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Risk And Side Effects

This is not all the safety information about VENTOLIN® HFA. This information does not replace talking with your healthcare provider about your medical condition or treatment. Please see the Patient Information for more information, or ask your healthcare provider or pharmacist.

Do not use VENTOLIN HFA if you are allergic to albuterol sulfate or any of the ingredients in
VENTOLIN HFA. See the full Patient Information Leaflet for a complete list of ingredients in
VENTOLIN HFA.
Before you use VENTOLIN HFA, tell your healthcare provider if you:
  • have heart problems
  • have high blood pressure (hypertension)
  • have convulsions (seizures)
  • have thyroid problems
  • have diabetes
  • have low potassium levels in your blood
  • are pregnant or plan to become pregnant. It is not known if VENTOLIN HFA will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if VENTOLIN HFA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using VENTOLIN HFA.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

VENTOLIN HFA and other medicines may affect each other and cause side effects.

VENTOLIN HFA may affect the way other medicines work, and other medicines may affect the way VENTOLIN HFA works.

Especially tell your healthcare provider if you take:
  • other inhaled medicines or asthma medicines
  • beta-blocker medicines
  • diuretics
  • digoxin
  • monoamine oxidase inhibitors
  • tricyclic antidepressants
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
VENTOLIN HFA may cause serious side effects, including:
  • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using VENTOLIN HFA and call your healthcare provider or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
  • heart problems, including faster heart rate and higher blood pressure
  • possible death in people with asthma who use too much VENTOLIN HFA
  • allergic reactions. Call your healthcare provider right away if you have any of the following symptoms of an allergic reaction:
    • itchy skin
    • swelling beneath your skin or in your throat
    • rash
    • worsening trouble breathing
  • low potassium levels in your blood
  • worsening of other medical problems in people who also use VENTOLIN HFA, including increases in blood sugar
Common side effects of VENTOLIN HFA include:
  • your heart feels like it is pounding or racing (palpitations)
  • chest pain
  • fast heart rate
  • shakiness
  • nervousness
  • headache
  • pain
  • dizziness
  • sore throat
  • runny nose

Tell your healthcare provider 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 the FDA at
1-800-FDA-1088.
  • Use VENTOLIN HFA exactly as your healthcare provider tells you to use it.
  • Do not increase your dose or take extra doses of VENTOLIN HFA without first talking to your healthcare provider.
  • If your child needs to use VENTOLIN HFA, watch your child closely to make sure your child uses the inhaler correctly. Your healthcare provider will show you how your child should use
    VENTOLIN HFA.
  • Each dose of VENTOLIN HFA should last up to 4 hours to 6 hours.
  • Get medical help right away if VENTOLIN HFA no longer helps your symptoms.
  • Get medical help right away if your symptoms get worse or if you need to use your inhaler more often.
  • While you are using VENTOLIN HFA, use other inhaled medicines and asthma medicines only as directed by your healthcare provider.
  • Call your healthcare provider if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Your healthcare provider may need to give you another medicine to treat your symptoms.

APPROVED USES FOR VENTOLIN HFA

VENTOLIN HFA is a prescription medicine used to treat or prevent bronchospasm in people 4 years of age and older with reversible obstructive airway disease. VENTOLIN HFA is also used to prevent exercise-induced bronchospasm (EIB) in patients 4 years of age and older. It is not known if VENTOLIN HFA is safe and effective in children under 4 years of age.

IMPORTANT SAFETY INFORMATION FOR
VENTOLIN HFA

  • Do not use VENTOLIN HFA if you are allergic to albuterol sulfate or any of the ingredients in VENTOLIN HFA. If you have any questions or are not sure, you should ask your healthcare provider.
  • Tell your healthcare provider about the medicines you take and about all of your medical conditions.
  • Use VENTOLIN HFA exactly as your healthcare provider tells you to use it.
  • Do not increase your dose or take extra doses of VENTOLIN HFA without first talking to your healthcare provider.
  • Get medical help right away if VENTOLIN HFA no longer helps your symptoms (like wheezing and trouble breathing), if your symptoms get worse, or if you need to use your inhaler more often.
  • While you are using VENTOLIN HFA, use other inhaled medicines and asthma medicines only as directed by your healthcare provider.
  • VENTOLIN HFA may cause serious side effects, including:
    • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using VENTOLIN HFA and call your healthcare provider or get emergency help right away. This is more likely to happen with your first use of a new canister of medicine.
    • heart problems, including faster heart rate and higher blood pressure.
    • possible death in people with asthma who use too much VENTOLIN HFA.
    • allergic reactions. Call your healthcare provider right away if you have any of the following symptoms of an allergic reaction:
      • itchy skin
      • swelling beneath your skin or in your throat
      • rash
      • worsening trouble breathing
    • low potassium levels in your blood.
    • worsening of other medical problems in people who also use VENTOLIN HFA, including increases in blood sugar.
  • Common side effects of VENTOLIN HFA include:
    • your heart feels like it is pounding or racing (palpitations)
    • chest pain
    • fast heart rate
    • shakiness
    • nervousness
    • headache
    • pain
    • dizziness
    • sore throat
    • runny nose

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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