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Proair

Last reviewed on RxList: 3/8/2019
Proair Side Effects Center

Last reviewed on RxList 3/8/2019

Proair (albuterol sulfate) is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs used to prevent and treat wheezing and shortness of breath caused by breathing problems such as asthma and chronic obstructive pulmonary disease. Proair is also used to prevent exercise-induced asthma. Common side effects of Proair include:

ProAir is a dry powder inhaler supplied for 200 measured inhalation doses. ProAir may interact with other inhaled medicines, other asthma medicines, beta-blockers, diuretics, digoxin, monoamine oxidase inhibitors (MAOIs), and antidepressants. Tell your doctor all medications and supplements you use.During pregnancy, ProAir should be used only if prescribed. It is unknown if ProAir passes into breast milk. Consult your doctor before breastfeeding.

Our ProAir (albuterol sulfate) inhalation powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Asthma is a chronic respiratory disease. See Answer
Proair Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • chest pain, fast heart rate, pounding heartbeats or fluttering in your chest;
  • severe headache, pounding in your neck or ears;
  • pain or burning when you urinate;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
  • low potassium--leg cramps, constipation, irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • chest pain, fast or pounding heartbeats;
  • dizziness;
  • feeling shaky or nervous;
  • headache, back pain, body aches;
  • upset stomach; or
  • sore throat, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Proair (Albuterol Sulfate Inhalation Aerosol)

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow
Proair Professional Information

SIDE EFFECTS

Use of PROAIR HFA may be associated with the following:

  • Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular Effects [see WARNINGS AND PRECAUTIONS]
  • Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS]

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)
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
* 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.

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.

Read the entire FDA prescribing information for Proair (Albuterol Sulfate Inhalation Aerosol)

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