Important Safety Information | Trudhesa® (dihydroergotamine mesylate) nasal spray

Trudhesa may cause:

Cardiac events: Cardiac events in patients with risk factors of coronary artery diseases: Consider administration of the first dose of Trudhesa under medical supervision (including the use of an electrocardiogram)
Cerebrovascular events: Cerebrovascular events (eg, cerebral hemorrhage, subarachnoid hemorrhage, and stroke) have been reported, particularly with dihydroergotamine mesylate injection
Vasospasm/elevated blood pressure: Dihydroergotamine may cause vasospasm or elevation in blood pressure
Fibrotic complications: Rare cases have been reported following prolonged daily use of dihydroergotamine mesylate. Administration of Trudhesa should not exceed the dosing guidelines or be used for chronic daily administration
Medication overuse headache: Detoxification may be necessary
Preterm labor: Advise pregnant women of the risk
Local irritation: Local irritation has been reported following administration of Trudhesa