85/100 · Critical
Manufactured by Accord Healthcare Inc.
High Safety Concerns with OXALIPLATIN, Particularly Serious Adverse Reactions
127,128 FDA adverse event reports analyzed
Last updated: 2026-05-12
OXALIPLATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 127,128 FDA adverse event reports, OXALIPLATIN 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 OXALIPLATIN include DIARRHOEA, NAUSEA, OFF LABEL USE, VOMITING, DISEASE PROGRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXALIPLATIN.
Oxaliplatin 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 127,128 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Diarrhoea, Nausea, Off Label Use. Of classified reports, 96.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse reactions such as death, sepsis, and respiratory failure are common.
Neurological and hematological toxicities are frequent, with peripheral neuropathy and neutropenia being particularly notable. Drug interactions and warnings are necessary due to the high incidence of serious adverse events.
Patients taking Oxaliplatin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. OXALIPLATIN can cause severe hematological and neurological toxicities, and patients should be monitored closely for signs of these adverse reactions. Drug interactions and warnings are necessary due to the high incidence of serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oxaliplatin received a safety concern score of 85/100 (high concern). This is based on a 96.9% serious event ratio across 69,965 classified reports. The score accounts for 127,128 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: 35,162, Female: 24,361, Unknown: 542. The most frequently reported age groups are age 70 (1,875 reports), age 67 (1,865 reports), age 62 (1,778 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 69,965 classified reports for OXALIPLATIN:
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.
OXALIPLATIN can cause severe hematological and neurological toxicities, and patients should be monitored closely for signs of these adverse reactions. Drug interactions and warnings are necessary due to the high incidence of serious adverse events.
If you are taking Oxaliplatin, here are important things to know. The most commonly reported side effects include diarrhoea, nausea, off label use, vomiting, disease progression. 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 peripheral neuropathy and neutropenia, and any symptoms should be reported to their healthcare provider immediately. Healthcare providers should be aware of the potential for serious adverse reactions and should manage patients accordingly. 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 ongoing, with a focus on monitoring and managing the serious adverse events associated with OXALIPLATIN. Healthcare providers should be vigilant in managing patient care and reporting adverse events.
The FDA has received approximately 127,128 adverse event reports associated with Oxaliplatin. 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 Oxaliplatin include Diarrhoea, Nausea, Off Label Use, Vomiting, Disease Progression. By volume, the top reported reactions are: Diarrhoea (6,579 reports), Nausea (5,137 reports), Off Label Use (4,373 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Oxaliplatin.
Out of 69,965 classified reports, 67,831 (96.9%) were classified as serious and 2,134 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 Oxaliplatin break down by patient sex as follows: Male: 35,162, Female: 24,361, Unknown: 542. 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 Oxaliplatin adverse events are: age 70: 1,875 reports, age 67: 1,865 reports, age 62: 1,778 reports, age 68: 1,768 reports, age 69: 1,760 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 Oxaliplatin 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 Oxaliplatin include: Neutropenia, Neuropathy Peripheral, Thrombocytopenia, Dyspnoea, 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 Oxaliplatin 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.
Oxaliplatin 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. Serious adverse reactions such as death, sepsis, and respiratory failure are common.
Key safety signals identified in Oxaliplatin's adverse event data include: Peripheral neuropathy and neutropenia are key safety signals.. High incidence of serious adverse reactions, including death and sepsis.. Multiple reports of respiratory failure and pulmonary embolism.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
OXALIPLATIN can cause severe hematological and neurological toxicities, and patients should be monitored closely for signs of these adverse reactions. Drug interactions and warnings are necessary due to the high incidence of serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oxaliplatin.
Patients should be closely monitored for signs of peripheral neuropathy and neutropenia, and any symptoms should be reported to their healthcare provider immediately. Healthcare providers should be aware of the potential for serious adverse reactions and should manage patients accordingly.
Oxaliplatin has 127,128 adverse event reports on file with the FDA. Neurological and hematological toxicities are frequent, with peripheral neuropathy and neutropenia being particularly notable. The volume of reports for Oxaliplatin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring and managing the serious adverse events associated with OXALIPLATIN. Healthcare providers should be vigilant in managing patient care and reporting adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Accord Healthcare Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with OXALIPLATIN:
Drugs related to OXALIPLATIN based on therapeutic use, drug class, or shared indications: