"The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing "...
(Generic versions may still be available.)
Proventil Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Proventil HFA (albuterol inhalation) is an inhaler medication containing the beta-2 adrenergic drug albuterol, which acts as a bronchodilator. Proventil HFA is used to treat bronchospasm (wheezing, shortness of breath) associated with reversible obstructive airway disease such as asthma. Proventil HFA is available in generic form. Common adverse side effects of Proventil HFA treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about use of Proventil HFA.
Proventil HFA may interact with other drugs including beta-blockers, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and other bronchodilators.
Our Proventil HFA (albuterol inhalation) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Proventil in Detail - Patient Information: Side Effects
Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
- chest pain and fast, pounding, or uneven heart beats;
- tremor, nervousness;
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- headache, dizziness, nervousness;
- sleep problems (insomnia);
- cough, hoarseness, sore throat, runny or stuffy nose;
- dry mouth and throat;
- muscle pain; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Proventil (Albuterol Inhalation) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Proventil Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat.
Get medical help right away if you have any rare but very serious side effects, including: chest pain, irregular heartbeat, rapid breathing, confusion.
Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, get medical help right away.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Proventil (Albuterol Inhalation)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Proventil FDA Prescribing Information: Side Effects
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)|
|Application Site Disorders||Inhalation Site Sensation||6||9||2|
|Inhalation Taste Sensation||4||3||3|
|Body as a Whole||Allergic Reaction/Symptoms||6||4||< 1|
|Central and Peripheral Nervous System||Tremor||7||8||2|
|Heart Rate and Rhythm Disorder||Tachycardia||7||2||< 1|
|Respiratory System Disorders||Respiratory Disorder (unspecified)||6||4||5|
|Upper Resp Tract Infection||21||20||18|
|Urinary System Disorder||Urinary Tract Infection||3||4||2|
|*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.|
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 than 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, hyperkinesia, 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 trial 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, metabolic acidosis, and drying or irritation of the oropharynx.
Read the entire FDA prescribing information for Proventil (Albuterol Inhalation) »
Additional Proventil HFA Information
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