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EPIPEN (epinephrine) Adverse Reactions

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Adverse Reactions

Adverse Drug Reaction Overview

Adverse reactions of epinephrine include transient, moderate anxiety; feelings of over stimulation; apprehensiveness; restlessness; tremor; weakness; shakiness; dizziness; sweating; tachycardia; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. Ventricular arrhythmias may follow administration of epinephrine. While these symptoms occur in some patients treated with epinephrine, they are likely to be more pronounced in patients with hypertension or hyperthyroidism. These signs and symptoms usually subside rapidly, especially with bed rest.

Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include elderly individuals, pregnant women, and patients with diabetes.
Patients with coronary artery disease are prone to more severe or persistent effects, and may experience angina. Cases of takotsubo (stress) cardiomyopathy have been reported in patients treated with epinephrine. Patients with epinephrine-triggered takotsubo cardiomyopathy are predominantly women and are younger than the typical takotsubo cardiomyopathy patient. These events are characterized by rapid onset of symptoms after epinephrine administration and high complication rates, mostly in the form of cardiogenic shock and acute pulmonary edema. The prognosis is however good with complete recovery in most cases.

Excessive doses cause acute hypertension. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease.

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs (see DRUG INTERACTIONS).

Lacerations, bent needles, and embedded needles have been reported when EpiPen® has been injected into the thigh of young children who are uncooperative and kick or move during the injection [see WARNING AND PRECAUTIONS section].

Injection into the buttock has resulted in cases of gas gangrene.

Accidental injections can lead to injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

Serious Infections at the Injection Site
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection in the thigh. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see WARNINGS AND PRECAUTIONS section]

The potential for epinephrine to produce these types of adverse reactions does not contraindicate its use in an acute life-threatening allergic reaction.

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