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

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

• inhalation powder, inhalation suspension
• rectal foam

Serious side effects of Pulmicort Respules

Along with its needed effects, budesonide (the active ingredient contained in Pulmicort Respules) 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
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny nose
• shivering
• sneezing
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Bladder pain
• bleeding after defecation
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody or cloudy urine
• blurred vision
• burning feeling while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in vision
• chest pain or tightness
• 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
• heartburn
• increase in body movements
• increased thirst
• increased urge to urinate during the night
• irregular heartbeat
• lower back or side pain
• mood changes
• nervousness
• pain or discomfort in the chest, upper stomach, or throat
• pinpoint red or purple spots on the skin
• pounding in the ears
• rectal bleeding
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• severe constipation
• shakiness in the legs, arms, hands, or feet
• shivering
• skin rash, encrusted, scaly, and oozing
• slow or fast heartbeat
• stomach cramps or pain
• sweating
• swelling of the legs and feet
• swelling or puffiness of the face
• trouble sleeping
• uncomfortable swelling around the anus
• upper abdominal or stomach pain
• waking to urinate at night
• weight gain or 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

Other side effects of Pulmicort Respules

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

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

Less common

• Accumulation of pus
• agitation
• bloated or full feeling
• change in hearing
• cracked, dry, or scaly skin
• cracks in the skin at the corners of mouth
• difficulty having a bowel movement
• difficulty with moving
• dizziness or lightheadedness
• ear drainage
• earache or pain in the ear
• excess air or gas in the stomach or bowels
• fatty hump between the shoulders
• feeling of constant movement of self or surroundings
• increased appetite
• increased hair growth, especially on the face
• lack or loss of strength
• loss of memory
• loss or thinning of the hair
• muscle stiffness
• nervousness
• pain, swelling, or redness in the joints
• passing gas
• pressure in the stomach
• problems with memory
• redness, swelling, or soreness of the tongue
• sensation of spinning
• 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

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.

General

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]

Respiratory

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

Endocrine

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%): 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]

Immunologic

Common (1% to 10%): Oral candidiasis

Frequency not reported: Immunosuppression, abscess^[Ref]

Gastrointestinal

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]

Psychiatric

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]

Hypersensitivity

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

Postmarketing reports: Cough, wheezing, bronchospasm^[Ref]

Musculoskeletal

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]

Cardiovascular

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

Uncommon (0.1% to 1%): Hypertension

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

Metabolic

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

Hematologic

Common (1% to 10%): Leukocytosis

Uncommon (0.1% to 1%): Anemia

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

Ocular

Common (1% to 10%): Conjunctivitis

Frequency not reported: Eye abnormality, abnormal vision

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

Genitourinary

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

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

Dermatologic

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]

Hepatic

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

Other

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

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