Pulmicort Flexhaler Warnings

ORAL CANDIDIASIS: Inhaled corticosteroids such as Pulmicort Flexhaler (inhaled budesonide) can lead to oral candidiasis (localized fungal infections in the mouth and throat by a fungus called Candida albicans). To lower the risk, rinse your mouth with water after each use of Pulmicort Flexhaler inhaler and spit it out. Do not swallow the water. Tell your doctor without delay if these side effects occur, i.e., if you notice white patches or rash, sore mouth, throat trouble, or other local symptoms in your mouth and throat. You may need to take an antifungal medicine to treat oral thrush.

NOT FOR TREATMENT OF ACUTE EPISODES: Pulmicort Flexhaler is an inhaled corticosteroid used for the long-term treatment and prevention of asthma attacks. It should not be used to treat a severe asthma attack after it has begun. Your doctor will prescribe a short-acting rescue inhaler such as albuterol for sudden breathing problems and other acute episodes.

SERIOUS ALLERGIC REACTIONS: In a small number of people, Pulmicort Flexhaler (budesonide) can cause severe allergic reactions, including life-threatening skin rash, hives, itching, swelling, and anaphylaxis (throat closing). Stop taking the medicine and seek emergency medical attention if you develop signs of severe hypersensitivity reactions.

Pulmicort Flexhaler contains small amounts of lactose and can cause allergic reactions in people with an allergy to milk proteins.

IMMUNOSUPPRESSION: Pulmicort Flexhaler is an inhaled steroid medicine that can be systemically absorbed into the bloodstream and lead to suppression of the body’s immune system, similar to an oral steroid. This can put people using steroid medications at an increased risk, including fatal outcomes, from infections such as chickenpox and measles.

Before starting treatment with Pulmicort Flexhaler, tell your healthcare provider if you have not been immunized against vaccine-preventable diseases like chickenpox and measles and have not had these infections in the past. Avoid contact with people who are sick with these infections. Tell your doctor immediately if you are exposed to someone with chickenpox or measles. You may need to be treated with varicella zoster immune globulin (VZIG) for protection against chickenpox or pooled intravenous immunoglobulin (IVIG) for protection against measles.

In addition, people with active or quiescent tuberculosis, ocular herpes simplex, respiratory infections, and other bacterial, viral, fungal, or parasitic infections should not take inhaled corticosteroids.

TRANSITION FROM SYSTEMIC CORTICOSTEROIDS: Inhaled corticosteroids such as Pulmicort Flexhaler provide less systemically available steroid medicine than oral corticosteroids. If a patient is transitioned too quickly from oral steroids to inhaled corticosteroid therapy, it can lead to potentially life-threatening adrenal insufficiency due to suppression of the hypothalamic-pituitary-adrenal (HPA) axis. It can take several months for HPA function to recover fully. Your doctor will gradually lower the dose of oral corticosteroids to prevent this from occurring. They will also monitor lung function during the transition.

Seek immediate medical care for signs and symptoms of adrenal insufficiency, such as fatigue, weakness, low energy, muscle pain, joint pain, nausea, vomiting, and low blood pressure.

In addition, transition from oral to inhaled steroids can unmask signs and symptoms of conditions such as allergic rhinitis, conjunctivitis, arthritis, eczema, and eosinophilic conditions such as vasculitis (Churg-Strauss syndrome). 

HYPERCORTICISM AND ADRENAL INSUFFICIENCY: Inhaled corticosteroids such as Pulmicort Flexhaler (budesonide) can be absorbed into the bloodstream and have systemic effects, including hypercorticism (high cortisol levels) and adrenal insufficiency or adrenal crisis (low adrenal gland hormones). The risk of these side effects occurring is higher during periods of stress and in patients who are on high doses of Pulmicort Flexhaler or long-term treatment with this drug. If you develop systemic corticosteroid effects, your healthcare provider will lower the dose of Pulmicort Flexhaler gradually.

INTERACTIONS WITH OTHER DRUGS: Using Pulmicort Flexhaler (inhaled budesonide) with certain other drugs called cytochrome P450 3A4 inhibitors can lead to increased levels of budesonide in the body and an increased risk of adverse effects. Examples of strong cytochrome P450 3A4 inhibitors include HIV medicines such as ritonavir, atazanavir, indinavir, nelfinavir, and saquinavir; antibiotics such as clarithromycin and telithromycin; antifungal agents such as ketoconazole and itraconazole; and antidepressants such as nefazodone. Give your doctor a complete list of your medications before starting treatment with Pulmicort Flexhaler to avoid potentially dangerous interactions.

REDUCTION IN BONE MINERAL DENSITY: Long-term use of inhaled steroids, including Pulmicort Flexhaler, can lead to a decrease in bone mineral density (BMD). It is unclear if this reduction in BMD is severe enough to qualify as osteoporosis or increase the risk of bone fractures. Tell your doctor if you have other risk factors for osteoporosis, such as a family history, prolonged immobilization, smoking, postmenopausal status, advanced age, poor nutrition, or long-term use of other drugs that can also affect bone mineral density, such as oral steroids or anticonvulsants.

EFFECTS ON GROWTH IN CHILDREN: Steroid medications can lead to decreased growth rates in children. Your child’s doctor will monitor growth carefully if they are on Pulmicort Flexhaler for the prevention of asthma attacks.

EYE PROBLEMS: Long-term use of Pulmicort Flexhaler and other corticosteroids can increase the risk of eye conditions such as cataracts and glaucoma (increased intraocular pressure). Tell your doctor without delay if you notice any eye pain or changes in vision.

PARADOXICAL BRONCHOSPASM: Pulmicort Flexhaler can sometimes paradoxically cause bronchospasm (narrowing or tightening of the airways), leading to wheezing, cough, difficulty breathing, and chest discomfort. Use a rescue inhaler and get medical attention immediately if you develop sudden breathing problems immediately after using Pulmicort Flexhaler (budesonide).