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Proventil

Last reviewed on RxList: 4/25/2019
Proventil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/25/2019

Proventil HFA (albuterol inhalation) is a beta-2 bronchodilator used to treat bronchospasm (wheezing, shortness of breath) associated with reversible obstructive airway disease such as asthma. The brand name drug Proventil HFA is no longer available in the U.S. Generic forms may still be available. Common side effects of Proventil HFA (albuterol inhalation) include:

Tell your doctor right away if you have any serious side effects of Proventil HFA including:

  • fast or pounding heartbeat,
  • bronchospasm (wheezing, chest tightness, trouble breathing),
  • 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).

Get medical help right away if you have any rare but very serious side effects of Proventil HFA including:

  • chest pain,
  • irregular heartbeat,
  • rapid breathing, or
  • confusion.

The usual dosage of Proventil HFA for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. Proventil HFA may interact with other drugs including beta-blockers, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and other bronchodilators. Tell your doctor if you are pregnant or plan to become pregnant while using Proventil HFA. It is unknown if Proventil HFA will harm a fetus. It is unknown if Proventil HFA passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Proventil HFA is not recommended.

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.

Proventil Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • chest pain, fast heart rate, pounding heartbeats or fluttering in your chest;
  • pain or burning when you urinate;
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • back pain, body aches;
  • headache, dizziness;
  • feeling nervous;
  • nausea, diarrhea, upset stomach; or
  • sore throat, sinus pain, stuffy runny nose.

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.

Read the entire detailed patient monograph for Proventil (Albuterol Inhalation)

Proventil Professional 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
Back Pain 4 2 3
Fever 6 2 5
Central and Peripheral Nervous System Tremor 7 8 2
Gastrointestinal System Nausea 10 9 5
Vomiting 7 2 3
Heart Rate and Rhythm Disorder Tachycardia 7 2 <1
Psychiatric Disorders Nervousness 7 9 3
Respiratory System Disorders Respiratory Disorder (unspecified) 6 4 5
Rhinitis 16 22 14
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)

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