Does Pulmicort Flexhaler (budesonide) cause side effects?
Pulmicort Flexhaler (budesonide) is a man-made glucocorticoid steroid related to the naturally-occurring hormone, cortisol or hydrocortisone which is produced in the adrenal glands used to treat asthma by inhalation.
Glucocorticoid steroids such as cortisol or budesonide have potent anti-inflammatory actions that reduce inflammation and hyper-reactivity (spasm) of the airways caused by asthma. When used as an inhaler, the budesonide goes directly to the inner lining of the inflamed airways to exert its effects.
Only 39% of an inhaled dose of budesonide is absorbed into the body, and the absorbed budesonide contributes little to the effects on the airways. While some improvement in the symptoms of asthma may occur within 24 hours, it may take a few weeks to obtain the maximum therapeutic benefits of Pulmicort Flexhaler when used to treat asthma.
Common side effects of Pulmicort Flexhaler include
- mild cough,
- oral candidiasis or thrush (a fungal infection of the throat),
- sore throat, and
- changes in voice.
Serious side effects of Pulmicort Flexhaler include
- weakened bones and ultimately osteoporosis and fractures,
- suppression of the adrenal glands, and
- hypersensitivity reactions (anaphylaxis, rash, contact dermatitis, itching, angioedema, and bronchospasm).
Drug interactions of Pulmicort Flexhaler include strong liver enzyme inhibitors (CYP 3A4 inhibitors) such as ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, and telithromycin because the concentration in blood of budesonide may rise increasing the probability of an individual experiencing more side effects.
Studies of pregnant women using inhaled budesonide during early pregnancy do not show an increase in the rate of fetal abnormalities. Nevertheless, since these studies cannot exclude the possibility of rare effects on the fetus, inhaled Pulmicort Flexhaler should be used with caution during pregnancy.
Budesonide like other drugs of its class is secreted in breast milk. It is unknown if the small amounts that may appear in breast milk have effects on the infant. The benefits of breastfeeding an infant should be weighed against the possible risks associated with using Pulmicort Flexhaler in a nursing mother.
What are the important side effects of Pulmicort Flexhaler (budesonide)?
- The most commonly noted side effects associated with inhaled budesonide are mild cough or wheezing; these effects may be minimized by using a bronchodilator inhaler, for example, albuterol (Ventolin HFA), prior to the budesonide.
- Oral candidiasis or thrush (a fungal infection of the throat) may occur in 1 in 25 persons who use budesonide without a spacer device on the inhaler. The risk is even higher with large doses, but is less in children than in adults.
- Hoarseness or sore throat also may occur in 1 in 10 persons. Using a spacer device on the inhaler and washing the mouth out with water following each use reduces the risk of both thrush and hoarseness.
- Less commonly, alterations in voice may occur.
High doses of inhaled glucocorticoid steroids may decrease the formation and increase the breakdown of bone leading to weakened bones and ultimately osteoporosis and fractures. High doses may suppress the body's ability to make its own natural glucocorticoid in the adrenal gland. It is possible that these effects are shared by budesonide.
People with suppression of their adrenal glands (which can be tested for by the doctor) need increased amounts of glucocorticoid steroids orally or intravenously during periods of high physical stress, for example, during infections, to prevent serious illness and shock.
Hypersensitivity reactions, which have been reported with the issue of inhaled budesonide include
Use of budesonide should be discontinued if such reactions occur.
Pulmicort Flexhaler (budesonide) side effects list for healthcare professionals
Systemic and inhaled corticosteroid use may result in the following:
- Candida albicans infection
- Hypersensitivity Including Anaphylaxis
- Hypercorticism and Adrenal Suppression
- Reduction in Bone Mineral Density
- Growth Effects
- Glaucoma and Cataracts
- Eosinophilic conditions and Churg-Strauss
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Pulmicort Flexhaler (budesonide inhalation powder)
Patients 6 years and older
- The incidence of common adverse reactions in Table 1 is based upon pooled data reported in patients treated with Pulmicort Flexhaler (budesonide inhalation powder) 180 or 90 mcg in two double blind, placebo-controlled clinical trials in which 226 patients (106 females and 120 males) with mild to moderate asthma, previously receiving bronchodilators, inhaled corticosteroids, or both, were treated with Pulmicort Flexhaler (budesonide inhalation powder), administered as 360 mcg twice daily for 12 weeks.
- In these trials, the patients on Pulmicort Flexhaler had a mean age of 28 years (range 6-80 years) and were predominantly Caucasian (59.7%) and Asian (31.4%).
- Table 1 includes all adverse reactions (regardless of investigator causality assessment) that occurred at a rate of ≥ 1% in the Pulmicort Flexhaler (budesonide inhalation powder) group and more commonly than the placebo group.
Table 1 : Adverse Reactions occurring at an incidence of ≥ 1% and more commonly than placebo in the Pulmicort Flexhaler (budesonide inhalation powder) group: pooled data from two 12-week, double-blind, placebo-controlled clinical asthma trials in patients 6 years and older
|Adverse Event||Pulmicort Flexhaler (budesonide inhalation powder) 360 mcg|
|Viral upper respiratory tract infection||2.2||1.3|
|Average exposure duration (days)||76.2||68.2|
Long-Term Safety in Patients 6 years of age and older
- Non-placebo controlled long-term studies in children (at doses up to 360 mcg daily), and adolescent and adult subjects (at doses up to 720 mcg daily), treated for up to one year with Pulmicort Flexhaler (budesonide inhalation powder), revealed a similar pattern and incidence of adverse events.
Pulmicort Turbuhaler; a different Pulmicort DPI
The following adverse reactions occurred in placebo-controlled clinical trials with similar or lower doses with inhaled budesonide via a different Pulmicort dry powder inhaler with an incidence of ≥ 1% in the budesonide group and were more common than in the placebo group:
- ≥ 3%: respiratory infection, sinusitis, headache, pain, back pain, fever.
- ≥ 1-3%: neck pain, syncope, abdominal pain, dry mouth, vomiting, weight gain, fracture, myalgia, hypertonia, migraine, ecchymosis, insomnia, infection, taste perversion, voice alteration.
Higher doses of inhaled budesonide (800 mcg twice daily) via a different Pulmicort dry powder inhaler resulted in an increased incidence of voice alteration, flu syndrome, dyspepsia, gastroenteritis, nausea, and back pain, compared with doses of 400 mcg twice daily.
In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the incidence of adverse reactions was evaluated with 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) of inhaled budesonide via a different Pulmicort dry powder inhaler and compared with placebo (N=53).
In considering these data, the increased average duration of exposure for inhaled budesonide patients (78 days for inhaled budesonide vs. 41 days for placebo) should be taken into account.
Adverse reactions, regardless of investigator causality assessment, reported in more than five patients in the budesonide group and which occurred more commonly than the placebo group in decreasing order of frequency include:
- respiratory infection,
- oral candidiasis,
- cough increased,
- nausea and
The following adverse reactions have been reported during post-approval use of Pulmicort Flexhaler (budesonide inhalation powder). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Immune system disorders: immediate and delayed hypersensitivity reactions including anaphylactic reaction, angioedema, bronchospasm, rash, contact dermatitis, urticaria, and cough, wheezing or bronchospasm in patients with severe milk protein hypersensitivity
- Endocrine disorders: symptoms of hypocorticism and hypercorticism
- Eye disorders: cataracts, glaucoma, increased intraocular pressure
- Psychiatric disorders: psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety
- Respiratory, thoracic, and mediastinal disorders: throat irritation
- Skin and subcutaneous tissue disorders: skin bruising
What drugs interact with Pulmicort Flexhaler (budesonide)?
Inhibitors of Cytochrome P4503A4
- The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4).
- After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased.
- Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide.
- Caution should be exercised when considering the co-administration of Pulmicort Flexhaler (budesonide inhalation powder) with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin).
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Related Disease Conditions
Asthma is a condition in which hyperreactive airways constrict and result in symptoms like wheezing, coughing, and shortness of breath. Causes of asthma include genetics, environmental factors, personal history of allergies, and other factors. Asthma is diagnosed by a physician based on a patient's family history and results from lung function tests and other exams. Inhaled corticosteroids (ICS) and long-acting bronchodilators (LABAs) are used in the treatment of asthma. Generally, the prognosis for a patient with asthma is good. Exposure to allergens found on farms may protect against asthma symptoms.
Asthma: Over the Counter Treatment
Patients who have infrequent, mild bouts of asthma attacks may use over-the-counter (OTC) medications to treat their asthma symptoms. OTC asthma medicines are limited to epinephrine and ephedrine. These OTC drugs are best used with the guidance of a physician, as there may be side effects and the drugs may not be very effective.
COPD vs. Asthma (Differences and Similarities)
COPD (chronic obstructive pulmonary disease) and asthma both have common symptoms like coughing, wheezing, shortness of breath, and a tight feeling in the chest. COPD is caused by tobacco smoking, while asthma is caused by your inherited genetic makeup and their interactions with the environment. Risk factors for asthma are obesity, exposure to cigarette smoke (even secondhand smoke), and personal history of hay fever. There is no cure for either disease, but symptoms can be managed with medication. A person with asthma has a better prognosis and life expectancy than someone with COPD.
There are two types of asthma medications: long-term control with anti-inflammatory drugs and quick relief from bronchodilators. Asthma medicines may be inhaled using a metered-dose inhaler or nebulizer or they may be taken orally. People with high blood pressure, diabetes, thyroid disease, or heart disease shouldn't take OTC asthma drugs like Primatene Mist and Bronkaid.
What Is the Treatment for Asthmatic Bronchitis?
Asthmatic bronchitis refers to inflammation of the bronchial tubes carrying air inside the lungs that occurs because of asthma. Treatment for asthmatic bronchitis involves bronchodilators, steroids, treating secretions, leukotriene inhibitors, antibiotics, oxygen administration and avoiding triggers.
What Is Asthma? 19 Complex Facts
There are many unusual symptoms of asthma, including sighing, difficulty sleeping, anxiety, chronic cough, recurrent walking pneumonia, and rapid breathing. These symptoms may vary from individual to individual. These asthma complexities make it difficult to accurately diagnose and treat asthma.
How Can I Treat My Child's Asthma at Home?
Treatment of a child’s asthma involves following an action plan developed in consultation with your child’s pediatrician. Severe asthmatic attacks require immediate medical attention and treatment at the hospital.
Asthma in Children
Asthma in children manifests with symptoms such as coughing and wheezing. Rates of asthma in children are increasing. Asthma in children is usually diagnosed based on the description of symptoms. Lung function tests may also be used. A variety of medications are used for the treatment of childhood asthma.
How Long Does Asthmatic Bronchitis Last?
The duration of the disease usually depends on the patient’s overall health and age. In patients with acute bronchitis symptoms may last less than 10 days. In patients with severe asthmatic bronchitis, the symptoms are recurrent and usually last between 30 days to even 2 years with flares and remissions.
Can Asthma Go Away on Its Own?
Asthma is a long-term condition for many people, particularly if it first develops when you're an adult. In children, it sometimes goes away or improves during the teenage years, but can come back later in life.
Occupational asthma is a type of asthma caused by exposure to a substance in the workplace. Symptoms and signs include wheezing, chest tightness, and shortness of breath. The usual treatment for occupational asthma involves removal from exposure and the use of bronchodilators and inhaled anti-inflammatory medicines.
Adult-onset asthma is asthma that is diagnosed in people over 20 years of age. Symptoms include wheezing, coughing, shortness of breath and difficulty breathing. Treatment may involve anti-inflammatory medications or bronchodilators.
What Are the Four Types of Asthma?
Asthma is a chronic inflammatory disease of the airways (bronchi). Bronchi generally allow for the passage of air in and out of the lungs. In asthma, these airways develop hypersensitivity, inflammation, and narrowing. This causes difficulty in breathing. The four types are mild intermittent, mild persistent, moderate persistent and severe persistent.
Exercise-induced asthma is asthma triggered by vigorous exercise. Symptoms include coughing, shortness of breath, chest tightness, wheezing, and fatigue while exercising. Preventing exercise-induced asthma attacks involves using inhaled medicines before exercising, performing warm-up exercises and cooling down afterward, avoiding exercising outdoors when pollen counts are high, restricting exercise when you have a viral infection, and wearing a mask over your nose and mouth when exercising in cold weather.
Treatment & Diagnosis
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- Best Exercises for Asthma: Yoga, Swimming, Biking, and Walking
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Medications & Supplements
- Prednisone vs. Budesonide
- budesonide breath-activated inhaler - oral, Pulmicort
- budesonide - oral, Entocort EC
- budesonide suspension for nebulizer - inhalation
- budesonide liquid spray - nasal, Rhinocort Aqua
- budesonide (oral inhalation, Pulmicort, Pulmicort Flexhaler)
- budesonide nasal inhaler (Rhinocort Allergy, Rhinocort Aqua)
- budesonide (Entocort EC, Uceris)
- budesonide/formoterol hfa inhaler (Symbicort)
- Side Effects of Rhinocort Aqua (budesonide)
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.