Ampyra
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Ampyra
Ampyra Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ampyra in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these 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 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 may include:
- headache, dizziness;
- sleep problems (insomnia);
- nausea, constipation, upset stomach;
- weakness;
- back pain;
- stuffy nose, sinus pain, sore throat; or
- mild skin itching.
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) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ampyra FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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.
The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label: Seizures, Anaphylaxis, and Urinary Tract Infections.
Controlled Clinical Trials Experience
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 treatment emergent adverse events leading to discontinuation, compared to 2% (5/238) of placebo-treated patients. The treatment emergent adverse events 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 MS patients, and more frequent with AMPYRA compared to
placebo in controlled clinical trials
| Adverse Reaction | Placebo (N=238) |
10 mg twice (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).
Read the entire FDA prescribing information for Ampyra (Dalfampridine Extended-Release Tablets) »
Additional Ampyra Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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