78/100 · Elevated
Manufactured by Actavis Pharma, Inc.
Metaxalone Adverse Events: High Seriousness and Diverse Reactions
6,668 FDA adverse event reports analyzed
Last updated: 2026-05-12
METAXALONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 6,668 FDA adverse event reports, METAXALONE has a safety score of 78 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 METAXALONE include COMPLETED SUICIDE, DRUG INEFFECTIVE, FATIGUE, PAIN, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METAXALONE.
Metaxalone has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 6,668 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Completed Suicide, Drug Ineffective, Fatigue. Of classified reports, 62.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Metaxalone reports include a high percentage of serious adverse events, particularly related to suicide and death.
The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and respiratory issues. Fatigue, pain, and nausea are among the most frequently reported side effects.
Patients taking Metaxalone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metaxalone can cause drug interactions, and patients should be cautious when using it with other medications. Warnings include potential serotonin syndrome and drug abuse. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metaxalone received a safety concern score of 78/100 (high concern). This is based on a 62.4% serious event ratio across 3,263 classified reports. The score accounts for 6,668 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: Female: 2,233, Male: 811, Unknown: 6. The most frequently reported age groups are age 56 (83 reports), age 60 (72 reports), age 38 (65 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 3,263 classified reports for METAXALONE:
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.
Metaxalone can cause drug interactions, and patients should be cautious when using it with other medications. Warnings include potential serotonin syndrome and drug abuse.
If you are taking Metaxalone, here are important things to know. The most commonly reported side effects include completed suicide, drug ineffective, fatigue, pain, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any pre-existing conditions, especially mental health issues, before starting Metaxalone. Do not stop taking the medication abruptly without consulting your doctor, as this can lead to withdrawal symptoms. 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 Metaxalone due to its high rate of serious adverse events. Healthcare providers should be vigilant in monitoring patients for signs of adverse reactions.
The FDA has received approximately 6,668 adverse event reports associated with Metaxalone. 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 Metaxalone include Completed Suicide, Drug Ineffective, Fatigue, Pain, Nausea. By volume, the top reported reactions are: Completed Suicide (261 reports), Drug Ineffective (202 reports), Fatigue (195 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Metaxalone.
Out of 3,263 classified reports, 2,036 (62.4%) were classified as serious and 1,227 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 Metaxalone break down by patient sex as follows: Female: 2,233, Male: 811, Unknown: 6. 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 Metaxalone adverse events are: age 56: 83 reports, age 60: 72 reports, age 38: 65 reports, age 55: 65 reports, age 58: 64 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 Metaxalone adverse event reports is Actavis Pharma, 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 Metaxalone include: Headache, Toxicity To Various Agents, Fall, Diarrhoea, Dizziness. 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 Metaxalone 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.
Metaxalone has a safety concern score of 78 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. Metaxalone reports include a high percentage of serious adverse events, particularly related to suicide and death.
Key safety signals identified in Metaxalone's adverse event data include: Completed suicide and death are among the most serious adverse events.. Neurological issues such as depression, confusion, and gait disturbance are frequently reported.. Gastrointestinal issues like nausea, diarrhea, and vomiting are common.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metaxalone can cause drug interactions, and patients should be cautious when using it with other medications. Warnings include potential serotonin syndrome and drug abuse. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metaxalone.
Inform your healthcare provider about any pre-existing conditions, especially mental health issues, before starting Metaxalone. Do not stop taking the medication abruptly without consulting your doctor, as this can lead to withdrawal symptoms.
Metaxalone has 6,668 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and respiratory issues. The volume of reports for Metaxalone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Metaxalone due to its high rate of serious adverse events. Healthcare providers should be vigilant in monitoring patients for signs of adverse reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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