Budesonide/formoterol

Budesonide/formoterol has shown efficacy to prevent asthma attacks.[14] It is unclear if budesonide/formoterol differs from fluticasone and salmeterol in chronic asthma.[15]

The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease (COPD).[2] However, a 2020 review of the literature does support use as needed during acute worsening in those with mild disease, and as maintenance followed by extra doses during worsening.[4]

Use for both maintenance and as needed treatment is also known as single maintenance and reliever therapy ( SMART) and is a well-established treatment.[16][17] It has been shown to reduce asthma exacerbations that require oral corticosteroids, hospital visits better than maintenance inhaled corticosteroids alone at a higher dose, or inhaled corticosteroid at the same or higher dose with a long acting bronchodilator (LABA)), with a short-acting bronchodilator (SABA) as a reliever.[16][17] More studies using budesonide/formoterol SMART in children are needed.[17]

• Mild throat irritation
• Coughing
• Hoarseness
• Oral candidiasis (thrush. significantly less likely if the patient rinses their mouth out with water after inhalations)
• Headache

Often mild, and usually disappear as the medication continues to be used:

• Heart palpitations
• Trembling

• Feeling restlessness, nervous, or agitated
• Disturbed sleep
• Feeling dizzy
• Nausea
• Tachycardia (fast heart rate)
• Bruising of the skin
• Muscle cramps

• Rash
• Itchiness
• Bronchospasm (tightening of the muscles in the airways causing wheezing immediately after use of the medication, which is possibly sign of an allergic reaction and should be met with immediate medical attention)
• Hypokalemia (low levels of potassium in the blood)
• Heart arrhythmia

• Depression
• Changes in behaviour, especially in children
• Chest pain or tightness in chest
• Increase in blood glucose levels
• Taste changes, such as an unpleasant taste in the mouth
• Changes in blood pressure

With high doses for a long period of time.

• Reduced bone mineral density, causing osteoporosis
• Cataracts
• Glaucoma
• Slowed rate of growth in children and adolescents
• Dysfunction of the adrenal gland, which affects the production of various hormones

• Angioedema (swelling of the face, mouth, tongue, and/or throat. Difficulty swallowing. Hives. Difficulty breathing. Feeling of faintness)
• Bronchospasm (sudden acute wheezing or shortness of breath immediately after use of medication. The patient should use their reliever medication immediately.)[18]

Unopened Symbicort Turbuhaler (left) and opened (middle and right)

Symbicort in the United States is a metered-dose inhaler and is available in 160/4.5mcg and 80/4.5mcg per actuation.

In the European Union, Australia, Canada, Israel, Saudi Arabia and elsewhere the combination is available as a dry powder inhaler in the following doses: 50/3 (40/2.25), 100/3 (80/2.25), 100/6 (80/4.5), 200/6 (160/4.5) and 400/12 (320/9), where the larger number is the dose per actuation of budesonide (in micrograms) and the lower number the dose of formoterol (also in micrograms).

Budesonide/formoterol formulation was introduced in Sweden in 2000. It was approved for use in the United States in July 2006.[8][19] It is now approved for use in at least 70 countries, yielding global sales in excess of $1 billion in 2005, and now approximately $3.7 billion per annum.

Budesonide/formoterol was approved for use in the European Union in April 2014.[20][21]

There are several patents related to the drug; some of them are already expired.[22] It was initially marketed by AstraZeneca.