Overview

Common Causes

What Causes a Life-Threatening Allergic Reaction (Anaphylaxis)?

A life-threatening allergic reaction (anaphylaxis) is usually a severe reaction to a specific allergen (trigger). These triggers can include but are not limited to food, stinging and biting insects, medications and latex. While less common, anaphylaxis can also be triggered by exercise, and some reactions may have unknown causes, which should be further evaluated by your health care professional. Not everyone exposed to an allergen (trigger) will have a life-threatening allergic reaction.

Anaphylaxis occurs when the body perceives a trigger as a threat and starts forming antibodies (special proteins made by the body’s immune system) to defend itself. These antibodies cause the release of substances (molecules released by the immune system when harmful agents invade the body), which produce the immediate symptoms of anaphylaxis.

Consult a health care professional if you or your child has had even a mild reaction to an allergen (trigger) because a prior mild reaction is not an indicator of the severity of future reactions. A mild allergic reaction can progress and become life-threatening within minutes.

Important Safety Information

EpiPen® (epinephrine) Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. DO NOT INJECT INTO YOUR VEIN, BUTTOCK, FINGERS, TOES, HANDS OR FEET. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure and heart disease, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your doctor all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you take the EpiPen or EpiPen Jr Auto Injector.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest.

Talk to your health care professional to see if EpiPen or EpiPen Jr Auto-Injector is right for you.

Indications

EpiPen® (epinephrine) 0.3 mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate self administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information please contact us at 800-395-3376.