Active substance
Dihydroergotamine
- US FDA 18
- Health Canada 2
- US price lines 4
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MIGRANAL | 0.5MG/SPRAY | spray, metered · nasal | BAUSCH | Prescription | 8 Dec 1997 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 9 Jun 2003 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 15 Sep 2017 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | SAGENT PHARMS INC | Prescription | 11 Jul 2018 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | MILLA PHARMS | Prescription | 7 Jan 2020 |
| DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | spray, metered · nasal | HIKMA PHARMS | Prescription | 28 Feb 2020 |
| DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | spray, metered · nasal | CIPLA | Prescription | 20 May 2020 |
| TRUDHESA | 0.725MG/SPRAY | spray, metered · nasal | IMPEL PHARMS | Prescription | 2 Sep 2021 |
| DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | spray, metered · nasal | RUBICON RESEARCH | Prescription | 22 Jun 2023 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | GLAND | Prescription | 18 Aug 2023 |
| DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | spray, metered · nasal | SOMERSET THERAPS LLC | Prescription | 26 Feb 2025 |
| ATZUMI | EQ 5.2MG BASE | powder · nasal | SATSUMA PHARMS | Prescription | 30 Apr 2025 |
| BREKIYA (AUTOINJECTOR) | 1MG/ML | solution · subcutaneous | AMNEAL | Prescription | 14 May 2025 |
| D.H.E. 45 | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | BAUSCH | Discontinued | 12 Apr 1946 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | PADAGIS US | Discontinued | 28 Apr 2003 |
| DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | spray, metered · nasal | AMNEAL | Discontinued | 4 Jan 2022 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | CIPLA | Discontinued | 20 Sep 2024 |
| DIHYDROERGOTAMINE MESYLATE | 1MG/ML | injectable · injection | BAXTER HLTHCARE CORP | Discontinued | 7 Jan 2025 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| DIHYDROERGOTAMINE (DHE) | 00027243 | 1 MG / ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR | STERIMAX INC |
| MIGRANAL NASAL SPRAY 4MG/ML | 02228947 | 0.5 MG / ACT | LIQUID · NASAL | STERIMAX INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DIHYDROERGOTAMINE 4 MG/ML SPRY | $49.63034 | per ML | 23 Sep 2026 |
| US NADAC | DIHYDROERGOTAMINE 4 MG/ML SPRY | $29.43546 | per ML | 23 Sep 2026 |
| US NADAC | DIHYDROERGOTAMINE MESYLATE 4 MG/ML NASAL SPRAY | $49.63034 | per ML | 23 Sep 2026 |
| US NADAC | DIHYDROERGOTAMINE MESYLATE 4 MG/ML NASAL SPRAY | $29.43546 | per ML | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 9 May 2022 D.H.E. 45 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 May 2022 MIGRANAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.