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

Applies to budesonide / formoterol: inhalation aerosol liquid.

Serious side effects of Symbicort

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 of Symbicort

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]