D.H.E. 45 Side Effects

Generic Name: dihydroergotamine

Please note - some side effects for D.H.E. 45 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of D.H.E. 45 - for the Consumer

D.H.E. 45

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using D.H.E. 45:

Abnormal skin sensations; anxiety; diarrhea; dizziness; flushing; headache; increased sweating; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty breathing; itching; muscle pain or weakness in the arms and legs; numbness, coldness, loss of color, or tingling in the fingers and toes; swelling; swelling or itching at the injection site; temporary speeding or slowing of the heart rate.

D.H.E. 45 Side Effects - for the Professional

D.H.E. 45

Serious cardiac events, including some that have been fatal, have occurred following use of D.H.E. 45® (dihydroergotamine mesylate) Injection, USP, but are extremely rare. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation.. Fibrotic complications have been reported in association with long term use of injectable dihydroergotamine mesylate.

Post-introduction Reports

The following events derived from postmarketing experience have been occasionally reported in patients receiving D.H.E. 45® (dihydroergotamine mesylate) Injection, USP: 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.

D.H.E. 45® (dihydroergotamine mesylate) Injection, USP is not recommended for prolonged daily use.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and diarrhea have been reported to occur commonly.

The most frequent side effect with the use of intravenous dihydroergotamine is nausea. Following intramuscular or intranasal administration, the incidence of nausea is low.

Other

Other side effects including arterial spasm, sometimes with resulting limb necrosis, have been reported rarely. The incidence is believed to be about 1 to 3 per 100,000 patients treated for thromboprophylaxis.

Musculoskeletal

Musculoskeletal side effects including muscle cramps and weakness have been reported.

Nervous system

Nervous system side effects including drowsiness, restlessness, cerebral arteriopathy, and paresthesias have been reported.

Local

Local side effects including pain, burning, itching, edemas, and hematomas at the site of parenteral administration have been reported to occur commonly.

Cardiovascular

Cardiovascular side effects including hypertension, tachycardia, bradycardia, precordial distress, and chest pain have been reported. Myocardial ischemia and myocardial infarction have been reported rarely.

Respiratory

Respiratory side effects including pleural fibrosis have been reported following long-term high dose treatment.

Renal

Renal side effect including retroperitoneal fibrosis have been reported following long-term high dose treatment.

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