Does Relpax (eletriptan) cause side effects?

Relpax (eletriptan) is a "triptan" used to treat migraine headaches

Migraine headaches are believed to be the result of abnormal activity in the brain that leads to dilation of the blood vessels on the surface of the brain as well as the tissues that surround the brain. 

The dilation of the blood vessels is believed to be associated with inflammation. The triptan class of drugs, including Relpax, constricts the blood vessels, thus preventing migraine headache

While it is very effective in relieving migraine, it does not prevent or reduce the number of attacks of migraine. In a large study, it was shown to be more effective than sumatriptan in relieving migraine headache pain within two hours. 

Common side effects of Relpax include

Serious side effects of Relpax include

Drug interactions of Relpax include ergots, like dihydroergotamine and ergotamine tartrate, or methysergide, which can cause constriction of blood vessels. It is possible these effects may add to the effects of Relpax.

Safe use of Relpax in pregnancy has not been established. Safe use of Relpax in nursing mothers has not been established. Consult your doctor before breastfeeding.

What are the side effects of Relpax (eletriptan)?

Common side effects include:

More serious side effects include:

  • heat attacks,
  • abnormal heartbeats,
  • severe blood pressure elevation,
  • stroke,
  • bleeding, and
  • seizures.

Relpax (eletriptan) side effects list for healthcare professionals

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

  • Myocardial ischemia and myocardial infarction, and Prinzmetal's angina
  • Arrhythmias
  • Chest, throat, neck, and/or jaw pain/tightness/pressure
  • Cerebrovascular events
  • Other vasospasm reactions
  • Medication overuse headache
  • Serotonin syndrome
  • Increase in blood pressure
  • Hypersensitivity reactions

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 Relpax in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with Relpax 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 a Relpax 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 Relpax and More Than Placebo

Adverse Reaction TypePlacebo
(n=988)
Relpax 20 mg
(n=431)
Relpax 40 mg
(n=1774)
Relpax 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 Relpax 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.

Postmarketing Experience

The following adverse reaction(s) have been identified during post-approval use of Relpax. 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.

What drugs interact with Relpax (eletriptan)?

Ergot-Containing Drugs Including Other 5-HT1B/1D Agonists

  • Ergot-containing drugs have been reported to cause prolonged vasospastic reactions.
  • Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine [DHE] or methysergide) and Relpax within 24 hours of each other is contraindicated.
  • Concomitant use of other 5-HT1 agonists within 24 hours of Relpax treatment is contraindicated.

CYP3A4 Inhibitors

  • Potent CYP3A4 inhibitors significantly increase the exposure of Relpax. Relpax should not be used within at least 72 hours of treatment with potent CYP3A4 inhibitors.

Selective Serotonin Reuptake Inhibitors/Serotonin And Norepinephrine Reuptake Inhibitors And Serotonin Syndrome

  • Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs and MAO inhibitors.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 12/2/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.