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Breztri Aerosphere Side Effects

Generic name: budesonide / formoterol / glycopyrrolate

Medically reviewed by Drugs.com. Last updated on Apr 13, 2021.

Note: This document contains side effect information about budesonide / formoterol / glycopyrrolate. Some of the dosage forms listed on this page may not apply to the brand name Breztri Aerosphere.

For the Consumer

Applies to budesonide/formoterol/glycopyrrolate: inhalation aerosol liquid

Side effects requiring immediate medical attention

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:

Less common

  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chest pain or tightness
  • chills
  • cough
  • darkening of the skin
  • decrease in urine volume and frequency of urination
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty breathing
  • dizziness
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • headache
  • hives, itching, skin rash
  • hoarseness
  • increased hunger
  • increased thirst
  • increased urination
  • irritation
  • joint pain, stiffness, or swelling
  • loss of appetite
  • lower back or side pain
  • mental depression
  • muscle aches and pains
  • nausea
  • noisy breathing
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin
  • shivering
  • sneezing
  • sore mouth, throat, or tongue
  • stomach pain
  • stuffy or runny nose
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • tremor
  • trouble sleeping
  • trouble swallowing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • white patches in the mouth or on the tongue

Side effects not requiring immediate medical attention

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:

Less common

  • Agitation
  • anxiety
  • back pain
  • bruising
  • muscle spasms
  • nervousness
  • restlessness
  • throat irritation

For Healthcare Professionals

Applies to budesonide / formoterol / glycopyrrolate: inhalation aerosol

Immunologic

Common (1% to 10%): Upper respiratory tract infection, pneumonia, oral candidiasis, influenza, urinary tract infection, sinusitis

Frequency not reported: Candida albicans infection, increased risk of pneumonia in COPD, immunosuppression and risk of infections[Ref]

Respiratory

Common (1% to 10%): Cough

Frequency not reported: Paradoxical bronchospasm, serious asthma-related events (hospitalization, intubation, death)[Ref]

Cardiovascular

Frequency not reported: Cardiovascular effects (increases in pulse rate, systolic or diastolic blood pressure; cardiac arrhythmias such as supraventricular tachycardia and extrasystoles), palpitations, angina pectoris, tachycardia, chest pain[Ref]

Endocrine

Frequency not reported: Hypercorticism and adrenal suppression, sign or symptoms of systemic glucocorticoid steroid effects (e.g. hypofunctional adrenal gland)[Ref]

Ocular

Uncommon (0.1% to 1%): Cataracts

Frequency not reported: Worsening of narrow-angle glaucoma and cataracts, glaucoma, increased intraocular pressure[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions including anaphylaxis[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle spasms

Frequency not reported: Reduction in bone marrow density[Ref]

Psychiatric

Common (1% to 10%): Dysphonia

Frequency not reported: Anxiety, insomnia, depression, agitation, restlessness, nervousness, abnormal behavior[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea

Frequency not reported: Dry mouth, throat irritation[Ref]

Genitourinary

Frequency not reported: Worsening of urinary retention, urinary retention

Nervous system

Frequency not reported: Headache, tremor, dizziness[Ref]

Metabolic

Frequency not reported: Hyperglycemia[Ref]

Dermatologic

Frequency not reported: Bruising[Ref]

References

1. "Product Information. Breztri Aerosphere (budesonide / formoterol / glycopyrrolate)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Further information

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

Some side effects may not be reported. You may report them to the FDA.