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Ventolin HFA Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ventolin HFA (albuterol sulfate inhalation aerosol) is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Ventolin HFA is also used to prevent exercise-induced bronchospasm. Ventolin HFA is a bronchodilator, and it is available in generic form. Common side effects include nervousness, shaking (tremor), palpitations, headache, mouth/throat dryness or irritation, cough, nausea or dizziness. Seek medical help immediately if you have rare but serious side effects, including chest pain or irregular heartbeat.
The dose of Ventolin HFA for adults and children for treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm is 2 inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. For exercise-induced bronchospasm, the dose is 2 inhalations 15 to 30 minutes before exercise. Ventolin HFA may adversely interact with diuretics (water pills), digoxin, beta-blockers, antidepressants, MAO inhibitors, or other bronchodilators. Tell your doctor all medications you are taking. During pregnancy, Ventolin HFA should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Our Ventolin HFA 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.
Ventolin HFA in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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;
- sleep problems (insomnia);
- cough, hoarseness, sore throat, runny or stuffy nose;
- mild nausea, vomiting;
- dry mouth and throat;
- muscle pain; or
Read the entire detailed patient monograph for Ventolin HFA (Albuterol Sulfate Inhalation Aerosol)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Ventolin HFA 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 Ventolin HFA (Albuterol Sulfate Inhalation Aerosol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ventolin HFA FDA Prescribing Information: Side Effects
Use of VENTOLIN HFA (albuterol sulfate inhalation aerosol) may be associated with the following:
- Paradoxical bronchospasm [see WARNINGS and PRECAUTIONS]
- Cardiovascular effects [see WARNINGS and PRECAUTIONS]
- Immediate hypersensitivity reactions [see WARNINGS and PRECAUTIONS]
- Hypokalemia [see WARNINGS and PRECAUTIONS]
Clinical Trials Experience
The safety data described below reflects exposure to VENTOLIN HFA (albuterol sulfate inhalation aerosol) in 248 patients treated with VENTOLIN HFA (albuterol sulfate inhalation aerosol) in 3 placebo-controlled clinical trials of 2 to 12 weeks' duration. The data from adults and adolescents is based upon 2 clinical trials in which 202 patients with asthma 12 years of age and older were treated with VENTOLIN HFA (albuterol sulfate inhalation aerosol) 2 inhalations 4 times daily for 12 weeks' duration. The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other. The data from pediatric patients are based upon 1 clinical trial in which 46 patients with asthma 4 to 11 years of age were treated with VENTOLIN HFA (albuterol sulfate inhalation aerosol) 2 inhalations 4 times daily for 2 weeks' duration. The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults and Adolescents 12 Years of Age and Older: The two 12-week, randomized, double-blind studies in 610 adolescent and adult patients with asthma that compared VENTOLIN HFA (albuterol sulfate inhalation aerosol) , a CFC 11/12-propelled albuterol inhaler, and an HFA-134a placebo inhaler. Overall, the incidence and nature of the adverse reactions reported for VENTOLIN HFA (albuterol sulfate inhalation aerosol) and a CFC 11/12-propelled albuterol inhaler were comparable. Table 1 lists the incidence of all adverse reactions (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 (albuterol sulfate inhalation aerosol) and more frequently in the group treated with VENTOLIN HFA (albuterol sulfate inhalation aerosol) than in the HFA-134a placebo inhaler group.
Table 1. Overall Adverse Reactions With ≥ 3% Incidence
in 2 Large 12-Week Clinical Trials in Adolescents and Adults*
|Adverse Reaction||Percent of Patients|
|VENTOLIN HFA (albuterol sulfate inhalation aerosol)
(n = 202)
(n = 207)
(n = 201)
|Ear, nose<, and throat|
|Upper respiratory inflammation||5||5||2|
|Viral respiratory infections||7||4||4|
|*This table includes all adverse reactions (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 reactions reported by less than 3% of the adolescent and adult patients receiving VENTOLIN HFA (albuterol sulfate inhalation aerosol) 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 (albuterol sulfate inhalation aerosol) include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitation and dizziness have also been observed with VENTOLIN HFA (albuterol sulfate inhalation aerosol) .
Pediatric Patients: Results from the 2-week pediatric clinical study in patients with asthma 4 to 11 years of age showed that this pediatric population had an adverse reaction profile similar to that of the adolescent and adult populations.
Three studies have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in patients between birth and 4 years of age. The results of these studies did not establish the efficacy of VENTOLIN HFA (albuterol sulfate inhalation aerosol) in this age-group [see Pediatric Use]. Since the efficacy of VENTOLIN HFA (albuterol sulfate inhalation aerosol) has not been demonstrated in children between birth and 48 months of age, the safety of VENTOLIN HFA (albuterol sulfate inhalation aerosol) in this age-group cannot be established. However, the safety profile observed in the pediatric population under 4 years of age was comparable to that observed in the older pediatric patients and in adolescents and adults. Where adverse reaction incidence rates were greater in patients under 4 years of age compared with older patients, the higher incidence rates were noted in all treatment arms, including placebo. These adverse reactions included upper respiratory tract infection, nasopharyngitis, pyrexia, and tachycardia.
In addition to the adverse reactions listed in section 6.1, the following adverse reactions have been identified during postapproval use of VENTOLIN HFA (albuterol sulfate inhalation aerosol) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cases of paradoxical bronchospasm, hoarseness, arrhythmias (including atrial fibrillation, supraventricular tachycardia), and hypersensitivity reactions (including urticaria, angioedema, rash) have been reported after the use of VENTOLIN HFA (albuterol sulfate inhalation aerosol) .
In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertension, peripheral vasodilatation, angina, tremor, central nervous system stimulation, hyperactivity, sleeplessness, headache, muscle cramps, and drying or irritation of the oropharynx.
Read the entire FDA prescribing information for Ventolin HFA (Albuterol Sulfate Inhalation Aerosol)
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