Pulmicort Flexhaler

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.

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

Other dosage forms:

• inhalation powder, inhalation suspension
• rectal foam

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

• Bruising easily
• chills
• colds
• cough or hoarseness
• fever
• flu-like symptoms
• sneezing
• sore throat

Less common

• Abdominal or stomach pain
• bladder pain
• bleeding after defecation
• bloody or cloudy urine
• blurred vision
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• convulsions
• cough producing mucus
• decreased urine
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• dizziness
• dry mouth
• eye pain
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• general feeling of discomfort or illness
• headache
• heartburn
• increase in body movements
• increased thirst
• increased urge to urinate during the night
• irregular heartbeat
• joint pain
• loss of appetite
• lower back or side pain
• mood changes
• muscle aches and pains
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the chest, upper stomach, or throat
• pounding in the ears
• rectal bleeding
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• severe constipation
• shakiness in the legs, arms, hands, or feet
• shivering
• slow or fast heartbeat
• stomach cramps
• sweating
• swelling of the legs and feet
• swelling or puffiness of the face
• tightness in the chest
• trouble sleeping
• uncomfortable swelling around the anus
• unusual tiredness or weakness
• upper abdominal or stomach pain
• waking to urinate at night
• weight gain
• weight loss

Incidence not known

• Bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• difficulty with swallowing
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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

• Acid or sour stomach
• belching
• blemishes on the skin
• heartburn
• indigestion
• pain or tenderness around the eyes and cheekbones
• pimples
• rounded or moon face
• stomach discomfort, upset, or pain
• stuffy nose

Less common

• Accumulation of pus
• agitation
• blistering, crusting, irritation, itching, or reddening of the skin
• bloated or full feeling
• change in hearing
• changes in vision
• cracked, dry, or scaly skin
• cracks in the skin at the corners of mouth
• difficulty having a bowel movement (stool)
• difficulty with moving
• dizziness or lightheadedness
• ear drainage
• earache or pain in the ear
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• increased appetite
• increased hair growth, especially on the face
• lack or loss of strength
• loss of memory
• muscle pains or stiffness
• nervousness
• pain, swelling, or redness in the joints
• passing gas
• pinpoint red or purple spots on the skin
• pressure in the stomach
• problems with memory
• redness, swelling, or soreness of the tongue
• sensation of spinning
• skin rash
• skin rash, encrusted, scaly, and oozing
• sleepiness or unusual drowsiness
• soreness or redness around the fingernails and toenails
• swelling of the abdominal or stomach area
• swollen joints
• uterine bleeding between menstrual periods

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

Epidemiological 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

Deaths 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

Common (1% to 10%): Oral candidiasis

Frequency not reported: Immunosuppression, abscess

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

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

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

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

Postmarketing reports: Cough, wheezing, bronchospasm

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

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.

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

Uncommon (0.1% to 1%): Hypertension

Frequency not reported: Tachycardia, chest pain, dependent edema, flushing

Frequency not reported: Weight gain, increased appetite, hypokalemia

Common (1% to 10%): Leukocytosis

Uncommon (0.1% to 1%): Anemia

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

Common (1% to 10%): Conjunctivitis

Frequency not reported: Eye abnormality, abnormal vision

Postmarketing reports: Glaucoma, cataracts, increased intraocular pressure

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

Frequency not reported: Dysuria, micturition frequency, nocturia

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

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

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

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