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ELETRIPTAN Hydrobromide Tablets (GREENSTONE LLC) Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in other sections of the prescribing information:

6.1 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.

Among 4,597 patients who treated the first migraine headache with eletriptan in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with eletriptan were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related.

In long-term open-label studies where patients were allowed to treat multiple migraine attacks for up to 1 year, 128 (8.3%) out of 1,544 patients discontinued treatment due to adverse reactions.

Table 1 lists adverse reactions that occurred in the subset of 5,125 migraineurs who received eletriptan doses of 20 mg, 40 mg and 80 mg or placebo in worldwide placebo-controlled clinical trials.

Only adverse reactions that were more frequent in an eletriptan treatment group compared to the placebo group with an incidence greater than or equal to 2% are included in Table 1.

Table 1: Adverse Reactions Incidence in Placebo-Controlled Migraine Clinical Trials: Reactions Reported by ≥ 2% Patients Treated with Eletriptan and More Than Placebo
Adverse Reaction TypePlacebo
(n=988)
Eletriptan
20 mg
(n=431)
Eletriptan
40 mg
(n=1774)
Eletriptan
80 mg
(n=1932)
ATYPICAL SENSATIONS
Paresthesia2%3%3%4%
Flushing/feeling of warmth2%2%2%2%
PAIN AND PRESSURE SENSATIONS
Chest – tightness/pain/pressure1%1%2%4%
Abdominal – pain/discomfort/stomach pain/ cramps/pressure1%1%2%2%
DIGESTIVE
Dry mouth2%2%3%4%
Dyspepsia1%1%2%2%
Dysphagia – throat tightness/difficulty swallowing0.2%1%2%2%
Nausea5%4%5%8%
NEUROLOGICAL
Dizziness3%3%6%7%
Somnolence4%3%6%7%
Headache3%4%3%4%
OTHER
Asthenia3%4%5%10%

The frequency of adverse reactions in clinical trials did not increase when up to 2 doses of eletriptan were taken within 24 hours. The incidence of adverse reactions in controlled clinical trials was not affected by gender, age, or race of the patients. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (e.g., SSRIs, beta blockers, calcium channel blockers, tricyclic antidepressants), estrogen replacement therapy or oral contraceptives.

6.2 Postmarketing Experience

The following adverse reaction(s) have been identified during post approval use of eletriptan. Because these reactions 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.

Neurological: seizure

Digestive: vomiting

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