Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Serious cardiac events, including some that have been fatal, have occurred following use of Dihydroergotamine Mesylate Injection but are extremely rare.
Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation.
(See CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS .).
Fibrotic complications have been reported in association with long term use of injectable dihydroergotamine mesylate (See WARNINGS: Fibrotic Complications ).
Post-introduction Reports The following events derived from postmarketing experience have been occasionally reported in patients receiving Dihydroergotamine Mesylate Injection: vasospasm, paraesthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating, and pleural and retroperitoneal fibrosis after long-term use of dihydroergotamine.
Extremely rare cases of myocardial infarction and stroke have been reported.
A causal relationship has not been established.
Dihydroergotamine Mesylate Injection is not recommended for prolonged daily use.
(See DOSAGE AND ADMINISTRATION .) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS Dihydroergotamine Mesylate Injection should only be used where a clear diagnosis of migraine headache has been established.
CYP3A4 Inhibitors (e.g.
Macrolide Antibiotics and Protease Inhibitors) There have been rare reports of serious adverse events in connection with the coadministration of dihydroergotamine and potent CYP3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or and ischemia of the extremities.
The use of potent CYP3A4 inhibitors with dihydroergotamine should therefore be avoided (see CONTRAINDICATIONS ).
Examples of some of the more potent CYP3A4 inhibitors include: anti-fungals ketoconazole and itraconazole, the protease inhibitors ritonavir, nelfinavir, and indinavir, and macrolide antibiotics erythromycin, clarithromycin, and troleandomycin.
Like all medications, Dihydroergotamine Mesylate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: