EpiPen 2-Pak Side Effects

Generic name: epinephrine

Note: This document contains side effect information about epinephrine. Some of the dosage forms listed on this page may not apply to the brand name EpiPen 2-Pak.

Some side effects of EpiPen 2-Pak may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to epinephrine: injectable kit, injectable solution, intravenous solution

Before using epinephrine (the active ingredient contained in EpiPen 2-Pak) a second time, call your doctor if your first injection caused a side effect such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

• sweating;

• nausea and vomiting;

• pale skin;

• feeling short of breath;

• dizziness;

• weakness or tremors;

• headache; or

• feeling nervous or anxious.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to epinephrine: compounding powder, inhalation aerosol, inhalation solution, injectable kit, injectable solution, intravenous solution, subcutaneous suspension

Nervous system

Nervous system side effects have included fear, agitation, anxiety, tenseness, restlessness, headache, tremor, dizziness, lightheadedness, nervousness, sleeplessness, excitability, weakness, and increased parkinsonian tremors. Complications associated with epidural anesthesia with epinephrine (the active ingredient contained in EpiPen 2-Pak) have included nerve root ischemia and clinical paralysis/plegia.

Cardiovascular

Cardiovascular side effects have included elevations in heart rate or blood pressure in up to 55% and arrhythmias in 3% to 17% (including fatal ventricular arrhythmias) when used to treat cardiac arrest. In smaller doses, epinephrine (the active ingredient contained in EpiPen 2-Pak) has caused peripheral coronary arterial vasodilation, but in larger doses, epinephrine has caused diffuse vasoconstriction. This has caused increased peripheral vascular resistance, which was important in patients with coronary artery disease (worsened myocardial ischemia/angina) or hypertension (risk of emergent hypertension/stroke). Dilated cardiomyopathy and acute left ventricular dysfunction have been associated with the use of epinephrine.

Arrhythmias, including fatal ventricular fibrillation, have been reported in patients with underlying cardiac disease. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease.

Epinephrine can induce hypokalemia with resultant T wave changes on the electrocardiogram.

Rare cases of myocardial infarction have been associated with relatively small doses of epinephrine in patients at risk for coronary artery disease.

Rare cases of cardiomyopathy have been associated with brief and chronic exposure to epinephrine (including inhaled epinephrine). Animal studies have shown that catecholamines can cause an influx of calcium into myocardial cells, which may cause myocardial injury, particularly during periods of epinephrine-induced coronary vasoconstriction. Limited animal data suggest that calcium antagonists may protect against the cardiotoxic effects of catecholamines by preventing the generation of plasma borne cytotoxic compounds, which are probably free radicals.

Epinephrine may be more arrhythmogenic in some patients, such as patients with congenital long QT syndrome.

Local

Local side effects have included local tissue ischemia after repeated injections. Chronic IM epinephrine (the active ingredient contained in EpiPen 2-Pak) injections have induced local vasoconstriction, predisposing patients to Clostridial infections. Other local reactions have included injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

Psychiatric

Psychiatric side effects have included agitation, disorientation, impaired memory, aggressive or assaultive behavior, hallucinations, and psychosis.

Respiratory

Respiratory side effects have rarely included pulmonary edema. In some cases, acute left ventricular dysfunction has been documented in the presence of epinephrine-induced pulmonary edema. In some patients, epinephrine (the active ingredient contained in EpiPen 2-Pak) has precipitated severe, prolonged asthmatic attacks.

Metabolic

Metabolic side effects have included severe metabolic acidosis because of elevated blood concentrations of lactic acid after prolonged use of intravenous epinephrine (the active ingredient contained in EpiPen 2-Pak) Catecholamines have induced glycogenolysis, elevated blood glucose and insulin concentrations, and hypokalemia. Rare cases of hyperglycemia and acidosis have been associated with high catecholamine states, such as anaphylaxis.

Renal

Mattana and Singhal reviewed 420 consecutive cases of cardiac arrest and found a 28.6% incidence of acute renal failure (ARF) among patients who survived for at least 24 hours after cardiac arrest. Patients in whom ARF developed received markedly higher doses of epinephrine (the active ingredient contained in EpiPen 2-Pak) during resuscitative efforts than patients without ARF. High doses of epinephrine were associated with a longer duration of cardiopulmonary resuscitation. The patients with ARF had a significantly decreased survival rate. It is possible that patients with severe cardiac disease were less resuscitatable, required more epinephrine, and were prone to develop ARF anyway. Other data have failed to associated ARF with the use of high dose epinephrine.

Renal side effects have included new or worsened renal insufficiency in adult survivors of cardiac arrest, adults who underwent epinephrine-assisted venography, and in rare pediatric cases.

Hypersensitivity

Hypersensitivity side effects have been extremely unusual. Contact dermatitis has been associated with ocularly applied epinephrine (the active ingredient contained in EpiPen 2-Pak) These reactions have typically presented with lid edema and a thick yellow discharge.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

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