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Do you know the signs and symptoms of anaphylaxis?

Anaphylaxis (an-a-fi-lax-is) is the medical term for a potentially life-threatening allergic reaction. It can occur within minutes after exposure to an allergen . That’s why it’s important to know what symptoms to look for:

Mouth icon

Mouth

  • Itching
  • Swelling of lips and/or tongue
Lung icon

Lungs

  • Shortness of breath
  • Coughing
  • Wheezing
Heart icon

Heart

  • Weak pulse
  • Dizziness
  • Passing out
  • Shock
Skin icon

Skin

  • Itching
  • Hives
  • Redness
  • Swelling
Throat icon

Throat

  • Itching
  • Tightness/closure
  • Coughing
Stomach icon

Stomach

  • Vomiting
  • Nausea
  • Diarrhea
  • Cramps

Why is it important to know these signs and symptoms?

Anaphylaxis is unpredictable—a mild allergic reaction one time can be life-threatening or severe the next. For example, someone who has a peanut allergy may accidentally eat a peanut and feel tingling lips and watery eyes that eventually go away. However, if the same person is accidentally exposed to a peanut on a different occasion, it could cause difficulty breathing, weak pulse, shortness of breath, fainting and hives that may quickly become life-threatening. Both are instances of anaphylaxis, but the severity, progression, symptoms and duration of the symptoms are inconsistent and unpredictable.

Is shock (sometimes called anaphylactic shock) a symptom of anaphylaxis?

Shock is just one of the many possible symptoms of anaphylaxis. It occurs when there is inadequate blood flow to critical organs of the body during anaphylaxis. However, shock may not be one of the symptoms a person experiences during anaphylaxis. More than half of all patients in a 10-year study showed no signs of shock during anaphylaxis. That’s why the term anaphylaxis is not interchangeable with the term anaphylactic shock—the first term encompasses all possible symptoms of a life-threatening allergic reaction.

Vigilance is essential

Because of this unpredictability, it’s crucial for parents and caregivers of children living with potentially life-threatening, or severe, allergies—as well as adults with severe allergies—to be vigilant about any type of allergic reaction ranging from mild to severe. Talk to a healthcare professional about how to identify the signs and symptoms of a life-threatening allergic reaction (anaphylaxis).

When to use EPIPEN® (epinephrine injection, USP) or EPIPEN JR® (epinephrine injection, USP) Auto-Injector (or the authorized generics)

The drug in EPIPEN and EPIPEN JR Auto-Injectors (and their authorized generics) is epinephrine. It’s important to administer epinephrine at the first signs of anaphylaxis.

According to National Food Allergy Guidelines, epinephrine is the first-line treatment for life-threatening allergic reactions. A delay in administering epinephrine can be life-threatening.

If you, your child or someone you're caring for shows signs or symptoms of a life-threatening allergic reaction, administer EPIPEN or EPIPEN JR Auto-Injector immediately as prescribed and seek emergency medical care.

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Antihistamines are not recommended for the life-threatening symptoms of anaphylaxis.

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IMPORTANT SAFETY INFORMATION (the following information applies to both EPIPEN and its Authorized Generic)

Use EPIPEN (epinephrine injection, USP) 0.3 mg or EPIPEN JR (epinephrine injection, USP) 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. EPIPEN or EPIPEN JR should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

IMPORTANT SAFETY INFORMATION (the following information applies to both EPIPEN and its Authorized Generic)

Use EPIPEN (epinephrine injection, USP) 0.3 mg or EPIPEN JR (epinephrine injection, USP) 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. EPIPEN or EPIPEN JR should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

Rarely, patients who have used EPIPEN or EPIPEN JR may develop an infection at the injection site within a few days. Some of these infections can be serious. Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, 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 healthcare professional 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 use EPIPEN or EPIPEN JR.

Common side effects include fast, irregular or “pounding” heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Indications (the following information applies to both Epipen and its Authorized Generic)

EPIPEN and EPIPEN JR  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 administration as emergency supportive therapy only. Seek immediate emergency medical help right away.


Please see the full Prescribing Information and Patient Information for EPIPEN.

Please see the full Prescribing Information and Patient Information for the Authorized Generic for EPIPEN.

For additional information please contact us at 800-796-9526.

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.

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