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D.H.E. 45 Side Effects

Generic name: dihydroergotamine

Medically reviewed by Drugs.com. Last updated on Oct 4, 2022.

Note: This document contains side effect information about dihydroergotamine. Some dosage forms listed on this page may not apply to the brand name D.H.E. 45.

Applies to dihydroergotamine: injection solution. Other dosage forms:

Warning

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.

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

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

Other 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

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

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]

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]

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

The most frequent side effect with the use of intravenous dihydroergotamine (the active ingredient contained in D.H.E. 45) is nausea. Following intramuscular or intranasal administration, the incidence of nausea is lower.[Ref]

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]

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

More about D.H.E. 45 (dihydroergotamine)

Patient resources

Other brands

Trudhesa, Migranal

Professional resources

Related treatment guides

References

1. Robbins L, Remmes A "Outpatient repetitive intravenous dihydroergotamine." Headache 32 (1992): 455-8

2. Malaquin F, Urban T, Ostinelli J, Ghedira H, Lacronique J "Pleural and retroperitoneal fibrosis from dihydroergotamine ." N Engl J Med 321 (1989): 1760

3. "Product Information. D.H.E. 45 (dihydroergotamine)." Sandoz Pharmaceuticals Corporation (2002):

4. Backonja M, Beinlich B, Dulli D, Schutta HS "Haloperidol and lorazepam for the treatment of nausea and vomiting associated with the treatment of intractable migraine headaches ." Arch Neurol 46 (1989): 724

5. Schulman EA, Rosenberg SB "Claudication: an unusual side effect of DHE administration." Headache 31 (1991): 237-9

6. "Drugs for migraine." Med Lett Drugs Ther 37 (1995): 17-20

7. Lipton RB "Ergotamine tartrate and dihydroergotamine mesylate: safety profiles." Headache 37 Suppl (1997): s33-41

8. Mattsson E, Ohlin A, Balkfors B, Fredin HO, Nilsson P, Bergqvist D "Lower-limb vasospasm and renal failure during postoperative thromboprophylaxis. Case report." Eur J Surg 157 (1991): 289-92

9. Bachner EJ, Konsens RM, Priem L, King T, Froimson AI "Reversible vasospasm in association with the use of heparin and dihydroergotamine." Clin Orthop No. 283 (1992): 261-4

10. Henry PY, Larre P, Aupy M, Lafforgue JL, Orgogozo JM "Reversible cerebral arteriopathy associated with the administration of ergot derivatives." Cephalalgia 4 (1984): 171-8

Further information

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.