Dihydroergotamine side effects: what 1,269 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Dihydroergotamine Mesylate (Dihydroergotamine Mesylate)
Who reports
1,269 reports · 51% serious · 20 with death outcome · 60% female
Used for
Dihydroergotamine 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.
What it is
DESCRIPTION Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl)-, (5'α)-, monomethane-sulfonate.
Boxed warning
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.
Causality screen of the 31 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 12 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sedation | 308 | 197.4 179.0–217.7ROR 260.3 · χ² 59,346 / p <1e-300 | 192.7 EB05 175.3 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 301.6 · ♀ 0% (drug 60%) | no trial data cached |
| Nightmare | 308 | 147.6 133.9–162.8ROR 194.5 · χ² 44,374 / p <1e-300 | 145.0 EB05 131.9 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 278.7 · ♀ 0% (drug 60%) | no trial data cached |
| Nephrolithiasis (kidney stones) | 222 | 80.5 71.4–90.8ROR 97.4 · χ² 17,309 / p <1e-300 | 79.6 EB05 71.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 99.1 · ♀ 0% (drug 60%) | no trial data cached |
| Hyperhidrosis (excessive sweating) | 323 | 41.5 37.7–45.6ROR 55.3 · χ² 12,759 / p <1e-300 | 41.3 EB05 37.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 73.9 · ♀ 5% (drug 60%) | no trial data cached |
| Extrapyramidal disorder | 42 | 27.7 20.6–37.3ROR 28.6 · χ² 1,053 / p 2e-231 | 27.3 EB05 21.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 100% (drug 60%) · 95% clinician | no trial data cached |
| Nasal congestion (stuffy nose) | 81 | 22.9 18.5–28.2ROR 24.4 · χ² 1,675 / p <1e-300 | 22.7 EB05 18.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.5 | no trial data cached |
| Ligament sprain | 12 | 20.1 11.4–35.3ROR 20.3 · χ² 199 / p 2e-45 | 19.2 EB05 11.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Eyelid ptosis | 12 | 19.5 11.1–34.3ROR 19.7 · χ² 192 / p 5e-44 | 18.6 EB05 10.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Migraine | 105 | 18.3 15.2–22.0ROR 19.9 · χ² 1,705 / p <1e-300 | 18.2 EB05 15.5 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 28.3 · ♀ 93% (drug 60%) | no trial data cached |
| Product use in unapproved indication | 262 | 17.7 15.9–19.7ROR 22.1 · χ² 4,162 / p <1e-300 | 17.7 EB05 16.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 44.5 · ♀ 8% (drug 60%) | no trial data cached |
| Tenderness | 11 | 17.4 9.7–31.4ROR 17.6 · χ² 154 / p 1e-35 | 16.2 EB05 8.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Coordination abnormal | 13 | 15.3 8.9–26.3ROR 15.4 · χ² 160 / p 7e-37 | 14.2 EB05 8.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 | no trial data cached |
| Mydriasis | 11 | 14.2 7.9–25.5ROR 14.3 · χ² 122 / p 1e-28 | 12.6 EB05 6.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 | no trial data cached |
| Apathy | 11 | 12.5 6.9–22.5ROR 12.6 · χ² 105 / p 5e-25 | 10.7 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 | no trial data cached |
| Photophobia (light sensitivity) | 14 | 12.4 7.4–20.9ROR 12.5 · χ² 135 / p 1e-31 | 11.1 EB05 6.4 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.3 | no trial data cached |
| Meningioma | 11 | 12.3 6.9–22.2ROR 12.4 · χ² 104 / p 1e-24 | 10.5 EB05 5.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Drug ineffective for unapproved indication | 41 | 12.2 9.0–16.4ROR 12.5 · χ² 409 / p 3e-91 | 11.8 EB05 8.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 29.0 · ♀ 97% (drug 60%) · 93% clinician | no trial data cached |
| Treatment failure | 58 | 11.7 9.1–15.0ROR 12.2 · χ² 557 / p 2e-123 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.7 · ♀ 93% (drug 60%) · 95% clinician | no trial data cached |
| Impaired quality of life | 10 | 11.5 6.2–21.3ROR 11.6 · χ² 85 / p 1e-20 | 9.4 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 | no trial data cached |
| Amenorrhoea (missed periods) | 11 | 10.9 6.0–19.6ROR 11.0 · χ² 89 / p 2e-21 | 9.0 EB05 4.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 | no trial data cached |
| Hypocalcaemia (low calcium) | 11 | 9.6 5.3–17.3ROR 9.7 · χ² 77 / p 1e-18 | 7.8 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Muscle twitching | 13 | 9.3 5.4–16.0ROR 9.4 · χ² 88 / p 3e-21 | 7.7 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Disability | 11 | 9.2 5.1–16.5ROR 9.3 · χ² 72 / p 9e-18 | 7.4 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Upper limb fracture | 11 | 9.1 5.0–16.4ROR 9.1 · χ² 71 / p 2e-17 | 7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Diplopia (double vision) | 14 | 8.9 5.3–15.0ROR 9.0 · χ² 91 / p 9e-22 | 7.5 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Impaired work ability | 11 | 8.5 4.7–15.3ROR 8.5 · χ² 65 / p 3e-16 | 6.7 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.2 | no trial data cached |
| Limb discomfort | 14 | 7.5 4.4–12.6ROR 7.5 · χ² 72 / p 1e-17 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Drug ineffective (drug did not work) | 553 | 6.9 6.5–7.4ROR 11.5 · χ² 2,991 / p <1e-300 | 6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 · ♀ 33% (drug 60%) | no trial data cached |
| Nervous system disorder | 13 | 6.9 4.0–11.8ROR 6.9 · χ² 59 / p 7e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 | no trial data cached |
| Expired product administered | 11 | 5.5 3.0–9.9ROR 5.5 · χ² 36 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Crying | 11 | 5.0 2.8–9.0ROR 5.0 · χ² 31 / p 1e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 553 | 6.9 6.5–7.4ROR 11.5 · χ² 2,991 / p <1e-300 | 6.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 · ♀ 33% (drug 60%) | no trial data cached |
| Hyperhidrosis (excessive sweating) | 323 | 41.5 37.7–45.6ROR 55.3 · χ² 12,759 / p <1e-300 | 41.3 EB05 37.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 73.9 · ♀ 5% (drug 60%) | no trial data cached |
| Nightmare | 308 | 147.6 133.9–162.8ROR 194.5 · χ² 44,374 / p <1e-300 | 145.0 EB05 131.9 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 278.7 · ♀ 0% (drug 60%) | no trial data cached |
| Sedation | 308 | 197.4 179.0–217.7ROR 260.3 · χ² 59,346 / p <1e-300 | 192.7 EB05 175.3 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 301.6 · ♀ 0% (drug 60%) | no trial data cached |
| Product use in unapproved indication | 262 | 17.7 15.9–19.7ROR 22.1 · χ² 4,162 / p <1e-300 | 17.7 EB05 16.0 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 44.5 · ♀ 8% (drug 60%) | no trial data cached |
| Nephrolithiasis (kidney stones) | 222 | 80.5 71.4–90.8ROR 97.4 · χ² 17,309 / p <1e-300 | 79.6 EB05 71.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 99.1 · ♀ 0% (drug 60%) | no trial data cached |
| Migraine | 105 | 18.3 15.2–22.0ROR 19.9 · χ² 1,705 / p <1e-300 | 18.2 EB05 15.5 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 28.3 · ♀ 93% (drug 60%) | no trial data cached |
| Nasal congestion (stuffy nose) | 81 | 22.9 18.5–28.2ROR 24.4 · χ² 1,675 / p <1e-300 | 22.7 EB05 18.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.5 | no trial data cached |
| Treatment failure | 58 | 11.7 9.1–15.0ROR 12.2 · χ² 557 / p 2e-123 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.7 · ♀ 93% (drug 60%) · 95% clinician | no trial data cached |
| Extrapyramidal disorder | 42 | 27.7 20.6–37.3ROR 28.6 · χ² 1,053 / p 2e-231 | 27.3 EB05 21.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 100% (drug 60%) · 95% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 41 | 12.2 9.0–16.4ROR 12.5 · χ² 409 / p 3e-91 | 11.8 EB05 8.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 29.0 · ♀ 97% (drug 60%) · 93% clinician | no trial data cached |
| Limb discomfort | 14 | 7.5 4.4–12.6ROR 7.5 · χ² 72 / p 1e-17 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Diplopia (double vision) | 14 | 8.9 5.3–15.0ROR 9.0 · χ² 91 / p 9e-22 | 7.5 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Photophobia (light sensitivity) | 14 | 12.4 7.4–20.9ROR 12.5 · χ² 135 / p 1e-31 | 11.1 EB05 6.4 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.3 | no trial data cached |
| Nervous system disorder | 13 | 6.9 4.0–11.8ROR 6.9 · χ² 59 / p 7e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Sedation — n=308, PRR 197.4
- Nightmare — n=308, PRR 147.6
- Nephrolithiasis — n=222, PRR 80.5
- Hyperhidrosis — n=323, PRR 41.5
- Extrapyramidal disorder — n=42, PRR 27.7
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dihydroergotamine?
In FDA FAERS, the most frequently co-reported reaction terms for Dihydroergotamine are hyperhidrosis, nightmare, sedation, nephrolithiasis, migraine, nasal congestion. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dihydroergotamine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: 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.
Do FAERS signals prove that Dihydroergotamine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 4cb78f66-6ccf-4ac7-8599-e199f6995f05, effective 20250930; matched on
openfda.generic_name.exact:"DIHYDROERGOTAMINE MESYLATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 43 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.