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

  • Itching
  • Swelling of lips and/or tongue

Lungs

  • Shortness of breath
  • Coughing
  • Wheezing

Heart

  • Weak pulse
  • Dizziness
  • Passing out
  • Shock

Skin

  • Itching
  • Hives
  • Redness
  • Swelling

Throat

  • Itching
  • Tightness/closure
  • Coughing

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 emergency (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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INDICATIONS (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN® and EPIPEN JR® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN or EPIPEN JR.

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

EPIPEN® (epinephrine injection, USP) 0.3 mg and EPIPEN JR® (epinephrine injection, USP) 0.15 mg Auto-Injectors are used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and happen within minutes. If untreated, anaphylaxis can cause death. This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes.

Always carry 2 EPIPEN or 2 EPIPEN JR Auto-Injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care.

When you have an allergic emergency (anaphylaxis), use EPIPEN or EPIPEN JR auto-injectors right away. Get emergency medical help right away even if you have used the EPIPEN or EPIPEN JR auto-injector. You can use a second EPIPEN or EPIPEN JR auto-injector if symptoms continue or if the first auto-injector is activated. If you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider.

Before you use EPIPEN or EPIPEN JR auto-injectors, tell your healthcare provider about all your medical conditions if you have heart problems with high blood pressure, diabetes, thyroid problems, asthma, a history of depression, Parkinson’s disease, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider about all of your known allergies. 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 your EPIPEN or EPIPEN JR auto-injector.

Especially tell your healthcare provider if you take certain asthma medicines. EPIPEN and EPIPEN JR and other medicines may affect the way other medicines work. Other medicines may affect how EPIPEN and EPIPEN JR auto-injector works.

EPIPEN or EPIPEN JR auto-injector should 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. It is very important that you hold the EPIPEN or EPIPEN JR auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the EPIPEN or EPIPEN JR auto-injector might not have time to deliver the correct dose of medicine. If you accidentally inject EPIPEN or EPIPEN JR auto-injectors into any place other than the middle of your outer thigh, go to the nearest emergency room right away. If you inject a young child, hold their leg firmly in place before and during the 3 second injection to prevent injuries.

Rarely, patients who have used EPIPEN or EPIPEN JR auto-injectors may get infections 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.

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 may go away with rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.


 Click here for the full Prescribing Information and Patient Information for EPIPEN.

Click here for 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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INDICATIONS (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN® and EPIPEN JR® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN or EPIPEN JR.

INDICATIONS (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN® and EPIPEN JR® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN or EPIPEN JR.

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

EPIPEN® (epinephrine injection, USP) 0.3 mg and EPIPEN JR® (epinephrine injection, USP) 0.15 mg Auto-Injectors are used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and happen within minutes. If untreated, anaphylaxis can cause death. This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes.

Always carry 2 EPIPEN or 2 EPIPEN JR Auto-Injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care.

When you have an allergic emergency (anaphylaxis), use EPIPEN or EPIPEN JR auto-injectors right away. Get emergency medical help right away even if you have used the EPIPEN or EPIPEN JR auto-injector. You can use a second EPIPEN or EPIPEN JR auto-injector if symptoms continue or if the first auto-injector is activated. If you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider.

Before you use EPIPEN or EPIPEN JR auto-injectors, tell your healthcare provider about all your medical conditions if you have heart problems with high blood pressure, diabetes, thyroid problems, asthma, a history of depression, Parkinson’s disease, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider about all of your known allergies. 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 your EPIPEN or EPIPEN JR auto-injector.

Especially tell your healthcare provider if you take certain asthma medicines. EPIPEN and EPIPEN JR and other medicines may affect the way other medicines work. Other medicines may affect how EPIPEN and EPIPEN JR auto-injector works.

EPIPEN or EPIPEN JR auto-injector should 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. It is very important that you hold the EPIPEN or EPIPEN JR auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the EPIPEN or EPIPEN JR auto-injector might not have time to deliver the correct dose of medicine. If you accidentally inject EPIPEN or EPIPEN JR auto-injectors into any place other than the middle of your outer thigh, go to the nearest emergency room right away. If you inject a young child, hold their leg firmly in place before and during the 3 second injection to prevent injuries.

Rarely, patients who have used EPIPEN or EPIPEN JR auto-injectors may get infections 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.

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 may go away with rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.


 Click here for full Prescribing Information and Patient Information for EPIPEN.

Click here for 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.

  • About EPIPEN and Its Authorized Generic
  • What is Anaphylaxis?
  • Have a Plan
  • Access to EPIPEN and the Authorized Generic to EPIPEN
  • About EPIPEN and Its Authorized Generic
  • What is Anaphylaxis?
  • Have a Plan
  • Access to EPIPEN and the Authorized Generic to EPIPEN
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