Pulmicort Respules Side Effects

Generic name: budesonide

Generic Name: budesonide,Budesonide

Please note - some side effects for Pulmicort Respules may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pulmicort Respules - for the consumer

Pulmicort Respules Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pulmicort Respules Suspension:

Cough; diarrhea; nosebleed; runny or stuffy nose; throat irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone or joint pain; depression; ear pain or discharge; fainting; increased wheezing; infection (fever, chills, persistent cough or sore throat); mental or mood changes (eg, aggressiveness, anxiety, irritability); red, swollen, itchy, or watery eyes; severe dizziness; sudden weight loss; tightness in the lungs; unusual weakness; vision changes; white patches in the mouth or throat.

By body system

General side effects

Budesonide is generally well tolerated. Due to the nature of its administration (inhalation or enteric-coated capsules), it is not likely to cause the systemic adverse effects generally associated with the use of corticosteroids. General side effects of oral budesonide have included fatigue, flu-like disorder, viral infection, malaise, ear infection, fever, abscess, and pain .

Respiratory side effects

Respiratory side effects of inhaled budesonide have included dysphonia and sore throat. Cough, rhinitis, and sinusitis have also been reported. Respiratory side effects of oral enteric-coated budesonide have included respiratory infection, bronchitis, dyspnea, pharynx disorder, rhinitis, and sinusitis.

Endocrine side effects

Endocrine side effects have included suppression of the hypothalamic-pituitary-adrenal (HPA) axis. The risk of adrenal suppression from inhaled or enteric-coated budesonide is less than that associated with systemic corticosteroids and may occur less frequently with lower daily doses.

Immunologic side effects

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the relabeling of inhaled corticosteroids following concerns about the risk of their use during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.

The danger of infection from immune suppression associated with inhaled corticosteroids has been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled budesonide. There are no data concerning immune suppression form oral enteric-coated budesonide.

Gastrointestinal side effects

Gastrointestinal side effects of inhaled budesonide have included oropharyngeal candidiasis, dry mouth, taste perversion, nausea, dyspepsia, and abdominal pain. Gastrointestinal side effects of oral enteric-coated budesonide have included nausea, diarrhea, dyspepsia, abdominal pain, flatulence, anus disorder, aggravation of Crohn's disease, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder, and vomiting.

Nervous system side effects

Nervous system side effects of inhaled budesonide have included headache, asthenia, and pain. Nervous system side effects of oral enteric-coated budesonide have included headache, dizziness, hyperkinesia, paresthesia, tremor, vertigo, asthenia, and pain.

Psychiatric side effects

Psychiatric side effects of inhaled budesonide have included rare reports of depression, aggression, irritability, anxiety, and psychosis. Psychiatric side effects of oral budesonide have included agitation, increased appetite, confusion, insomnia, nervousness, sleep disorder, amnesia, and somnolence.

Hypersensitivity side effects

Hypersensitivity side effects of inhaled budesonide have included immediate and delayed reactions including rash, contact dermatitis, urticaria, angioedema, and bronchospasm. Postmarketing experience has included very reports of cough, wheezing, or bronchospasm in patients with severe milk protein hypersensitivity.

Musculoskeletal side effects

Musculoskeletal side effects of inhaled budesonide have included a reduction in bone density. This effect may be dose-related and has been reported with high dosages and prolonged use (over 1 year). Musculoskeletal side effects of oral enteric-coated budesonide have included back pain and arthralgia.

Cardiovascular side effects

Cardiovascular side effects of oral budesonide have included chest pain, palpitations, tachycardia, dependent edema, face edema, hypertension, flushing, and increased C-reactive protein.

Metabolic side effects

Metabolic side effects of oral budesonide have included hypokalemia and weight increase.

Hematologic side effects

Hematologic side effects of oral budesonide have included leukocytosis and purpura.

Ocular side effects

Ocular side effects of oral budesonide have included conjunctivitis, eye abnormality, and abnormal vision. Glaucoma and cataracts have also been reported.

Genitourinary side effects

Genitourinary side effects of oral budesonide have included dysuria, increased micturition frequency, nocturia, urinary tract infection, intermenstrual bleeding, and menstrual disorder.

Dermatologic side effects

Dermatologic side effects of oral budesonide have included acne, alopecia, dermatitis, eczema, increased sweating and skin disorder.

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