Medical Editor: John P. Cunha, DO, FACOEP
What Is Albuterol Sulfate?
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. Albuterol sulfate is available in generic form.
What Are Side Effects of Albuterol Sulfate?
Common side effects of albuterol sulfate include:
- headache,
- dizziness,
- sleep problems (insomnia),
- cough,
- hoarseness,
- sore throat,
- runny or stuffy nose,
- nausea,
- vomiting,
- dry mouth and throat,
- muscle pain, or
- diarrhea.
Tell your doctor if you experience serious side effects of albuterol sulfate including 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); 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).
Dosage for Albuterol Sulfate
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.
What Drugs, Substances, or Supplements Interact with Albuterol Sulfate?
Albuterol sulfate may interact with diuretics (water pills), digoxin, beta-blockers, antidepressants, MAO inhibitor, or other bronchodilators. Tell your doctor all medications you use.
Albuterol Sulfate During Pregnancy and Breastfeeding
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.
Additional Information
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.
SLIDESHOW
What Is Asthma? Symptoms, Causes, and Treatments See SlideshowGet 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;
- upset stomach, vomiting;
- painful urination;
- dizziness;
- feeling shaky or nervous;
- headache, back pain, body aches; or
- cough, 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.
QUESTION
Asthma is a chronic respiratory disease. See AnswerSIDE 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)
© Albuterol Sulfate Patient Information is supplied by Cerner Multum, Inc. and Albuterol Sulfate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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