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Xopenex HFA Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol is used to treat reversible obstructive airway conditions such as asthma, bronchitis, and emphysema. It is a bronchodilator. Common side effects include headache, nausea, nervousness, dizziness, shaking (tremor), trouble sleeping, dry mouth, cough, sore throat, or runny nose.
For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage of Xopenex HFA Inhalation Aerosol for adults and children 4 years of age and older is 2 inhalations (90 mcg) repeated every 4 to 6 hours. Xopenex HFA may interact with beta-blockers, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), diuretics (water pills), digoxin, other inhaled bronchodilators, caffeine, diet pills, or decongestants. Tell your doctor all medications you use. Xopenex HFA 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 HFA (levalbuterol tartrate) 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 HFA 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
- tremor or nervousness;
- 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 HFA (Levalbuterol Tartrate Inhalation Aerosol) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Xopenex HFA Overview - Patient Information: Side Effects
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 HFA (Levalbuterol Tartrate Inhalation Aerosol)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Xopenex HFA FDA Prescribing Information: Side Effects
Use of XOPENEX 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 the drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adult and Adolescents 12 Years of Age and Older
Adverse reaction information concerning XOPENEX HFA in adults and adolescents is derived from two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials in 748 adult and adolescent patients with asthma that compared XOPENEX HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler. 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 2% or greater in the group treated with XOPENEX HFA and more frequently than in the HFA-134a placebo inhaler group.
Table 1: Adverse Reaction Incidence (% of Patients) in
Two 8-Week Clinical Trials in Adults and Adolescents > 12 Years of Age*
|Body System||Preferred Term||XOPENEX HFA 90 mcg
|Racemic Albuterol HFA 180 mcg
|Body as a Whole||Pain||4||3||4|
|Central Nervous System||Dizziness||3||1||2|
|*This table includes all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA and more frequently than in the HFA-134a placebo inhaler group.|
Adverse reactions reported by less than 2% and at least 2 or more of the adolescent and adult patients receiving XOPENEX HFA and by a greater proportion than receiving HFA-134a placebo inhaler include cyst, flu syndrome, viral infection, constipation, gastroenteritis, myalgia, hypertension, epistaxis, lung disorder, acne, herpes simplex, conjunctivitis, ear pain, dysmenorrhea, hematuria, and vaginal moniliasis. There were no significant laboratory abnormalities observed in these studies.
Pediatric Patients 4 to 11 Years of Age
Adverse reaction information concerning XOPENEX HFA in children is derived from a 4-week, randomized, double-blind trial of XOPENEX HFA, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma. Table 2 lists the adverse reactions reported for XOPENEX HFA in children at a rate of 2% or greater and more frequently than for placebo.
Table 2: Adverse Reaction Incidence (% of Patients) in a
4-Week Clinical Trials in Children 4-11 Years*
|Body System||Preferred Term||XOPENEX HFA 90 mcg
|Racemic Albuterol HFA 180 mcg
|Body as a Whole||Accidental injury||9||10||6|
|* This table includes all adverse reactions (whether considered by the investigator to be related or unrelated to drug) from the trial that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA and more frequently than in the HFA-134a placebo inhaler group.|
The incidence of systemic beta-adrenergic adverse reactions (e.g., tremor, nervousness) was low and comparable across all treatment groups, including placebo.
In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in postapproval use of levalbuterol 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, dyspnea, metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria.
In addition, XOPENEX HFA, 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 HFA (Levalbuterol Tartrate Inhalation Aerosol) »
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