Ventolin HFA

• Overview
• Consumer Information
• Professional Information

 

Ventolin HFA Side Effects Center

What Is Ventolin?

Ventolin HFA (albuterol sulfate inhalation aerosol) is a bronchodilator 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 available in generic form.

What Are Side Effects of Ventolin?

Common side effects of Ventolin HFA include:

• nervousness,
• shaking (tremor),
• palpitations,
• headache,
• mouth/throat dryness or irritation,
• cough,
• hoarseness,
• sore throat,
• runny or stuffy nose,
• nausea,
• vomiting,
• dizziness,
• sleep problems (insomnia),
• muscle pain,
• changes in taste, or
• diarrhea.

Seek medical help immediately if you have rare but serious side effects of Ventolin HFA, including:

• chest pain or
• irregular heartbeat.

Dosage for Ventolin

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.

What Drugs, Substances, or Supplements Interact with Ventolin?

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.

Ventolin During Pregnancy and Breastfeeding

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 breastfeeding.

Additional Information

Our Ventolin HFA Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Ventolin HFA 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;
• severe headache, pounding in your neck or ears;
• pain or burning when you urinate;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• low potassium--leg cramps, constipation, irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• chest pain, fast or pounding heartbeats;
• upset stomach, vomiting;
• painful urination;
• dizziness;
• feeling shaky or nervous;
• headache, back pain, body aches; or
• cough, sore throat, sinus pain, runny or stuffy 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 Ventolin HFA (Albuterol Sulfate Inhalation Aerosol)

 

Ventolin HFA Professional Information

SIDE EFFECTS

Use of VENTOLIN HFA 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

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflects exposure to VENTOLIN HFA in 248 subjects treated with VENTOLIN HFA 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 subjects with asthma aged 12 years and older were treated with VENTOLIN HFA 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 subjects are based upon 1 clinical trial in which 46 subjects with asthma aged 4 to 11 years were treated with VENTOLIN HFA 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.

Adult and Adolescent Subjects Aged 12 Years and Older: The two 12-week, randomized, double-blind trials in 610 adult and adolescent subjects with asthma that compared VENTOLIN HFA, 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 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 trials that occurred at a rate of 3% or greater 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.

Table 1: Adverse Reactions with VENTOLIN HFA with ≥ 3% Incidence and More Common than Placebo in Adult and Adolescent Subjects

Adverse Reaction	Percent of Subjects
	VENTOLIN HFA (n = 202) %	CFC 11/12-Propelled Albuterol Inhaler (n = 207) %	Placebo HFA-134a (n = 201) %
Ear, nose, and throat
Throat irritation	10	6	7
Upper respiratory inflammation	5	5	2
Lower respiratory
Viral respiratory infections	7	4	4
Cough	5	2	2
Musculoskeletal
Musculoskeletal pain	5	5	4

Adverse reactions reported by less than 3% of the adult and adolescent subjects receiving VENTOLIN HFA and by a greater proportion of subjects receiving VENTOLIN HFA than receiving HFA-134a placebo inhaler and that have the potential to be related to VENTOLIN HFA include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitations and dizziness have also been observed with VENTOLIN HFA.

Pediatric Subjects Aged 4 to 11 Years: Results from the 2-week clinical trial in pediatric subjects with asthma aged 4 to 11 years showed that this pediatric population had an adverse reaction profile similar to that of the adult and adolescent populations.

Three trials have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in subjects between birth and 4 years of age. The results of these trials did not establish the efficacy of VENTOLIN HFA in this age-group [see Use in Specific Populations]. Since the efficacy of VENTOLIN HFA has not been demonstrated in children between birth and 48 months of age, the safety of VENTOLIN HFA in this age-group cannot be established. However, the safety profile observed in the pediatric population younger than 4 years was comparable to that observed in the older pediatric subjects and in adults and adolescents. Where adverse reaction incidence rates were greater in subjects younger than 4 years compared with older subjects, the higher incidence rates were noted in all treatment arms, including placebo. These adverse reactions included upper respiratory tract infection, nasopharyngitis, pyrexia, and tachycardia.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of albuterol sulfate. 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to albuterol or a combination of these factors.

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.

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, drying or irritation of the oropharynx, and metabolic acidosis.

Read the entire FDA prescribing information for Ventolin HFA (Albuterol Sulfate Inhalation Aerosol)

&Copy; Ventolin HFA Patient Information is supplied by Cerner Multum, Inc. and Ventolin HFA Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.