FDA-filed SPL labeling · retrieved through openFDA

Dihydroergotamine Nasal Spray

Dihydroergotamine nasal spray is an ergotamine-derived medication used to treat acute migraine attacks, with or without aura, in adults.

Brand names Migranal Nasal SprayTrudhesa Nasal SprayTrudhesaAtzumiBrekiya +1 more
Drug class Ergotamine Derivative
Rx Forms 2 Route Nasal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveSep 3, 2026
Clinical labels in scope 8
AvailabilityRx
Earliest approval/marketing year 1946
FDA-listed product records 20
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Dihydroergotamine Nasal Spray at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dihydroergotamine nasal spray is an effective acute treatment for migraine attacks in adults, but it carries real cardiovascular risks and must not be combined with several common medications, especially strong CYP3A4 inhibitors. It should never be used daily or as a migraine preventive. Always have a heart health check before starting, and use only as directed by your prescriber.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Taking dihydroergotamine nasal spray (specifically Trudhesa) together with strong CYP3A4 inhibitors — a class that includes certain antifungal, antibiotic, and HIV medications — can cause a serious, potentially life-threatening condition called peripheral ischemia (dangerously reduced blood flow to the limbs or brain). This happens because these drugs raise dihydroergotamine levels in the blood, increasing the risk of blood vessel spasm. Signs to watch for include numbness, tingling, coldness, or color changes in your fingers or toes, or sudden neurological symptoms. Combining Trudhesa with strong CYP3A4 inhibitors is strictly contraindicated — meaning it must never be done.

Read the full warning on DailyMed →

📖 Dihydroergotamine Nasal Spray: Patient Information Guide

A plain-language walkthrough of Dihydroergotamine Nasal Spray — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Dihydroergotamine nasal spray is used to stop a migraine attack that is already happening — it is not taken daily to prevent migraines.

  • Atzumi (nasal powder) is approved for the acute treatment of migraine with or without aura in adults
  • Migranal (nasal spray) is used for the acute treatment of migraine headaches in adults
  • Trudhesa (nasal spray) is approved for the acute treatment of migraine with or without aura in adults
  • None of these products are approved for hemiplegic migraine or migraine with brainstem aura
  • None of these products are intended for preventive (daily) migraine therapy
⚙️How it works

Dihydroergotamine binds to certain serotonin receptors in the brain, particularly 5-HT1D receptors. Activating these receptors is thought to narrow blood vessels that have widened during a migraine, and also to reduce the release of inflammatory chemicals from pain-sensing nerves connected to the trigeminal system — the main pain pathway involved in migraines. Together, these actions help relieve the headache.

Dihydroergotamine also interacts with other receptor types, including adrenaline and dopamine receptors, and has a uterus-stimulating (oxytocic) effect — which is why it must be avoided during pregnancy.

💊How it's taken

Dihydroergotamine nasal spray and nasal powder are both delivered into the nostril at the time of a migraine attack. A dose can usually be repeated once if the migraine persists, but you must wait the required time between doses. These products are acute (as-needed) treatments only — not daily preventive medications.

  • Atzumi (nasal powder): delivered into one nostril using the provided device; the white air pump is squeezed three times while inhaling
  • Migranal and Trudhesa (nasal sprays): administered into the nostril per product-specific instructions
  • Do not exceed the maximum number of doses per 24-hour period, per week, or per month — follow your prescriber's guidance and the labeling for the specific product you are using
🤒Side effects — in detail

Nasal irritation is the most commonly reported issue with these products, but several other side effects can occur:

  • Rhinitis (runny or stuffy nose) — very common
  • Altered or abnormal sense of taste
  • Nausea and vomiting
  • Dizziness
  • Throat irritation (pharyngitis)
  • Diarrhea
  • Application site reactions in the nose
  • Sinusitis or nasal discomfort

More serious reactions — including chest pain, severe blood vessel spasm, significant blood pressure elevation, or stroke symptoms — require immediate medical attention. Stop using the medication and call for emergency help if any of these occur.

⚠️Warnings & precautions

The biggest risk with dihydroergotamine is vasospasm — dangerous narrowing of blood vessels. This can affect the heart (causing heart attack or abnormal heart rhythms), the brain (causing stroke or brain bleed), or the limbs and bowel (causing ischemia, meaning loss of blood flow). Anyone with pre-existing heart disease, coronary artery spasm, peripheral artery disease, or uncontrolled high blood pressure must not use this medication.

  • CYP3A4 inhibitors: Combining dihydroergotamine with certain antibiotics, antifungals, or HIV medications can be life-threatening — this combination is contraindicated for Trudhesa and should be strictly avoided across all products
  • Medication overuse headache: Using any acute headache treatment 10 or more days per month can make headaches worse over time; if this is happening, talk to your doctor
  • Fibrotic complications: Prolonged daily use has been linked to scar tissue formation in the lungs and abdomen — never use these products every day
  • Pregnancy: May cause preterm labor; avoid during pregnancy and do not breastfeed for at least 3 days after the last dose
  • Blood pressure: Can raise blood pressure significantly; not safe for those with uncontrolled hypertension
🔀What it interacts with

Dihydroergotamine interacts with several important medications and substances:

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin) — contraindicated; dramatically raise drug levels and risk of dangerous vasospasm
  • Triptans (e.g., sumatriptan) — must not be used within 24 hours; additive risk of coronary artery spasm
  • Other ergotamine or ergot-type medications and methysergide — must not be used within 24 hours
  • Peripheral and central vasoconstrictors — must not be combined; additive blood pressure elevation
  • Beta-blockers (e.g., propranolol) — may increase the blood vessel-narrowing effect of dihydroergotamine
  • Nicotine — promotes vasoconstriction and may worsen ischemia risk
  • SSRIs (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline) — rare reports of weakness, overactive reflexes, and coordination problems when combined with similar drugs

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you have ischemic heart disease, angina, a history of heart attack, or documented coronary artery vasospasm
  • Do not use if you have uncontrolled high blood pressure
  • Do not use if you have peripheral artery disease, have had vascular surgery, or have sepsis
  • Do not use if you have severely impaired liver or kidney function
  • Do not use for hemiplegic migraine or migraine with brainstem aura
  • Do not use if you have a known allergy to ergot alkaloids
  • Avoid during pregnancy — may cause preterm labor
  • Do not breastfeed during use or for 3 days after the last dose; pump and discard breast milk during this time
  • Safety and effectiveness have not been established in children
  • Older adults should use with extra caution due to greater likelihood of reduced organ function and multiple medications
  • A heart health evaluation is recommended before your first dose, especially if you have risk factors for heart disease
🚑If you take too much

Taking more than the recommended amount raises the risk of severe blood vessel spasm (ergotism). Symptoms can include numbness, tingling, pain and bluish discoloration in the fingers or toes, absent pulses in the limbs, confusion, seizures, changes in blood pressure, and nausea. Treatment involves stopping the drug, applying warmth to affected areas, and using medications to open blood vessels. If you suspect an overdose, contact a Poison Control Center or emergency services immediately.

📡Pharmacodynamics — effects in the body

Dihydroergotamine can raise blood pressure, sometimes significantly, even in people without a prior history of high blood pressure. It also has oxytocic properties — meaning it can stimulate uterine contractions — which is why it must be avoided during pregnancy. These effects on blood vessels and smooth muscle are central to both its usefulness in migraine and its most important safety concerns.

🔬Pharmacokinetics — how your body processes it

When delivered nasally, dihydroergotamine reaches the bloodstream with about 32% of the bioavailability seen with injectable administration — and absorption can vary from person to person depending on technique. The drug is heavily bound to proteins in the blood (about 93%) and is processed mainly by the liver, with most of it leaving the body through bile and the stool. The active drug has a terminal half-life of roughly 10 hours, meaning it takes about that long for blood levels to drop by half. Because the liver handles most of the clearance, people with severe liver impairment should not use this medication.

📦How to store it

Store below 25°C (77°F). Do not refrigerate or freeze.

📄 Written from Dihydroergotamine Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Dihydroergotamine Nasal Spray — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this medication for? My doctor said it's for migraines, but I want to understand more.
This medication is used to treat a migraine attack while it's happening — it's not something you take every day to stop migraines from starting. It works on migraines with or without the visual or sensory warning signs called aura. If you've been diagnosed with a specific type called hemiplegic migraine or migraine with brainstem aura, this is not the right treatment for those.
How do I actually use the nasal spray or powder correctly?
The technique matters with these products. If you're using Atzumi (the nasal powder), you remove the blue tab, insert the nozzle into one nostril, and squeeze the white pump three separate times while inhaling — let the pump fully spring back between each squeeze. If you're using Migranal or Trudhesa (nasal sprays), follow the specific steps on the product labeling. In all cases, the medication goes into just one nostril. You can take a second dose if needed, but you must wait at least the required time between doses — check your specific product's instructions for that window.
Are there medications I absolutely cannot take with this?
Yes, and this is really important. Certain antibiotics (like erythromycin and clarithromycin), antifungals (like ketoconazole), and HIV medications (like ritonavir) must never be combined with dihydroergotamine — this combination can cause a dangerous and potentially life-threatening spasm of blood vessels. You also can't take a triptan migraine medication like sumatriptan within 24 hours. Make sure every doctor and pharmacist you see knows you're on this medication, because interactions can be serious.
What side effects should I expect, and which ones mean I should call for help?
The most common things you might notice are nasal irritation, a runny nose, an odd taste in your mouth, nausea, or dizziness. These are usually mild and temporary. What you want to watch for and act on quickly: chest pain or tightness, numbness or coldness in your fingers or toes, sudden severe headache, weakness on one side of your body, or vision changes. Those could signal dangerous blood vessel spasm, a heart problem, or a stroke — get emergency help right away if any of those happen.
Can I use this medication during pregnancy or while breastfeeding?
No on both counts. Dihydroergotamine nasal spray should be avoided during pregnancy because it may cause preterm labor. If you're breastfeeding, you should not use this medication, and you shouldn't nurse for at least 3 days after your last dose — during that time, pump your milk and discard it to keep up your supply. If you're pregnant, planning to become pregnant, or breastfeeding, talk to your doctor about safer migraine options.
I've been using my migraine nasal spray pretty often lately. Is that okay?
Using acute migraine medications — including dihydroergotamine — 10 or more days per month can actually make your headaches worse over time. This is called medication overuse headache, and it can turn into a cycle of daily or more frequent migraines. If you think you're relying on this medication more than that, bring it up with your doctor. It doesn't mean you've done anything wrong — but it's a pattern worth addressing, and your doctor can help you find a better long-term plan.
Is Dihydroergotamine Nasal Spray available over the counter?
Dihydroergotamine Nasal Spray is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Dihydroergotamine Nasal Spray first available?
Dihydroergotamine Nasal Spray has been available in the United States since at least 1946, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Dihydroergotamine Nasal Spray?
Dihydroergotamine Nasal Spray is supplied by 12 manufacturers listed in the FDA NDC Directory, including Cipla USA Inc., Advagen Pharma Ltd, Hikma Pharmaceuticals USA Inc..

💬 Answers drafted from Dihydroergotamine Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Dihydroergotamine Nasal Spray comes

Dihydroergotamine Nasal Spray is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Nasal spray

In the nose
Brands Migranal Trudhesa
How this form is used
What it may be used for
  • Migranal is used for the acute treatment of migraine headaches in adults
  • Trudhesa is used for the acute treatment of migraine with or without aura in adults
Important instructions
  • Trudhesa and Migranal are administered nasally at the onset of a migraine attack
  • Trudhesa must not be used with strong CYP3A4 inhibitors — this combination is contraindicated due to risk of life-threatening blood vessel spasm
  • Do not exceed the recommended dosing frequency for either Migranal or Trudhesa; neither should be used for chronic daily administration
  • A cardiovascular evaluation is recommended before the first dose of Trudhesa; patients with heart disease risk factors should receive their first dose in a healthcare setting
Available strengths 1 strength
18 FDA-listed product records

Nasal powder

In the nose
Brands Atzumi
How this form is used
What it may be used for
  • Atzumi is indicated for the acute treatment of migraine with or without aura in adults
  • Atzumi is not for preventing migraines and is not for hemiplegic migraine or migraine with brainstem aura
Important instructions
  • Atzumi is administered into one nostril only — no priming is needed before use
  • To use Atzumi, remove the round blue tab, insert the blue nozzle into one nostril, and squeeze the white air pump 3 separate times while inhaling — allow the pump to fully expand between each squeeze
  • Atzumi's dose may be repeated once if needed, but wait at least 1 hour after the first dose
  • Atzumi should not be used more than the recommended maximum number of doses per week or per month — consult your prescriber and the product labeling
Available strengths 1 strength
2 FDA-listed product records

📊 Dihydroergotamine Nasal Spray across the U.S. market

How Dihydroergotamine Nasal Spray appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms
12
Manufacturers
5
Brand names
20
FDA-listed product records
1946
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Cipla USA Inc.15%
Advagen Pharma Ltd10%
Hikma Pharmaceuticals USA Inc.10%
Impel Pharmaceuticals Inc.10%
Impel Pharmaceuticals LLC10%
Oceanside Pharmaceuticals10%
Other makers35%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Dihydroergotamine Nasal Spray is used

A general measure of how commonly Dihydroergotamine Nasal Spray is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Dihydroergotamine Nasal Spray is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,813
Medicaid prescriptions filled (Q1–Q4 2025)
$903,601 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dihydroergotamine Nasal Spray prescribed? Of the 1,596 medications we measure, Dihydroergotamine Nasal Spray ranks #1,140 by Medicaid prescriptions — more than 29% of them.

Where Dihydroergotamine Nasal Spray ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Dihydroergotamine Nasal Spray product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

dihydroergotamine mesylate 0.5 MG/ACTUAT Metered Dose Nasal Spray

2,813 Medicaid prescriptions (Q1–Q4 2025) 100% of Dihydroergotamine Nasal Spray prescriptions shown $903,601 gross reimbursement (before rebates) ≈ $321 per prescription (gross)

Summed across the 6 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861668

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dihydroergotamine Nasal Spray, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 18 listed Dihydroergotamine Nasal Spray NDCs with Medicaid activity.

🔍 Compare Dihydroergotamine Nasal Spray products

A representative set of FDA-listed product records for Dihydroergotamine Nasal Spray — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Nasal powder
5.2 mg Nasal Satsuma Pharmaceuticals, Inc. × 2 listings NDA View NDC →
💊Nasal spray
4 mg/mL Nasal Advagen Pharma Ltd × 2 listings ANDA View NDC →
4 mg/mL Nasal Amneal Pharmaceuticals NY LLC ANDA View NDC →
4 mg/mL Nasal Bausch Health US, LLC NDA View NDC →
4 mg/mL Nasal Cipla USA Inc. × 3 listings ANDA View NDC →
4 mg/mL Nasal Hikma Pharmaceuticals USA Inc. × 2 listings ANDA View NDC →
4 mg/mL Nasal Impel Pharmaceuticals Inc. × 2 listings NDA View NDC →
4 mg/mL Nasal Impel Pharmaceuticals LLC × 2 listings NDA View NDC →
4 mg/mL Nasal Leucadia Pharmaceuticals ANDA View NDC →
4 mg/mL Nasal Oceanside Pharmaceuticals × 2 listings NDA AUTHORIZED GENERIC View NDC →
4 mg/mL Nasal Somerset Therapeutics, LLC ANDA View NDC →
4 mg/mL Nasal Trifluent Pharma, LLC ANDA View NDC →

Showing 20 of 20 products — FDA National Drug Code Directory. See every product, package size and price: browse all 20 Dihydroergotamine Nasal Spray NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Dihydroergotamine Nasal Spray RxCUI 3418 6 dose forms · 8 strengths
  1. Dose form (SCDF) Nasal Powder RxCUI 2714186 In current FDA listings
    Clinical drug / strength (SCD) 5.2 MG RxCUI 2714187
  2. Dose form (SCDF) Oral Tablet RxCUI 371844 No current FDA listing
    Clinical drug / strength (SCD) mesylate 1 MG RxCUI 1233876
  3. Dose form (SCDF) Sublingual Tablet RxCUI 608727 No current FDA listing
    Clinical drug / strength (SCD) mesylate 0.5 MG RxCUI 1233874 mesylate 1 MG RxCUI 1233880

Look up RxCUI 3418 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Migranal Nasal Spray Trudhesa Nasal Spray Trudhesa Atzumi Brekiya Migranal

🏭 Manufacturers & labelers

Cipla USA Inc. 3 Advagen Pharma Ltd 2 Hikma Pharmaceuticals USA Inc. 2 Impel Pharmaceuticals Inc. 2 Impel Pharmaceuticals LLC 2 Oceanside Pharmaceuticals 2 Satsuma Pharmaceuticals, Inc. 2 Amneal Pharmaceuticals NY LLC 1 Bausch Health US, LLC 1 Leucadia Pharmaceuticals 1 Somerset Therapeutics, LLC 1 Trifluent Pharma, LLC 1

RxNorm drug class

Dihydroergotamine Nasal Spray belongs to the Ergotamine Derivative class.

Pharmacologic class Ergotamine Derivative
Drug family (ATC) Ergot alkaloids

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 3, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dihydroergotamine Nasal Spray.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dihydroergotamine Nasal Spray after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
8
NDC products indexed
20
Distinct labelers/manufacturers represented
12
Linked representative label
Impel Pharmaceuticals LLC
Linked label effective
Sep 3, 2026
Composite sections available
29
Linked SPL Set ID
b81397b0-910d-4eb4-8fee-a9a3c9d94d63
Linked SPL Document ID
ff3340ed-c740-497d-9959-c369049030d0
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Impel Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.