Ubrogepant

Ubrogepant is a calcitonin gene-related peptide receptor antagonist.

• 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.ICD-10: G43.909

• UBRELVY is contraindicated: With concomitant use of strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 )] 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 [see Warnings and Precautions ( 5.1 )] Concomitant use with strong CYP3A4 inhibitors.contraindicated

The recommended dose is 50 mg or 100 mg taken orally, as needed. ( 2.1 ) If needed, a second dose may be administered at least 2 hours after the initial dose. ( 2.1 ) The maximum dose in a 24-hour period is 200 mg. ( 2.1 ) 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. ( 2.2 , 8.6 , 8.7 ) 2.1 Recommended Dosage The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food. If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established. 2.2 Dosage Modification s Dosing modifications for concomitant use of specific drugs and for patients with hepatic or renal impairment are provided in Table 1.

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. ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 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. If a serious or severe hypersensitivity reaction occurs, discontinue UBRELVY and institute appropriate therapy [see Contraindications ( 4 ) and Adverse Reactions ( 6.2 )] . 5. 2 Hyper tension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including UBRELVY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation.

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 2% and greater than placebo) were nausea and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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 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 [see Clinical Studies ( 14 )] . Of the UBRELVY-treated patients in these 2 studies, approximately 89% were female, 82% were White, 15% were Black, and 17% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range of 18-75 years). 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.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Avoid use in patients with end-stage renal disease. ( 8.7 ) 8.1 Pregnancy 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. In animal studies, adverse effects on embryofetal development were observed following administration of ubrogepant during pregnancy (increased embryofetal mortality in rabbits) or during pregnancy and lactation (decreased body weight in offspring in rats) at doses greater than those used clinically and which were associated with maternal toxicity ( see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2% -2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Metabolism

Absorption Following oral administration of UBRELVY, ubrogepant is absorbed with peak plasma concentrations at approximately 1.5 hours. Ubrogepant displays dose-proportional pharmacokinetics within the recommended dose range [see Dosage and Administration ( 2.1 )] .

OVERDOS AG E 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.

• Dec 23, 2019NDANDA211765Abbvie

1. 1Drug Ineffective1,00718%
2. 2Migraine81514%
3. 3Nausea5079.0%
4. 4Headache5069.0%
5. 5Fatigue3486.2%
6. 6Off Label Use2694.8%
7. 7Dizziness2624.7%
8. 8Pain2434.3%
9. 9Product Dose Omission Issue2103.7%
10. 10Vomiting2023.6%
11. 11Pruritus1612.9%
12. 12Covid-191532.7%
13. 13Injection Site Pain1532.7%
14. 14Somnolence1512.7%
15. 15Diarrhoea1492.6%

The 10 most recently updated of 23 ClinicalTrials.gov registrations naming Ubrogepant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
  Recruiting · Phase 3 · Interventional · 1,059 enrolled · AbbVie
  NCT05125302updated 2026-06-05
• An Observational Study to Assess Change in Disease Activity When Ubrogepant Tablets Are Combined With Atogepant Tablets to Treat Migraine in Adult Participants
  Completed · Observational · 391 enrolled · AbbVie
  NCT05653986updated 2026-06-03
• Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
  Recruiting · Phase 3 · Interventional · 496 enrolled · AbbVie
  NCT06417775updated 2026-06-02
• An Observational Study to Assess Ubrogepant Tablets and Atogepant Tablets to Treat Migraine in Adult Participants
  Completed · Observational · 226 enrolled · AbbVie
  NCT05827887updated 2026-04-03
• Study to Assess Function and Satisfaction of Oral Ubrogepant in Adult Participants After Multiple Migraine Attacks In Canada
  Active not recruiting · Observational · 178 enrolled · AbbVie
  NCT06692881updated 2026-04-03
• Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks
  Recruiting · Observational · 189 enrolled · AbbVie
  NCT07310290updated 2026-02-10
• Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
  Recruiting · Observational · 1,884 enrolled · AbbVie
  NCT05158894updated 2025-12-15
• A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
  Completed · Phase 1 · Interventional · 43 enrolled · H. Lundbeck A/S
  NCT06578585updated 2025-10-14
• Migraine Medication Effects on Urinary Symptoms
  Enrolling by invitation · Observational · 200 enrolled · The Cleveland Clinic
  NCT06212661updated 2025-10-01
• Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
  Enrolling by invitation · Phase 3 · Interventional · 1,200 enrolled · AbbVie
  NCT05127954updated 2025-07-20

Frequently asked questions

How does Ubrogepant work?

Ubrogepant is a calcitonin gene-related peptide receptor antagonist.

What is Ubrogepant used for?

According to FDA labeling, Ubrogepant carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ubrogepant?

Ubrogepant is classified as Calcitonin gene-related peptide (CGRP) antagonists, Calcitonin Gene-related Peptide Receptor Antagonist, Calcitonin Gene-related Peptide Receptor Antagonists, Cytochrome P450 3A4 Inhibitors, Receptor Interactions.

What are the brand names for Ubrogepant?

Ubrogepant is marketed under brand names including Ubrelvy.

What are the contraindications for Ubrogepant?

Ubrogepant labeling lists contraindications including: UBRELVY is contraindicated: With concomitant use of strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 )] 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 [see Warnings and Precautions ( 5.1 )] Concomitant use with strong CYP3A4 inhibitors.. Always consult the full prescribing information and a clinician.