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Proair

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Proair HFA

Proair Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Proair (albuterol sulfate) is used to prevent and treat wheezing and shortness of breath caused by breathing problems such as asthma and chronic obstructive pulmonary disease. It is also used to prevent exercise-induced asthma. Proair belongs to a class of drugs known as bronchodilators that relaxes muscles in the airways and increases air flow to the lungs. Common side effects include nervousness, shaking (tremor), headache, mouth/throat dryness or irritation, cough, nausea or dizziness.

Proair is inhaled by mouth as directed by a doctor, usually every 4 to 6 hours as needed. Dosage is based on your medical condition and response to treatment. Proair may adversely interact with other medications including diuretics (water pills), digoxin, beta-blockers, antidepressants, MAO inhibitors, and other bronchodilators. Tell your doctor all medications you are taking. This medication should be used only when clearly needed during pregnancy. Tell your doctor if you are pregnant. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Proair (albuterol sulfate) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Proair in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • tremor, nervousness;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • headache, dizziness;
  • sleep problems (insomnia);
  • cough, hoarseness, sore throat, runny or stuffy nose;
  • mild nausea, vomiting;
  • dry mouth and throat;
  • muscle pain; or
  • diarrhea.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Proair Overview - Patient Information: Side Effects

SIDE EFFECTS: Nervousness, shaking (tremor), headache, mouth/throat dryness or irritation, cough, nausea or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat.

Get medical help right away if you have any rare but very serious side effects, including: chest pain, irregular heartbeat, rapid breathing, confusion.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Proair (Albuterol Sulfate Inhalation Aerosol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Proair FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Use of PROAIR HFA (albuterol sulfate inhalation aerosol) 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 (albuterol sulfate inhalation aerosol) Inhalation Aerosol, or with the same formulation of albuterol as in PROAIR HFA (albuterol sulfate inhalation aerosol) 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 (albuterol sulfate inhalation aerosol) 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 (albuterol sulfate inhalation aerosol) Inhalation Aerosol treatment group and more frequently in the PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol treatment group than in the matched placebo group. Overall, the incidence and nature of the adverse events reported for PROAIR HFA (albuterol sulfate inhalation aerosol) 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 activecomparator
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 (albuterol sulfate inhalation aerosol) Inhalation Aerosol but by a greater proportion of PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol patients than the matched placebo patients, which have the potential to be related to PROAIR HFA (albuterol sulfate inhalation aerosol) 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 (albuterol sulfate inhalation aerosol) 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 (albuterol sulfate inhalation aerosol) . 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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Proair HFA - User Reviews

Proair HFA User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Proair HFA sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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