Pulmicort Turbuhaler Side Effects

Generic name: budesonide

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 Turbuhaler.

Some side effects of Pulmicort Turbuhaler may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to budesonide: oral capsule extended release, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking budesonide (the active ingredient contained in Pulmicort Turbuhaler) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• thinning skin, easy bruising, increased acne or facial hair;

• menstrual problems (in women), impotence or loss of interest in sex (in men); or

• stretch marks, changes in the shape or location of body fat (especially in your face, neck, back, and waist).

Common side effects may include:

• headache;

• mild nausea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral tablet extended release

General

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 (the active ingredient contained in Pulmicort Turbuhaler) have included fatigue, flu-like disorder, viral infection, malaise, ear infection, fever, abscess, and pain .

Respiratory

Respiratory side effects of inhaled budesonide (the active ingredient contained in Pulmicort Turbuhaler) 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

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

Immunologic

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

Gastrointestinal side effects of inhaled budesonide (the active ingredient contained in Pulmicort Turbuhaler) 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

Nervous system side effects of inhaled budesonide (the active ingredient contained in Pulmicort Turbuhaler) 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. Benign intracranial hypertension has been reported with oral budesonide.

Psychiatric

Psychiatric side effects of inhaled budesonide (the active ingredient contained in Pulmicort Turbuhaler) 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

Hypersensitivity side effects of inhaled budesonide (the active ingredient contained in Pulmicort Turbuhaler) 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. Anaphylactic reactions have been reported with oral budesonide.

Musculoskeletal

Musculoskeletal side effects of inhaled budesonide (the active ingredient contained in Pulmicort Turbuhaler) 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

Cardiovascular side effects of oral budesonide (the active ingredient contained in Pulmicort Turbuhaler) have included chest pain, palpitations, tachycardia, dependent edema, face edema, hypertension, flushing, and increased C-reactive protein.

Metabolic

Metabolic side effects of oral budesonide (the active ingredient contained in Pulmicort Turbuhaler) have included hypokalemia and weight increase.

Hematologic

Hematologic side effects of oral budesonide (the active ingredient contained in Pulmicort Turbuhaler) have included leukocytosis and purpura.

Ocular

Ocular side effects of oral budesonide (the active ingredient contained in Pulmicort Turbuhaler) have included conjunctivitis, eye abnormality, and abnormal vision. Glaucoma and cataracts have also been reported.

Genitourinary

Genitourinary side effects of oral budesonide (the active ingredient contained in Pulmicort Turbuhaler) have included dysuria, increased micturition frequency, nocturia, urinary tract infection, intermenstrual bleeding, and menstrual disorder.

Dermatologic

Dermatologic side effects of oral budesonide (the active ingredient contained in Pulmicort Turbuhaler) have included acne, alopecia, dermatitis, eczema, increased sweating and skin disorder.

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