What the label lists and what reports show
Dihydroergotamine side effects
Dihydroergotamine's FDA label: “The most commonly reported adverse events associated with the use of Dihydroergotamine Mesylate Nasal Spray during placebo-controlled, double-blind studies for the treatment of migraine headache and not reported at an equal incidence by placebo-treated …” FAERS holds 1,270 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (365 reports).
- Generic listed
- Boxed warning
Check it at the source: the dihydroergotamine FDA label on DailyMed (effective March 6, 2025, Oceanside Pharmaceuticals); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse events associated with the use of Dihydroergotamine Mesylate Nasal Spray during placebo-controlled, double-blind studies for the treatment of migraine headache and not reported at an equal incidence by placebo-treated patients were rhinitis, altered sense of taste, application site reactions, dizziness, nausea, and vomiting.
Table 3: Adverse Reactions Reported by at least 1% of the Dihydroergotamine Mesylate Nasal Spray Treated Patients and Occurred More Frequently than in the Placebo-Group in the Migraine Placebo-Controlled Trials
| Reaction | Dihydroergotamine Mesylate Nasal Spray N=597 | Placebo N=631 |
|---|---|---|
| Rhinitis | 26% | 7% |
| Pharyngitis | 3% | 1% |
| Sinusitis | 1% | 1% |
| Nausea | 10% | 4% |
| Vomiting | 4% | 1% |
| Diarrhea | 2% | <1% |
| Altered Sense of Taste | 8% | 1% |
| Application Site Reaction | 6% | 2% |
| Dizziness | 4% | 2% |
| Somnolence | 3% | 2% |
| Paraesthesia | 2% | 2% |
| Hot Flashes | 1% | <1% |
| Fatigue | 1% | 1% |
| Asthenia | 1% | 0% |
| Mouth Dry | 1% | 1% |
| Stiffness | 1% | <1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedDuring clinical studies and the foreign postmarketing experience with Dihydroergotamine Mesylate Nasal Spray there have been no fatalities due to cardiac events. Serious cardiac events, including some that have been fatal, have occurred following use of the parenteral form of dihydroergotamine mesylate (D.H.E. 45 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 ). Incidence in Controlled Clinical Trials Of the 1,796 patients and subjects treated with Dihydroergotamine Mesylate Nasal Spray doses 2 mg or less in U.S. and foreign clinical studies, 26 (1.4%) discontinued because of adverse events. The adverse events associated with discontinuation were, in decreasing order of frequency: rhinitis 13, dizziness 2, facial edema 2, and one each due to cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paraesthesia.
Source: FDA drug label, 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?
1,270 reports list dihydroergotamine among the medicines taken, 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. Of the 18 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dihydroergotamine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions