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Pulmicort Flexhaler is a steroid that is used to prevent asthma attacks.
Pulmicort Flexhaler is for use in adults and children at least 6 years old.
Pulmicort Respules is for use in children 12 months to 8 years old.
Budesonide may also be used for purposes not listed in this medication guide.
Budesonide is not a rescue medicine for asthma attacks. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.
You should not use budesonide if you are allergic to it, or if:
you have a severe allergy to milk proteins; or
you are having an asthma attack.
Tell your doctor if you have ever had:
food or drug allergies;
liver disease;
osteoporosis, or low bone mineral density;
glaucoma, cataracts, or herpes infection of the eyes;
tuberculosis; or
any type of infection caused by bacteria, fungus, virus, or parasite.
Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, if you have a family history of osteoporosis, or if you are a woman going through menopause.
Tell your doctor if you are pregnant or breast-feeding.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Pulmicort Flexhaler is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Use only the inhaler device that comes with Pulmicort Flexhaler. Do not place the device in water or try to take it apart.
Pulmicort Respules should be used only with a standard jet nebulizer connected to an air compressor. Do not mix with other medicines in the nebulizer cup (reservoir).
Rinse your mouth with water after using Pulmicort Flexhaler, to help prevent thrush (a fungal infection in the mouth or throat). If you are using a nebulizer with a face mask, wash the mask area of your face after each use.
Do not allow a young child to use Pulmicort Flexhaler without help from an adult.
Your doctor will need to check your progress on a regular basis.
Call your doctor if your symptoms do not improve of if they get worse. If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.
Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.
Store at room temperature, away from moisture, light, and heat. Keep the cover on your inhaler device while not in use.
In case of emergency, wear or carry medical identification to let others know you use a steroid medication.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
High doses or long-term use of budesonide can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
Avoid getting Pulmicort Flexhaler in your eyes.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.
Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching; chest pain, difficult breathing, feeling anxious; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
worsening asthma symptoms;
wheezing, choking, or other breathing problems after using this medication;
white patches or sores inside your mouth or on your lips;
blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
signs of infection--fever, chills, body aches, ear pain, nausea, vomiting; or
signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.
Pulmicort Flexhaler can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
runny or stuffy nose, sneezing;
red, itchy, and watery eyes;
fever, sore throat, cough;
nausea, vomiting, diarrhea, stomach pain, loss of appetite;
nosebleed; or
headache, back pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your other medicines, especially:
antifungal medicine (such as ketoconazole);
drugs that weaken your immune system;
seizure medication; or
other steroid medicine (flunisolide, fluticasone, mometasone, and others).
This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Pulmicort Flexhaler (www.drugs.com/mtm/pulmicort-flexhaler.html).
Note: This document contains side effect information about budesonide. Some of the dosage forms listed on this page may not apply to the brand name Pulmicort Flexhaler.
Applies to budesonide: oral capsule delayed release, oral tablet extended release
Other dosage forms:
Along with its needed effects, budesonide (the active ingredient contained in Pulmicort Flexhaler) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking budesonide:
More common
Less common
Incidence not known
Some side effects of budesonide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral delayed release capsule, oral tablet extended release, rectal foam
The most commonly reported adverse events with inhaled use have included nasopharyngitis, nasal congestion pharyngitis, rhinitis, and oral candidiasis. Headache, nausea, abdominal pain, and fatigue have been commonly reported with oral and rectal use. Due to the nature of its administration (inhalation, gastro-protective oral formulations, and rectal enema), it is less likely to cause systemic adverse effects associated with the use of corticosteroids.
Epidemiological studies have shown an increased incidence of pneumonia in patients with chronic obstructive pulmonary disease (COPD) treated with inhaled corticosteroids.
Very common (10% or more): Respiratory infection (up to 13%)
Common (1% to 10%): Nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, epistaxis, cough, dysphonia, hoarseness
Frequency not reported: Bronchitis, dyspnea, pharynx disorder, pneumonia
Postmarketing reports: Throat irritation, sinusitis
Deaths due to adrenal insufficiency have been reported in asthmatic patients during and after transferring from systemic corticosteroids to less systemically available inhaled corticosteroids.
Common (1% to 10%): Decreased blood cortisol, moon face
Uncommon (0.1% to 1%): Hirsutism, Cushingoid syndrome
Frequency not reported: Intermenstrual bleeding, menstrual disorder, HPA axis suppression, deaths due to adrenal insufficiency
Postmarketing reports: Hypocorticism
Common (1% to 10%): Oral candidiasis
Frequency not reported: Immunosuppression, abscess
Very common (10% or more): Nausea (up to 13%); abdominal pain (21%)
Common (1% to 10%): Viral gastroenteritis, upper abdominal pain, flatulence, abdominal distension, constipation, dyspepsia, vomiting, diarrhea, sore/irritated throat, dry mouth, bad taste, rectal disorder, rectal hemorrhage, ulcerative colitis, burning in the rectum or pain
Frequency not reported: Anus disorder, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder
Postmarketing reports: Pancreatitis
Very common (10% or more): Headache (up to 28%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Disturbance of smell
Very rare (less than 0.01%): Pseudotumor cerebri (including papilledema)
Frequency not reported: Hyperkinesia, paresthesia, tremor, somnolence
Postmarketing reports: Benign intracranial hypertension
Common (1% to 10%): Mood changes, sleep changes, insomnia,
Frequency not reported: Amnesia
Postmarketing reports: Psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, anxiety, mood swings
Frequency not reported: Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, bronchospasm
Postmarketing reports: Cough, wheezing, bronchospasm
Common (1% to 10%): Arthralgia, back pain
Very rare (less than 0.01%): Osteoporosis, aseptic necrosis of bone (femur and head of the humerus)
Frequency not reported: Bone mineral density reductions, arthritis, cramps, myalgia, growth suppression
Long-term studies in clinical practice suggest that children treated with inhaled drug generally achieve adult height. However, in a long-term study in which inhaled drug dose was not titrated to the lowest effective dose, children were found to be 1.2 cm shorter as adults than those randomized to placebo.
Common (1% to 10%): Fluid retention, palpitation
Uncommon (0.1% to 1%): Hypertension
Frequency not reported: Tachycardia, chest pain, dependent edema, flushing
Frequency not reported: Weight gain, increased appetite, hypokalemia
Common (1% to 10%): Leukocytosis
Uncommon (0.1% to 1%): Anemia
Rare (0.01% to 0.1%): Eosinophilic conditions, Churg-Strauss
Common (1% to 10%): Conjunctivitis
Frequency not reported: Eye abnormality, abnormal vision
Postmarketing reports: Glaucoma, cataracts, increased intraocular pressure
Common (1% to 10%): Urinary tract infection, moniliasis
Frequency not reported: Dysuria, micturition frequency, nocturia
Common (1% to 10%): Acne, rash, contact dermatitis, eczema, pustular rash, pruritus, purpura
Very rare (less than 0.01%): Allergic exanthema, red striae, petechiae, ecchymosis, delayed wound healing
Frequency not reported: Face edema, alopecia, dermatitis, eczema, skin disorder, increased sweating, purpura
Postmarketing reports: Skin bruising
Uncommon (0.1% to 1%): Increase in liver enzymes
Common (1% to 10%): Otitis media, fatigue, earache
Frequency not reported: Asthenia, malaise, fever, flu-like disorder, vertigo
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Pulmicort Flexhaler (www.drugs.com/mtm/pulmicort-flexhaler.html).
May 12, 2020
May 12, 2020
May 12, 2020
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