August 28, 2015
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Albuterol Sulfate

"Jan 3, 2011 -- The Ritedose Corporation has recalled some single-dose vials of Albuterol Sulfate Inhalation Solution because an incorrect label could lead to a possible overdose.

The recall includes 0.083% Albuterol Sulfate Inhalation S"...

Albuterol Sulfate




Albuterol Sulfate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/8/2015

Albuterol sulfate (albuterol sulfate inhalation solution) is a bronchodilator used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Albuterol is also used to prevent exercise-induced bronchospasm. This medication is available in generic form. Common side effects of albuterol sulfate include bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine; nervousness; shaking (tremor); headache; chest pain and fast, pounding, or irregular/uneven heartbeats (palpitations); nausea, or dizziness.

The usual starting dosage of Albuterol sulfate for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate inhalation solution administered 3 or 4 times daily, as needed, by nebulization. Albuterol sulfate may interact with diuretics (water pills), digoxin, beta-blockers, antidepressants, MAO inhibitor, or other bronchodilators. Tell your doctor all medications you use. During pregnancy, Albuterol sulfate should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Albuterol sulfate (albuterol sulfate inhalation solution) 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.

Albuterol Sulfate 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 Albuterol Sulfate (Albuterol Sulfate Inhalation Solution)

What is Prescribing information?

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

Albuterol Sulfate FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reaction information concerning PROVENTIL® HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following 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 PROVENTIL HFA Inhalation Aerosol treatment group and more frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.

Adverse Experience Incidences (% of patients) in a Large 12-week Clinical Trial*

Body System/ Adverse Event (Preferred Term) PROVENTIL® HFA Inhalation Aerosol
(N=193)
CFC 11/12 Propelled Albuterol Inhaler
(N=186)
HFA-134a Placebo Inhaler
(N=186)
Application Site Disorders Inhalation Site Sensation 6 9 2
Inhalation Taste Sensation 4 3 3
Body as a Whole Allergic Reaction/Symptoms 6 4 < 1
Back Pain 4 2 3
Fever 6 2 5
Central and Peripheral Nervous System Tremor 7 8 2
Gastrointestinal System Nausea 10 9 5
Vomiting 7 2 3
Heart Rate and Rhythm Disorder Tachycardia 7 2 < 1
Psychiatric Disorders Nervousness 7 9 3
Respiratory System Disorders Respiratory Disorder (unspecified) 6 4 5
Rhinitis 16 22 14
Upper Resp Tract Infection 21 20 18
Urinary System Disorder Urinary Tract Infection 3 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 PROVENTIL HFA Inhalation Aerosol group and more frequently in the PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.

Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation Aerosol patients than placebo patients, which have the potential to be related to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation Aerosol.

Adverse events reported in a 4-week pediatric clinical trial comparing PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.

In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.

Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of the oropharynx.

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

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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