Dalfampridine Side Effects

Some side effects of dalfampridine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dalfampridine: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking dalfampridine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking dalfampridine and call your doctor at once if you have a serious side effect such as:

• seizure (convulsions);

• pain or burning when you urinate;

• problems with balance;

• numbness, burning pain, or tingly feeling;

• relapse or worsening of MS symptoms;

Less serious side effects of dalfampridine may include:

• headache, dizziness;

• sleep problems (insomnia);

• nausea, constipation, upset stomach;

• weakness;

• stuffy nose, sinus pain, sore throat; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to dalfampridine: oral tablet extended release

Renal

Renal side effects including urinary tract infection (12%) have been reported.

General

General side effects including insomnia (9%) and asthenia (7%) have been reported.

Nervous system

Nervous system side effects including dizziness (7%), headache (7%), balance disorder (5%), multiple sclerosis relapse (4%), and paresthesia (4%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (7%), constipation (3%), dyspepsia (2%), and pharyngolaryngeal pain (2%) have been reported.

Musculoskeletal

Musculoskeletal side effects including back pain (5%) have been reported.

Respiratory

Respiratory side effects including nasopharyngitis (4%) have been reported.

Genitourinary

Genitourinary side effects have been have reported in animal studies which noted a significant increase in uterine polyps at the highest dose tested.

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