Prescription medicine
Dihydroergotamine Brand names: Atzumi, Trudhesa, Brekiya; first approved as D.H.E.
Dihydroergotamine (Trudhesa) is a prescription medicine with an FDA approval on record since 1946. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $29.44 per mL (Dihydroergotamine mesylate 4 mg/mL nasal spray) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the dihydroergotamine FDA label on DailyMed (effective March 6, 2025, Oceanside Pharmaceuticals); the NDA 5929 record on Drugs@FDA; every dihydroergotamine label on DailyMed.
Highlights of the record
FDA label of March 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS.
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of DIHYDROERGOTAMINE, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (see CONTRAINDICATIONS and WARNINGS ).
Used for
From the label: indications and usageDihydroergotamine Mesylate Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.
Forms and strengths
- 5.2 mg
- 1 mg/ml
- 4 mg/ml
Injection; spray; spray (metered); injection (solution); powder.
On the market
- Earliest approval on file
- April 12, 1946 D.H.E. 45, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first April 28, 2003; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 9 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- January 4, 2039 Trudhesa spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $29.44 per mL Dihydroergotamine mesylate 4 mg/mL nasal spray
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2014 0 Class I among all firms' recalls; latest November 22, 2024; 2 more by firms not listed as its makers
- FAERS reports
- 1,270 through July 30, 2026
What is dihydroergotamine used for?
From the label: indications and usageDihydroergotamine Mesylate Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine Mesylate Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.
Conditions named in the indications of dihydroergotamine's FDA labels, with every medicine labeled for each:
From other dihydroergotamine labelsMigraine: INDICATIONS AND USAGE Dihydroergotamine Mesylate Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.
FDA pharmacologic class: Ergotamine Derivative.
Source: FDA drug label (Dihydroergotamine Mesylate), NDA020148 (Bausch), as published by Oceanside Pharmaceuticals, effective March 6, 2025 (SPL set 977de209-c53a-4cb4-9f3f-1e850600a9dc), via openFDA; the full label on DailyMed
Is there a generic for dihydroergotamine (Trudhesa)?
The FDA approved the first generic dihydroergotamine on April 28, 2003. 13 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dihydroergotamine from 9 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Trudhesa spray, the last expiring on January 4, 2039; a patent listed only for Atzumi powder runs to October 12, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1946 earliest approval on file
- 2003 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dihydroergotamine (Trudhesa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $29.44 per mL (Dihydroergotamine mesylate 4 mg/mL nasal spray), down 10% from $32.77 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dihydroergotamine mesylate 4 mg/mL nasal spray (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dihydroergotamine 4 mg/mL spry | Generic | $29.44 per mL | n/a | n/a |
| Dihydroergotamine mesylate 4 mg/mL nasal spray | Generic | $29.44 per mL | n/a | -10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dihydroergotamine been recalled?
The FDA's Enforcement Report lists 4 recalls naming dihydroergotamine since 2014: 0 Class I (the most serious), 4 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of dihydroergotamine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 22, 2024 | Class II | Provepharm Inc. | Discoloration |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| July 24, 2015 | Class II | JD & SN Inc., dba Moses Lake Professional Pharmacy not a listed maker | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry |
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dihydroergotamine label say about other medicines?
The dihydroergotamine label names 19 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name dihydroergotamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | contraindications | The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated ( see WARNINGS, CYP 3A4 Inhibitors ). |
| Clotrimazole | warnings | Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. |
| Epinephrine | drug interactions | … propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine. |
| Ergotamine | drug interactions | Beta-Blockers Although the results of a clinical study did not indicate a safety problem associated with the administration of Dihydroergotamine Mesylate Nasal Spray to subjects already receiving propranolol, there have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking … |
| Erythromycin | contraindications | The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated ( see WARNINGS, CYP 3A4 Inhibitors ). |
| Fluconazole | warnings | Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. |
| Fluoxetine | drug interactions | SSRI’s Weakness, hyperreflexia, and incoordination have been reported rarely when 5HT 1 agonists have been coadministered with SSRI’s (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline). |
| Fluvoxamine | drug interactions | SSRI’s Weakness, hyperreflexia, and incoordination have been reported rarely when 5HT 1 agonists have been coadministered with SSRI’s (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline). |
| Itraconazole | contraindications | The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated ( see WARNINGS, CYP 3A4 Inhibitors ). |
| Ketoconazole | contraindications | The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated ( see WARNINGS, CYP 3A4 Inhibitors ). |
| Nefazodone | warnings | Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. |
| Nelfinavir | contraindications | The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated ( see WARNINGS, CYP 3A4 Inhibitors ). |
| Nicotine | drug interactions | Nicotine Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy. |
| Paroxetine | drug interactions | SSRI’s Weakness, hyperreflexia, and incoordination have been reported rarely when 5HT 1 agonists have been coadministered with SSRI’s (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline). |
Every other medicine the dihydroergotamine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Propranolol | drug interactions | … Dihydroergotamine Mesylate Nasal Spray to subjects already receiving propranolol, there have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the … |
| Ritonavir | contraindications | The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated … |
| Sertraline | drug interactions | SSRI’s Weakness, hyperreflexia, and incoordination have been reported rarely when 5HT 1 agonists have been coadministered with SSRI’s (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline). |
| Sumatriptan | contraindications | Dihydroergotamine Mesylate Nasal Spray, 5-HT 1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of each other. |
| Zileuton | warnings | Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. |
Other labels that name dihydroergotamine
Source: FDA drug label (Dihydroergotamine Mesylate), NDA020148 (Bausch), as published by Oceanside Pharmaceuticals, effective March 6, 2025 (SPL set 977de209-c53a-4cb4-9f3f-1e850600a9dc), via openFDA; the full label on DailyMed
What do FAERS reports show for dihydroergotamine?
The FDA Adverse Event Reporting System holds 1,270 reports that list dihydroergotamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 154 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dihydroergotamine?
3 other medicines are given the same way (nasal) and in the same FDA class as dihydroergotamine or labeled mainly for the same use (migraine), the same class first. Migraine lists all 27 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (nasal) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sumatriptan | Migraine | 5 labelers | $16.51 per unit 20 mg nasal spray | No current entry |
| Zolmitriptan | Migraine | 2 labelers | $44.04 per unit 5 mg nasal spray | No current entry |
| Zavegepant | Migraine | none listed | $189.80 per unit 10 mg nasal spray | No current entry |
Every medicine labeled for the same conditions as dihydroergotamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dihydroergotamine compare with medicines for the same use?
1 side-by-side page set dihydroergotamine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dihydroergotamine
- 3 medicines for the same use
- Other ergotamine derivatives
- the pharmacologic class, with prices and generics
- Dihydroergotamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other