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Symbicort

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Symbicort

Symbicort

Symbicort Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Symbicort (budesonide and formoterol fumarate dihydrate) is used to prevent bronchospasm in people with asthma or chronic obstructive pulmonary disease (COPD). Symbicort is a combination of budesonide, a steroid, and formoterol, a long-acting bronchodilator. Common side effects include headache, throat irritation, or stomach upset.

For patients 12 years of age and older, the dosage of Symbicort is 2 inhalations twice daily (morning and evening, approximately 12 hours apart). Symbicort may interact with antibiotics, antifungal medication, MAO inhibitor, antidepressants, beta-blockers, or diuretics (water pills). Tell your doctor all medications you are taking. During pregnancy, Symbicort should be used only when prescribed. Budesonide passes into breast milk. It is unknown if formoterol passes into breast milk. Consult your doctor before breast-feeding.

Our Symbicort (budesonide and formoterol fumarate dihydrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Symbicort in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • worsening asthma symptoms;
  • chest pain, fast or pounding heartbeats, tremors, nervousness;
  • wheezing, throat irritation, choking, or other breathing problems after using this medication;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding, unusual weakness;
  • blurred vision, eye pain, or seeing halos around lights;
  • white patches or sores in your mouth or throat; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • headache;
  • nausea, vomiting, diarrhea, upset stomach;
  • back pain;
  • stuffy nose;
  • muscle or joint pain; or
  • changes in your voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Symbicort (Budesonide and Formoterol Fumarate Dihydrate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Symbicort Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, throat irritation, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, signs of infection (such as fever, persistent sore throat), mental/mood changes (such as nervousness), trouble sleeping, vision problems (such as blurred vision), increased thirst/urination, muscle cramps, shaking (tremors).

Get medical help right away if any of these rare but serious side effects occur: chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting, seizures.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, sudden trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Symbicort (Budesonide and Formoterol Fumarate Dihydrate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Symbicort FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. One of the active ingredients of SYMBICORT (budesonide and formoterol fumarate dihydrate) is formoterol, a long-acting beta2-agonist. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adreneergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. [see WARNINGS AND PRECAUTIONS].

Systemic and inhaled corticosteroid use may result in the following:

- Candida albicans infection [see WARNINGS AND PRECAUTIONS]
- Pneumonia or lower respiratory tract infections in patients with COPD [see WARNINGS AND PRECAUTIONS]
- Immunosuppression [see WARNINGS AND PRECAUTIONS]
- Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
- Growth effects in pediatric patients [see WARNINGS AND PRECAUTIONS]
- Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience in Asthma Patients 12 years and older

The overall safety data in adults and adolescents are based upon 10 active- and placebo-controlled clinical trials in which 3393 patients ages 12 years and older (2052 females and 1341 males) with asthma of varying severity were treated with SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5 or 160/4.5 mcg taken two inhalations once or twice daily for 12 to 52 weeks. In these trials, the patients on SYMBICORT (budesonide and formoterol fumarate dihydrate) had a mean age of 38 years and were predominantly Caucasian (82%).

The incidence of common adverse events in Table 1 below is based upon pooled data from three 12-week, double-blind, placebo-controlled clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated with two inhalations of SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5 or SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 twice daily. The SYMBICORT (budesonide and formoterol fumarate dihydrate) group was composed of mostly Caucasian (84%) patients with a mean age of 38 years, and a mean percent predicted FEV1 at baseline of 76 and 68 for the 80/4.5 mcg and 160/4.5 mcg treatment groups, respectively. Control arms for comparison included two inhalations of budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebo (MDI and DPI) twice daily. Table 1 includes all adverse events that occurred at an incidence of ≥ 3% in any one SYMBICORT (budesonide and formoterol fumarate dihydrate) group and more commonly than in the placebo group with twice-daily dosing. In considering these data, the increased average duration of patient exposure for SYMBICORT (budesonide and formoterol fumarate dihydrate) patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.

Table 1: Adverse reactions occurring at an incidence of ≥ 3% and more commonly than placebo in the SYMBICORT (budesonide and formoterol fumarate dihydrate) groups: pooled data from three 12-week, double-blind, placebo-controlled clinical asthma trials in patients 12 years and older

Treatment* SYMBICORT Budesonide Formoterol Placebo
Adverse Event 80/4.5 mcg
N = 277
%
160/4.5 mcg
N =124
%
80 mcg
N =121
%
160 mcg
N = 109
%
4.5 mcg
N = 237
%
N = 400
%
Nasopharyngitis 10.5 9.7 14.0 11.0 10.1 9.0
Headache 6.5 11.3 11.6 12.8 8.9 6.5
Upper respiratory tract infection 7.6 10.5 8.3 9.2 7.6 7.8
Pharyngolaryngeal pain 6.1 8.9 5.0 7.3 3.0 4.8
Sinusitis 5.8 4.8 5.8 2.8 6.3 4.8
Influenza 3.2 2.4 6.6 0.9 3.0 1.3
Back pain 3.2 1.6 2.5 5.5 2.1 0.8
Nasal congestion 2.5 3.2 2.5 3.7 1.3 1.0
Stomach discomfort 1.1 6.5 2.5 4.6 1.3 1.8
Vomiting 1.4 3.2 0.8 2.8 1.7 1.0
Oral Candidiasis 1.4 3.2 0 0 0 0.8
Average Duration of Exposure (days) 77.7 73.8 77.0 71.4 62.4 55.9
*All treatments were administered as two inhalations twice daily.

Long-term safety - asthma clinical trials in patients 12 years and older

Long-term safety studies in adolescent and adult patients 12 years of age and older, treated for up to 1 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 1 year in safety measures including chemistry, hematology, ECG, Holter monitor, and HPA-axis assessments.

Clinical Trials Experience in Chronic Obstructive Pulmonary Disease

The incidence of common adverse events in Table 2 below is based upon pooled data from two double-blind, placebo-controlled clinical studies (6 and 12 months in duration) in which 771 adult COPD patients (496 males and 275 females) 40 years of age and older were treated with SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5, two inhalations twice daily. Of these patients 651 were treated for 6 months and 366 were treated for 12 months. The SYMBICORT (budesonide and formoterol fumarate dihydrate) group was composed of mostly Caucasian (93%) patients with a mean age of 63 years, and a mean percent predicted FEV1 at baseline of 33%. Control arms for comparison included two inhalations of budesonide HFA (MDI) 160 mcg, formoterol (DPI) 4.5 mcg or placebo (MDI and DPI) twice daily. Table 2 includes all adverse events that occurred at an incidence of ≥ 3% in the SYMBICORT (budesonide and formoterol fumarate dihydrate) group and more commonly than in the placebo group. In considering these data, the increased average duration of patient exposure to SYMBICORT (budesonide and formoterol fumarate dihydrate) should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.

Table 2: Adverse reactions occurring at an incidence of ≥ 3% and more commonly than placebo in the SYMBICORT (budesonide and formoterol fumarate dihydrate) group: pooled data from two double-blind, placebo-controlled clinical COPD trials

Treatment* SYMBICORT Budesonide Formoterol Placebo
Adverse Event 160/4.5 mcg
N = 771
%
160 mcg
N = 275
%
4.5 mcg
N = 779
%
N = 781
%
Nasopharyngitis 7.3 3.3 5.8 4.9
Oral candidiasis 6.0 4.4 1.2 1.8
Bronchitis 5.4 4.7 4.5 3.5
Sinusitis 3.5 1.5 3.1 1.8
Upper respiratory tract infection viral 3.5 1.8 3.6 2.7
Average Duration of Exposure (days) 255.2 157.1 240.3 223.7
* All treatments were administered as two inhalations twice daily.

Lung infections other than pneumonia (mostly bronchitis) occurred in a greater percentage of subjects treated with SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 compared with placebo (7.9% vs. 5.1%, respectively). There were no clinically important or unexpected patterns of abnormalities observed for up to 1 year in chemistry, haematology, ECG, ECG (Holter) monitoring, HPA-axis, bone mineral density and ophthalmology assessments.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of SYMBICORT (budesonide and formoterol fumarate dihydrate) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Some of these adverse reactions may also have been observed in clinical studies with SYMBICORT (budesonide and formoterol fumarate dihydrate) .

Cardiac disorders: angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, palpitations

Endocrine disorders: hypercorticism, growth velocity reduction in pediatric patients

Eye disorders: cataract, glaucoma, increased intraocular pressure

Gastrointestinal disorders: oropharyngeal candidiasis, nausea

Immune system disorders: immediate and delayed hypersensitivity reactions, such as anaphylactic reaction, angioedema, bronchospasm, urticaria, exanthema, dermatitis, pruritus

Metabolic and nutrition disorders: hyperglycemia, hypokalemia

Musculoskeletal, connective tissue, and bone disorders: muscle cramps

Nervous system disorders: tremor, dizziness

Psychiatric disorders: behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness

Respiratory, thoracic, and mediastinal disorders: dysphonia, cough, throat irritation

Skin and subcutaneous tissue disorders: skin bruising

Vascular disorders: hypotension, hypertension

Read the entire FDA prescribing information for Symbicort (Budesonide and Formoterol Fumarate Dihydrate) »

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Symbicort - User Reviews

Symbicort User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Symbicort sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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