Brand Name

Ubrelvy

Generic Name
Ubrogepant
View Brand Information
FDA approval date: December 23, 2019
Classification: Calcitonin Gene-related Peptide Receptor Antagonist
Form: Tablet

What is Ubrelvy (Ubrogepant)?

For millions of people living with migraines, an attack can feel like losing control of the day, intense head pain, light sensitivity, and nausea that stop everything in its tracks. For those who can’t take or don’t respond well to traditional migraine medications like triptans, newer therapies offer hope. Ubrelvy (generic name: ubrogepant) is one such treatment designed to stop migraine attacks once they start, helping patients regain comfort and functionality faster.

Ubrelvy belongs to a newer class of medications known as CGRP receptor antagonists. It’s the first oral medication in this group approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine, with or without aura, in adults. Unlike preventive migraine drugs, Ubrelvy is used on demand, when a migraine begins, offering a modern, targeted way to manage symptoms and reduce the disabling impact of attacks.

What does Ubrelvy do?

Ubrelvy is prescribed to treat migraine attacks after they start, not to prevent future ones. It works by relieving the pain and associated symptoms such as nausea, sensitivity to light (photophobia), and sound (phonophobia).

In clinical trials, many patients reported meaningful pain relief within two hours of taking Ubrelvy, with some experiencing sustained relief for up to 24 hours (FDA, 2019). Unlike triptans, which constrict blood vessels, Ubrelvy works through a different biological pathway, making it an alternative for patients who cannot use triptans due to cardiovascular conditions.

By quickly blocking migraine signals in the brain, Ubrelvy allows patients to resume normal activities sooner, which can significantly improve quality of life. It is often considered a first-line oral option for patients seeking effective, well-tolerated, and non-vasoconstrictive migraine relief.

How does Ubrelvy work?

Migraines are believed to result from the overactivation of pain pathways in the brain involving a molecule called calcitonin gene-related peptide (CGRP). During an attack, CGRP levels rise, causing inflammation and widening of blood vessels, which contribute to throbbing pain and sensitivity.

Ubrelvy targets this mechanism directly by blocking CGRP receptors. When these receptors are blocked, CGRP cannot attach to them, effectively interrupting the migraine process and reducing pain transmission.

Clinically, this mechanism is important because it stops migraine progression without causing blood vessel constriction, making it safer for patients with a history of heart disease, stroke, or uncontrolled hypertension, conditions where triptans are often contraindicated.

In short, Ubrelvy doesn’t just mask the pain; it works at the molecular level to halt the biological process driving the migraine itself.

Ubrelvy side effects

Ubrelvy is generally well tolerated, but as with any medication, side effects can occur. Most are mild and temporary.

Common side effects include:

  • Nausea
  • Sleepiness or fatigue
  • Dry mouth

Less common side effects:

  • Dizziness
  • Mild changes in taste
  • Abdominal discomfort

Serious but rare side effects:

  • Severe allergic reactions (rash, itching, or swelling of the face or throat)
  • Shortness of breath or chest tightness
  • Liver-related issues in people taking other medications that affect liver enzymes

Patients should seek immediate medical attention if they experience symptoms of an allergic reaction or jaundice (yellowing of skin or eyes).

Those with severe liver or kidney disease should discuss alternative options with their doctor, as Ubrelvy’s clearance depends partly on these organs. Patients taking medications that strongly affect liver enzymes (CYP3A4 inhibitors or inducers) may also require dose adjustments or should avoid concurrent use (Mayo Clinic, 2024).

Overall, clinical data show that most side effects are mild and self-limiting, and the drug is considered safe for repeated use as directed by a physician.

Ubrelvy dosage

Ubrelvy comes as an oral tablet taken as soon as migraine symptoms begin. It can be taken with or without food, and patients may take a second dose after a few hours if symptoms persist, following their doctor’s specific instructions.

While no routine blood testing is typically required, monitoring may be advised for patients with:

  • Liver disease, to assess how well the body processes the drug
  • Kidney impairment, to ensure proper clearance
  • Polypharmacy (multiple medications), especially if other drugs affect CYP3A4 metabolism

Doctors often remind patients not to exceed the recommended dosing frequency to prevent potential overuse headaches or increased side effects.

For older adults, no specific dosage changes are usually needed, but careful monitoring ensures that drug interactions or organ function issues are identified early.

Does Ubrelvy have a generic version?

As of 2025, no FDA-approved generic version of Ubrelvy is available. The medication is currently manufactured and distributed by AbbVie Inc., which markets it under the brand name Ubrelvy.

Because it’s a relatively new therapy (approved in 2019), patent protections are still active, and a generic form is not expected for several years.

Patients concerned about affordability can explore manufacturer savings programs or insurance coverage options, as AbbVie offers copay assistance for eligible individuals. When a generic version becomes available, it will be required to meet FDA standards ensuring it is bioequivalent, equally effective, and safe as the brand-name drug.

Conclusion

Ubrelvy represents a major step forward in migraine care, offering targeted, effective relief without the vascular risks associated with older migraine drugs. For patients who experience frequent or severe attacks, this medication can mean faster recovery, less disruption to daily life, and renewed confidence in managing their condition.

Though not every patient responds the same way, consistent communication with a healthcare provider helps ensure the best treatment outcomes. Doctors can tailor Ubrelvy use based on attack frequency, other medications, and overall health profile.

When prescribed and monitored by a qualified healthcare professional, Ubrelvy is a safe and effective way to stop migraines in their tracks, helping patients reclaim comfort, clarity, and control when they need it most.

References

  1. U.S. Food and Drug Administration (FDA). Ubrelvy (ubrogepant) Prescribing Information. 2019. https://www.fda.gov/
  2. Mayo Clinic. “Ubrogepant (Oral Route).” Updated 2024. https://www.mayoclinic.org/
  3. National Institutes of Health (NIH). MedlinePlus: Ubrogepant Oral Tablets. Accessed 2024. https://www.nih.gov/

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Brand Information

UBRELVY (ubrogepant)
1INDICATIONS AND USAGE
UBRELVY is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
UBRELVY is not indicated for the preventive treatment of migraine.
2DOSAGE FORMS AND STRENGTHS
UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side.
UBRELVY 100 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U100” on one side.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
  • Hypersensitivity Reactions 
  • Hypertension
  • Raynaud’s Phenomenon
4.1Clinical 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 practice.
The safety of UBRELVY was evaluated in 3,624 subjects who received at least one dose of UBRELVY. In two randomized, double-blind, placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 1,439 patients received UBRELVY 50 mg or 100 mg
Long-term safety was assessed in 813 patients, dosing intermittently for up to 1 year in an open-label extension study. Patients were permitted to treat up to 8 migraines per month with UBRELVY. Of these 813 patients, 421 patients were exposed to 50 mg or 100 mg for at least 6 months, and 364 patients were exposed to these doses for at least one year, all of whom treated at least two migraine attacks per month, on average. In that study, 2.5% of patients were withdrawn from UBRELVY because of an adverse reaction. The most common adverse reaction resulting in discontinuation in the long-term safety study was nausea. 
Adverse reactions in Studies 1 and 2 are shown in Table 2.
 *Somnolence includes the adverse reaction-related terms sedation and fatigue.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of UBRELVY. 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.
Immune System Disorders: Hypersensitivity (e.g., anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus) [see Contraindications(4) and Warnings and Precautions(5.1)]
Vascular Disorders: Hypertension [see Warnings and Precautions (5.2)], Raynaud’s phenomenon [see Warnings and Precautions (5.3)]
5OVERDOSAGE
The elimination half-life of ubrogepant is approximately 5 to 7 hours; therefore, monitoring of patients after overdose with UBRELVY should continue for at least 24 hours, or while symptoms or signs persist.
6DESCRIPTION
The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'
The following structural formula for UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide.
The molecular formula is C
UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.
7CLINICAL STUDIES
The efficacy of UBRELVY for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials [Study 1 (NCT02828020) and Study 2 (NCT02867709)].  Study 1 randomized patients to placebo (n=559) or UBRELVY 50 mg (n=556) or 100 mg (n=557) and Study 2 randomized patients to placebo (n=563) or UBRELVY 50 mg (n=562).  In all studies, patients were instructed to treat a migraine with moderate to severe headache pain intensity. A second dose of study medication (UBRELVY or placebo), or the patient’s usual acute treatment for migraine, was allowed between 2 to 48 hours after the initial treatment for a non-responding or recurrent migraine headache. Up to 23% of patients were taking preventive medications for migraine at baseline. None of these patients were on concomitant preventive medication that act on the CGRP pathway.
The primary efficacy analyses were conducted in patients who treated a migraine with moderate to severe pain. The efficacy of UBRELVY was established by an effect on pain freedom at 2 hours post-dose and most bothersome symptom (MBS) freedom at 2 hours post-dose, compared to placebo, for Studies 1 and 2. Pain freedom was defined as a reduction of moderate or severe headache pain to no pain, and MBS freedom was defined as the absence of the self-identified MBS (i.e., photophobia, phonophobia, or nausea). Among patients who selected an MBS, the most commonly selected was photophobia (56%), followed by phonophobia (24%), and nausea (19%).
In both studies, the percentage of patients achieving headache pain freedom and MBS freedom 2 hours post-dose was significantly greater among patients receiving UBRELVY compared to those receiving placebo (see 
The incidence of photophobia and phonophobia was reduced following administration of UBRELVY at both doses (50 mg and 100 mg) as compared to placebo.
* Not statistically significant (NS) 
Figure 1 presents the percentage of patients achieving migraine pain freedom within 2 hours following treatment in Studies 1 and 2.
Figure 1: Percentage of Patients Achieving Pain Freedom within 2 Hours in Pooled Studies 1 and 2
Figure 1: Percentage of Patients Achieving Pain Freedom within 2 Hours in Pooled Studies 1 and 2
a The 100 mg arm was only included in Study 1.
Figure 2 presents the percentage of patients achieving MBS freedom within 2 hours in Studies 1 and 2.
Figure 2: Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Studies 1 and 2
Figure 2: Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Studies 1 and 2
a The 100 mg arm was only included in Study 1.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Hypersensitivity Reactions
Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with UBRELVY. Advise patients to discontinue UBRELVY and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions
Hypertension
Inform patients that hypertension can develop or pre-existing hypertension can worsen with UBRELVY, and that they should contact their healthcare providers if they experience elevation in their blood pressure
Raynaud’s Phenomenon
Inform patients that Raynaud’s phenomenon can develop or worsen with UBRELVY. Advise patients to discontinue UBRELVY and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon
Drug Interactions
Inform patients that UBRELVY may interact with certain other drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription medications, over-the-counter medications, or herbal products 
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant
Lactation
Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed
Manufactured for:
AbbVie Inc.
© 2025 AbbVie. All rights reserved.
20093630 June 2025
9PRINCIPAL DISPLAY PANEL
NDC 0023-6498-10
contains
10 tablets
Rx Only

UBRELVY®
(ubrogepant) tablets
50 mg
PRINCIPAL DISPLAY PANEL
NDC 0023-6498-10
contains 
10 tablets
Rx Only

UBRELVY®
(ubrogepant) tablets
50 mg
10PRINCIPAL DISPLAY PANEL
NDC 0023-6501-10
contains
10 tablets
Rx Only

UBRELVY®
(ubrogepant) tablets
100 mg
PRINCIPAL DISPLAY PANEL
NDC 0023-6501-10
contains
10 tablets
Rx Only

UBRELVY®
(ubrogepant) tablets
100 mg