72/100 · Elevated
Manufactured by Merz Pharmaceuticals, LLC
Dalafprimidine Adverse Events: Gait Disturbances and Falls Predominate
157,067 FDA adverse event reports analyzed
Last updated: 2026-05-12
DALFAMPRIDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Merz Pharmaceuticals, LLC. Based on analysis of 157,067 FDA adverse event reports, DALFAMPRIDINE 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 DALFAMPRIDINE include GAIT DISTURBANCE, DRUG INEFFECTIVE, FALL, FATIGUE, BALANCE DISORDER. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DALFAMPRIDINE.
Dalfampridine 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 157,067 adverse event reports for this medication, which is primarily manufactured by Merz Pharmaceuticals, Llc.
The most commonly reported adverse events include Gait Disturbance, Drug Ineffective, Fall. Of classified reports, 28.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Gait disturbances and falls are the most common adverse events, indicating potential mobility issues.
Fatigue and balance disorders are also frequent, suggesting overall physical and cognitive impacts. Serious adverse events, including death and infections, are reported but less frequently. Drug ineffectiveness and therapy cessation are significant, highlighting patient dissatisfaction. Insomnia and headaches are common, affecting quality of life.
Patients taking Dalfampridine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dalafprimidine may interact with other drugs affecting central nervous system function, and patients should avoid alcohol and other sedatives. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dalfampridine received a safety concern score of 72/100 (elevated concern). This is based on a 28.1% serious event ratio across 70,781 classified reports. The score accounts for 157,067 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: 49,561, Male: 17,456, Unknown: 359. The most frequently reported age groups are age 55 (1,263 reports), age 58 (1,213 reports), age 60 (1,183 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 70,781 classified reports for DALFAMPRIDINE:
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.
Dalafprimidine may interact with other drugs affecting central nervous system function, and patients should avoid alcohol and other sedatives.
If you are taking Dalfampridine, here are important things to know. The most commonly reported side effects include gait disturbance, drug ineffective, fall, fatigue, balance disorder. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any gait disturbances or falls immediately to their healthcare provider. Monitor for signs of fatigue and balance issues, and adjust dosing as needed. 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.
Regulatory oversight is ongoing, with Dalafprimidine requiring close monitoring for safety and efficacy, especially in elderly patients.
The FDA has received approximately 157,067 adverse event reports associated with Dalfampridine. 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 Dalfampridine include Gait Disturbance, Drug Ineffective, Fall, Fatigue, Balance Disorder. By volume, the top reported reactions are: Gait Disturbance (10,928 reports), Drug Ineffective (8,253 reports), Fall (7,293 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dalfampridine.
Out of 70,781 classified reports, 19,869 (28.1%) were classified as serious and 50,912 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 Dalfampridine break down by patient sex as follows: Female: 49,561, Male: 17,456, Unknown: 359. 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 Dalfampridine adverse events are: age 55: 1,263 reports, age 58: 1,213 reports, age 60: 1,183 reports, age 56: 1,159 reports, age 57: 1,123 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 Dalfampridine adverse event reports is Merz Pharmaceuticals, 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 Dalfampridine include: Multiple Sclerosis Relapse, Therapy Cessation, Dizziness, Urinary Tract Infection, Condition Aggravated. 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 Dalfampridine 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.
Dalfampridine 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. Gait disturbances and falls are the most common adverse events, indicating potential mobility issues.
Key safety signals identified in Dalfampridine's adverse event data include: Frequent gait disturbances and falls. High incidence of fatigue and balance disorders. Serious events like death and infections. Drug ineffectiveness and patient discontinuation. Common sleep disturbances and headaches. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dalafprimidine may interact with other drugs affecting central nervous system function, and patients should avoid alcohol and other sedatives. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dalfampridine.
Patients should report any gait disturbances or falls immediately to their healthcare provider. Monitor for signs of fatigue and balance issues, and adjust dosing as needed.
Dalfampridine has 157,067 adverse event reports on file with the FDA. Fatigue and balance disorders are also frequent, suggesting overall physical and cognitive impacts. The volume of reports for Dalfampridine reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with Dalafprimidine requiring close monitoring for safety and efficacy, especially in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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