D.H.E. 45 Side Effects

Generic name: dihydroergotamine

Medically reviewed by Drugs.com. Last updated on Mar 24, 2024.

Note: This document provides detailed information about D.H.E. 45 Side Effects associated with dihydroergotamine. Some dosage forms listed on this page may not apply specifically to the brand name D.H.E. 45.

Applies to dihydroergotamine: injection solution.

Other dosage forms:

• nasal spray

Important Warnings This medicine can cause some serious health issues

Injection 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.

Common side effects of D.H.E. 45

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:

More common

• burning or tingling sensation, dryness, soreness, or pain in the nose

Serious side effects of D.H.E. 45

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 immediately if any of the following side effects occur while taking dihydroergotamine:

Rare

• dizziness
• headache
• numbness or tingling in the arms or legs
• trouble thinking, speaking, or walking
• weakness

Incidence not known

• chest pain, discomfort, or tightness
• confusion
• continuing or severe abdominal or stomach pain
• continuing or severe nausea and vomiting
• increased frequency of urination
• lower back or side pain
• pain or discomfort in the arms, jaw, back, or neck
• stroke
• sweating
• trouble breathing
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking dihydroergotamine:

Symptoms of overdose

• blurred vision
• change or loss of consciousness
• cold clammy skin
• confusion as to time, place, or person
• decreased awareness or responsiveness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• nausea
• nervousness
• numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds
• pale or blue lips, fingernails, or skin
• pounding in the ears
• seizures
• severe sleepiness
• slow or fast heartbeat
• stomach pain
• sweating
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting

For Healthcare Professionals

Applies to dihydroergotamine: injectable solution, nasal spray.

General

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.

Cardiovascular

• 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^[Ref]

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.^[Ref]

Nervous system

• 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^[Ref]

Local

• Very common (10% or more): Local irritation (nasal spray; 30%)
• Common (1% to 10%): Application site reactions
• Uncommon (0.1% to 1%): Local anesthesia^[Ref]

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.^[Ref]

Respiratory

• 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^[Ref]

Gastrointestinal

• 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^[Ref]

The most frequent side effect with the use of intravenous dihydroergotamine is nausea. Following intramuscular or intranasal administration, the incidence of nausea is lower.^[Ref]

Other

• Uncommon (0.1% to 1%): Vertigo, tinnitus, earache, feeling cold, malaise, rigors, fever, fatigue, asthenia^[Ref]

Musculoskeletal

• 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^[Ref]

Renal

• Frequency not reported: Renal artery spasm^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions such as skin rash, face edema, urticaria, and dyspnea

Ocular

• Uncommon (0.1% to 1%): Photophobia, conjunctivitis, abnormal lacrimation, abnormal vision, periorbital edema
• Rare (less than 0.1%): Eye pain

Psychiatric

• Uncommon (0.1% to 1%): Nervousness, euphoria, insomnia, impaired concentration
• Rare (less than 0.1%): Anxiety

Dermatologic

• 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

Genitourinary

• Uncommon (0.1% to 1%): Increased micturition frequency, cystitis
• Rare (less than 0.1%): Pelvic inflammation, vaginitis

Frequently asked questions

• What are the new drugs for the treatment of migraines?

Further information

D.H.E. 45 side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer