Applies to formoterol / glycopyrrolate: inhalation aerosol powder.

Serious side effects

Along with its needed effects, 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 formoterol / glycopyrrolate:

Less common

• Bladder pain
• bloody or cloudy urine
• chest pain
• chills
• cough
• diarrhea
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• pain or tenderness around the eyes and cheekbones
• shivering
• sore throat
• stuffy or runny nose
• sweating
• tightness of the chest
• trouble sleeping
• troubled breathing
• unusual tiredness or weakness
• vomiting

Incidence not known

• Agitation
• blurred vision
• decrease in the frequency of urination
• difficulty in passing urine (dribbling)
• dizziness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• flushed, dry skin
• fruit-like breath odor
• hives or welts, itching, or skin rash
• hoarseness
• increased hunger
• increased thirst
• irritation
• joint stiffness or swelling
• redness of the skin
• restlessness
• stomach pain
• swelling of the eyelids, face, lips, hands, or feet
• tremor
• trouble swallowing
• unexplained weight loss

Other side effects

Some side effects of 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

• Anxiety
• arm or leg pain
• bruise
• difficulty with moving
• falls
• mouth or throat pain
• muscle spasm or stiffness
• toothache

For Healthcare Professionals

Applies to formoterol / glycopyrrolate: inhalation aerosol.

Respiratory

Common (1% to 10%): Cough (4%); In less than 2%: Chest pain, influenza, acute sinusitis^[Ref]

Cardiovascular

Frequency not reported: Formoterol fumarate: Palpitations, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystoles)^[Ref]

Gastrointestinal

Common (1% to 10%): In less than 2%: Tooth abscess, oropharyngeal pain, vomiting, dry mouth

Frequency not reported: Formoterol fumarate: Nausea^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (2.6%)

Frequency not reported: Worsening of urinary retention^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (formoterol fumarate)^[Ref]

Metabolic

Frequency not reported: Formoterol fumarate: Hyperglycemia^[Ref]

Musculoskeletal

Common (1% to 10%): In less than 2%: Arthralgia, muscle spasm, pain in the extremity^[Ref]

Nervous system

Common (1% to 10%): In less than 2%: Headache, dizziness

Frequency not reported: Formoterol fumarate: Tremor^[Ref]

Ocular

Frequency not reported: Worsening of narrow-angle glaucoma^[Ref]

Other

Common (1% to 10%): In less than 2%: Fall, fatigue, contusion^[Ref]

Psychiatric

Common (1% to 10%): Anxiety (less than 2%)

Frequency not reported: Paradoxical bronchospasm; Formoterol fumarate: Restlessness, sleep disturbances, agitation^[Ref]