Side Effects > Ventolin

Ventolin Side Effects

Generic Name: albuterol

Please note - some side effects for Ventolin 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).

Side Effects of Ventolin - for the Consumer

Ventolin 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 Ventolin HFA Aerosol:

Cough; headache; nervousness; sinus inflammation; sore or dry throat; tremor; trouble sleeping; unusual taste in mouth.

Seek medical attention right away if any of these SEVERE side effects occur when using Ventolin HFA Aerosol:

Severe 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.

Ventolin 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 Ventolin Aerosol:

Cough; headache; nausea; nervousness; sinus inflammation; sore or dry throat; tremor; trouble sleeping; unusual taste in mouth; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Ventolin Aerosol:

Severe 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.

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Ventolin Side Effects - for the Professional

Ventolin

Use of Ventolin HFA may be associated with the following:

• Paradoxical bronchospasm [see Warnings and Precautions (5.1)]
• Cardiovascular effects [see Warnings and Precautions (5.4)]
• Immediate hypersensitivity reactions [see Warnings and Precautions (5.6)]
• Hypokalemia [see Warnings and Precautions (5.8)]

6.1 Clinical Trials Experience

The safety data described below reflects exposure to Ventolin HFA in 248 patients 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 patients with asthma 12 years of age 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 patients are based upon 1 clinical trial in which 46 patients with asthma 4 to 11 years of age 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.

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, 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 studies 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. Overall Adverse Reactions With ≥3% Incidence in 2 Large 12-Week Clinical Trials in Adolescents and Adults*

Adverse Reaction	Percent of Patients
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
*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 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 include diarrhea, laryngitis, oropharyngeal edema, cough, lung disorders, tachycardia, and extrasystoles. Palpitation and dizziness have also been observed with Ventolin HFA.

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 in this age-group [see Pediatric Use (8.4)]. 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 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.

6.2 Postmarketing Experience

In addition to the adverse reactions listed in section 6.1, the following adverse reactions have been identified during postapproval use of Ventolin HFA. 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.

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.

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Side Effects by Body System

General

Albuterol is generally well-tolerated and adverse effects seen are consistent with its pharmacological activity. In general, the severity of these adverse effects is dependent on the dose and route of administration. Administration by metered-dose inhaler (MDI) is associated with less systemic effects than administration of higher dosages orally or by nebulizer. Tolerance may develop to the adverse effects of albuterol.

Cardiovascular

Changes in heart rate of approximately 20% may be produced by 0.18 mg of albuterol by MDI. Aggravation of angina may be due to tachycardia produced by albuterol. Atrial fibrillation was reported in one patient when a spacer device was utilized with an albuterol inhaler, thus increasing the available dose for systemic absorption. Supraventricular ectopic beats and ventricular tachycardia have also been reported. Higher doses of albuterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.

The cardiovascular side effects have included palpitations, peripheral vasodilatation and reflex tachycardia with blood pressure increasing or decreasing. Albuterol in higher dosages has been reported to aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias. Pulmonary edema has been reported in pregnant patients receiving intravenous albuterol. Postmarketing reports have included hypotension.

Musculoskeletal

Musculoskeletal side effects have included tremors, particularly at higher dosages. Tolerance can develop to the tremorogenic effects. Severe muscle cramping may occur infrequently.

Metabolic

Following doses of 15 mg albuterol via nebulizer, hyperkalemic patients on hemodialysis experienced a 0.9 mEq/L decrease in plasma potassium which was sustained for 6 hours. Albuterol may stimulate sodium-potassium ATPase, resulting in an intracellular shift of potassium.

Transient lactic acidosis has been reported after administration of inhaled albuterol for an asthma attack.

Metabolic side effects have included hypokalemia, and less commonly, hyperglycemia and lactic acidosis. Postmarketing reports have included metabolic acidosis. Diabetic ketoacidosis has been reported due to overdose of albuterol.

Nervous system

Nervous system side effects have included restlessness, anxiety, nervousness, irritability, and insomnia. Postmarketing reports have included tremor.

Psychiatric

Psychiatric side effects have included psychoses presenting as auditory hallucinations and persecutory delusions. These effects are generally associated with higher dosages.

Other

Concern over the development of tachyphylaxis to the bronchodilating effects of albuterol has been expressed. Although conflicting data exist, complete tolerance has not been reported.

Respiratory

Respiratory side effects have included paradoxical bronchospasm.

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