Quick answers
- What is Dihydroergotamine mesylate used for?
- The FDA-approved label (Brekiya, Amneal Pharmaceuticals LLC, October 4, 2025) says: “BREKIYA is indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Limitations of Use BREKIYA is not indicated for the preventive treatment of migraine. BREKIYA is not indicated for the management of hemiplegic migraine or migraine with brainstem aura. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dihydroergotamine mesylate have a boxed warning?
- Yes. The FDA label for Brekiya has a boxed warning (“WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dihydroergotamine mesylate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dihydroergotamine mesylate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 22, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dihydroergotamine mesylate?
- 13 companies list prescription products of Dihydroergotamine mesylate in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Provepharm Inc. and Amneal Pharmaceuticals LLC.
What Dihydroergotamine mesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BREKIYA is indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Limitations of Use BREKIYA is not indicated for the preventive treatment of migraine. BREKIYA is not indicated for the management of hemiplegic migraine or migraine with brainstem aura. …
— FDA label: Brekiya, Amneal Pharmaceuticals LLC, effective October 4, 2025. Read the full label on DailyMed →
The FDA has 15 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS
. Read it on the full label →
15 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dihydroergotamine mesylate 4 mg/mL spray | Generic | $29.35–$49.14 per mL 4 packages, lowest to highest |
| dihydroergotamine mesylate 4 mg/mL spray, metered | Generic | $29.35–$49.14 per mL 3 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.3 products
- Provepharm Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Gland Pharma Limited1 product
- Somerset Therapeutics, LLC1 product
- Advagen Pharma Ltd1 product
- Impel Pharmaceuticals LLC1 product
- Baxter Healthcare Corporation1 product
- Trifluent Pharma, LLC1 product
- Cipla USA Inc.1 product
- Oceanside Pharmaceuticals1 product
- Milla Pharmaceuticals Inc.1 product
- Satsuma Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020148 MIGRANAL | Bausch | December 8, 1997 | 14, latest May 9, 2022 2022: Labeling · 2019: Labeling · 2014: Manufacturing (CMC) |
| NDA213436 TRUDHESA | Impel Pharms | September 2, 2021 | — |
| NDA215400 BREKIYA (AUTOINJECTOR) | Amneal | May 14, 2025 | — |
| NDA217901 ATZUMI | Satsuma Pharms | April 30, 2025 | — |
Generic approvals (9)
- ANDA040453Hikma · June 9, 2003
- ANDA206621Hikma Pharms · September 15, 2017
- ANDA212046Milla Pharms · January 7, 2020
- ANDA211393Hikma · February 28, 2020
- ANDA212907Cipla · May 20, 2020
- ANDA216881Rubicon Research · June 22, 2023
- ANDA215623Gland · August 18, 2023
- ANDA216747Baxter Hlthcare Corp · January 7, 2025
- ANDA215228Somerset Theraps LLC · February 26, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 22, 2024 · Class II · Ongoing · D-0150-2025
Discoloration
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05 — Provepharm Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Brekiya, Amneal Pharmaceuticals LLC, effective October 4, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →