Budesonide / Formoterol / Glycopyrrolate Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 16, 2024.

Applies to budesonide / formoterol / glycopyrrolate: inhalation aerosol liquid.

Precautions

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

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.

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.

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.

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death, especially in patients with asthma who take bronchodilators without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

You may get infections more easily while using this medicine. Tell your doctor right away if you 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 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 using 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 have 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 develop a skin rash, hives, swelling of the tongue, lips, or face, 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 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.

Check with your doctor right away if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine, or painful urination.

Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe COPD 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

Along with its needed effects, budesonide/formoterol/glycopyrrolate 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/glycopyrrolate:

Other side effects

Some side effects of budesonide / formoterol / glycopyrrolate 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 / glycopyrrolate: inhalation aerosol.

Respiratory adverse events

• Very common (10% or more): Nasopharyngitis (up to 11.4%)
• Common (1% to 10%): Chronic obstructive pulmonary disease, upper respiratory tract infection, pneumonia, bronchitis, dyspnea, influenza, cough, sinusitis, dysphonia
• Uncommon (0.1% to 1%): Throat irritation, bronchospasm
• Frequency not reported: Paradoxical bronchospasm

Budesonide-Containing Products (Orally Inhaled):

• Frequency not reported: Localized Candida albicans infection of the pharynx

Inhaled Corticosteroids:

• Frequency not reported: Lower respiratory tract infections (including pneumonia)

Long-Acting Beta2-Adrenergic Agonists (LABA):

• Frequency not reported: Serious asthma-related events (hospitalization, intubation, death)^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, muscle spasms
• Frequency not reported: Reduction in bone marrow density (BMD)

Inhaled Corticosteroids:

• Frequency not reported: Decreases in BMD^[Ref]

Gastrointestinal

• Common (1% to 10%): Oral candidiasis, diarrhea, nausea
• Uncommon (0.1% to 1%): Dry mouth

Budesonide-Containing Products (Orally Inhaled):

• Frequency not reported: Localized C albicans infection of the mouth^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, palpitations
• Uncommon (0.1% to 1%): Angina pectoris, tachycardia, cardiac arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia, extrasystoles)

Formoterol:

• Frequency not reported: Clinically significant cardiovascular effects (increased pulse rate, increased systolic/diastolic blood pressure, cardiac arrhythmias [e.g., supraventricular tachycardia, extrasystoles])

Beta-Agonists:

• Frequency not reported: ECG changes (e.g., flattening of the T wave, prolongation of the QTc interval, ST segment depression)

Inhaled Sympathomimetic Drugs:

• Frequency not reported: Significant cardiovascular effects and fatalities^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Uncommon (0.1% to 1%): Urinary retention

Nervous system

• Common (1% to 10%): Headache
• Uncommon (0.1% to 1%): Tremor, dizziness^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, insomnia
• Uncommon (0.1% to 1%): Depression, agitation, restlessness, nervousness
• Very rare (less than 0.01%): Abnormal behavior^[Ref]

Metabolic

• Common (1% to 10%): Hyperglycemia

Beta2-Adrenergic Agonists:

• Frequency not reported: Significant hypokalemia, transient hyperglycemia^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions (including anaphylaxis)^[Ref]

Other

• Uncommon (0.1% to 1%): Chest pain

Dermatologic

• Uncommon (0.1% to 1%): Bruising
• Frequency not reported: Angioedema^[Ref]

Endocrine

• Very rare (less than 0.01%): Signs/symptoms of systemic glucocorticoid steroid effects (e.g., hypofunctional adrenal gland)^[Ref]

Ocular

• Uncommon (0.1% to 1%): Cataracts
• Frequency not reported: Blurred vision, glaucoma

Inhaled Corticosteroids (Long-Term) or Inhaled Anticholinergics:

• Frequency not reported: Glaucoma, increased intraocular pressure, cataracts^[Ref]

See also:

Frequently asked questions

• What is the difference between Breztri vs Trelegy?
• Why is Breztri not for asthma?

Further information

Budesonide/formoterol/glycopyrrolate 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.

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