ADVERSE REACTIONS
Adverse reaction information concerning PROVENTIL HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the PROVENTIL HFA Inhalation Aerosol treatment group and more frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.
Adverse Experience Incidences (% of patients) in a Large 12-week Clinical Trial* Body System/
Adverse Event (Preferred Term) | PROVENTIL
HFA
Inhalation
Aerosol
(N=193) | CFC 11/12
Propelled
Albuterol Inhaler
(N=186) | HFA-134a
Placebo
Inhaler
(N=186) |
|---|
|
*This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROVENTIL HFA Inhalation Aerosol group and more frequently in the PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.
|
| Application Site Disorders | Inhalation Site Sensation
Inhalation Taste Sensation | 6
4 | 9
3 | 2
3 |
| Body as a Whole | Allergic
Reaction/Symptoms
Back Pain
Fever | 6
4
6 | 4
2
2 | <1
3
5 |
| Central and Peripheral Nervous System | Tremor | 7 | 8 | 2 |
| Gastrointestinal System | Nausea
Vomiting | 10
7 | 9
2 | 5
3 |
| Heart Rate and Rhythm Disorder | Tachycardia | 7 | 2 | <1 |
| Psychiatric Disorders | Nervousness | 7 | 9 | 3 |
| Respiratory System Disorders | Respiratory Disorder
(unspecified)
Rhinitis
Upper Resp Tract
Infection | 6
16
21 | 4
22
20 | 5
14
18 |
| Urinary System Disorder | Urinary Tract Infection | 3 | 4 | 2 |
Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation Aerosol patients thatn placebo patients, which have the potential to be related to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesias, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation Aerosol.
Adverse events reported in a 4-week pediatric clinical trail comparing PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.
In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, and drying or irritation of the oropharynx.
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