Note: This document contains side effect information about albuterol. Some of the dosage forms listed on this page may not apply to the brand name ProAir HFA.

For the Consumer

Applies to albuterol: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• inhalation aerosol powder, inhalation powder, inhalation solution, inhalation suspension

Along with its needed effects, albuterol (the active ingredient contained in ProAir HFA) 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 albuterol:

More common

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

Less common

• Fast, irregular, pounding, or racing heartbeat or pulse

Rare

• Cough
• difficulty breathing
• difficulty with swallowing
• hives or welts
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• redness of the skin
• shortness of breath
• skin rash
• slow or irregular breathing
• swelling of the mouth or throat
• tightness in the chest
• wheezing

Incidence not known

• Agitation
• anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• confusion
• convulsions
• extra heartbeats
• fainting
• hallucinations
• headache
• irritability
• lightheadedness
• mood or mental changes
• muscle pain or cramps
• muscle spasm or jerking of all extremities
• nervousness
• nightmares
• pounding in the ears
• restlessness
• sudden loss of consciousness
• sweating
• total body jerking
• unusual feeling of excitement
• vomiting

Some side effects of albuterol 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

• Dizziness
• feeling of warmth
• irritability
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleeplessness
• trouble with holding or releasing urine
• trouble sleeping
• unable to sleep

Rare

• Sleepiness
• unusual drowsiness

Incidence not known

• Bad, unusual, or unpleasant (after) taste
• change in taste
• feeling of constant movement of self or surroundings
• gagging
• rough, scratchy sound to voice
• sensation of spinning
• tightness in the throat

For Healthcare Professionals

Applies to albuterol: compounding powder, inhalation aerosol, inhalation aerosol with adapter, inhalation capsule, inhalation powder, inhalation solution, oral syrup, oral tablet, oral tablet extended release

General

The most commonly reported adverse reactions are: Taste alteration (bad, unpleasant and unusual taste), mouth and throat irritation, fine tremor (usually of the hands), nausea, sweating, restlessness, headache and dizziness. These undesirable effects may subside on continuation of treatment.

Cardiovascular

Very common (10% or more): Peripheral vasodilation, increase in heart rate

Common (1% to 10%): Palpitations, tachycardia, pallor

Rare (0.01% to 0.1%): Myocardial ischemia, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extra systoles)

Very rare (less than 0.01%): Cardiovascular collapse, thrombopenia

Frequency not reported: Angina, hypertension, hypotension, flushing

Nervous system

Very common (10% or more): Headache (up to 18.8%), tremor (up to 24.2%), excitement (up to 20%), nervousness (up to 15%)

Common (1% to 10%): Migraine, dizziness, shakiness, hyperkinesia, emotional lability

Uncommon (0.1% to 1%): Somnolence, dizziness, drowsiness, restlessness, irritability

Frequency not reported: Central nervous system stimulation

Dermatologic

Common (1% to 10%): Skin/Appendage Infection (1.7%), pruritus, rash, erythema, urticaria, angioedema, sweating

Gastrointestinal

Common (1% to 10%): Gastroenteritis, nausea, oropharyngeal pain, vomiting, increased appetite

Uncommon (0.1% to 1%): Epigastric pain, stomach ache, loss of appetite

Rare (less than 0.1%): Sore mouth

Frequency not reported: Oropharyngeal edema, throat irritation, altered taste, glossitis, tongue ulceration, gagging, drying or irritation of the oropharynx

Genitourinary

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

Rare (less than 0.1%): Nephritis

Frequency not reported: Difficulty in micturition

Hypersensitivity

Common (1% to 10%): Allergic reaction

Very rare (less than 0.01%): angioedema, urticaria, bronchospasm, hypotension and collapse

Immunologic

Common (1% to 10%): Lymphadenopathy

Local

Common (1% to 10%): Application site reaction (mouth and throat irritation, burning sensation of the tongue)

Frequency not reported: Slight pain or stinging (IM injection)

Musculoskeletal

Common (1% to 10%): Back pain, muscles cramps

Uncommon (0.1% to 1%): Myalgia

Very rare (less than 0.01%): Fine tremor (particularly of hands)

Frequency not reported: Myoclonus

Other

Common (1% to 10%): Cold symptoms, flue syndrome, pain, pyrexia, hyperactivity, excitement

Uncommon (0.1% to 1%): Epistaxis, fatigue, otitis media,

Frequency not reported: Weakness

Psychiatric

Common (1% to 10%): Tenseness

Uncommon (0.1% to 1%): Sleepiness, sleep disturbance

Rare (0.01% to 0.1%): Hallucinations

Very rare (less than 0.01%): Insomnia

Respiratory

Common (1% to 10%): Asthma exacerbation (13%), chest pain, bronchitis, sinus headache, upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough

Very rare (less than 0.01%): Paradoxical bronchospasm, bronchospasm

Frequency not reported: Aggravated bronchospasm, asthma exacerbation, chest discomfort, pulmonary edema

Ocular

Uncommon (0.1% to 1%): Dilated pupils, conjunctivitis

Metabolic

Rare (less than 0.1%): Hypokalemia, hyperglycemia, increase of insulin, free fatty acids, glycerol and ketone bodies

Postmarketing reports: Metabolic acidosis, lactic acidosis