65/100 · Elevated
Manufactured by Natco Pharma Limited
Moderate Safety Concerns with Ondansetron Tablets
215,481 FDA adverse event reports analyzed
Last updated: 2026-05-12
ONDANSETRON TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Natco Pharma Limited. Based on analysis of 215,481 FDA adverse event reports, ONDANSETRON TABLETS has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ONDANSETRON TABLETS include NAUSEA, FATIGUE, DIARRHOEA, VOMITING, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ONDANSETRON TABLETS.
Ondansetron Tablets has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 215,481 adverse event reports for this medication, which is primarily manufactured by Natco Pharma Limited.
The most commonly reported adverse events include Nausea, Fatigue, Diarrhoea. Of classified reports, 81.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea, fatigue, and diarrhea are the most common adverse reactions.
Serious adverse events, including death and pneumonia, are reported. Drug interactions and decreased white blood cell count are significant concerns.
Patients taking Ondansetron Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ondansetron can interact with other drugs, and patients should be monitored for decreased white blood cell count and thrombocytopenia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ondansetron Tablets received a safety concern score of 65/100 (elevated concern). This is based on a 81.0% serious event ratio across 103,297 classified reports. The score accounts for 215,481 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 57,269, Male: 37,165, Unknown: 118. The most frequently reported age groups are age 66 (2,041 reports), age 65 (1,988 reports), age 69 (1,946 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 103,297 classified reports for ONDANSETRON TABLETS:
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.
Ondansetron can interact with other drugs, and patients should be monitored for decreased white blood cell count and thrombocytopenia.
If you are taking Ondansetron Tablets, here are important things to know. The most commonly reported side effects include nausea, fatigue, diarrhoea, vomiting, off label use. 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. Follow prescribed dosages and do not alter the medication without consulting a healthcare professional. 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 ondansetron and has not issued any new warnings based on this data.
The FDA has received approximately 215,481 adverse event reports associated with Ondansetron Tablets. 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 Ondansetron Tablets include Nausea, Fatigue, Diarrhoea, Vomiting, Off Label Use. By volume, the top reported reactions are: Nausea (11,557 reports), Fatigue (8,199 reports), Diarrhoea (7,791 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ondansetron Tablets.
Out of 103,297 classified reports, 83,720 (81.0%) were classified as serious and 19,577 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 Ondansetron Tablets break down by patient sex as follows: Female: 57,269, Male: 37,165, Unknown: 118. 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 Ondansetron Tablets adverse events are: age 66: 2,041 reports, age 65: 1,988 reports, age 69: 1,946 reports, age 67: 1,879 reports, age 61: 1,865 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 Ondansetron Tablets adverse event reports is Natco Pharma Limited. 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 Ondansetron Tablets include: Death, Pyrexia, Dyspnoea, Febrile Neutropenia, Pain. 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 Ondansetron Tablets 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.
Ondansetron Tablets has a safety concern score of 65 out of 100 (elevated 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. Nausea, fatigue, and diarrhea are the most common adverse reactions.
Key safety signals identified in Ondansetron Tablets's adverse event data include: Death is a serious adverse event reported in 2.2% of cases.. Pneumonia and other respiratory issues are notable.. Decreased white blood cell count and thrombocytopenia are key safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ondansetron can interact with other drugs, and patients should be monitored for decreased white blood cell count and thrombocytopenia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ondansetron Tablets.
Patients should report any new or worsening symptoms to their healthcare provider. Follow prescribed dosages and do not alter the medication without consulting a healthcare professional.
Ondansetron Tablets has 215,481 adverse event reports on file with the FDA. Serious adverse events, including death and pneumonia, are reported. The volume of reports for Ondansetron Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of ondansetron and has not issued any new warnings based on this 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 ONDANSETRON TABLETS:
Drugs related to ONDANSETRON TABLETS based on therapeutic use, drug class, or shared indications: