Applies to salmeterol: inhalation powder.

Serious side effects of Salmeterol

Along with its needed effects, salmeterol 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 salmeterol:

More common

• Cough producing mucus
• difficulty with breathing
• headache
• irritation of the throat
• runny nose
• sneezing
• stuffy nose
• tightness in the chest

Less common

• Blistering, burning, crusting, dryness, or flaking of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• colds
• diarrhea
• dizziness
• dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• hoarseness
• increased hunger
• increased thirst
• increased urination
• itching, scaling, severe redness, soreness, or swelling of the skin
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• noisy breathing
• pain
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• shivering
• skin rash, encrusted, scaly and oozing
• slow or fast heartbeat
• sore mouth, tongue, or throat
• stomach pain
• sweating
• swelling
• trouble with sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• white patches in the mouth or on the tongue

Incidence not known

• Choking or feeling of choking
• difficulty swallowing
• extra heartbeat
• fainting
• fast, pounding, or irregular heartbeat or pulse
• hives or welts
• mouth irritation
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur while taking salmeterol:

Symptoms of overdose

• Arm, back, or jaw pain
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• seizures
• shakiness in the legs, arms, hands, or feet
• sleeplessness
• trembling or shaking of the hands or feet

Other side effects of Salmeterol

Some side effects of salmeterol 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
• belching
• bone pain
• burning, dry, or itching eyes
• difficulty with moving
• discharge or excessive tearing
• eye redness, irritation, or pain
• headache, severe and throbbing
• heartburn
• indigestion
• mouth or tooth pain
• muscle cramps, spasm, stiffness, or tightness
• redness of the skin
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• stomach discomfort or upset

For Healthcare Professionals

Applies to salmeterol: inhalation aerosol, inhalation aerosol with adapter, inhalation powder.

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (12%)

Common (1% to 10%): Arthralgia, articular rheumatism, muscle cramps and spasm, bone and skeletal pain, muscle pain, muscle stiffness, muscle tightness, muscle rigidity, musculoskeletal inflammation

Frequency not reported: Join pain^[Ref]

Nervous system

Very common (10% or more): Headache (up to 14%)

Common (1% to 10%): Dizziness, migraines, tremor

Frequency not reported: Sinus headache, paresthesia^[Ref]

Cardiovascular

Common (1% to 10%): Pallor, hypertension, palpitations

Uncommon (0.1% to 1%): Tachycardia

Very rare (less than 0.01%): Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)

Frequency not reported: Peripheral vasodilation and a compensatory small increase in heart rate^[Ref]

Dermatologic

Common (1% to 10%): Skin rashes, urticaria, photodermatitis

Frequency not reported: Contact dermatitis, eczema^[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal signs and symptoms, nausea, vomiting, candidiasis mouth/throat, dental discomfort and pain, dyspeptic symptoms, gastrointestinal infections, hyposalivation

Frequency not reported: Oral mucosal abnormality^[Ref]

Hepatic

Common (1% to 10%): Transient elevation of hepatic enzymes^[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia

Rare (less than 0.1%): Hypokalemia^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, keratitis^[Ref]

Other

Common (1% to 10%): Influenza, ear signs and symptoms, edema and swelling

Frequency not reported: Localized aches and pains, pyrexia of unknown origin^[Ref]

Psychiatric

Common (1% to 10%): Anxiety

Uncommon (0.1% to 1%): Nervousness

Rare (less than 0.1%): Insomnia

Frequency not reported: Sleep disturbances^[Ref]

Respiratory

Common (1% to 10%): Nasal/sinus congestion, rhinitis, asthma, tracheitis/bronchitis, pharyngitis, sinusitis, upper respiratory tract infection, cough, throat irritation, lower respiratory signs and symptoms

Very rare (less than 0.01%): Paradoxical bronchospasm, non specific chest pain, oropharyngeal irritation

Frequency not reported: Bronchospasm

Postmarketing reports: Upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reactions including edema and angioedema, bronchospasm and anaphylactic shock

Frequency not reported: Immediate hypersensitivity reactions

Postmarketing reports: Anaphylaxis^[Ref]