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Note: This document contains side effect information about dihydroergotamine. Some of the dosage forms listed on this page may not apply to the brand name D.H.E. 45.
Applies to dihydroergotamine: nasal spray
Nasal route (Solution)
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration 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.
Along with its needed effects, dihydroergotamine (the active ingredient contained in D.H.E. 45) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur while taking dihydroergotamine:
Less common or rare
Symptoms of overdose
Some side effects of dihydroergotamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to dihydroergotamine: injectable solution, nasal spray
The most commonly reported adverse events have included nausea and vomiting; with use of the nasal spray, rhinitis, altered sense of taste, and application site reactions have also been reported.
Deaths due to cardiac events have been reported with parenteral use, but no cardiac related deaths were reported during clinical studies with the nasal spray. Reports of serious cardiac events with the injection appear to be rare.
Uncommon (0.1% to 1%): Edema, palpitation, tachycardia
Rare (less than 0.1%): Hypotension, peripheral ischemia, angina, cardiac valvular fibrosis
Frequency not reported: Acute myocardial infarction, transient myocardial ischemia, ventricular tachycardia, ventricular fibrillation, coronary artery vasospasm, bradycardia, extrasystoles, intermittent claudication, Raynaud's phenomenon
Postmarketing reports: Vasospasm, hypertension, flushing, peripheral ischemia, gangrene
Common (1% to 10%): Dizziness, somnolence, paraesthesia
Uncommon (0.1% to 1%): Tremor, hypoesthesia, altered sense of smell
Rare (less than 0.1%): Speech disorder, hyperkinesia, stupor, abnormal gait, depression, aggravated migraine, convulsions
Frequency not reported: Cerebral hemorrhage, subarachnoid hemorrhage, stroke, headache
Almost 30% of patients receiving the nasal spray reported irritation in the nose, throat, and/or disturbances in taste. Symptoms of congestion, burning, dryness, paraesthesia, discharge, epistaxis, pain, and soreness, mostly mild to moderate and transient, have been reported. In most (approximately 70%), symptoms resolved within 4 hours. The consequence of extended and repeated use on the nasal mucosa have not been studied.
Very common (10% or more): Local irritation (nasal spray; 30%)
Common (1% to 10%): Application site reactions
Uncommon (0.1% to 1%): Local anesthesia
Very common (10% or more): Rhinitis (nasal spray; 26%)
Common (1% to 10%): Pharyngitis, sinusitis
Uncommon (0.1% to 1%): Dyspnea, upper respiratory tract infections
Rare (less than 0.1%): Bronchospasm, bronchitis, pleural pain, epistaxis, yawning
Postmarketing reports: Pleural fibrosis
Common (1% to 10%): Nausea, vomiting, diarrhea
Uncommon (0.1% to 1%): Abdominal pain, dyspepsia, hiccup, dry mouth
Rare (less than 0.1%): Increased salivation, esophagospasm, anorexia
Frequency not reported: Colonic ischemia
Postmarketing reports: Retroperitoneal fibrosis
The most frequent side effect with the use of intravenous dihydroergotamine is nausea. Following intramuscular or intranasal administration, the incidence of nausea is lower.
Uncommon (0.1% to 1%): Vertigo, tinnitus, earache, feeling cold, malaise, rigors, fever, fatigue, asthenia
Common (1% to 10%): Stiffness
Uncommon (0.1% to 1%): Cramps, myalgia, muscular weakness, dystonia
Rare (Less than 0.1%): Arthralgia, involuntary muscle contractions, rigidity
Frequency not reported: Leg pain, muscle spasms
Frequency not reported: Renal artery spasm
Frequency not reported: Hypersensitivity reactions such as skin rash, face edema, urticaria, and dyspnea
Uncommon (0.1% to 1%): Photophobia, conjunctivitis, abnormal lacrimation, abnormal vision, periorbital edema
Rare (less than 0.1%): Eye pain
Uncommon (0.1% to 1%): Nervousness, euphoria, insomnia, impaired concentration
Rare (less than 0.1%): Anxiety
Uncommon (0.1% to 1%): Petechia, pruritus, rash, cold clammy skin
Rare (less than 0.1%): Papular rash, urticaria, herpes simplex
Frequency not reported: Sweating
Uncommon (0.1% to 1%): Increased micturition frequency, cystitis
Rare (less than 0.1%): Pelvic inflammation, vaginitis
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