Does Ampyra (dalfampridine) cause side effects?

Ampyra (dalfampridine) is a potassium channel blocker used to treat multiple sclerosis (MS). Its exact mechanism of action is unknown, but it is known to block movement of potassium between nerve cells. In animal studies Ampyra increased the conduction of nerve signals.

Common side effects of Ampyra include

Serious side effects of Ampyra include

Symptoms of anaphylaxis include

Drug interactions have not been identified for Ampyra. 

There are no adequate studies of Ampyra in pregnant women. It is unknown if Ampyra is excreted in breast milk. Consult your doctor before breastfeeding.

What are the important side effects of Ampyra (dalfampridine)?

The most common side effect of Ampyra is urinary tract infections.

Other common side effects include:

Serious side effects of Ampyra include:

People with a history of seizures should not use Ampyra.

Signs and symptoms of anaphylaxis include

Ampyra (dalfampridine) side effects list for healthcare professionals

The following serious adverse reactions are described in more detail elsewhere in the labeling:

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In three placebo-controlled clinical trials of up to 14 weeks duration, 4% (15/400) of patients treated with Ampyra 10 mg twice daily experienced one or more adverse reactions leading to discontinuation, compared to 2% (5/238) of placebo-treated patients.

The adverse reactions leading to discontinuation of at least 2 patients treated with Ampyra and that led to discontinuation more frequently compared to placebo were

  • headache (Ampyra 0.5%, placebo 0%),
  • balance disorder (Ampyra 0.5%, placebo 0%),
  • dizziness (Ampyra 0.5%, placebo 0%), and
  • confusional state (Ampyra 0.3%, placebo 0%).

Table 1 lists adverse reactions that occurred in ≥2% of patients treated with Ampyra 10 mg twice daily, and more frequently than in placebo-treated patients, in controlled clinical trials.

Table 1: Adverse Reactions with an Incidence ≥2% of Ampyra-Treated Adult MS Patients and More Frequent with Ampyra Compared to Placebo in Controlled Clinical Trials

Adverse ReactionPlacebo
(N=238) %
Ampyra 10 mg twice daily
(N=400) %
Urinary tract infection812
Insomnia49
Dizziness47
Headache47
Nausea37
Asthenia47
Back pain25
Balance disorder15
Multiple sclerosis relapse34
Paresthesia34
Nasopharyngitis24
Constipation23
Dyspepsia12
Pharyngolaryngeal pain12

Other Adverse Reactions
  • Ampyra has been evaluated in a total of 1,952 subjects, including 917 MS patients.
  • A total of 741 patients have been treated with Ampyra for over six months, 501 for over one year and 352 for over two years.
  • The experience in open-label clinical trials is consistent with the safety profile observed in the placebo-controlled clinical trials.
  • As in controlled clinical trials, a dose-dependent increase in the incidence of seizures has been observed in open-label clinical trials with Ampyra in patients with MS as follows:
    • Ampyra 10 mg twice daily 0.41 per 100 person-years (95% confidence interval 0.13-0.96);
    • dalfampridine 15 mg twice daily 1.7 per 100 person-years (95% confidence interval 0.21-6.28).

Postmarketing Experience

The following adverse event has been identified during post-marketing experience with dalfampridine. Because adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: vomiting.

What drugs interact with Ampyra (dalfampridine)?

OCT2 Inhibitors

  • Concurrent treatment with OCT2 inhibitors, such as cimetidine, may cause increased exposure to dalfampridine.
  • Elevated levels of dalfampridine increase the risk of seizures.
  • The potential benefits of taking OCT2 inhibitors concurrently with Ampyra should be considered against the risk of seizures in these patients.

Baclofen

  • No interaction was identified between dalfampridine and baclofen.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 12/23/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.