Side effect of symbicort


Generic Name: budesonide and formoterol (inhalation) (bue DES oh nide and for MOE te rol)
Brand Names: Symbicort

Medically reviewed by Sanjai Sinha, MD Last updated on Aug 4, 2019.

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What is Symbicort?

Symbicort contains a combination of budesonide and formoterol. Budesonide is a corticosteroid that reduces inflammation in the body. Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Symbicort is used to control and prevent the symptoms of asthma in adults and children at least 6 years old.

Symbicort is also used to help control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Symbicort is not for use in treating an asthma or bronchospasm attack.

For people with asthma: Symbicort is for use only if asthma is severe or is not well-controlled on other long-term asthma medicines. Your doctor may tell you to stop using this medicine once your asthma is well-controlled.

Formoterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when budesonide and formoterol are used together as a combination product.

Important Information

Symbicort is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Seek medical attention you have worsening breathing problems, or if you think your medications are not working as well.

Before taking this medicine

You should not use Symbicort if you are allergic to budesonide or formoterol.

Budesonide can weaken your immune system. Tell your doctor about any illness or infection you’ve had within the past several weeks.

To make sure Symbicort is safe for you, tell your doctor if you have ever had:

  • heart disease, high blood pressure;

  • a seizure;

  • a weak immune system;

  • liver disease;

  • osteoporosis;

  • glaucoma, cataracts, or other vision problems;

  • diabetes;

  • a drug allergy;

  • tuberculosis;

  • a thyroid disorder; or

  • an electrolyte imbalance (such as low potassium levels in your blood).

Tell your doctor if you are pregnant. It is not known whether budesonide or formoterol will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breastfeed while using Symbicort. Ask your doctor about any risk.

Symbicort is not approved for use by anyone younger than 6 years old.

How should I use Symbicort?

Symbicort comes with a medication guide for safe and effective use, and directions for priming and cleaning the Symbicort inhaler device. Ask your doctor or pharmacist if you have any questions.

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor’s instructions about tapering your dose.

Symbicort is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not allow a young child to use Symbicort without help from an adult.

Rinse your mouth with water after each use of your inhaler.

It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor’s advice.

If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Store at room temperature in an upright position, with the mouthpiece down. Keep away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Throw the canister away when the inhalations counter shows a 0, or if it has been longer than 3 months since you first took the canister out of its foil pouch.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, fast heartbeats, and feeling shaky or nervous.

What should I avoid while using Symbicort?

If this medication gets in your eyes, rinse with water and call your doctor if you have severe eye redness or irritation.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as budesonide.

Do not use a second inhaled bronchodilator that contains formoterol or a similar medicine (such as arformoterol, formoterol, indacaterol, olodaterol, salmeterol, or vilanterol).

Symbicort side effects

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

Call your doctor at once if you have:

  • worsened breathing problems;

  • sores or white patches in your mouth and throat, pain when swallowing;

  • tremors, nervousness, chest pain, fast or pounding heartbeats;

  • cough with mucus, feeling short of breath;

  • wheezing, choking, or other breathing problems after using this medication;

  • blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;

  • flu symptoms – fever, chills, body aches, unusual tiredness;

  • high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;

  • low potassium level – leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or

  • signs of a hormonal disorder – tiredness or weakness, feeling light-headed, nausea, vomiting.

Budesonide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Symbicort side effects may include:

  • throat pain or irritation;

  • white patches in your mouth or throat;

  • stomach discomfort, vomiting;

  • back pain, headache;

  • flu symptoms; or

  • cold symptoms such as stuffy or runny nose, sneezing, sinus pain, sore throat.

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 other drugs will affect Symbicort?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with budesonide and formoterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 9.02.

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More about Symbicort (budesonide / formoterol)

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Consumer resources

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Professional resources

  • Symbicort (FDA)

Related treatment guides

  • COPD
  • Asthma, Maintenance
  • COPD, Maintenance


  • SYMBICORT combines an ICS, budesonide and a LABA medicine, formoterol. LABA medicines, such as formoterol, when used alone can increase the risk of hospitalizations and death from asthma problems. When an ICS and LABA are used together, this risk is not significantly increased
  • Do not use SYMBICORT for sudden severe symptoms of COPD or asthma
  • Before you use SYMBICORT, tell your healthcare provider about all of your medical conditions, including if you have heart conditions or high blood pressure, and all the medicines you may be taking. Some patients taking SYMBICORT may experience increased blood pressure, heart rate, or change in heart rhythm
  • Do not use SYMBICORT more often than prescribed. SYMBICORT should be taken as 2 puffs 2 times each day
  • While taking SYMBICORT, do not use another medicine containing a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines
  • Call your healthcare provider or get medical care right away if:
    • Your breathing problems worsen
    • You need to use your rescue inhaler more often than usual or your rescue inhaler doesn’t work as well at relieving symptoms
  • SYMBICORT may cause serious side effects, including:
    • Using too much of a LABA medicine may cause chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache or nervousness
    • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using SYMBICORT to help reduce your chance of getting thrush
    • Pneumonia and other lower respiratory tract infections. People with COPD may have a higher chance of pneumonia and other lung infections. ICS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: increase in mucus production or change in color, fever, increased cough, chills, or increased breathing problems
    • Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as: fever, body aches, feeling tired, vomiting, pain, chills, or nausea
    • Adrenal insufficiency. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
    • Increased wheezing right after taking SYMBICORT. Always have a rescue inhaler with you to treat sudden wheezing
    • Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction
    • Lower bone mineral density can happen in people who have a high chance for low bone mineral density (osteoporosis)
    • Slowed growth in children. A child’s growth should be checked regularly while using SYMBICORT
    • Eye problems including glaucoma and cataracts. You should have regular eye exams while using SYMBICORT
    • Swelling of blood vessels. This can happen in people with asthma. Tell your healthcare provider right away if you have: a feeling of pins and needles or numbness of arms or legs, rash, flu like symptoms, or pain and swelling of the sinuses
    • Decreases in blood potassium levels (hypokalemia)
    • Increases in blood sugar levels (hyperglycemia)
  • The most common side effects of SYMBICORT include:
    • COPD: throat irritation, thrush in the mouth and throat, bronchitis, sinusitis, and upper respiratory tract infection
    • Asthma: throat irritation, headache, upper respiratory tract infection, throat pain, sinusitis, flu, back pain, nasal congestion, stomach discomfort, vomiting, and thrush in the mouth and throat

LABA monotherapy (without ICS) may increase risk of asthma-related events (death, hospitalizations, intubations). Do not initiate in rapidly or acutely deteriorating COPD or asthma. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin prophylaxis or antiviral ­treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress, a severe COPD exacerbation, or a severe asthma attack. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, intraocular pressure, glaucoma, or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Eosinophilic conditions. Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, osteoporosis, postmenopausal). Labor & delivery. Pregnancy. Nursing mothers.

In 2011, FDA required the drug companies manufacturing fixed-dose combination drugs containing an ICS and LABA (GlaxoSmithKline, Merck, Astra Zeneca) to conduct several large, 26-week, randomized, double-blind, active-controlled clinical safety trials to evaluate the risk of serious asthma-related events when long-acting beta agonists (LABAs) were used in fixed-dose combination with an inhaled corticosteroid (ICS) compared to ICS alone in patients with asthma. We reviewed the results of four trials involving 41,297 patients. A fifth trial was originally required, however it was terminated early when Novartis withdrew Foradil (formoterol) from the U.S. market.

Three of the four trials included adults and adolescents 12 years and older. One of the trials compared fluticasone/salmeterol (Advair Diskus) to fluticasone, one compared mometasone/formoterol (Dulera) to mometasone, and one compared budesonide/formoterol (Symbicort) to budesonide. The fourth trial included pediatric patients 4-11 years and compared fluticasone/salmeterol to fluticasone. The primary safety endpoint for all four trials was serious asthma-related events (hospitalizations, intubations, and deaths). All hospitalizations, intubations, and deaths were adjudicated to determine relatedness to asthma. The three adult/adolescent trials were designed to rule out a risk margin of 2.0, and the pediatric trial was designed to rule out a risk margin of 2.7. Each individual trial met this objective. Although each individual trial met this objective, the trials were not designed to show that there is no increase in risk with ICS/LABA compared to ICS. Data from the three trials conducted in adults and adolescents were combined in a meta-analysis to provide greater precision of the risk of serious asthma-related events with ICS/LABA products. The results demonstrate that the use of ICS/LABA in fixed-dose combination does not result in a significant increase in the risk of serious asthma-related events compared to ICS alone, with 95% confidence limits ranging from 0.85 to 1.44 (See Table 2 below). The results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results.

Table 2. Meta-analysis of Serious Asthma-Related Events in Patients with Asthma 12 Years and Older*

* Randomized patients who took at least one dose of study medication.
†Patients could have more than one event. Planned treatment used for analysis.
‡Estimated using a Cox proportional hazards model for time to first event with baseline hazards stratified by each of the three trials.
§Events that occurred within 6 months after the first use of study drug or 7 days after the last date of study drug treatment, whichever date was later. A single, blinded, independent adjudication committee determined whether events were asthma-related.

The pediatric safety trial included 6,208 patients 4-11 years who received fluticasone/salmeterol or fluticasone. In this trial, 27/3,107 (0.9%) patients randomized to fluticasone/salmeterol and 21/3,101 (0.7%) patients randomized to fluticasone experienced a serious asthma-related event. There were no asthma-related deaths or intubations. Fluticasone/salmeterol did not show a significantly increased risk of serious asthma-related events compared to fluticasone based on the pre-specified risk margin (2.7), with an estimated hazard ratio of time to first event of 1.29 (95% confidence interval: 0.73, 2.27).

The four trials also assessed efficacy of the ICS/LABA products. The primary efficacy endpoint was asthma exacerbation, defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days, or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The results showed that the ICS/LABA combination reduced asthma exacerbations compared to ICS alone (see Table 3 below), noting that the majority of these exacerbations were those that required at least 3 days of systemic corticosteroids. This efficacy information has been added to the Clinical Studies section of the ICS/LABA drug labels.

Table 3. Efficacy Results

Dec. 21, 2017 — New evidence regarding safety is spurring the U.S. Food and Drug Administration to remove a Boxed Warning from certain inhaled medications used to treat asthma and chronic obstructive pulmonary disease (COPD).

The decision applies to a class of medications known as Long-Acting Beta Agonists (LABAs) used in combination with inhaled corticosteroid (ICS) medicines.

These medicines include brand name products such as Advair, Airduo, Breo, Dulera and Symbicort.

In 2011, the FDA told makers of such medicines to conduct large safety trials to assess the risk of serious side effects such as hospitalization, intubation and death among asthma patients.

A review of data from those trials found that treating asthma with LABAs in combination with ICS medicines “does not result in significantly more serious asthma-related side effects than ICS alone. Based on these results, the FDA has approved changes to the labeling of these products removing the Boxed Warning about asthma-related death,” the FDA said.

However, the agency said that “using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death. Therefore, the Boxed Warning stating this will remain in the labeling of all single-ingredient LABA medicines.”

The FDA also noted that labeling on medicines that contain both an ICS and LABAs will still have a Warning and Precaution about the risk of using LABAs without an ICS for asthma and will provide information on the completed safety trials.

Just How “Dangerous” Are Long-Acting Beta-Agonists, Really?

Gustavo Rodriguez and Jose Castro-Rodriguez reviewed 20 systematic reviews and databases reporting on the incidence of adverse events with long-acting beta-agonist (LABA) therapy for asthma, for the April 2012 Thorax.

They conclude the following:

  • LABAs as monotherapy significantly increase the risk for adverse effects and bad outcomes from asthma. Authors estimate a number-needed-to-kill using LABA monotherapy of about 1,200 people with asthma.
  • LABAs when used with inhaled corticosteroids are helpful. Multiple reviews/meta-analyses suggest that long-acting beta-agonists + inhaled corticosteroids reduce asthma hospitalizations compared to inhaled corticosteroids alone. (One review by Salpeter et al concludes the opposite, and they try to discredit it.)

Most of all, they emphasize the weakness of the primary data in terms of statistical strength, simply because asthma-related deaths and intubations are so rare. For example:

  • In the FDA’s meta-analysis (which did not include all available data), 44 deaths and intubations occurred in 30,100 LABA-exposed patients total. 43 of those deaths occurred in patients participating in studies in which inhaled corticosteroid use was not mandatory.
  • In the 7,862 patients in the FDA’s meta-analysis who were obligated to take ICS (usually because a combination product was being tested), there was only one death.

The FDA issued its black-box warning for LABAs (including those in combination products like Advair and Symbicort) not just because of the perceived risk, but because the FDA also did not see unequivocal clinical benefit from LABAs (unlike these authors). Since so many generally healthy people take asthma inhalers, they demanded a high benefit-to-risk ratio, and felt LABAs did not clearly meet that standard. The FDA has demanded that Pharma conduct 5 large trials to test LABA/ICS safety; these authors are skeptical that those will settle the issue either, since event rates are so low and achieving the power to conclude anything will be exceedingly difficult.

Both authors report receiving “consulting fees” from multiple producers of asthma inhalers.

Rodrigo GJ, Castro-Rodriguez JA. Safety of long-acting β agonists for the treatment of asthma: clearing the air. Thorax 2012;67:342-349. Black Box Warning for long-acting beta-agonists (LABA) for asthma.

FDA’s explanation for the decision to make the warning, in the New England Journal of Medicine.

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Consumer medicine information

How to use Symbicort Turbuhaler

How to use your Turbuhaler

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

Each pack of Symbicort Turbuhaler contains an instruction leaflet that tells you the correct way to use it. Please read this carefully.

If you are not sure how to use the Turbuhaler, ask your doctor or pharmacist to show you how.

How much to take

ASTHMA (Adults and children 12 years and over)

Your healthcare professional should give you a personal Asthma Action Plan to help manage your asthma. This plan will include what medicines to take as a reliever when you have symptoms or sudden attacks of asthma, medicines you take prevent symptoms from occurring (eg prior to exercise or allergen exposure) and if you need to take daily maintenance medicines to help control your asthma.

It is important that you discuss with your doctor both your exposure to triggers and how often you exercise, as these could impact how your doctor prescribes your Symbicort Turbuhaler.

Your doctor may have prescribed Symbicort Turbuhaler for you to use as:

  • an anti-inflammatory reliever medicine only,
  • both an anti-inflammatory reliever and a daily maintenance preventer medicine or,
  • as a daily maintenance preventer only, where another medicine is used as a reliever.

Ask your doctor if you have any questions about how you should be using your Symbicort Turbuhaler.

If your asthma has been under control for some time, your doctor may tell you to take less inhalations of Symbicort Turbuhaler, prescribe you a lower strength of Symbicort Turbuhaler or recommended that you use Symbicort Turbuhaler in a different way.

If you are using more inhalations of your reliever medicine or you are wheezing or breathless more than usual tell your doctor as your asthma may be getting worse.

Anti-inflammatory reliever only (Symbicort Turbuhaler 200/6)

For patients aged 12 years and over, Symbicort Turbuhaler 200/6 can be used to treat asthma symptoms when they happen and to help stop asthma symptoms from happening (eg just before exercise or before you get exposed to other triggers).

If you get asthma symptoms, take 1 inhalation and wait a few minutes. If you do not feel better, take another inhalation.

Your doctor will tell you how many inhalations to take before exercising or exposure to other triggers to help stop symptoms from happening.

Do not use more than 6 inhalations on a single occasion or more than 12 inhalations in any day. If your symptoms continue to worsen over 3 days, despite using additional inhalations, tell your doctor. Have your Symbicort Turbuhaler reliever with you at all times.

Anti-inflammatory reliever plus maintenance therapy (Symbicort Turbuhaler 100/6 and 200/6)

For patients aged 12 years and over, Symbicort Turbuhaler 100/6 and 200/6 can be used to treat asthma symptoms when they happen. Symbicort Turbuhaler 200/6 can also be used to help stop asthma symptoms from happening (eg just before exercise or before you get exposed to other triggers).

If you get asthma symptoms, take 1 inhalation of Symbicort Turbuhaler 100/6 or 200/6 and wait a few minutes. If you do not feel better, take another inhalation.

Your doctor will tell you how many inhalations of Symbicort Turbuhaler 200/6 to take before exercising or exposure to other triggers to help stop symptoms from happening.

Have your Symbicort Turbuhaler 100/6 or 200/6 reliever with you at all times.

You also need to take your Symbicort Turbuhaler (100/6 or 200/6) daily as your maintenance preventer. The usual maintenance dose is 2 inhalations per day (given either as 1 inhalation in the morning and evening or as 2 inhalations in either the morning or evening). Your doctor may prescribe a maintenance dose of Symbicort Turbuhaler 200/6, 2 inhalations twice a day.

Do not use more than 6 inhalations on a single occasion or more than 12 inhalations of Symbicort Turbuhaler (as needed and daily dose) in any day. If your symptoms continue to worsen over 3 days, despite using additional inhalations, tell your doctor.

NOTE: Symbicort Turbuhaler 400/12 is not recommended to be used as anti-inflammatory reliever medicine.

Daily fixed dose maintenance therapy (Symbicort Turbuhaler 100/6, 200/6 and 400/12)

For patients aged 12 years and over, Symbicort Turbuhaler 100/6 and 200/6 can be used as a daily fixed-dose maintenance preventer. The usual dose is 1-2 inhalations twice a day.

Symbicort Turbuhaler 400/12 is recommended only for patients aged 18 years and over who need a higher daily dose.

The usual dose is 2 inhalations twice a day. Your doctor may also tell you to take 1 inhalation twice a day if your asthma has been under control.

Do not take more than 2 inhalations twice a day of Symbicort Turbuhaler 100/6, 200/6 or 400/12.

Have your separate reliever with you at all times.

COPD (Adults)

The usual dose (also maximum recommended dose) is:

  • 2 inhalations of Symbicort Turbuhaler 200/6 twice daily


  • 1 inhalation of Symbicort Turbuhaler 400/12 twice daily.

Your doctor should tell you the best way to manage your symptoms and any flare ups. This may include additional medicines (such as reliever medicines) to use when you have sudden attacks of breathlessness.

If you are using more inhalations of your reliever medicine or you are wheezing or breathless more than usual tell your doctor.

If your COPD gets worse, your doctor may give you some additional medicines (such as oral corticosteroids or antibiotics).

If you forget to use it

If you miss a dose of Symbicort Turbuhaler, take your dose as soon as you remember.

Do not use a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are using Symbicort Turbuhaler as a reliever medicine, consult your doctor on the correct use of the product.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

How long to use it

If your doctor has told you to take Symbicort Turbuhaler daily, it is important that you use it every day even if you feel well.

Symbicort Turbuhaler helps control your asthma or COPD but does not cure it.

Keep using it for as long as your doctor tells you to. Do not stop using it unless your doctor tells you to.

If you take too much (overdose)

Telephone your doctor, pharmacist or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have used too much Symbicort Turbuhaler.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you use too much Symbicort Turbuhaler, you may feel sick or vomit, have a fast or irregular heartbeat, a headache, tremble, feel shaky, agitated, anxious, tense, restless, excited or be unable to sleep.

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