72/100 · Elevated
Manufactured by Bausch Health US, LLC
Primidone Adverse Events: High Incidence of Neurological and Gastrointestinal Issues
19,417 FDA adverse event reports analyzed
Last updated: 2026-05-12
PRIMIDONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US, LLC. Based on analysis of 19,417 FDA adverse event reports, PRIMIDONE 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 PRIMIDONE include DRUG INEFFECTIVE, FALL, FATIGUE, TREMOR, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PRIMIDONE.
Primidone 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 19,417 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us, Llc.
The most commonly reported adverse events include Drug Ineffective, Fall, Fatigue. Of classified reports, 65.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Primidone reports show a high incidence of neurological issues such as falls, tremors, and seizures.
Gastrointestinal symptoms like diarrhea, nausea, and vomiting are also frequently reported. Serious adverse events, including death and pneumonia, account for a significant portion of reports.
Patients taking Primidone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Primidone can cause drug interactions, and patients should be warned about potential interactions with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Primidone received a safety concern score of 72/100 (elevated concern). This is based on a 65.8% serious event ratio across 9,782 classified reports. The score accounts for 19,417 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: 5,515, Male: 3,638, Unknown: 20. The most frequently reported age groups are age 70 (217 reports), age 72 (199 reports), age 71 (198 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 9,782 classified reports for PRIMIDONE:
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.
Primidone can cause drug interactions, and patients should be warned about potential interactions with other medications.
If you are taking Primidone, here are important things to know. The most commonly reported side effects include drug ineffective, fall, fatigue, tremor, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of neurological issues and adjust dosing as necessary. Inform patients about the risk of falls and dizziness and advise them to avoid activities that could be dangerous. Closely monitor patients with pre-existing conditions such as epilepsy or respiratory issues. 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.
Primidone is subject to FDA oversight, and patients should report any adverse events to their healthcare provider.
The FDA has received approximately 19,417 adverse event reports associated with Primidone. 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 Primidone include Drug Ineffective, Fall, Fatigue, Tremor, Dizziness. By volume, the top reported reactions are: Drug Ineffective (815 reports), Fall (651 reports), Fatigue (616 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Primidone.
Out of 9,782 classified reports, 6,435 (65.8%) were classified as serious and 3,347 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 Primidone break down by patient sex as follows: Female: 5,515, Male: 3,638, Unknown: 20. 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 Primidone adverse events are: age 70: 217 reports, age 72: 199 reports, age 71: 198 reports, age 69: 196 reports, age 77: 188 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 Primidone adverse event reports is Bausch Health Us, Llc. 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 Primidone include: Diarrhoea, Off Label Use, Nausea, Headache, Drug Interaction. 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 Primidone 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.
Primidone 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. Primidone reports show a high incidence of neurological issues such as falls, tremors, and seizures.
Key safety signals identified in Primidone's adverse event data include: Falls and dizziness are common, indicating potential risk of injury.. Seizures and convulsions are reported, suggesting a risk for patients with epilepsy.. Death and pneumonia are serious adverse events that require close monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Primidone can cause drug interactions, and patients should be warned about potential interactions with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Primidone.
Monitor patients for signs of neurological issues and adjust dosing as necessary. Inform patients about the risk of falls and dizziness and advise them to avoid activities that could be dangerous. Closely monitor patients with pre-existing conditions such as epilepsy or respiratory issues.
Primidone has 19,417 adverse event reports on file with the FDA. Gastrointestinal symptoms like diarrhea, nausea, and vomiting are also frequently reported. The volume of reports for Primidone reflects both the drug's usage level and the vigilance of the reporting community.
Primidone is subject to FDA oversight, and patients should report any adverse events 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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