Ampyradalfampridine
According to the FDA label: AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14) ]. AMPYRA ® (dalfampridine) is a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ( 1 , 14 ).
71,174 adverse event reports submitted to the FDA (2006–2026)
Top Reported Adverse Events
The most frequently reported events in association with Ampyra in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Gait Disturbance 10,964 reports
Difficulty walking normally, such as an unsteady or altered way of walking.
Full definition in the glossary →Drug Ineffective 8,299 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fall 7,322 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Fatigue 5,511 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Balance Disorder 4,896 reports
Difficulty staying steady, often with a feeling of unsteadiness or near-falling.
Full definition in the glossary →Multiple Sclerosis Relapse 4,766 reports
A return or worsening of multiple sclerosis symptoms. It often appears in reports as part of the condition being treated.
Full definition in the glossary →- Therapy Cessation 4,510 reports
Dizziness 3,986 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Urinary Tract Infection 3,734 reports
An infection in the bladder, urethra, or kidneys, often called a UTI.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 3,482 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Asthenia 3,456 reports
Physical weakness or lack of strength.
Full definition in the glossary →Insomnia 3,305 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Headache 3,259 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Multiple Sclerosis 3,117 reports
A condition where the immune system affects the protective covering of nerves, which can disrupt movement and other functions. It often appears in reports as a condition being treated.
Full definition in the glossary →Mobility Decreased 2,995 reports
A reduced ability to move around.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 49,822 |
| Male | 17,537 |
| Unknown | 359 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 16 |
| 18-34 | 1,195 |
| 35-49 | 7,647 |
| 50-64 | 16,214 |
| 65-74 | 5,574 |
| 75+ | 892 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Ampyra. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 51,101 |
| Other Serious | 11,562 |
| Hospitalization | 10,110 |
| Death | 1,751 |
| Disability | 1,451 |
| Life-Threatening | 267 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Ampyra. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 6 |
| 2010 | 686 |
| 2011 | 837 |
| 2012 | 1,051 |
| 2013 | 1,618 |
| 2014 | 6,349 |
| 2015 | 7,532 |
| 2016 | 12,012 |
| 2017 | 10,164 |
| 2018 | 10,789 |
| 2019 | 7,165 |
| 2020 | 3,152 |
| 2021 | 2,695 |
| 2022 | 2,758 |
| 2023 | 2,245 |
| 2024 | 989 |
| 2025 | 746 |
| 2026 (partial) | 377 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Ampyra
In FDA adverse event reports that mention Ampyra, these medications appeared most often in the same report.
- Baclofen (11,482 reports)
- Dimethyl (11,148 reports)
- Ergocalciferol (10,855 reports)
- Gabapentin (7,477 reports)
- Interferon Beta-1a (5,999 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026