What the label lists and what reports show
Eptinezumab side effects
Eptinezumab's FDA label: “The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” FAERS holds 9,047 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 headache (953 reports).
- No generic listed
Check it at the source: the eptinezumab FDA label on DailyMed (effective June 5, 2026); 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 VYEPTI?VYEPTI may cause serious side effects, including: Allergic reactions. Allergic reactions can happen after receiving VYEPTI. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: o rash o swelling of your face, lips, tongue or throat o trouble breathing o hives o redness in your face Constipation with serious complications. Severe constipation can happen after receiving VYEPTI. In some cases, people have been hospitalized. Contact your healthcare provider if you have severe constipation or constipation is associated with symptoms such as severe or constant belly pain, vomiting, swelling of belly, or bloating. High blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving VYEPTI. Contact your healthcare provider if you have an increase in blood pressure. […]
Source: FDA drug label, Lundbeck Pharmaceuticals LLC, effective June 5, 2026 (SPL set 79065861-6aa5-4d1f-829f-3a6471286b36), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]. Constipation with Serious Complications [see Warnings and Precautions (5.2)] Hypertension [see Warnings and Precautions (5.3) ] Raynaud’s Phenomenon [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 clinical practice. The safety of VYEPTI was evaluated in 2076 patients with migraine who received at least one dose of VYEPTI, representing 1615 patient-years of exposure; of these, 1524 patients were exposed to 100 mg or 300 mg. Across all doses, 1872 patients were exposed for at least 6 months and 991 patients were exposed for 12 months. …
Source: FDA drug label, Lundbeck Pharmaceuticals LLC, effective June 5, 2026 (SPL set 79065861-6aa5-4d1f-829f-3a6471286b36), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,047 reports list eptinezumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 686 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. Reports rose sharply in 2024 (2,246, against a median of 156 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 6 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?
- Eptinezumab: 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