pharmacopeia
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/api/v1/drug/dihydroergotamine

Boxed warning

PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH POTENT CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the co-administration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 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 )

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha-Antagonists; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; Monoamine Oxidase Inhibitors; Serotonin Antagonists.

Cytochrome P450 3ACytochrome P450 3A4Monoamine OxidaseSerotonin

Indications

Sourced from openFDA
  • Dihydroergotamine Mesylate Injection is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.ICD-10: G43.909, R51.9

Contraindications

Sourced from openFDA
  • There have been a few reports of serious adverse events associated with the coadministration of dihydroergotamine and potent CYP3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP3A4 inhibitors (i.e., ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated (See WARNINGS: CYP3A4 Inhibitors ).contraindicated

Dosage & administration

Sourced from openFDA

Dihydroergotamine Mesylate Injection should be administered in a dose of 1 mL intravenously, intramuscularly or subcutaneously. The dose can be repeated, as needed, at 1 hour intervals to a total dose of 3 mL for intramuscular or subcutaneous delivery or 2 mL for intravenous delivery in a 24 hour period. The total weekly dosage should not exceed 6 mL. Dihydroergotamine Mesylate Injection should not be used for chronic daily administration.

Warnings & precautions

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Dihydroergotamine Mesylate Injection should only be used where a clear diagnosis of migraine headache has been established. CYP3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) There have been rare reports of serious adverse events in connection with the coadministration of dihydroergotamine and potent CYP3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or and ischemia of the extremities. The use of potent CYP3A4 inhibitors with dihydroergotamine should therefore be avoided (see CONTRAINDICATIONS ). Examples of some of the more potent CYP3A4 inhibitors include: anti-fungals ketoconazole and itraconazole, the protease inhibitors ritonavir, nelfinavir, and indinavir, and macrolide antibiotics erythromycin, clarithromycin, and troleandomycin. Other less potent CYP3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP3A4 of other agents being considered for concomitant use with dihydroergotamine. Fibrotic Complication There have been reports of pleural and retroperitoneal fibrosis in patients following prolonged daily use of injectable dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs has been associated with cardiac valvular fibrosis.

Adverse reactions

Sourced from openFDA

Serious cardiac events, including some that have been fatal, have occurred following use of Dihydroergotamine Mesylate Injection but are extremely rare. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. (See CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS .). Fibrotic complications have been reported in association with long term use of injectable dihydroergotamine mesylate (See WARNINGS: Fibrotic Complications ). Post-introduction Reports The following events derived from postmarketing experience have been occasionally reported in patients receiving Dihydroergotamine Mesylate Injection: vasospasm, paraesthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating, and pleural and retroperitoneal fibrosis after long-term use of dihydroergotamine. Extremely rare cases of myocardial infarction and stroke have been reported. A causal relationship has not been established. Dihydroergotamine Mesylate Injection is not recommended for prolonged daily use. (See DOSAGE AND ADMINISTRATION .) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

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Pregnancy Risk Summary Available data from published literature indicate an increased risk of preterm delivery with Dihydroergotamine Mesylate Injection use during pregnancy. Avoid use of Dihydroergotamine Mesylate Injection during pregnancy (see WARNINGS ) . Data collected over decades have shown no increased risk of major birth defects or miscarriage with the use of dihydroergotamine mesylate during pregnancy. In animal reproduction studies, adverse effects on development were observed following intranasal administration of dihydroergotamine mesylate during pregnancy (decreased fetal body weight and/or skeletal ossification) in rats and rabbits or during pregnancy and lactation in rats (decreased body weight and impaired reproductive function in the offspring) at doses that were not associated with maternal toxicity (see Data). The estimated rate of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Overdosage

Sourced from openFDA

To date, there have been no reports of acute overdosage with this drug. Due to the risk of vascular spasm, exceeding the recommended dosages of Dihydroergotamine Mesylate Injection is to be avoided. Excessive doses of dihydroergotamine may result in peripheral signs and symptoms of ergotism. Treatment includes discontinuance of the drug, local application of warmth to the affected area, the administration of vasodilators, and nursing care to prevent tissue damage. In general, the symptoms of an acute Dihydroergotamine Mesylate Injection overdose are similar to those of an ergotamine overdose, although there is less pronounced nausea and vomiting with Dihydroergotamine Mesylate Injection. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain. In laboratory animals, significant lethality occurs when dihydroergotamine is given at I.V.

Approval history

Sourced from openFDA
  • Dec 8, 1997NDANDA020148Bausch
  • Jun 9, 2003ANDAANDA040453Hikma
  • Sep 15, 2017ANDAANDA206621Hikma Pharms
  • Jan 7, 2020ANDAANDA212046Milla Pharms
  • Feb 28, 2020ANDAANDA211393Hikma
  • Sep 2, 2021NDANDA213436Impel Pharms
  • Apr 30, 2025NDANDA217901Satsuma Pharms
  • May 14, 2025NDANDA215400Amneal

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,201 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective52243%
  2. 2Nausea32927%
  3. 3Off Label Use31927%
  4. 4Hyperhidrosis29625%
  5. 5Nightmare28223%
  6. 6Sedation28223%
  7. 7Product Use In Unapproved Indication23620%
  8. 8Nephrolithiasis19316%
  9. 9Migraine1038.6%
  10. 10Dyspnoea857.1%
  11. 11Nasal Congestion786.5%
  12. 12Headache605.0%
  13. 13Treatment Failure584.8%
  14. 14Diarrhoea514.2%
  15. 15Cough494.1%

Literature

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Recent PubMed references pinned to Dihydroergotamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Dihydroergotamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dihydroergotamine work?
Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha-Antagonists; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; Monoamine Oxidase Inhibitors; Serotonin Antagonists.
What is Dihydroergotamine used for?
According to FDA labeling, Dihydroergotamine carries indications including: Dihydroergotamine Mesylate Injection is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dihydroergotamine?
Dihydroergotamine is classified as Ergot alkaloids, Ergotamine Derivative, Adrenergic alpha-Agonists, Adrenergic alpha-Antagonists, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inhibitors, Monoamine Oxidase Inhibitors, Serotonin Antagonists, Cerebral Arterial Vasoconstriction, Cutaneous Arterial Vasoconstriction, Vasoconstriction.
What are the brand names for Dihydroergotamine?
Dihydroergotamine is marketed under brand names including Atzumi, Brekiya, Migranal, Trudhesa.
What are the contraindications for Dihydroergotamine?
Dihydroergotamine labeling lists contraindications including: There have been a few reports of serious adverse events associated with the coadministration of dihydroergotamine and potent CYP3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP3A4 inhibitors (i.e., ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated (See WARNINGS: CYP3A4 Inhibitors ).. Always consult the full prescribing information and a clinician.
Note. Data for dihydroergotamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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