Breyna Side Effects

Generic name: budesonide / formoterol

Medically reviewed by Drugs.com. Last updated on Oct 5, 2024.

Note: This document provides detailed information about Breyna.

Applies to budesonide / formoterol: inhalation aerosol liquid Side Effects associated with budesonide / formoterol. Some dosage forms listed on this page may not apply specifically to the brand name Breyna.

Applies to budesonide / formoterol: inhalation aerosol liquid.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma attack when they do occur. Be sure to read about these risks in the patient information leaflet and talk to your doctor about any questions or concerns that you have.

This medicine should not be used if you are having a sudden COPD attack, or if symptoms of COPD attack has already started. Your doctor will give you a short-acting inhaler to use for this condition. If the short-acting inhaler is not working, tell your doctor right away.

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

Talk to your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine for a few days or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

Do not use this medicine together with other inhaled medicines for COPD, including arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), olodaterol, salmeterol (Serevent®), or vilanterol.

Do not change your dose or stop using your medicine without first asking your doctor.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.

Patients with COPD may be more likely to have pneumonia when taking this medicine. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, or wheezing.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

Call your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Breyna

Along with its needed effects, budesonide / formoterol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking budesonide / formoterol:

Get emergency help immediately if any of the following symptoms of overdose occur while taking budesonide / formoterol:

Symptoms of overdose

• arm, back, or jaw pain
• chest pain or discomfort
• darkening of the skin
• drowsiness
• mental depression
• rapid, deep breathing
• restlessness
• skin rash
• stomach cramps

Other side effects of Breyna

Some side effects of budesonide / formoterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to budesonide / formoterol: inhalation aerosol.

General adverse events

General side effects have included oral candidiasis, and transient mild tremor and palpitations which tend to disappear within a few days of treatment.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 11.3%)
• Common (1% to 10%): Tremor
• Uncommon (0.1% to 1%): Dizziness, thirst tiredness
• Very rare (less than 0.01%): taste disturbances^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (up to 10.5%), upper respiratory tract infection (up to 10.5%)
• Common (1% to 10%): Sinusitis, nasal congestion, bronchitis, mild irritation in the throat, coughing, hoarseness, pneumonia
• Rare (0.01% to 0.1%): Bronchospasm
• Very rare (less than 0.01%): Paradoxical bronchospasm
• Postmarketing reports: Dysphonia, cough, throat irritation^[Ref]

Cardiovascular

• Common (1% to 10%): Palpitations
• Uncommon (0.1% to 1%): Tachycardia
• Rare (0.01% to 0.1%): Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
• Very rare (less than 0.01%): Angina pectoris, prolongation of QTc-interval, variations in blood pressure
• Postmarketing reports: Atrial and ventricular tachyarrhythmias, hypotension, hypertension^[Ref]

Gastrointestinal

• Common (1% to 10%): Pharyngolaryngeal pain, stomach discomfort, vomiting, oral candidiasis
• Uncommon (0.1% to 1%): Nausea
• Postmarketing reports: Oropharyngeal candidiasis^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain,
• Uncommon (0.1% to 1%): Muscle cramps^[Ref]

Other

• Common (1% to 10%): Influenza^[Ref]

Psychiatric

Common (1% to 10%):

• Uncommon (0.1% to 1%): Aggression, psychomotor hyperactivity, anxiety, sleep disorders
• Very rare (less than 0.01%): Depression, behavioral changes
• Postmarketing reports: Behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Skin bruising^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Weight gain
• Rare (0.01% to 0.1%): Hypokalemia
• Very rare (less than 0.01%): Hyperglycemia^[Ref]

Ocular

• Uncommon (0.1% to 1%): Blurred vision
• Very rare (less than 0.01%): Cataract, glaucoma
• Frequency not reported: Central serous retinopathy
• Postmarketing reports: Increased intraocular pressure^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction^[Ref]

Endocrine

• Very rare (less than 0.01%): Cushing's syndrome, adrenal suppression, growth retardation, decrease in bone mineral density
• Postmarketing reports: Hypercorticism, growth velocity reduction in pediatric patients^[Ref]

See also:

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Further information

Breyna side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer