What the label lists and what reports show
Eletriptan side effects
Eletriptan's FDA label: “Most common adverse reactions (≥ 5% and > placebo) were asthenia, nausea, dizziness, and somnolence.” FAERS holds 6,996 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (499 reports).
- Generic listed
Check it at the source: the eletriptan FDA label on DailyMed (effective November 27, 2024, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of eletriptan hydrobromide tablets?Eletriptan hydrobromide tablets may cause serious side effects. See “What is the most important information I should know about eletriptan hydrobromide tablets?” These serious side effects include: changes in color or sensation in your fingers and toes (Raynaud’s syndrome) stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain stomach pain after meals weight loss nausea or vomiting constipation or diarrhea bloody diarrhea fever problems with blood circulation to your legs and feet (peripheral vascular ischemia). […]
Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective November 27, 2024 (SPL set 62dc12ce-4f19-41c6-9593-3cae29f04af1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 5% and > placebo) were asthenia, nausea, dizziness, and somnolence.
Table 1: Adverse Reactions Incidence in Placebo-Controlled Migraine Clinical Trials: Reactions Reported by ≥2% Patients Treated with Eletriptan Hydrobromide and More Than Placebo
| Reaction | Adverse Reaction Type Placebo (n=988) | Eletriptan Hydrobromide 20 mg (n=431) | Eletriptan Hydrobromide 40 mg (n=1774) | Eletriptan Hydrobromide 80 mg (n=1932) |
|---|---|---|---|---|
| Paresthesia | 2% | 3% | 3% | 4% |
| Flushing/feeling of warmth | 2% | 2% | 2% | 2% |
| Chest – tightness/pain/pressure | 1% | 1% | 2% | 4% |
| Abdominal – | 1% | 1% | 2% | 2% |
| Dry mouth | 2% | 2% | 3% | 4% |
| Dyspepsia | 1% | 1% | 2% | 2% |
| Dysphagia – throat tightness/difficulty | 0.2% | 1% | 2% | 2% |
| Nausea | 5% | 4% | 5% | 8% |
| Dizziness | 3% | 3% | 6% | 7% |
| Somnolence | 4% | 3% | 6% | 7% |
| Headache | 3% | 4% | 3% | 4% |
| Asthenia | 3% | 4% | 5% | 10% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 )] Most common adverse reactions (≥ 5% and > placebo) were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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.
Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective November 27, 2024 (SPL set 62dc12ce-4f19-41c6-9593-3cae29f04af1), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,996 reports list eletriptan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 97 are coded as a death and 1,223 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Eletriptan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions