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

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

Serious side effects of Breztri Aerosphere

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

Other side effects of Breztri Aerosphere

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.

Respiratory

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]