72/100 · Elevated
Manufactured by Allergan, Inc.
ONABOTULINUMTOXINA Safety Profile Analysis
126,795 FDA adverse event reports analyzed
Last updated: 2026-05-12
ONABOTULINUMTOXINA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 126,795 FDA adverse event reports, ONABOTULINUMTOXINA has a safety score of 72 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 ONABOTULINUMTOXINA include DRUG INEFFECTIVE, OFF LABEL USE, THERAPEUTIC RESPONSE DECREASED, HEADACHE, PRODUCT PREPARATION ERROR. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ONABOTULINUMTOXINA.
Onabotulinumtoxina has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 126,795 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Therapeutic Response Decreased. Of classified reports, 18.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events account for 18.7% of all reports, indicating a notable risk.
Headache and injection site pain are the most common side effects, affecting a significant portion of users. There is a diverse range of reactions, suggesting potential for various adverse effects.
Patients taking Onabotulinumtoxina should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are not explicitly mentioned, but users should avoid using ONABOTULINUMTOXINA with other neuromodulators to prevent adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Onabotulinumtoxina received a safety concern score of 72/100 (elevated concern). This is based on a 18.7% serious event ratio across 74,098 classified reports. The score accounts for 126,795 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: 53,854, Male: 7,701, Unknown: 249. The most frequently reported age groups are age 53 (973 reports), age 50 (903 reports), age 40 (852 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 74,098 classified reports for ONABOTULINUMTOXINA:
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.
Drug interactions are not explicitly mentioned, but users should avoid using ONABOTULINUMTOXINA with other neuromodulators to prevent adverse effects.
If you are taking Onabotulinumtoxina, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, therapeutic response decreased, headache, product preparation error. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosage and usage instructions carefully to minimize the risk of adverse reactions. Report any unusual symptoms to your healthcare provider promptly. 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 ONABOTULINUMTOXINA and may take further action based on ongoing data analysis.
The FDA has received approximately 126,795 adverse event reports associated with Onabotulinumtoxina. 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 Onabotulinumtoxina include Drug Ineffective, Off Label Use, Therapeutic Response Decreased, Headache, Product Preparation Error. By volume, the top reported reactions are: Drug Ineffective (26,176 reports), Off Label Use (11,097 reports), Therapeutic Response Decreased (4,502 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Onabotulinumtoxina.
Out of 74,098 classified reports, 13,892 (18.7%) were classified as serious and 60,206 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 Onabotulinumtoxina break down by patient sex as follows: Female: 53,854, Male: 7,701, Unknown: 249. 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 Onabotulinumtoxina adverse events are: age 53: 973 reports, age 50: 903 reports, age 40: 852 reports, age 45: 806 reports, age 43: 803 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 Onabotulinumtoxina adverse event reports is Allergan, 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 Onabotulinumtoxina include: Injection Site Pain, Eyelid Ptosis, Multiple Use Of Single-Use Product, Migraine, Nausea. 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 Onabotulinumtoxina 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.
Onabotulinumtoxina has a safety concern score of 72 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. Serious adverse events account for 18.7% of all reports, indicating a notable risk.
Key safety signals identified in Onabotulinumtoxina's adverse event data include: Death and botulism are reported, highlighting severe risks.. Multiple use of a single-use product and incorrect dose administration are key safety signals.. Severe reactions like pneumonia and cerebrovascular accident are reported, indicating potential for serious complications.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are not explicitly mentioned, but users should avoid using ONABOTULINUMTOXINA with other neuromodulators to prevent adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Onabotulinumtoxina.
Follow the prescribed dosage and usage instructions carefully to minimize the risk of adverse reactions. Report any unusual symptoms to your healthcare provider promptly.
Onabotulinumtoxina has 126,795 adverse event reports on file with the FDA. Headache and injection site pain are the most common side effects, affecting a significant portion of users. The volume of reports for Onabotulinumtoxina reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of ONABOTULINUMTOXINA and may take further action based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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