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Adverse Reactions Associated With Intramuscular/Subcutaneous Use (For Anaphylaxis)

Common adverse reactions to systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism [see WARNINGS AND PRECAUTIONS].

Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system:

Cardiovascular: angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, and ventricular ectopy.

Angina may occur in patients with coronary artery disease [see WARNINGS AND PRECAUTIONS].

Arrhythmias, including fatal ventricular fibrillation, have occurred, particularly in patients with underlying organic heart disease or patients receiving drugs that sensitize the heart to arrhythmias [see WARNINGS AND PRECAUTIONS].

Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see WARNINGS AND PRECAUTIONS].

Respiratory: respiratory difficulties.

Neurological: dizziness , disorientation , excitability , headache , impaired memory , lightheadedness , nervousness , panic, psychomotor agitation, sleepiness , tingling , tremor, and weakness.

Psychiatric: anxiety, apprehensiveness, restlessness.

Gastrointestinal: nausea, vomiting.

Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms [see WARNINGS AND PRECAUTIONS].

Diabetic patients may experience transient increases in blood sugar [see WARNINGS AND PRECAUTIONS].

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see WARNINGS AND PRECAUTIONS]. Adverse events experienced as a result of an injection into these areas include increased heart rate, local reactions including injection site pallor, coldness, hypoesthesia, and tissue loss, or injury at the injection site resulting in bruising, bleeding, discoloration, erythema, and skeletal injury.

Injection into the buttock has resulted in cases of gas gangrene [see WARNINGS AND PRECAUTIONS].

Skin: sweating.

Adverse Reactions Associated With Intraocular Use (For Mydriasis)

Epinephrine containing sodium bisulfite has been associated with corneal endothelial damage when used in the eye at undiluted concentrations (1 mg/mL).

To report SUSPECTED ADVERSE REACTIONS, contact JHP Pharmaceuticals at 1800-866-923-2547 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.