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Xopenex

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Xopenex

Xopenex

Xopenex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Xopenex (levalbuterol HCl) is used to treat reversible obstructive airway conditions such as asthma, bronchitis, and emphysema. It is a bronchodilator. This medication is available in generic form in some strengths. Common side effects include headache, nervousness, shaking (tremor), dizziness, trouble sleeping, dry mouth, nausea, stomach upset, diarrhea, cough, sore throat, or runny nose.

The recommended dosage of Xopenex Inhalation Solution for patients 6-11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day. The recommended starting dosage of Xopenex for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization. Xopenex may interact with beta-blockers, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), diuretics (water pills), digoxin, other inhaled bronchodilators, caffeine, diet pills, or decongestants. Xopenex should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Xopenex (levalbuterol HCl) 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.

Xopenex in Detail - Patient Information: Side Effects

Stop using levalbuterol inhalation and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • worsening of respiratory symptoms (shortness of breath, wheezing); or
  • chest pain or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to use levalbuterol inhalation and talk to your doctor if you experience

  • dizziness;
  • tremor or nervousness;
  • anxiety;
  • headache;
  • cough or runny nose;
  • upset stomach; or
  • leg cramps.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xopenex (Levalbuterol) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Xopenex Overview - Patient Information: Side Effects

SIDE EFFECTS: Nervousness, dizziness, shaking (tremor), trouble sleeping, headache, nausea, dry mouth, increased coughing, or runny nose may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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/irregular heartbeat, muscle cramps/weakness, increased thirst/urination.

Get medical help right away if you have any very serious side effects, including: chest pain, 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 Xopenex (Levalbuterol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Xopenex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared with 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

Adverse reaction information concerning XOPENEX Inhalation Solution in adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 362 patients with asthma 12 years of age and older. Adverse reactions reported in ≥ 2% of patients receiving XOPENEX Inhalation Solution or racemic albuterol and more frequently than in patients receiving placebo are listed in Table 1.

Table 1: Adverse Reactions Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥ 12 Years Old

Body System
Preferred Term
Percentof Patientsa
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
a One treatment group, racemic albuterol 1.25 mg, with 68 subjects is omitted

The incidence of certain systemic beta-adrenergic adverse reactions (e.g., tremor, nervousness) was slightly less in the XOPENEX Inhalation Solution 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 Inhalation Solution 1.25 mg and racemic albuterol 2.5 mg groups (see Table 2). Changes in heart rate and plasma glucose were slightly less in the XOPENEX Inhalation Solution 0.63 mg group compared with the other active treatment groups (see Table 2). 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 2: 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 reactions, 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, hyperesthesia of the hand, insomnia, paresthesia, tremor

Special Senses: eye itch

The following reactions, 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.

Pediatric Patients 6 to 11 Years of Age

Adverse reaction information concerning XOPENEX Inhalation Solution in pediatric patients is derived from one 3-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 316 pediatric patients 6 to 11 years of age. Adverse reactions reported in ≥ 2% of patients in any treatment group and more frequently than in patients receiving placebo are listed in Table 3.

Table 3: Most Frequently Reported Adverse Reactions ( ≥ 2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo during the Double-Blind Period (ITT Population, 6-11 Years Old)

Body System Preferred Term Percent of Patients
Placebo
(n=59)
XOPENEX 0.31 mg
(n=66)
XOPENEX 0.63 mg
(n=67)
Racemic albuterol 1.25 mg
(n=64)
Racemic albuterol 2.5 mg
(n=60)
Body as a Whole
  Abdominal pain 3.4 0 1.5 3.1 6.7
  Accidental injury 3.4 6.1 4.5 3.1 5
  Asthenia 0 3 3 1.6 1.7
  Fever 5.1 9.1 3 1.6 6.7
  Headache 8.5 7.6 11.9 9.4 3.3
  Pain 3.4 3 1.5 4.7 6.7
  Viral infection 5.1 7.6 9 4.7 8.3
Digestive System
  Diarrhea 0 1.5 6 1.6 0
Hemic and Lymphatic
  Lymphadenopathy 0 3 0 1.6 0
Musculoskeletal System
  Myalgia 0 0 1.5 1.6 3.3
Respiratory System
  Asthma 5.1 9.1 9 6.3 10
  Pharyngitis 6.8 3 10.4 0 6.7
  Rhinitis 1.7 6.1 10.4 3.1 5
Skin and Appendages
  Eczema 0 0 0 0 3.3
  Rash 0 0 7.5 1.6 0
  Urticaria 0 0 3 0 0
Special Senses
  Otitis media 1.7 0 0 0 3.3
Note: Subjects may have more than one adverse event per body system and preferred term.

Changes in heart rate, plasma glucose, and serum potassium are shown in Table 4. The clinical significance of these small differences is unknown.

Table 4: Mean Changes from Baseline Heart Rate at 30 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) and Last Dose (Day 21) in Children 6-11 Years Old

Treatment Mean Changes(Day 1)
Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L)
XOPENEX 0.31 mg, n=66 0.8 4.9 -0.31
XOPENEX 0.63 mg, n=67 6.7 5.2 -0.36
Racemic albuterol 1.25 mg, n=64 6.4 8 -0.27
Racemic albuterol 2.5 mg, n=60 10.9 10.8 -0.56
Placebo, n=59 -1.8 0.6 -0.05
  Mean Changes (Day 21)
Treatment Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L)
XOPENEX 0.31 mg, n=60 0 2.6 -0.32
XOPENEX 0.63 mg, n=66 3.8 5.8 -0.34
Racemic albuterol 1.25 mg, n=62 5.8 1.7 -0.18
Racemic albuterol 2.5 mg, n=54 5.7 11.8 -0.26
Placebo, n=55 -1.7 1.1 -0.04

Post-marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in postapproval use of XOPENEX Inhalation Solution. 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 their seriousness, their frequency of reporting, or their likely beta-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dysphonia, dyspnea, gastrooesophageal reflux disease (GERD), metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria.

In addition, XOPENEX Inhalation Solution, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.

Read the entire FDA prescribing information for Xopenex (Levalbuterol) »

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Xopenex - User Reviews

Xopenex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Xopenex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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