Note: This document contains side effect information about dihydroergotamine. Some dosage forms listed on this page may not apply to the brand name Trudhesa.
Applies to dihydroergotamine: injection solution. Other dosage forms:
- nasal spray
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 Trudhesa
Along with its needed effects, dihydroergotamine (the active ingredient contained in Trudhesa) 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
Other side effects of Trudhesa
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 Trudhesa) 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
