MigraineActive ingredient
Ubrogepant
CGRP receptor antagonist (gepant)1 FDA label read
Ubrogepant is sold as Ubrelvy and is the acute-only gepant: a tablet taken when an attack starts. Its label states the boundary itself - Ubrelvy is not indicated for the preventive treatment of migraine.
Highlights of the labels
- Ubrelvy
- Acute treatment of migrainecovers migraine
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| UbrelvyAllergan, Inc. | What its label approvesAcute treatment of migraineCovers migraine | SupplyPrescription | Label version5 June 2025 |
How it works
Ubrogepant blocks the CGRP receptor, the same target as the other gepants. It is a conventional tablet taken as needed at the start of an attack, with the option of a second dose after at least two hours.
Mechanism of action, Ubrelvy label
Ubrogepant is a calcitonin gene-related peptide receptor antagonist.
What the FDA approved it for
The approved uses, as worded in the label.
- Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine.
- UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.
Forms and strengths
The presentations and strengths listed in the label.
- UBRELVY 100 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with "U100" on one side.
- Tablets: 50 mg and 100 mg
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- The recommended dose is 50 mg or 100 mg taken orally, as needed.
- If needed, a second dose may be administered at least 2 hours after the initial dose.
- The maximum dose in a 24-hour period is 200 mg.
- Severe Hepatic or Severe Renal Impairment: Recommended dose is 50 mg; if needed, a second 50 mg dose may be taken at least 2 hours after the initial dose.
Most common adverse reactions
The adverse reactions the label reports as most common.
- most common adverse reactions (at least 2% and greater than placebo) were nausea and somnolence.
- most common adverse reaction resulting in discontinuation in the long-term safety study was nausea.
Warnings and precautions
The warnings and precautions section of the label.
- Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue UBRELVY and initiate appropriate therapy.
- Severe hypersensitivity reactions have included anaphylaxis and dyspnea.
- These reactions can occur within minutes, hours, or days after administration.
- Hypertension: New-onset or worsening of pre-existing hypertension may occur.
- Raynaud's phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur.
- 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported with use of UBRELVY.
- Hypersensitivity reactions can occur minutes, hours, or days after administration.
- Most reactions occurred within hours after dosing and were not serious, and some reactions led to discontinuation.
Contraindications
Situations in which the label states the medication must not be used.
- UBRELVY is contraindicated: With concomitant use of strong CYP3A4 inhibitors In patients with a history of serious hypersensitivity to ubrogepant or any component of UBRELVY.
- Reactions have included anaphylaxis, dyspnea, and facial or throat edema Concomitant use with strong CYP3A4 inhibitors.
- History of serious hypersensitivity to ubrogepant or any component of UBRELVY.
Drug interactions
Interactions the label singles out.
- Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure.
- For additional dose modifications for moderate or weak CYP3A4 inhibitors and inducers or BCRP and/or P-gp only inhibitors, refer to section 2.2.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while taking UBRELVY. Patients should be encouraged to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women.
Generic or brand
There is no FDA-approved generic ubrogepant: the register lists the brand application only.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Ubrelvy is brand-only, priced per tablet at brand level. What a person pays depends on insurance coverage. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per tablet, capsule or pen | Brand$109.17 (range $103.88 to $109.19, 170 listings) |
Median of 170 listings. Effective dates 2025-12-17 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Can Ubrelvy be taken daily to prevent migraines?
- The label answers directly: Ubrelvy is not indicated for the preventive treatment of migraine. Its dosing is as-needed - 50 mg or 100 mg at the start of an attack, an optional second dose at least 2 hours later, and a maximum of 200 mg in 24 hours.
- What is the difference between Ubrelvy and Nurtec?
- Both are gepant tablets for the acute treatment of migraine, but Nurtec additionally holds a preventive indication and Ubrelvy does not. Their dosing also differs: Ubrelvy allows a second dose in a day, Nurtec's acute dosing is a single 75 mg tablet as needed. The comparison page sets the two labels side by side.
- Does Ubrelvy carry cardiovascular contraindications like triptans?
- No. Its contraindications concern hypersensitivity and concomitant use with strong CYP3A4 inhibitors - a drug-interaction restriction, not a cardiovascular list.
Other medications under migraine
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Ubrelvy
Allergan, Inc.. Label version 27, effective 5 June 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.