Pulmicort Flexhaler Side Effects
Generic Name: budesonide
Note: This page contains side effects data for the generic drug budesonide. It is possible that some of the dosage forms included below may not apply to the brand name Pulmicort Flexhaler.
It is possible that some side effects of Pulmicort Flexhaler may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to budesonide: oral capsule delayed release, oral capsule extended release, oral tablet extended release
Other dosage forms:
As well as its needed effects, budesonide (the active ingredient contained in Pulmicort Flexhaler) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking budesonide, check with your doctor immediately:More common
- Bruising easily
- cough or hoarseness
- flu-like symptoms
- sore throat
- 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
- cough producing mucus
- decreased urine
- difficult or labored breathing
- difficult or painful urination
- dry mouth
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- general feeling of discomfort or illness
- 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
- 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
- slow or fast heartbeat
- stomach cramps
- 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
- Bulging soft spot on the head of an infant
- change in the ability to see colors, especially blue or yellow
- difficulty with swallowing
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash
Some budesonide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common
- Acid or sour stomach
- blemishes on the skin
- pain or tenderness around the eyes and cheekbones
- rounded or moon face
- stomach discomfort, upset, or pain
- stuffy nose
- Accumulation of pus
- 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
- 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
- unable to sleep
- uterine bleeding between menstrual periods
For Healthcare Professionals
Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral tablet extended release
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 Flexhaler) have included fatigue, flu-like disorder, viral infection, malaise, ear infection, fever, abscess, and pain .
Respiratory side effects of inhaled budesonide (the active ingredient contained in Pulmicort Flexhaler) 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 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 Flexhaler) is less than that associated with systemic corticosteroids and may occur less frequently with lower daily doses.
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 side effects of inhaled budesonide (the active ingredient contained in Pulmicort Flexhaler) 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 side effects of inhaled budesonide (the active ingredient contained in Pulmicort Flexhaler) 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 side effects of inhaled budesonide (the active ingredient contained in Pulmicort Flexhaler) 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 side effects of inhaled budesonide (the active ingredient contained in Pulmicort Flexhaler) 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 side effects of inhaled budesonide (the active ingredient contained in Pulmicort Flexhaler) 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 side effects of oral budesonide (the active ingredient contained in Pulmicort Flexhaler) have included chest pain, palpitations, tachycardia, dependent edema, face edema, hypertension, flushing, and increased C-reactive protein.
Metabolic side effects of oral budesonide (the active ingredient contained in Pulmicort Flexhaler) have included hypokalemia and weight increase.
Hematologic side effects of oral budesonide (the active ingredient contained in Pulmicort Flexhaler) have included leukocytosis and purpura.
Ocular side effects of oral budesonide (the active ingredient contained in Pulmicort Flexhaler) have included conjunctivitis, eye abnormality, and abnormal vision. Glaucoma and cataracts have also been reported.
Genitourinary side effects of oral budesonide (the active ingredient contained in Pulmicort Flexhaler) have included dysuria, increased micturition frequency, nocturia, urinary tract infection, intermenstrual bleeding, and menstrual disorder.
Dermatologic side effects of oral budesonide (the active ingredient contained in Pulmicort Flexhaler) have included acne, alopecia, dermatitis, eczema, increased sweating and skin disorder.
More about Pulmicort Flexhaler (budesonide)
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