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Drug Information for Albuterol Sulfate (Mylan Pharmaceuticals Inc.): ADVERSE REACTIONS
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- ADVERSE REACTIONS
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The results of clinical trials with albuterol sulfate inhalation solution in 135 patients showed the following side effects which were considered probably or possibly drug related:
Central Nervous System: tremors (20%), dizziness (7%), nervousness (4%), headache (3%), insomnia (1%).
Gastrointestinal: nausea (4%), dyspepsia (1%).
Ear, Nose and Throat: pharyngitis (<1%), nasal congestion (1%).
Cardiovascular: tachycardia (1%), hypertension (1%).
Respiratory: bronchospasm (8%), cough (4%), bronchitis (4%), wheezing (1%).
No clinically relevant laboratory abnormalities related to albuterol sulfate inhalation solution administration were determined in these studies.
In comparing the adverse reactions reported for patients treated with albuterol sulfate inhalation solution with those of patients treated with isoproterenol during clinical trials of three months, the following moderate to severe reactions, as judged by the investigators, were reported. This table does not include mild reactions.
Percent Incidence of Moderate to Severe Adverse Reactions Reaction AlbuterolN=65 IsoproterenolN=65 Central Nervous System Tremors 10.7% 13.8% Headache 3.1% 1.5% Insomnia 3.1% 1.5% Cardiovascular Hypertension 3.1% 3.1% Arrhythmias 0% 3% The finding of no arrhythmias and no palpitations after albuterol administration in this clinical study should not be interpreted as indicating that these adverse effects cannot occur after the administration of inhaled albuterol.Palpitation 0% 22% Respiratory In most cases of bronchospasm, this term was generally used to describe exacerbations in the underlying pulmonary disease.Bronchospasm 15.4% 18% Cough 3.1% 5% Bronchitis 1.5% 5% Wheeze 1.5% 1.5% Sputum Increase 1.5% 1.5% Dyspnea 1.5% 1.5% Gastrointestinal Nausea 3.1% 0% Dyspepsia 1.5% 0% Systemic Malaise 1.5% 0%
Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillations, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate inhalation solution.
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