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Formoterol / glycopyrrolate Side Effects

For the Consumer

Applies to formoterol / glycopyrrolate: inhalation aerosol powder

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
  • cough
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain

Incidence Not Known

  • Blindness
  • blurred vision
  • decrease in the frequency of urination
  • decrease in urine volume
  • decreased vision
  • difficulty with breathing
  • dizziness
  • eye pain
  • fainting
  • headache
  • hives or welts, itching, or skin rash
  • irregular heartbeat
  • nausea or vomiting
  • nervousness
  • noisy breathing
  • pounding in the ears
  • recurrent large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin
  • slow or fast heartbeat
  • tearing
  • tightness in the chest

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

  • Difficulty with moving
  • dry mouth
  • fear
  • fever
  • muscle pain or stiffness
  • muscle spasm
  • pain in the arms or legs
  • pain in the joints
  • pain or tenderness around the eyes and cheekbones
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness

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]

References

1. "Product Information. Bevespi Aerosphere (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.

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