ProAir HFA Side Effects

Generic Name: albuterol

Please note - some side effects for ProAir HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of ProAir HFA - for the Consumer

ProAir HFA Aerosol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using ProAir HFA Aerosol:

Cough; headache; nervousness; sinus inflammation; sore or dry throat; tremor; trouble sleeping; unusual taste in mouth.

Seek medical attention right away if any of these SEVERE side effects occur when using ProAir HFA Aerosol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; new or worsened trouble breathing; pounding in the chest; severe headache or dizziness; unusual hoarseness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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ProAir HFA Side Effects - for the Professional

ProAir HFA

Use of ProAir HFA may be associated with the following:

• Paradoxical bronchospasm [see Warnings and Precautions (5.1)]
• Cardiovascular Effects [see Warnings and Precautions (5.4)]
• Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)]
• Hypokalemia [see Warnings and Precautions (5.8)]

Clinical Trials Experience

A total of 1090 subjects were treated with ProAir HFA Inhalation Aerosol, or with the same formulation of albuterol as in ProAir HFA Inhalation Aerosol, during the worldwide clinical development program.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult and Adolescents 12 Years of Age and Older: The adverse reaction information presented in the table below concerning ProAir HFA Inhalation Aerosol is derived from a 6-week, blinded study which compared ProAir HFA Inhalation Aerosol (180 mcg four times daily) with a double-blinded matched placebo HFA-Inhalation Aerosol and an evaluator-blinded marketed active comparator HFA-134a albuterol inhaler in 172 asthmatic patients 12 to 76 years of age. The table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the ProAir HFA Inhalation Aerosol treatment group and more frequently in the ProAir HFA Inhalation Aerosol treatment group than in the matched placebo group. Overall, the incidence and nature of the adverse events reported for ProAir HFA Inhalation Aerosol and the marketed active comparator HFA-134a albuterol inhaler were comparable.

Adverse Experience Incidences (% of Patients) in a Six-Week Clinical Trial*

Body System/ Adverse Event (as Preferred Term)		ProAir HFA Inhalation Aerosol (N = 58)	Marketed active comparator HFA-134a albuterol inhaler (N = 56)	Matched Placebo HFA-134a Inhalation Aerosol (N = 58)
* This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the ProAir HFA Inhalation Aerosol group and more frequently in the ProAir HFA Inhalation Aerosol group than in the placebo HFA Inhalation Aerosol group.
Body as a Whole	Headache	7	5	2
Cardiovascular	Tachycardia	3	2	0
Musculoskeletal	Pain	3	0	0
Nervous System	Dizziness	3	0	0
Respiratory System	Pharyngitis	14	7	9
	Rhinitis	5	4	2

Adverse events reported by less than 3% of the patients receiving ProAir HFA Inhalation Aerosol but by a greater proportion of ProAir HFA Inhalation Aerosol patients than the matched placebo patients, which have the potential to be related to ProAir HFA Inhalation Aerosol, included chest pain, infection, diarrhea, glossitis, accidental injury (nervous system), anxiety, dyspnea, ear disorder, ear pain, and urinary tract infection.

In small cumulative dose studies, tremor, nervousness, and headache were the most frequently occurring adverse events.

Pediatric Patients 4 to 11 Years of Age: Adverse events reported in a 3-week pediatric clinical trial comparing the same formulation of albuterol as in ProAir HFA Inhalation Aerosol (180 mcg albuterol four times daily) to a matching placebo HFA inhalation aerosol occurred at a low incidence rate (no greater than 2% in the active treatment group) and were similar to those seen in adult and adolescent trials.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ProAir HFA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reports have included rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (reported fatal in one case), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging.

The following adverse events have been observed in postapproval use of inhaled albuterol: urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles). In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as: angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.

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Side Effects by Body System - for Healthcare Professionals

General

Albuterol is generally well-tolerated and adverse effects seen are consistent with its pharmacological activity. In general, the severity of these adverse effects is dependent on the dose and route of administration. Administration by metered-dose inhaler (MDI) is associated with less systemic effects than administration of higher dosages orally or by nebulizer. Tolerance may develop to the adverse effects of albuterol.

Cardiovascular

Changes in heart rate of approximately 20% may be produced by 0.18 mg of albuterol by MDI. Aggravation of angina may be due to tachycardia produced by albuterol. Atrial fibrillation was reported in one patient when a spacer device was utilized with an albuterol inhaler, thus increasing the available dose for systemic absorption. Supraventricular ectopic beats and ventricular tachycardia have also been reported. Higher doses of albuterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.

The cardiovascular side effects have included palpitations, peripheral vasodilatation and reflex tachycardia with blood pressure increasing or decreasing. Albuterol in higher dosages has been reported to aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias. Pulmonary edema has been reported in pregnant patients receiving intravenous albuterol. Postmarketing reports have included hypotension.

Musculoskeletal

Musculoskeletal side effects have included tremors, particularly at higher dosages. Tolerance can develop to the tremorogenic effects. Severe muscle cramping may occur infrequently.

Metabolic

Following doses of 15 mg albuterol via nebulizer, hyperkalemic patients on hemodialysis experienced a 0.9 mEq/L decrease in plasma potassium which was sustained for 6 hours. Albuterol may stimulate sodium-potassium ATPase, resulting in an intracellular shift of potassium.

Transient lactic acidosis has been reported after administration of inhaled albuterol for an asthma attack.

Metabolic side effects have included hypokalemia, and less commonly, hyperglycemia and lactic acidosis. Postmarketing reports have included metabolic acidosis. Diabetic ketoacidosis has been reported due to overdose of albuterol.

Nervous system

Nervous system side effects have included restlessness, anxiety, nervousness, irritability, and insomnia. Postmarketing reports have included tremor.

Psychiatric

Psychiatric side effects have included psychoses presenting as auditory hallucinations and persecutory delusions. These effects are generally associated with higher dosages.

Other

Concern over the development of tachyphylaxis to the bronchodilating effects of albuterol has been expressed. Although conflicting data exist, complete tolerance has not been reported.

Respiratory

Respiratory side effects have included paradoxical bronchospasm.

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