Proventil HFA Side Effects
Generic Name: Albuterol
Please note - some side effects for Proventil HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Proventil HFA - for the consumer
Proventil HFA Aerosol
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Proventil HFA Aerosol:
Seek medical attention right away if any of these SEVERE side effects occur when using Proventil HFA Aerosol:Cough; headache; nausea; nervousness; sinus inflammation; sore or dry throat; tremor; trouble sleeping; unusual taste in mouth; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; new or worsened trouble breathing; pounding in the chest; severe headache or dizziness; unusual hoarseness; wheezing.
For the professional
Proventil HFA
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.
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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) |
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|---|---|---|---|---|
*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.
TopMore resources:
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Proventil HFA - Includes detailed dosage instructions.
Proventil Repetabs Oral/Injection - Includes detailed dosage instructions.
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