Applies to aclidinium / formoterol: inhalation aerosol powder.

Serious side effects

Along with its needed effects, aclidinium/formoterol 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 aclidinium / formoterol:

More common

• Body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Bladder pain
• bloody or cloudy urine
• diarrhea
• difficult, burning, or painful urination
• frequent urge to urinate
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• pain or tenderness around the eyes and cheekbones
• shivering
• sweating
• tightness of the chest
• trouble sleeping
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking aclidinium / formoterol:

Symptoms of overdose

• Blurred vision
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• muscle spasms
• nervousness
• pounding in the ears
• slow heartbeat
• tremor

Other side effects

Some side effects of aclidinium / formoterol 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

• Back, arm, or leg pain
• bone pain
• difficulty in moving
• dry mouth
• mouth or throat pain
• muscle stiffness
• toothache

For Healthcare Professionals

Applies to aclidinium / formoterol: inhalation powder.

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, electrocardiogram QTc prolonged, palpitations, blood pressure increased^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, dry mouth, tooth abscess^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention, urinary tract infection^[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity

Frequency not reported: Angioedema^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycaemia, hypokalemia^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, muscle spasms, blood creatinine phosphokinase increased^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, tremor

Uncommon (0.1% to 1%): Dysgeusia^[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision^[Ref]

Other

Common (1% to 10%): Edema peripheral^[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia

Uncommon (0.1% to 1%): Agitation^[Ref]

Respiratory

Common (1% to 10%): Cough, nasopharyngitis, sinusitis

Uncommon (0.1% to 1%): Dysphonia, throat irritation

Rare (less than 0.1%): Bronchospasm, including paradoxical^[Ref]