Pulmicort Flexhaler

Budesonide Pulmicort Flexhaler (the brand version of Budesonide) is a medication used to treat asthma symptoms. It can help prevent asthma attacks and reduce their intensity by controlling inflammation and opening up airways. Pulmicort is an inhaled corticosteroid. Read more about asthma.
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How to use this information
This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your medical provider. If you have any questions, go to your patient dashboard and request a callback for complete information about this product and your specific health needs.
Medication Name

BUDESONIDE BREATH-ACTIVATED INHALER - ORAL INHALATION\ (bue-DES-oh-nide)

COMMON BRAND NAME(S): Pulmicort

What you should know about Budesonide Breath-Activated Inhaler - Oral Inhalation
  • Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways.
  • This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.
Other Uses for Budesonide Breath-Activated Inhaler - Oral Inhalation
  • This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your medical provider. Use this drug for a condition that is listed in this section only if it has been so prescribed by your medical provider.
  • This drug may also be used for lung diseases such as bronchitis and emphysema.
How to take Budesonide Breath-Activated Inhaler - Oral Inhalation
  • Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill.
  • Follow the illustrated directions for the proper use of this medication. If you have any questions, go to your patient dashboard and request a callback from your medical provider or ask your pharmacist.
  • Do not shake this product and do not use a spacer with it. Hold the device upright while using. If the inhaler device is dropped or shaken or if you accidentally breathe into the device after the dose has been loaded, you will lose the dose. Load another dose. Do not use the inhaler if it has been damaged or if the mouthpiece has come off.
  • Inhale this medication by mouth, usually once or twice daily or as directed by your medical provider. Inhale deeply and forcefully while using the device. Turn your mouth away from the device to breathe out before inhaling. Do not exhale back into the device.
  • If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication and use this drug (the corticosteroid) last.
  • To prevent dry mouth, hoarseness and oral yeast infections from developing, gargle and rinse your mouth with water, then spit it out after each use. Do not swallow the rinse water.
  • Keep track of each dose of medication you use. Discard the device after it has delivered the labeled number of doses or when the red mark reaches the bottom of the dose indicator window.
  • The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.
  • Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster and your risk of side effects will increase.
  • Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs).
  • Ask your medical provider ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week) or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.
  • If you are regularly taking a different corticosteroid by mouth (such as Prednisone), you should not stop taking it unless directed by your medical provider. Some conditions (such as asthma or allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness or dizziness). To help prevent withdrawal, your medical provider may slowly lower the dose of your old medication after you begin using Budesonide. Request a callback from your medical provider or speak with your pharmacist right away if you have withdrawal. See also Precautions section.
  • You may notice a benefit within 24 hours of starting this drug. It may take 1-2 weeks before the full benefit of this drug takes effect. Request a callback from your medical provider if your symptoms do not improve or if they worsen.
Potential side effects
  • See also “Precautions to be aware of” section.
  • Dry/irritated throat, hoarseness, voice changes, nausea, bad taste in the mouth, runny/stuffy nose or nosebleeds may occur. If any of these effects last or get worse, tell your medical provider or pharmacist promptly.
  • Remember that this medication has been prescribed because your medical provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
  • Rarely, this medication may cause sudden breathing problems/asthma right after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.
  • Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Request a callback from your medical provider right away if you have any signs of infection (such as ear pain, sore throat, fever or chills).
  • Use of this medication for prolonged or repeated periods may result in oral thrush (yeast infection). Request a callback from your medical provider if you notice white patches in your mouth or on your tongue.
  • Request a callback from your medical provider right away if you have any serious side effects, including:

    • Unusual tiredness
    • Vision problems
    • Easy bruising/bleeding
    • Puffy face
    • Unusual hair growth
    • Mental/mood changes (such as depression, mood swings or agitation)
    • Muscle weakness/pain
    • Thinning skin
    • Slow wound healing
    • Increased thirst or urination
  • A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

    • Rash
    • Itching or swelling (especially of the face, tongue or throat)
    • Severe dizziness
    • Trouble breathing
  • This is not a complete list of possible side effects. If you notice other effects not listed above, request a callback for medical advice. You may also report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Precautions to be aware of
  • Before using Budesonide, tell your medical provider or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients (such as lactose or milk proteins found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
  • Before using this medication, tell your medical provider or pharmacist your medical history, especially of:

    • Eye disease (such as cataracts or glaucoma)
    • High blood pressure
    • Liver disease
    • Thyroid problems
    • Diabetes
    • Stomach/intestinal problems (such as diverticulitis or ulcer)
    • Bone loss (osteoporosis)
    • Current/past infections (such as tuberculosis, positive tuberculosis test, herpes or fungal)
    • Bleeding problems
    • Mental/mood conditions (such as psychosis, anxiety or depression)
    • Decreased adrenal gland function
  • If you have switched from a corticosteroid taken by mouth (such as Prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your medical provider or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Request a callback from  your medical provider right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.
  • Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs and herbal products).
  • This medication may mask signs of infection. It can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles or flu). Talk to your medical provider if you have been exposed to an infection or for more details.
  • Tell your medical provider that you are using Budesonide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
  • This medication may temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. See your child’s pediatrician regularly so your child's height can be checked.
  • During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your OB/GYN.
  • This medication passes into breast milk. Consult your OB/GYN or child’s pediatrician before breastfeeding.
Drug interactions
  • Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
  • Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your medical provider and pharmacist. Do not start, stop or change the dosage of any medicines without your medical provider's approval.
  • Some products that may interact with this drug include: Aldesleukin, Mifepristone, Fexindazole, Desmopressin, Fusidic Acid, Loxapine.
  • This product may interfere with certain lab tests (such as skin tests). Make sure laboratory personnel and all your medical providers know you use this drug.
What to do in the event of an overdose
  • If someone has overdosed and has serious symptoms, such as passing out or trouble breathing, call 911. If symptoms from taking this medication are less severe, call your local poison control center at 1-800-222-1222 right away.
Additional notes
  • Do not share this medication with others.
  • Learn to use a peak flow meter, use it daily and promptly report worsening asthma (such as readings in the yellow/red range or increased use of quick-relief inhalers).
  • Lab and/or medical tests (such as cortisol levels, bone density tests, eye exams and height/weight measurements) should be done while you are using this medication. Keep all medical and lab appointments. Consult your medical provider for more details.
  • Avoid allergens (such as pollen and pet dander), irritants, smoking/secondhand smoke and other factors that make asthma worse.
  • Most people with asthma or ongoing lung disease should receive a flu shot annually. Discuss with your medical provider.
  • In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your medical provider about your risk and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).
What to do if you miss a dose
  • If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
How to store this medication
  • Store with the cover tightly in place at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
  • Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Treatment for
Generic Name
Budesonide
Brand
Pulmicort Flexhaler
Drug Class
Inhaled corticosteroid (ICS)

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