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ubrogepant

Sold as Ubrelvy. Class: Calcitonin gene-related peptide (CGRP) antagonists. First FDA approval 12/23/2019: 7 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (73/100)

Safety ×35%
A
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
C

Safety: 90

Evidence: 40

Regulatory history: 96

Money & lawsuits: 70

Options: 70

What the FDA label says

Approved uses

Not available.

Contraindications

None listed.

Warnings and precautions

Not available.

Adverse reactions (label)

Not available.

Source: FDA SPL label, effective .

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

6,026reports that mention this drug
6,021of those blame this drug, not another one the person was taking
35%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
1.7%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Drug Ineffective · 1,039Migraine · 878Headache · 541Nausea · 528Fatigue · 369Off Label Use · 287Dizziness · 274Pain · 264Product Dose Omission Issue · 223Vomiting · 215Pruritus · 172Injection Site Pain · 167Diarrhoea · 166Somnolence · 156Covid-19 · 155

Reports per year

20192020202120222023202420252026
174516501,1249441,0491,094681

8,589 reports blaming this drug for every million Medicare prescriptions filled, which is 3.1× the typical drug on this site. (2,819 reports in 2024–2026, against 328,213 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

0recall actions on file
1 / 0brand / generic applications
4label changes since 2021
NoREMS program

Evidence base

22randomized trials (PubMed)
11systematic reviews
24registered trials
53%of completed trials posted results
4%terminated or withdrawn
88%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $6,189,626 in payments to US physicians and hospitals tied to this drug across 183,906 transactions (Ubrelvy $6,189,626).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

83,437Medicare Part D patients (2024)
328,213prescriptions filled
$1,309average cost per fill
$430Mtotal Medicare spend

Same-class alternatives

1 drug in the same class grades a letter or more higher than ubrogepant on this site. Worth asking whether one of them would do the same job for you.

eptinezumaberenumabfremanezumabgalcanezumabzavegepant

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. The most-reported problems in FDA's adverse event data are migraine, headache, nausea. How would we recognize and handle those?
  2. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  3. Why this one over atogepant, eptinezumab, erenumab? What would make you pick one of those instead?
  4. There is no generic. Is there an older generic in the same class that works as well for my situation?
  5. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
  6. What result are we expecting, by when, and what is the plan if it does not happen?
  7. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)