Ampyra
- Generic Name: dalfampridine extended-release tablets
- Brand Name: Ampyra
Ampyra (Dalfampridine Extended-Release Tablets) side effects drug center
Ampyra Side Effects Center
What Is Ampyra?
Ampyra (dalfampridine) Extended-Release is a potassium channel blocker used to improve walking in patients with multiple sclerosis (MS).
What Are Side Effects of Ampyra?
Common side effects of Ampyra include:
- headache,
- dizziness,
- sleep problems (insomnia),
- nausea,
- constipation,
- upset stomach,
- weakness,
- back pain,
- runny or stuffy nose,
- sinus pain,
- sore throat,
- skin itching,
- urinary tract infection,
- problems with balance, or
- numbness or tingling feeling.
Tell your doctor if you have serious side effects of Ampyra including:
- seizures (convulsions);
- pain or burning when you urinate;
- problems with balance;
- numbness, burning pain, or tingly feeling; or
- relapse or worsening of MS symptoms.
Dosage for Ampyra
The maximum recommended dose of Ampyra is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. Doses should be taken approximately 12 hours apart.
What Drugs, Substances, or Supplements Interact with Ampyra?
Ampyra may interact with other drugs. Tell your doctor all medications and supplements you use.
Ampyra During Pregnancy and Breastfeeding
During pregnancy, Ampyra should be used only if prescribed. It is unknown if Ampyra passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Ampyra (dalfampridine) Extended-Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Ampyra Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop taking dalfampridine and call your doctor at once if you have:
- a seizure (convulsions);
- pain or burning when you urinate;
- numbness, burning pain, or tingly feeling;
- problems with balance; or
- relapse or worsening of MS symptoms.
Common side effects may include:
- headache, dizziness;
- weakness, drowsiness;
- sleep problems (insomnia);
- nausea, constipation, upset stomach;
- 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ampyra (Dalfampridine Extended-Release Tablets)
Ampyra Professional Information
SIDE EFFECTS
The following serious adverse reactions are described in more detail elsewhere in the labeling:
- Seizures [see WARNINGS AND PRECAUTIONS]
- Anaphylaxis [see WARNINGS AND PRECAUTIONS]
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 Reaction | Placebo (N=238) % | AMPYRA 10 mg twice daily (N=400) % |
| Urinary tract infection | 8 | 12 |
| Insomnia | 4 | 9 |
| Dizziness | 4 | 7 |
| Headache | 4 | 7 |
| Nausea | 3 | 7 |
| Asthenia | 4 | 7 |
| Back pain | 2 | 5 |
| Balance disorder | 1 | 5 |
| Multiple sclerosis relapse | 3 | 4 |
| Paresthesia | 3 | 4 |
| Nasopharyngitis | 2 | 4 |
| Constipation | 2 | 3 |
| Dyspepsia | 1 | 2 |
| Pharyngolaryngeal pain | 1 | 2 |
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.
Read the entire FDA prescribing information for Ampyra (Dalfampridine Extended-Release Tablets)
© Ampyra Patient Information is supplied by Cerner Multum, Inc. and Ampyra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.