Ventolin Syrup
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Ventolin Syrup
(Generic versions may still be available.)
Ventolin Syrup 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ventolin Syrup FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The adverse reactions to albuterol are similar in nature to those of other sympathomimetic agents. In clinical trials, the most frequent adverse reactions to VENTOLIN Syrup (albuterol sulfate syrup) in adults and older children were:
| Percent Incidence of Adverse Reactions in Adults and Children (6-12 Years of Age) | |
| Percent Incidence | |
| 10 | |
| Nervousness | 9 |
| Shakiness | 9 |
| 4 | |
| 3 | |
| Excitement | 2 |
| 2 | |
| 1 | |
| Disturbed sleep | <1 |
| Irritable behavior | <1 |
| Dilated pupils | <1 |
| Weakness | 1 |
| 1 | |
| <1 | |
| <1 | |
| <1 | |
| 1 | |
| Increased appetite | 3 |
| Epigastric pain | <1 |
| Stomachache | <1 |
| Musculoskeletal | |
| <1 | |
| <1 | |
In clinical trials, the following adverse reactions to VENTOLIN Syrup (albuterol sulfate syrup) were noted more frequently in young children 2 to 6 years of age than in adults and older children:
| Percent Incidence of Adverse Reactions Noted More Frequently in Children 2 to 6 Years of Age Than in Older Children and Adults | |
| Adverse Event | Percent Incidence |
| Central Nervous System | |
| Excitement | 20 |
| Nervousness | 15 |
| Hypokinesia | 4 |
| Sleeplessness | 2 |
| Emotional lability | 1 |
| 1 | |
| Cardiovascular | |
| Tachycardia | 2 |
| Pallor | 1 |
| Gastrointestinal | |
| Gastrointestinal symptoms | 2 |
| Loss of appetite | 1 |
| Ophthalmologic | |
| 1 | |
Cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been reported after the use of VENTOLIN Syrup (albuterol sulfate syrup) .
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as angina, central nervous system stimulation, drying or irritation of the oropharynx, hypertension, nausea, unusual taste, vertigo, and vomiting.
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with VENTOLIN Syrup (albuterol sulfate syrup) . In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.
Read the entire FDA prescribing information for Ventolin Syrup (Albuterol Sulfate Syrup) »
Additional Ventolin Syrup 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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