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Albuterol Extended Release (Albuterol Sulfate Extended Release) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The adverse reactions to albuterol are similar in nature to reactions to other sympathomimetic agents. The most frequent adverse reactions to albuterol are nervousness, tremor, headache, tachycardia, and palpitations. Less frequent adverse reactions are muscle cramps, insomnia, nausea, weakness, dizziness, drowsiness, flushing, restlessness, irritability, chest discomfort, and difficulty in micturition.

Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of albuterol.

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.

In controlled clinical trials of adult patients conducted in the United States, the following incidence of adverse events was reported:

Event Albuterol
Extended-Release
Tablets
(n =330)
Theophylline
(n =197)
Other
Beta-agonists
(n =20)
Placebo
(n =178)
Tremor 24.2% 6.1% 35.0% 1.1%
Headache 18.8% 26.9% 35.0% 20.8%
Nervousness 8.5% 5.1% 10.0% 2.8%
Nausea/Vomiting 4.2% 19.8% 5.0% 3.9%
Tachycardia 2.7% 0.5% 5.0% 0%
Muscle Cramps 2.7% 0.5% 5.0% 0.6%
Palpitations 2.4% 0.5% 0% 1.1%
Insomnia 2.4% 6.1% 0% 1.7%
Dizziness 1.5% 2.0% 0% 5.1%
Somnolence 0.3% 1.0% 0% 0.6%

A trend was observed among patients treated with albuterol extended-release tablets toward increasing frequency of muscle cramps with increasing patient age (12-20 years, 1.2%; 21-30 years, 2.6%; 31-40 years, 6.9%; 41-50 years, 6.9%), compared with no such events in the placebo group. Also observed was an increasing frequency of tremor with increasing patient age (12-20 years, 29.4%; 21-30 years, 29.9%; 31-40 years, 27.6%; 41-50 years, 37.9%), compared to 2.9% or less in the placebo group.

The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol extended-release tablets.

Drug label data at the top of this Page last updated: 2006-11-03

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