Xopenex Side Effects

Generic Name: levalbuterol

Please note - some side effects for Xopenex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Xopenex - for the Consumer

Xopenex 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 Xopenex HFA Aerosol:

Dizziness; dry mouth; nervousness; runny or stuffy nose; sore or dry throat; tremor.

Seek medical attention right away if any of these SEVERE side effects occur when using Xopenex 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 worsening wheezing, coughing, or trouble breathing; severe headache or dizziness; severe or persistent trouble sleeping; sudden shortness of breath; unusual hoarseness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Xopenex 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 Xopenex Solution:

Cough; diarrhea; dizziness; headache; nervousness; sinus inflammation; sore throat; stomach upset; stuffy nose; tremor.

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

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; fever; new or worsened trouble breathing; pounding in the chest; severe cough; severe headache or dizziness; unusual hoarseness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Xopenex Side Effects - for the Professional

Xopenex

Adverse events reported in ≥2% of patients receiving Xopenex Inhalation Solution or racemic albuterol and more frequently than in patients receiving placebo in a 4-week, controlled clinical trial are listed in Table 3.

Table 3: Adverse Events Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥12 years old

	Percent of Patients
Body System      Preferred Term	Placebo (n=75)	Xopenex 1.25 mg (n=73)	Xopenex 0.63 mg (n=72)	Racemic albuterol 2.5 mg (n=74)
Body as a Whole
Allergic reaction	1.3	0	0	2.7
Flu syndrome	0	1.4	4.2	2.7
Accidental injury	0	2.7	0	0
Pain	1.3	1.4	2.8	2.7
Back pain	0	0	0	2.7
Cardiovascular System
Tachycardia	0	2.7	2.8	2.7
Migraine	0	2.7	0	0
Digestive System
Dyspepsia	1.3	2.7	1.4	1.4
Musculoskeletal System
Leg cramps	1.3	2.7	0	1.4
Central Nervous System
Dizziness	1.3	2.7	1.4	0
Hypertonia	0	0	0	2.7
Nervousness	0	9.6	2.8	8.1
Tremor	0	6.8	0	2.7
Anxiety	0	2.7	0	0
Respiratory System
Cough increased	2.7	4.1	1.4	2.7
Infection viral	9.3	12.3	6.9	12.2
Rhinitis	2.7	2.7	11.1	6.8
Sinusitis	2.7	1.4	4.2	2.7
Turbinate edema	0	1.4	2.8	0

The incidence of certain systemic beta-adrenergic adverse effects (e.g., tremor, nervousness) was slightly less in the Xopenex 0.63 mg group compared with the other active treatment groups. The clinical significance of these small differences is unknown.

Changes in heart rate 15 minutes after drug administration and in plasma glucose and potassium 1 hour after drug administration on day 1 and day 29 were clinically comparable in the Xopenex 1.25 mg and racemic albuterol 2.5 mg groups. Changes in heart rate and plasma glucose were slightly less in the Xopenex 0.63 mg group compared with the other active treatment groups. The clinical significance of these small differences is unknown. After 4 weeks, effects on heart rate, plasma glucose, and plasma potassium were generally diminished compared with day 1 in all active treatment groups.

Table 4: Mean Changes from Baseline Heart Rate at 15 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) in Adults and Adolescents ≥12 years old

Treatment	Mean Changes (day 1)
	Heart Rate (bpm)	Glucose (mg/dL)	Potassium (mEq/L)
Xopenex 0.63 mg, n=72	2.4	4.6	–0.2
Xopenex 1.25 mg, n=73	6.9	10.3	–0.3
Racemic albuterol 2.5 mg, n=74	5.7	8.2	–0.3
Placebo, n=75	–2.8	–0.2	–0.2

No other clinically relevant laboratory abnormalities related to administration of Xopenex Inhalation Solution were observed in this study.

In the clinical trials, a slightly greater number of serious adverse events, discontinuations due to adverse events, and clinically significant ECG changes were reported in patients who received Xopenex 1.25 mg compared with the other active treatment groups.

The following adverse events, considered potentially related to Xopenex, occurred in less than 2% of the 292 subjects who received Xopenex and more frequently than in patients who received placebo in any clinical trial:

Body as a Whole:	chills, pain, chest pain
Cardiovascular System:	ECG abnormal, ECG change, hypertension,
	hypotension, syncope
Digestive System:	diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea
Hemic and Lymphatic System:	lymphadenopathy
Musculoskeletal System:	leg cramps, myalgia
Nervous System:	anxiety, hypesthesia of the hand, insomnia, paresthesia, tremor
Special Senses:	eye itch

The following events, considered potentially related to Xopenex, occurred in less than 2% of the treated subjects but at a frequency less than in patients who received placebo: asthma exacerbation, cough increased, wheezing, sweating, and vomiting.

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Side Effects by Body System - for Healthcare Professionals

General

Levalbuterol has been generally well-tolerated and adverse effects seen have been consistent with its pharmacological activity. In general, the severity of these adverse effects have been dose dependent. The potential and significance for fewer side effects with levalbuterol compared to racemic albuterol remains to be established.

Cardiovascular

Adverse cardiovascular effects may be due to significant hypokalemia produced by levalbuterol, thought to be due to intracellular shunting. Aggravation of angina may be due to tachycardia produced by levalbuterol. Supraventricular ectopic beats and ventricular tachycardia have also been reported. Higher doses of levalbuterol 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.

Cardiovascular side effects have included palpitations and peripheral vasodilatation, commonly resulting in reflex tachycardia. Blood pressure has been increased or decreased. Levalbuterol in higher dosages has rarely aggravated angina, myocardial ischemia, or cause atrial or ventricular arrhythmias. Pulmonary edema has been reported in pregnant patients receiving racemic albuterol.

Musculoskeletal

Musculoskeletal side effects have included tremors, particularly at higher dosages. Tolerance has developed to the tremorogenic effects. Severe muscle cramping has occurred infrequently.

Metabolic

One hour following doses of 0.63 mg and 1.25 mg levalbuterol via nebulizer, potassium levels decreased from baseline by 0.2 and 0.3 mEq/L and glucose levels increased from baseline by 4.6 and 10.3 mg/dL respectively.

Levalbuterol may stimulate sodium-potassium ATPase, resulting in an intracellular shift of potassium.

Metabolic side effects have included hypokalemia, and less commonly, hyperglycemia.

Nervous system

Nervous system side effects have included nervousness, headache, dizziness, anxiety, and insomnia.

Other

Other side effects have included the development of tachyphylaxis to the bronchodilating effects of albuterol. Although conflicting data exist, complete tolerance has not been reported.

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