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VoSpire ER

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VoSpire ER

VoSpire ER Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

VoSpire ER (albuterol sulfate) Extended-Release Tablets is a bronchodilator used to treat wheezing and shortness of breath caused by breathing problems (e.g., asthma, chronic obstructive pulmonary disease). This medication is available in generic form. Common side effects include nervousness, shaking (tremor), headache, trouble sleeping, dizziness, or nausea.

The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient. The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours. VoSpire ER may interact with ephedrine, epinephrine, beta-blockers, digoxin, tricyclic antidepressants, diuretics, or cough-and-cold products and diet aids. Tell your doctor all medications and supplements you use. During pregnancy, VoSpire ER should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our VoSpire ER (albuterol sulfate) Extended-Release Tablets 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 Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

VoSpire ER Overview - Patient Information: Side Effects

SIDE EFFECTS: Nervousness, shaking (tremor), headache, trouble sleeping, dizziness, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, muscle cramps/weakness.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, irregular heartbeat.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, seek immediate medical attention.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for VoSpire ER (Albuterol Sulfate Extended-Release Tablets)»

What is Prescribing information?

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

VoSpire ER FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Read the entire FDA prescribing information for VoSpire ER (Albuterol Sulfate Extended-Release Tablets) »

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VoSpire ER - User Reviews

VoSpire ER User Reviews

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Here is a collection of user reviews for the medication VoSpire ER sorted by most helpful. Patient Discussions FAQs

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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