Symbicort Side Effects

Please note - some side effects for Symbicort may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Symbicort - for the Consumer

Symbicort Aerosol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Symbicort Aerosol:

Dizziness; dry mouth; headache; nausea; nervousness; stomach pain or upset; stuffy nose; throat irritation; tiredness; tremor; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); back pain; bone pain; chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased mucus production or change in color of mucus; new or worsening asthma or COPD symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); seizures; severe or persistent dizziness, headache, nervousness, or tremor; severe or persistent muscle pain or cramps; trouble speaking; vision changes; white patches in your mouth or throat.

Symbicort Side Effects - for the Professional

Symbicort

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death.

The incidence of common adverse events in the table below is based upon three 12-week, double-blind, placebo-controlled US clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated twice daily with 2 inhalations of Symbicort 80/4.5 or Symbicort 160/4.5, budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebos (MDI and DPI).

*All treatments were administered as two inhalations twice daily.

The table above includes all events (whether or not considered drug-related by the investigators) that occurred at an incidence of ≥3% in any one Symbicort group and that were more common than in the placebo group with twice-daily dosing. In considering these data, the increased average duration of exposure for Symbicort patients should be taken into account, as incidences are not adjusted for unequal treatment duration.

The following additional adverse events occurred in patients ≥12 years of age in the active- and placebo-controlled clinical studies among 2344 patients treated with Symbicort twice daily with an incidence of ≥1% to <3% regardless of relationship to treatment, and are listed in decreasing order of incidence: asthma, nausea, dysphonia, pyrexia, sinus headache, diarrhea, pharyngitis, tremor, lower respiratory tract infection, muscle spasms, urinary tract infection, rhinitis, arthralgia, myalgia, dyspepsia, gastroenteritis viral, abdominal pain upper, dizziness, sinus congestion, rhinitis allergic, pain in extremity, palpitations, bronchitis acute, tension headache, migraine, post procedural pain. Additionally, the incidence of cough, bronchitis, and viral upper respiratory tract infection was ≥3% (but each <4%) in this population but did not meet criteria for inclusion in the above table, as these data are not derived from placebo-controlled trials for subjects ≥12 years old.

The following adverse events occurred in this same population (patients ≥12 years of age) with an incidence <1%, and are listed because they have previously been reported during treatment with any formulation of inhaled Symbicort, budesonide and/or formoterol, regardless of the indication: immediate and delayed hypersensitivity reactions, e.g., rash, pruritus, urticaria, angioedema; cardiac events, e.g., tachycardia, coronary ischemia, atrial and ventricular tachyarrhythmias; variations in blood pressure, e.g., hypotension, hypertension, hypertensive crisis; hypokalemia; hyperglycemia; taste disturbance; psychiatric symptoms, e.g., irritability, anxiety, restlessness, nervousness, agitation, depression; skin bruising.

Long-Term Safety: Long-term safety studies in adolescent and adult patients 12 years of age and older, treated for up to one year at doses up to 1280/36 mcg/day (640/18 mcg twice daily), revealed neither clinically important changes in the incidence nor new types of adverse events emerging after longer periods of treatment. Similarly, no significant or unexpected patterns of abnormalities were observed for up to one year in safety measures including chemistry, hematology, ECG, Holter monitor, and HPA-axis assessments.

Adverse Event Reports From Other Sources: Other relevant rare adverse events reported in the published literature, clinical trials or from worldwide marketing experience with any formulation of inhaled Symbicort, budesonide and/or formoterol, regardless of the indication include: immediate hypersensitivity reactions, such as anaphylactic reaction and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts, psychiatric symptoms, including aggressive reactions, behavioral disturbances, psychosis.

Side Effects by Body System

Respiratory

Respiratory side effects have included nasopharyngitis, upper and lower respiratory tract infection, sinusitis, nasal and sinus congestion, pharyngitis, allergic rhinitis,acute bronchitis, asthma,and pharyngolaryngeal pain.

Gastrointestinal

Gastrointestinal side effects have included stomach discomfort, vomiting, nausea, viral gastroenteritis, dyspepsia, upper abdominal pain, and diarrhea.

Musculoskeletal

Musculoskeletal side effects have included back pain, muscle spasms, arthralgia, myalgia, and pain in the extremities.

Genitourinary

Genitourinary side effects have included urinary tract infections.

Nervous system

Nervous system side effects have included tension headache, dizziness, sinus headache and migraine.

General

General side effects have included oral candidiasis, dysphonia, and pyrexia.

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