Overview

What is a Life-Threatening Allergic Reaction?

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

Anaphylaxis (a-na-fi-LAX-is) is a life-threatening allergic reaction that can occur quickly (as fast as within a couple of minutes). Symptoms of a life-threatening allergic reaction (anaphylaxis) vary, but can include hives, itching, flushing, and swelling of the lips, tongue, and roof of mouth. The airway is often affected, resulting in tightness of the throat, chest tightness and difficulty breathing. These reactions can also be accompanied by chest pain, low blood pressure, dizziness and headaches. A life-threatening allergic reaction (anaphylaxis) can be caused by a number of  triggers, including but not limited to certain foods, stinging and biting insects, medications, and latex.

Make sure you speak with your health care professional about how to identify the signs and symptoms of a life-threatening allergic reaction (anaphylaxis).  If you, your child or someone you're caring for shows signs or symptoms of a life-threatening allergic reaction (anaphylaxis), inject the health care professional-prescribed EpiPen®(epinephrine) or EpiPen Jr.®(epinephrine) immediately, then promptly call 911 and seek immediate medical attention. Failure to inject EpiPen Auto-Injector at the first signs of a life-threatening allergic reaction (anaphylaxis) can be life threatening.

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.