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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)

Adverse Event

Percent Incidence

Central Nervous System

 

Tremor

10

Nervousness

9

Shakiness

9

Headache

4

Dizziness

3

Excitement

2

Hyperactivity

2

Sleeplessness

1

Disturbed sleep

<1

Irritable behavior

<1

Dilated pupils

<1

Weakness

1

Cardiovascular

 

Tachycardia

1

Palpitations

<1

Sweating

<1

Chest Pain

<1

Ear, Nose, and Throat

 

Epistaxis

1

Gastrointestinal

 

Increased appetite

3

Epigastric pain

<1

Stomachache

<1

Musculoskeletal

 

Muscle spasm

<1

Respiratory

 

Cough

<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

Fatigue

1

Cardiovascular

 

Tachycardia

2

Pallor

1

Gastrointestinal

 

Gastrointestinal symptoms

2

Loss of appetite

1

Ophthalmologic

 

Conjunctivitis

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.