Accuneb Side Effects

Generic Name: albuterol

Please note - some side effects for Accuneb 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 Accuneb - for the Consumer

AccuNeb Solution

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 AccuNeb Solution:

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; ear pain; fast or irregular heartbeat; new or worsened trouble breathing; pounding in the chest; severe headache or dizziness; unusual hoarseness; wheezing.

Accuneb Side Effects - for the Professional

AccuNeb

Adverse events reported in >1% of patients receiving AccuNeb and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.

There was one case of ST segment depression in the 1.25 mg AccuNeb treatment group.

No clinically relevant laboratory abnormalities related to AccuNeb administration were seen in this study.

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.

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