AMPYRA SIDE EFFECTS
- Generic Name: dalfampridine extended-release tablets
- Brand Name: Ampyra
SIDE EFFECTS
The following serious adverse reactions are described in more detail elsewhere in the labeling:
- Seizures.
- Anaphylaxis.
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.
SRC: NLM .