82/100 · Critical
Manufactured by MAIA Pharmaceuticals, Inc.
Baclofen Adverse Events: High Seriousness and Diverse Reactions
183,365 FDA adverse event reports analyzed
Last updated: 2026-05-12
BACLOFEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by MAIA Pharmaceuticals, Inc.. Based on analysis of 183,365 FDA adverse event reports, BACLOFEN has a safety score of 82 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 BACLOFEN include FATIGUE, PAIN, DRUG INEFFECTIVE, FALL, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BACLOFEN.
Baclofen has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 183,365 adverse event reports for this medication, which is primarily manufactured by Maia Pharmaceuticals, Inc..
The most commonly reported adverse events include Fatigue, Pain, Drug Ineffective. Of classified reports, 66.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Baclofen reports show a high percentage of serious adverse events, particularly falls and respiratory issues.
The drug is associated with a wide range of reactions, indicating potential for diverse side effects. Falls and gait disturbances are common, suggesting caution in elderly patients.
Patients taking Baclofen should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Baclofen can cause falls and gait disturbances, and caution is advised in elderly patients. Drug interactions, including with other muscle relaxants and sedatives, are also a concern. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Baclofen received a safety concern score of 82/100 (high concern). This is based on a 66.5% serious event ratio across 83,455 classified reports. The score accounts for 183,365 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: 51,667, Male: 26,071, Unknown: 173. The most frequently reported age groups are age 57 (1,559 reports), age 58 (1,535 reports), age 59 (1,491 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 83,455 classified reports for BACLOFEN:
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.
Baclofen can cause falls and gait disturbances, and caution is advised in elderly patients. Drug interactions, including with other muscle relaxants and sedatives, are also a concern.
If you are taking Baclofen, here are important things to know. The most commonly reported side effects include fatigue, pain, drug ineffective, fall, nausea. 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 respiratory issues, especially in elderly patients. Be cautious with dose adjustments and monitor for falls and gait disturbances. 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 Baclofen for safety, and healthcare providers should be vigilant about potential serious adverse events, especially in elderly patients.
The FDA has received approximately 183,365 adverse event reports associated with Baclofen. 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 Baclofen include Fatigue, Pain, Drug Ineffective, Fall, Nausea. By volume, the top reported reactions are: Fatigue (6,148 reports), Pain (5,654 reports), Drug Ineffective (5,452 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Baclofen.
Out of 83,455 classified reports, 55,494 (66.5%) were classified as serious and 27,961 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 Baclofen break down by patient sex as follows: Female: 51,667, Male: 26,071, Unknown: 173. 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 Baclofen adverse events are: age 57: 1,559 reports, age 58: 1,535 reports, age 59: 1,491 reports, age 54: 1,461 reports, age 53: 1,454 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 Baclofen adverse event reports is Maia Pharmaceuticals, 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 Baclofen include: Headache, Gait Disturbance, Off Label Use, Dizziness, Urinary Tract Infection. 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 Baclofen 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.
Baclofen has a safety concern score of 82 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. Baclofen reports show a high percentage of serious adverse events, particularly falls and respiratory issues.
Key safety signals identified in Baclofen's adverse event data include: High percentage of serious adverse events (66.5%). Common reactions include falls, gait disturbances, and respiratory issues. Multiple sclerosis relapse and exacerbation are reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Baclofen can cause falls and gait disturbances, and caution is advised in elderly patients. Drug interactions, including with other muscle relaxants and sedatives, are also a concern. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Baclofen.
Monitor patients for signs of respiratory issues, especially in elderly patients. Be cautious with dose adjustments and monitor for falls and gait disturbances.
Baclofen has 183,365 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Baclofen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Baclofen for safety, and healthcare providers should be vigilant about potential serious adverse events, especially in elderly patients. 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 BACLOFEN:
Drugs related to BACLOFEN based on therapeutic use, drug class, or shared indications: