Albuterol Sulfate
Albuterol Sulfate Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Albuterol sulfate (albuterol sulfate inhalation solution) is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Albuterol is also used to prevent exercise-induced bronchospasm. It is a bronchodilator. This medication is available in generic form. Common side effects include nervousness, shaking (tremor), headache, 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
Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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, nervousness;
- sleep problems (insomnia);
- cough, hoarseness, sore throat, runny or stuffy nose;
- dry mouth and throat;
- muscle pain; or
- diarrhea.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. 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 events reported in > 1% of patients receiving albuterol sulfate (albuterol sulfate inhalation solution) and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.
Table 1: Adverse Events with an Incidence of > 1% of Patients
Receiving Albuterol Sulfate (albuterol sulfate inhalation solution) and Greater than Placebo (expressed as % of treatment
group)
| 1.25 mg Albuterol Sulfate (albuterol sulfate inhalation solution) (N=115) |
0.63 mg Albuterol Sulfate (albuterol sulfate inhalation solution) (N=117) |
Placebo (N=117) |
|
| Asthma Exacerbation | 13 | 11.1 | 8.5 |
| Otitis Media | 4.3 | 0.9 | 0 |
| Allergic Reaction | 0.9 | 3.4 | 1.7 |
| Gastroenteritis | 0.9 | 3.4 | 0.9 |
| Cold Symptoms | 0 | 3.4 | 1.7 |
| Flu Syndrome | 2.6 | 2.6 | 1.7 |
| Lymphadenopathy | 2.6 | 0.9 | 1.7 |
| Skin/Appendage Infection | 1.7 | 0 | 0 |
| Urticaria | 1.7 | 0.9 | 0 |
| Migraine | 0.9 | 1.7 | 0 |
| Chest Pain | 0.9 | 1.7 | 0 |
| Bronchitis | 0.9 | 1.7 | 0.9 |
| Nausea | 1.7 | 0.9 | 0.9 |
There was one case of ST segment depression in the 1.25 mg albuterol sulfate (albuterol sulfate inhalation solution) treatment group.
No clinically relevant laboratory abnormalities related to albuterol sulfate (albuterol sulfate inhalation solution) administration were seen in this study.
Read the entire FDA prescribing information for Albuterol Sulfate (Albuterol Sulfate Inhalation Solution) »
Additional Albuterol Sulfate Information
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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