Budesonide and Formoterol

Budesonide/formoterol is a prescription medication used to treat asthma and chronic obstructive pulmonary disease (COPD). It is a combination medication that contains an inhaled corticosteroid, budesonide, to help decrease inflammation in the lungs, and a long-acting beta2-agonist medicine (LABA), formoterol. LABA medicines, like formoterol, help the muscles around the airways in the lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath.

Budesonide/formoterol comes in a metered-dose inhaler. It is used twice daily.

Common side effects include throat irritation or pain, headaches, and colds.

Budesonide/formoterol is used to control symptoms of asthma, and prevent symptoms such as wheezing in adults and children ages six years and older. 

Budesonide/formoterol is used long term, twice daily to help improve lung function for better breathing in adults with COPD.

Budesonide/formoterol is not for adults and children who:

• have sudden asthma symptoms
• are well controlled with an asthma-control medicine such as a low to medium dose inhaled corticosteroid

It is not known if budesonide/formoterol is safe and effective in children under the age of six. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Use this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

Asthma Treatment:

• The recommended dose for children six years to 12 years old is 2 inhalations of 80/4.5 twice a day. (morning and evening, approximately 12 hours apart)
• The recommended dose for children 12 years and older is 2 inhalations of 160/4.5 or 80/4.5 twice a day. The starting dose will be based on the severity of asthma. (morning and evening, approximately 12 hours apart)

COPD Treatment:

• The recommended dosage is 2 inhalations of 160/4.5 mcg twice a day. (morning and evening, approximately 12 hours apart)

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as formoterol one of the active ingredients in budesonide/formoterol, 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, budesonide/formoterol 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 budesonide/formoterol) 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 budesonide/formoterol for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. 

Serious side effects have been reported with budesonide/formoterol including the following:

• People with asthma who take LABA medicines such as formoterol have an increased risk of death from asthma problems.  It is not known whether budesonide reduces the risk of death from asthma problems seen with formoterol.
• Call your healthcare provider if breathing problems worsen over time while using budesonide/formoterol.  You may need different treatment.
• Get emergency medical care if:
  • breathing problems worsen quickly, and
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems
• Budesonide/formoterol should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid
• When your asthma is well controlled, your healthcare provider may tell you to stop taking budesonide/formoterol.  Your healthcare provider will decide if you can stop budesonide/formoterol without loss of asthma control.  Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
• Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Do not use budesonide/formoterol

• to treat sudden severe symptoms of asthma or COPD
• if you are allergic to any of the ingredients in budesonide/formoterol

Serious side effects have been reported with budesonide/formoterol.  See the "Budesonide/formoterol Precautions" section.

Common side effects of budesonide/formoterol include the following:

• throat irritation
• headache
• upper respiratory tract infection
• throat pain
• inflammation of mucous membranes of the sinuses (sinusitis)
• flu
• back pain
• nasal congestion
• stomach discomfort
• vomiting
• thrust in the mouth and throat

This is not a complete list of budesonide/formoterol side effects.

Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. 

You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antifungal medications such as
  • ketoconazole (Nizoral) 
  • fluconazole (Diflucan) 
  • itraconazole (Sporanox) 
  • posaconazole (Noxafil)
• anti-HIV medications such as
  • efavirenz/emtricitabine/tenofovir (Atripla)
  • rilpivirine (Edurant)
  • emtricitabine (Emtriva)
  • elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild)
  • tenofovir/emtricitabine (Truvada)
  • tenofovir (Viread)
  • adefovir (Hepsera)

This is not a complete list of budesonide/formoterol drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy.  Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Budesonide/formoterol falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Budesonide, one of the ingredients in budesonide/formoterol, has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from budesonide/formoterol, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

It is unknown of formoterol, the other ingredient in budesonide/formoterol, is excreted in human breast milk.