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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.
For the ConsumerApplies 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
For Healthcare Professionals
Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral delayed release capsule, oral tablet extended release, rectal foam
GeneralThe 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.
RespiratoryEpidemiological 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
EndocrineDeaths 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
ImmunologicCommon (1% to 10%): Oral candidiasis
Frequency not reported: Immunosuppression, abscess
GastrointestinalVery 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
Nervous systemVery 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
PsychiatricCommon (1% to 10%): Mood changes, sleep changes, insomnia,
Frequency not reported: Amnesia
Postmarketing reports: Psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, anxiety, mood swings
HypersensitivityFrequency not reported: Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, bronchospasm
Postmarketing reports: Cough, wheezing, bronchospasm
MusculoskeletalCommon (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.
CardiovascularCommon (1% to 10%): Fluid retention, palpitation
Uncommon (0.1% to 1%): Hypertension
Frequency not reported: Tachycardia, chest pain, dependent edema, flushing
MetabolicFrequency not reported: Weight gain, increased appetite, hypokalemia
HematologicCommon (1% to 10%): Leukocytosis
Uncommon (0.1% to 1%): Anemia
Rare (0.01% to 0.1%): Eosinophilic conditions, Churg-Strauss
OcularCommon (1% to 10%): Conjunctivitis
Frequency not reported: Eye abnormality, abnormal vision
Postmarketing reports: Glaucoma, cataracts, increased intraocular pressure
GenitourinaryCommon (1% to 10%): Urinary tract infection, moniliasis
Frequency not reported: Dysuria, micturition frequency, nocturia
DermatologicCommon (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
HepaticUncommon (0.1% to 1%): Increase in liver enzymes
OtherCommon (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 1/3/2022.
Source: Drugs.com Pulmicort Flexhaler (www.drugs.com/mtm/pulmicort-flexhaler.html).
August 4, 2022
August 4, 2022
August 4, 2022
July 26, 2022
July 26, 2022
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