EPINEPHRINE ABBOJECT NDC 0409-4933-01 Adverse Reactions

(Epinephrine injection, USP ABBOJECT)

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in labeling:

The following adverse reactions have been associated with use of epinephrine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Cardiovascular disorders: tachycardia, supraventricular tachycardia, ventricular arrhythmias (including fatal ventricular fibrillation), myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema, hypertension

Gastrointestinal disorders: nausea, vomiting

General disorders and administrative site conditions: extravasation

Metabolic: insulin resistance, hypokalemia, lactic acidosis

Nervous system disorders: headache, paresthesia, tremor, stroke, central nervous system bleeding, weakness, dizziness, disorientation, impaired memory, panic, psychomotor agitation, somnolence

Psychiatric disorders: excitability, anxiety, apprehensiveness, nervousness, restlessness

Renal disorders: renal insufficiency

Respiratory: rales

Skin and subcutaneous tissue disorders: diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation.

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Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in labeling:

The following adverse reactions have been associated with use of epinephrine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Cardiovascular disorders: tachycardia, supraventricular tachycardia, ventricular arrhythmias (including fatal ventricular fibrillation), myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema, hypertension

Gastrointestinal disorders: nausea, vomiting

General disorders and administrative site conditions: extravasation

Metabolic: insulin resistance, hypokalemia, lactic acidosis

Nervous system disorders: headache, paresthesia, tremor, stroke, central nervous system bleeding, weakness, dizziness, disorientation, impaired memory, panic, psychomotor agitation, somnolence

Psychiatric disorders: excitability, anxiety, apprehensiveness, nervousness, restlessness

Renal disorders: renal insufficiency

Respiratory: rales

Skin and subcutaneous tissue disorders: diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation.

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