Applies to budesonide / formoterol: inhalation aerosol liquid.
Serious side effects
Along with its needed effects, budesonide/formoterol 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 / formoterol:
More common
- Body aches or pain
- chest tightness
- chills
- cough
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- pain or tenderness around the eyes and cheekbones
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- congestion
- cough producing mucus
- diarrhea
- difficult, burning, or painful urination
- dryness of the throat
- fast, irregular, pounding, or racing heartbeat or pulse
- frequent urge to urinate
- general feeling of discomfort or illness
- hoarseness
- joint pain
- loss of appetite
- lower back or side pain
- nausea
- noisy breathing
- shakiness in the legs, arms, hands, or feet
- shivering
- sore mouth or tongue
- stomach pain
- sweating
- tender, swollen glands in the neck
- trembling or shaking of the hands or feet
- trouble with sleeping
- trouble with swallowing
- voice changes
- vomiting
- white patches in the mouth or on the tongue
Rare
- Blurred vision
- confusion
- decreased urine
- dizziness or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- enlarged pupils
- fainting
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased sensitivity of the eyes to light
- increased sweating, possibly with fever or cold, clammy skin
- increased thirst
- increased urination
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle cramps
- nervousness
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- seizures
- severe chest pain
- severe headache
- slow, fast, pounding, or irregular heartbeat or pulse
- stiff or sore neck
- unexplained weight loss
Incidence not known
- Blindness
- decreased vision
- eye pain
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tearing
Get emergency help immediately if any of the following symptoms of overdose occur while taking budesonide / formoterol:
Symptoms of overdose
- Arm, back, or jaw pain
- chest pain or discomfort
- darkening of the skin
- drowsiness
- mental depression
- rapid, deep breathing
- restlessness
- skin rash
- stomach cramps
Other side effects
Some side effects of budesonide / formoterol 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
- Stomach discomfort
Less common
- Belching
- difficulty with moving
- heartburn
- indigestion
- muscle spasms or stiffness
- pain in the arms or legs
- stomach upset
- swollen joints
Rare
- Bad, unusual, or unpleasant (after) taste
- change in taste
- deep or fast breathing with dizziness
- fear
- hives or welts, itching skin
- irritability
- large, flat, blue, or purplish patches in the skin
- numbness in the feet, hands, and around the mouth
- redness of the skin
For Healthcare Professionals
Applies to budesonide / formoterol: inhalation aerosol.
General
General side effects have included oral candidiasis, and transient mild tremor and palpitations which tend to disappear within a few days of treatment.[Ref]
Nervous system
Very common (10% or more): Headache (up to 11.3%)
Common (1% to 10%): Tremor
Uncommon (0.1% to 1%): Dizziness, thirst tiredness
Very rare (less than 0.01%): taste disturbances[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (up to 10.5%), upper respiratory tract infection (up to 10.5%)
Common (1% to 10%): Sinusitis, nasal congestion, bronchitis, mild irritation in the throat, coughing, hoarseness, pneumonia
Rare (0.01% to 0.1%): Bronchospasm
Very rare (less than 0.01%): Paradoxical bronchospasm
Postmarketing reports: Dysphonia, cough, throat irritation[Ref]
Cardiovascular
Common (1% to 10%): Palpitations
Uncommon (0.1% to 1%): Tachycardia
Rare (0.01% to 0.1%): Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Very rare (less than 0.01%): Angina pectoris, prolongation of QTc-interval, variations in blood pressure
Postmarketing reports: Atrial and ventricular tachyarrhythmias, hypotension, hypertension[Ref]
Gastrointestinal
Common (1% to 10%): Pharyngolaryngeal pain, stomach discomfort, vomiting, oral candidiasis
Uncommon (0.1% to 1%): Nausea
Postmarketing reports: Oropharyngeal candidiasis[Ref]
Musculoskeletal
Common (1% to 10%): Back pain,
Uncommon (0.1% to 1%): Muscle cramps[Ref]
Other
Common (1% to 10%): Influenza[Ref]
Psychiatric
Common (1% to 10%):
Uncommon (0.1% to 1%): Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Very rare (less than 0.01%): Depression, behavioral changes
Postmarketing reports: Behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness[Ref]
Dermatologic
Uncommon (0.1% to 1%): Skin bruising[Ref]
Metabolic
Uncommon (0.1% to 1%): Weight gain
Rare (0.01% to 0.1%): Hypokalemia
Very rare (less than 0.01%): Hyperglycemia[Ref]
Ocular
Uncommon (0.1% to 1%): Blurred vision
Very rare (less than 0.01%): Cataract, glaucoma
Frequency not reported: Central serous retinopathy
Postmarketing reports: Increased intraocular pressure[Ref]
Hypersensitivity
Rare (less than 0.1%): Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction[Ref]
Endocrine
Very rare (less than 0.01%): Cushing's syndrome, adrenal suppression, growth retardation, decrease in bone mineral density
Postmarketing reports: Hypercorticism, growth velocity reduction in pediatric patients[Ref]
