WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA), such as formoterol one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue SYMBICORT) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids [see Warnings and Precautions].
SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.
SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.
SYMBICORT is NOT indicated for the relief of acute bronchospasm.
Published Studies Related to Symbicort (Budesonide Inhalation)
Effects of nebulized high-dose budesonide on moderate-to-severe acute
exacerbation of asthma in children: a randomized, double-blind,
placebo-controlled study. 
exacerbation of asthma... CONCLUSION: On the basis of nebulized short-acting bronchodilators, addition of
Safety and Tolerability of High-Dose Budesonide/Formoterol via Turbuhaler(R) in Japanese Patients with Asthma: A Randomized, Double-Blind, Crossover, Active Comparator-Controlled, Phase III Study. [2012.01.01]
Background: The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. Objective: This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of the inhaled corticosteroid budesonide and the long-acting beta(2)-adrenoceptor agonist formoterol with that of the beta(2)-agonist terbutaline for acute symptom relief in Japanese adults with persistent asthma who were already receiving a combination of budesonide/formoterol maintenance therapy...
A comparison of budesonide/formoterol maintenance and reliever therapy versus conventional best practice in asthma management in Spain. [2011.10]
OBJECTIVE: To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy(R) (Symbicort SMART(R)), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma... CONCLUSIONS: A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.
Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. [2011.09]
BACKGROUND: Few clinical trials in asthma have focused on Hispanic populations. OBJECTIVE: To compare the efficacy and safety of budesonide/formoterol (BUD/FM) with BUD in an ethnically diverse group of Hispanic participants with asthma previously treated with inhaled corticosteroids (ICS)... CONCLUSIONS: Improvement in clinically relevant control end points occurred in both BUD/FM and BUD groups; both treatments were well tolerated in this Hispanic asthma population but were not significantly differentiated. Copyright (c) 2011 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Bronchodilator responsiveness and onset of effect with budesonide/formoterol pMDI in COPD. [2011.08]
BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients are thought to have limited bronchodilator response, determined by changes in forced expiratory volume in 1s (FEV(1)). In this study, we assessed bronchodilator response in patients with COPD using not only FEV(1) but also changes in lung volume expressed as forced vital capacity (FVC) and inspiratory capacity (IC). We also evaluated the speed of onset of bronchodilation... CONCLUSIONS: Most patients with moderate to very severe COPD exhibit ATS-defined bronchodilator reversibility based on flow and lung volume measures after budesonide/formoterol pMDI or formoterol treatment. Budesonide/formoterol pMDI also has a rapid (within 5min) onset of bronchodilation that is maintained over time compared with formoterol alone. Copyright (c) 2011. Published by Elsevier Ltd.
Clinical Trials Related to Symbicort (Budesonide Inhalation)
A Comparison of Symbicort� Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma [Completed]
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with
treatment according to conventional best practice in adult patients with persistent asthma.
Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia [Completed]
The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy
(SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a
real life situation.
Comparing Bronchodilation of Symbicort With and With Out Valved Holding Chamber (Aerochamber Plus) [Recruiting]
This study will compare the amount of bronchial tube relaxation from the formoterol medicine
contained in the symbicort pMeterd Dose Inhaler( a combination of budesonide ,a steroid, and
formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using
the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing
in the medication. Breathing tests will be measured over a 12 hour period for the
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING [Completed]
Atlantis Symbicort [Completed]
The purpose of this study is to determine whether Symbicort compared with Advair, will be
more effective in controlling asthma in adults and adolescents.
Reports of Suspected Symbicort (Budesonide Inhalation) Side Effects
Drug Dose Omission (965),
Chronic Obstructive Pulmonary Disease (462),
Intentional Drug Misuse (319),
OFF Label USE (282),
Drug Ineffective (235), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 5 ratings/reviews, Symbicort has an overall score of 5.60. The effectiveness score is 8 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Symbicort review by 69 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || asthma, emphysema|
|Dosage & duration:|| || 80/4.5 (dosage frequency: bid) for the period of continue to take it|
|Other conditions:|| || Reactive Hypoglycemia|
|Other drugs taken:|| || Actos, 15mg|
|Benefits:|| || I had taken Pulmicort, and other inhalants, with no major changes. It became more difficult to maintain my exercise and lively life style. I gave in and began Symbicort and immediately experienced a relief of shortness of breath, weezing. I feel like a new person. I still have a reaction to cold wind, and very high humidity, but so much better. I rarely use my Albuterol.|
|Side effects:|| || none|
|Comments:|| || I take one puff in the am, rinse my mouth and gargle. I repeat the treatment in the evening before bed.|
Symbicort review by 20 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || Asthma/COPD|
|Dosage & duration:|| || 160/4.5 (dosage frequency: 2 puffs, twice a day) for the period of 2.5 months|
|Other conditions:|| || none|
|Other drugs taken:|| || singulair, proair|
|Benefits:|| || Moderately helped control my asthma and COPD.|
|Side effects:|| || back pain, chest pain, headaches, distorted vision, thyroid problems, fast pounding heart beats, irregular heart rhythm, gave me a sinus arrhythmia |
|Comments:|| || Started taking the drug in May, recently stopped due to the connection between all my heart problems that started when I started the drug. Now am having to see a cardiologist to make sure there is no long term damage to my heart.|
Symbicort review by care giver of 72 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Extremely Severe Side Effects|
|Condition / reason:|| || Asthma|
|Dosage & duration:|| || 1 puff (dosage frequency: daily) for the period of 2 months|
|Other conditions:|| || cardiomyopathy Iincluding atrial fibrillation, depression|
|Other drugs taken:|| || Warfarin, digoxin, prozac|
|Benefits:|| || Breathing became easier.|
|Side effects:|| || Had leg cramps, dizzyness, muscle weakness, tiredness - progressive over two months of taking Symbicort.
The patient died two months after commencing Symbicort. Discussion after death led to physician suggesting this was the cause of a massive MI and death. He was going to report this to the manufacturers.|
|Comments:|| || On using second issue of Symbicort death occured.|
Page last updated: 2014-11-30