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Pulmicort Flexhaler Side Effects

Generic name: budesonide

Medically reviewed by Last updated on Jun 10, 2024.

Note: This document contains side effect information about budesonide. Some dosage forms listed on this page may not apply to the brand name Pulmicort Flexhaler.

Applies to budesonide: oral capsule delayed release, oral capsule extended release, oral tablet extended release. Other dosage forms:

Serious side effects of Pulmicort Flexhaler

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

Other side effects of Pulmicort Flexhaler

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 suspension, oral tablet extended release, rectal foam.


The 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.[Ref]


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[Ref]

Epidemiological studies have shown an increased incidence of pneumonia in patients with chronic obstructive pulmonary disease (COPD) treated with inhaled corticosteroids.[Ref]


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[Ref]

Deaths due to adrenal insufficiency have been reported in asthmatic patients during and after transferring from systemic corticosteroids to less systemically available inhaled corticosteroids.[Ref]


Common (1% to 10%): Oral candidiasis

Frequency not reported: Immunosuppression, abscess[Ref]


Very 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[Ref]

Nervous system

Very 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[Ref]


Common (1% to 10%): Mood changes, sleep changes, insomnia,

Frequency not reported: Amnesia

Postmarketing reports: Psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, anxiety, mood swings[Ref]


Frequency not reported: Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, bronchospasm

Postmarketing reports: Cough, wheezing, bronchospasm[Ref]


Common (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[Ref]

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.[Ref]


Common (1% to 10%): Fluid retention, palpitation

Uncommon (0.1% to 1%): Hypertension

Frequency not reported: Tachycardia, chest pain, dependent edema, flushing[Ref]


Frequency not reported: Weight gain, increased appetite, hypokalemia[Ref]


Common (1% to 10%): Leukocytosis

Uncommon (0.1% to 1%): Anemia

Rare (0.01% to 0.1%): Eosinophilic conditions, Churg-Strauss[Ref]


Common (1% to 10%): Conjunctivitis

Frequency not reported: Eye abnormality, abnormal vision

Postmarketing reports: Glaucoma, cataracts, increased intraocular pressure[Ref]


Common (1% to 10%): Urinary tract infection, moniliasis

Frequency not reported: Dysuria, micturition frequency, nocturia[Ref]


Common (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[Ref]


Uncommon (0.1% to 1%): Increase in liver enzymes[Ref]


Common (1% to 10%): Otitis media, fatigue, earache

Frequency not reported: Asthenia, malaise, fever, flu-like disorder, vertigo[Ref]


1. (2001) "Product Information. Pulmicort Respules (budesonide)." Astra-Zeneca Pharmaceuticals

2. (2001) "Product Information. Entocort (budesonide)." AstraZeneca Pharma Inc

3. (2013) "Product Information. Uceris (budesonide)." Santarus Inc

4. (2016) "Product Information. Pulmicort Flexhaler (budesonide)." A-S Medication Solutions

5. (2016) "Product Information. Entocort EC (budesonide)." Perrigo, L. Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.