ADVERSE REACTIONS
Adverse reaction information concerning VENTOLIN HFA is derived from two 12-week, randomized, double-blind studies in 610 adolescent and adult patients with asthma that compared VENTOLIN HFA, a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. The following table lists the incidence of all adverse events (whether considered by the investigator to be related or unrelated to drug) from these studies that occurred at a rate of 3% or greater in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group. Overall, the incidence and nature of the adverse events reported for VENTOLIN HFA and a CFC 11/12-propelled albuterol inhaler were comparable. Results in a 2-week pediatric clinical study (n = 135) showed that the adverse event profile was generally similar to that of the adult.
Adverse Experience Incidence (% of Patients) in 2 Large 12-Week Adolescent and Adult Clinical Trials *
|
|
Percent of Patients
|
|
Adverse Event Type
|
VENTOLIN HFA
(n = 202) |
CFC 11/12-Propelled
Albuterol Inhaler
(n = 207) |
Placebo HFA-134a
(n = 201) |
|
Ear, nose, and throat
|
|
|
|
|
Throat irritation
|
10
|
6
|
7
|
|
Upper respiratory inflammation
|
5
|
5
|
2
|
|
Lower respiratory
|
|
|
|
|
Viral respiratory infections
|
7
|
4
|
4
|
|
Cough
|
5
|
2
|
2
|
|
Musculoskeletal
|
|
|
|
|
Musculoskeletal pain
|
5
|
5
|
4
|
|
*This table includes all adverse events (whether considered by the investigator to be drug-related or unrelated to drug) that occurred at an incidence rate of at least 3.0% in the group treated with VENTOLIN HFA and more frequently in the group treated with VENTOLIN HFA than in the HFA-134a placebo inhaler group.
|
|
Adverse events reported by less than 3% of the adolescent and adult patients receiving VENTOLIN HFA and by a greater proportion of patients receiving VENTOLIN HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to VENTOLIN HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitation and dizziness have also been observed with VENTOLIN HFA.
Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol, USP.
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.
|
