Eletriptan

Mechanism-of-action classes: Cytochrome P450 3A4 Inhibitors; Serotonin 1b Receptor Agonists; Serotonin 1d Receptor Agonists; Serotonin Agonists.

• Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established.ICD-10: G43.909

• Eletriptan hydrobromide tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.1)]. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see WARNINGS AND PRECAUTIONS (5.2)].contraindicated

The maximum recommended single dose is 40 mg. In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg dose than following a 20 mg dose [see CLINICAL STUDIES (14)]. If the migraine has not resolved by 2 hours after taking eletriptan hydrobromide tablets, or returns after transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose should not exceed 80 mg. The safety of treating an average of more than 3 migraine attacks in a 30-day period has not been established.

Eletriptan hydrobromide should only be used where a clear diagnosis of migraine has been established. 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina Eletriptan hydrobromide is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of eletriptan hydrobromide. Some of these reactions occurred in patients without known CAD. Eletriptan hydrobromide may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving eletriptan hydrobromide. Do not use eletriptan hydrobromide if there is evidence of CAD or coronary artery vasospasm [see CONTRAINDICATIONS (4)]. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first eletriptan hydrobromide dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration of eletriptan hydrobromide. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of eletriptan hydrobromide.

The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial ischemia and myocardial infarction, and Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.2)] Arrhythmias [see WARNINGS AND PRECAUTIONS (5.3)] Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS (5.4)] Cerebrovascular events [see WARNINGS AND PRECAUTIONS (5.4)] Other vasospasm reactions [see WARNINGS AND PRECAUTIONS (5.5)] Medication overuse headache [see WARNINGS AND PRECAUTIONS (5.6)] Serotonin syndrome [see WARNINGS AND PRECAUTIONS (5.7)] Increase in blood pressure [see WARNINGS AND PRECAUTIONS (5.8)] Hypersensitivity reactions [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.9)] 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 hydrobromide in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with eletriptan hydrobromide 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.

Pregnancy Risk Summary Available human data on the use of eletriptan hydrobromide in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, oral administration of eletriptan during pregnancy or throughout pregnancy and lactation was associated with developmental toxicity (decreased fetal and pup weights, increased incidences of fetal structural abnormalities, decreased pup viability) at clinically-relevant doses [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

The elimination half-life of eletriptan is about 4 hours [see CLINICAL PHARMACOLOGY (12.3)], therefore monitoring of patients after overdose with eletriptan should continue for at least 20 hours or longer while symptoms or signs persist. There is no specific antidote to eletriptan. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentration of eletriptan.

• Dec 26, 2002NDANDA021016Upjohn
• Jun 16, 2017ANDAANDA206409Zydus Pharms
• Jun 27, 2017ANDAANDA202040Teva Pharms Usa
• Aug 11, 2017ANDAANDA205152Mylan
• Jan 15, 2019ANDAANDA210708Aurobindo Pharma
• Jul 13, 2022ANDAANDA215467Regcon Holdings
• Jul 7, 2025ANDAANDA219143Annora Pharma

1. 1Drug Ineffective91013%
2. 2Migraine85812%
3. 3Headache73211%
4. 4Nausea4957.1%
5. 5Pain4196.0%
6. 6Fatigue3314.8%
7. 7Vomiting3284.7%
8. 8Malaise2884.1%
9. 9Dizziness2673.8%
10. 10Off Label Use2243.2%
11. 11Anxiety2193.1%
12. 12Feeling Abnormal2143.1%
13. 13Dyspnoea2052.9%
14. 14Insomnia2002.9%
15. 15Condition Aggravated1972.8%

The 10 most recently updated of 22 ClinicalTrials.gov registrations naming Eletriptan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• ACT Therapy for HF Migraine
  Completed · Interventional · 64 enrolled · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  NCT03461874updated 2026-02-11
• Phase 1b/2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury
  Recruiting · Phase 1 · Phase 2 · Interventional · 28 enrolled · Technophage, SA
  NCT06677229updated 2025-09-09
• Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
  Completed · Observational · 68,419 enrolled · Mayo Clinic
  NCT05854992updated 2024-12-02
• Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
  Completed · Phase 3 · Interventional · 1,141 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT01986270updated 2021-01-28
• Eletriptan Pharmacokinetics In Korean Males
  Completed · Phase 1 · Interventional · 16 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT01139515updated 2021-01-28
• Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
  Completed · Phase 3 · Interventional · 1,334 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT01978496updated 2021-01-28
• Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
  Completed · Phase 3 · Interventional · 1,008 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT01986088updated 2021-01-28
• Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
  Completed · Phase 3 · Interventional · 446 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT01989936updated 2021-01-27
• Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
  Completed · Phase 3 · Interventional · 971 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT01859481updated 2021-01-27
• Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
  Completed · Phase 4 · Interventional · 120 enrolled · Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  NCT00634985updated 2021-01-27

Frequently asked questions

How does Eletriptan work?

Mechanism-of-action classes: Cytochrome P450 3A4 Inhibitors; Serotonin 1b Receptor Agonists; Serotonin 1d Receptor Agonists; Serotonin Agonists.

What is Eletriptan used for?

According to FDA labeling, Eletriptan carries indications including: Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Eletriptan?

Eletriptan is classified as Selective serotonin (5HT1) agonists, Serotonin-1b and Serotonin-1d Receptor Agonist, Cytochrome P450 3A4 Inhibitors, Serotonin 1b Receptor Agonists, Serotonin 1d Receptor Agonists, Serotonin Agonists, Cerebral Arterial Vasoconstriction, Increased Central Nervous System Serotonin Activity.

What are the brand names for Eletriptan?

Eletriptan is marketed under brand names including Relpax.

What are the contraindications for Eletriptan?

Eletriptan labeling lists contraindications including: Eletriptan hydrobromide tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.1)]. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see WARNINGS AND PRECAUTIONS (5.2)].. Always consult the full prescribing information and a clinician.