65/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Moderate Safety Concerns with Ondansetron Hydrochloride
246,806 FDA adverse event reports analyzed
Last updated: 2026-05-12
ONDANSETRON HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 246,806 FDA adverse event reports, ONDANSETRON HYDROCHLORIDE 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 HYDROCHLORIDE 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 HYDROCHLORIDE.
Ondansetron Hydrochloride 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 246,806 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Nausea, Fatigue, Diarrhoea. Of classified reports, 80.0% 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 reactions such as death, pneumonia, and renal failure are reported. Drug interactions and ineffective drug performance are notable concerns.
Patients taking Ondansetron Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Onondansetron hydrochloride can interact with other drugs, leading to adverse effects. Warnings include drug ineffectiveness and potential for serious reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ondansetron Hydrochloride received a safety concern score of 65/100 (elevated concern). This is based on a 80.0% serious event ratio across 114,971 classified reports. The score accounts for 246,806 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: 64,665, Male: 40,571, Unknown: 131. The most frequently reported age groups are age 66 (2,241 reports), age 65 (2,203 reports), age 69 (2,096 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 114,971 classified reports for ONDANSETRON 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.
Onondansetron hydrochloride can interact with other drugs, leading to adverse effects. Warnings include drug ineffectiveness and potential for serious reactions.
If you are taking Ondansetron Hydrochloride, 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. Monitor for signs of serious reactions such as respiratory issues, renal failure, and infections. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking. 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 closely monitors onondansetron hydrochloride due to its high rate of serious adverse events. Patients should report any unusual symptoms to their healthcare provider.
The FDA has received approximately 246,806 adverse event reports associated with Ondansetron 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 Ondansetron Hydrochloride include Nausea, Fatigue, Diarrhoea, Vomiting, Off Label Use. By volume, the top reported reactions are: Nausea (13,443 reports), Fatigue (9,377 reports), Diarrhoea (8,859 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 Hydrochloride.
Out of 114,971 classified reports, 92,005 (80.0%) were classified as serious and 22,966 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 Hydrochloride break down by patient sex as follows: Female: 64,665, Male: 40,571, Unknown: 131. 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 Hydrochloride adverse events are: age 66: 2,241 reports, age 65: 2,203 reports, age 69: 2,096 reports, age 67: 2,091 reports, age 61: 2,051 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 Hydrochloride adverse event reports is Aurobindo 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 Hydrochloride include: Dyspnoea, Pyrexia, Death, Headache, 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 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.
Ondansetron Hydrochloride 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 Hydrochloride's adverse event data include: High frequency of serious reactions (80%). Diverse range of reactions including neurological, gastrointestinal, and respiratory issues. Significant number of reports involving death and severe infections. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Onondansetron hydrochloride can interact with other drugs, leading to adverse effects. Warnings include drug ineffectiveness and potential for serious reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ondansetron Hydrochloride.
Monitor for signs of serious reactions such as respiratory issues, renal failure, and infections. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking.
Ondansetron Hydrochloride has 246,806 adverse event reports on file with the FDA. Serious reactions such as death, pneumonia, and renal failure are reported. The volume of reports for Ondansetron Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors onondansetron hydrochloride due to its high rate of serious adverse events. Patients should report any unusual symptoms to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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