577 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: 37,267, Female: 24,567, Unknown: 675. The most frequently reported age groups are age 65 (1,561 reports), age 67 (1,535 reports), age 66 (1,530 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 74,819 classified reports for CISPLATIN:
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.
Cisplatin can interact with other drugs, and patients should be monitored for potential adverse effects, especially when used in combination with other chemotherapy agents.
If you are taking Cisplatin, here are important things to know. The most commonly reported side effects include off label use, nausea, neutropenia, disease progression, vomiting. 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. Follow all prescribed dosing instructions and attend regular check-ups to monitor for 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 cisplatin's safety profile, and updates are regularly issued based on new data.
The FDA has received approximately 137,577 adverse event reports associated with Cisplatin. 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 Cisplatin include Off Label Use, Nausea, Neutropenia, Disease Progression, Vomiting. By volume, the top reported reactions are: Off Label Use (5,579 reports), Nausea (5,289 reports), Neutropenia (4,712 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cisplatin.
Out of 74,819 classified reports, 72,426 (96.8%) were classified as serious and 2,393 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 Cisplatin break down by patient sex as follows: Male: 37,267, Female: 24,567, Unknown: 675. 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 Cisplatin adverse events are: age 65: 1,561 reports, age 67: 1,535 reports, age 66: 1,530 reports, age 62: 1,516 reports, age 60: 1,494 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 Cisplatin 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 Cisplatin include: Febrile Neutropenia, Anaemia, Diarrhoea, Thrombocytopenia, Pyrexia. 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 Cisplatin 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.
Cisplatin 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. Cisplatin is associated with a high number of serious adverse events, including death and severe infections.
Key safety signals identified in Cisplatin's adverse event data include: Neutropenia and anemia are key safety signals, with high counts of reports.. Death and sepsis are critical safety signals, indicating severe risks.. Drug interactions are reported, suggesting caution with concurrent medications.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cisplatin can interact with other drugs, and patients should be monitored for potential adverse effects, especially when used in combination with other chemotherapy agents. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cisplatin.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow all prescribed dosing instructions and attend regular check-ups to monitor for side effects.
Cisplatin has 137,577 adverse event reports on file with the FDA. The drug has a wide range of reactions, indicating potential for multiple side effects. The volume of reports for Cisplatin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor cisplatin's safety profile, and updates are regularly issued based on new data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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