Amerge (Naratriptan Hydrochloride) - Side Effects and Adverse Reactions

Clinical Trials Experience

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

In a long-term open-label trial where patients were allowed to treat multiple migraine attacks for up to 1 year, 15 patients (3.6%) discontinued treatment due to adverse reactions.

In controlled clinical trials, the most common adverse reactions were paresthesias, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms, which occurred at a rate of 2% and at least 2 times placebo rate.

Table 1 lists the adverse reactions that occurred in 5 placebo-controlled clinical trials of approximately 1,752 exposures to placebo and AMERGE in adult patients with migraine. Only reactions that occurred at a frequency of 2% or more in groups treated with AMERGE 2.5 mg and that occurred at a frequency greater than the placebo group in the 5 pooled trials are included in Table 1.

Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated With AMERGE and at a Frequency Greater Than Placebo

Adverse Reaction	Percent of Patients Reporting
	AMERGE 1 mg (n = 627)	AMERGE 2.5 mg (n = 627)	Placebo (n = 498)
Atypical sensation	2	4	1
Paresthesias (all types)	1	2	<1
Gastrointestinal	6	7	5
Nausea	4	5	4
Neurological	4	7	3
Dizziness	1	2	1
Drowsiness	1	2	<1
Malaise/fatigue	2	2	1
Pain and pressure sensation	2	4	2
Throat/neck symptoms	1	2	1

The incidence of adverse reactions in controlled clinical trials was not affected by age or weight of the patients, duration of headache prior to treatment, presence of aura, use of prophylactic medications, or tobacco use. There were insufficient data to assess the impact of race on the incidence of adverse reactions.