VoSpire ER
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VoSpire ER
VoSpire ER Side Effects Center
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
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) »
Additional VoSpire ER Information
VoSpire ER - User Reviews
VoSpire ER User Reviews
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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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