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Xopenex HFA

Last reviewed on RxList: 1/18/2017
Xopenex HFA Side Effects Center

Last reviewed on RxList 02/07/2017

Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol is a bronchodilator used to treat reversible obstructive airway conditions such as asthma, bronchitis, and emphysema. Common side effects of Xopenex HFA include:

Tell your doctor if you have serious side effects of Xopenex HFA including fast or pounding heartbeat.

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 and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Xopenex HFA; it is unknown if it will harm an unborn baby. It is unknown if Xopenex HFA passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Xopenex HFA is not recommended.

Our Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol 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.

Xopenex HFA Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • headache, tremors, feeling anxious or nervous;
  • sleep problems (insomnia);
  • cough, runny or stuffy nose;
  • mild nausea, vomiting;
  • dry mouth and throat;
  • muscle pain; or
  • diarrhea.

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.

Read the entire detailed patient monograph for Xopenex HFA (Levalbuterol Tartrate Inhalation Aerosol)

Xopenex HFA Professional Information

SIDE EFFECTS

Use of XOPENEX HFA may be associated with the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a 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 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
(n=403)
Racemic Albuterol HFA 180 mcg
(n=179)
Placebo
(n=166)
Body as a Whole Pain 4% 3% 4%
Central Nervous System Dizziness 3% 1% 2%
Respiratory System Asthma 9% 7% 6%
Pharyngitis 8% 2% 2%
Rhinitis 7% 2% 3%
* 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 Trial in Children 4-11 Years of Age*

Body System Preferred Term XOPENEX HFA 90 mcg
(n=76)
Racemic Albuterol HFA 180 mcg
(n=39)
Placebo
(n=35)
Body as a Whole Accidental injury 9% 10% 6%
Digestive System Vomiting 11% 8% 6%
Respiratory System Bronchitis 3% 0% 0%
Pharyngitis 7% 13% 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.

Post-marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in post-approval 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, dysphonia, dyspnea, gastrooesophageal reflux disease (GERD), 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)

Related Resources for Xopenex HFA

Read the Xopenex HFA User Reviews »

© Xopenex HFA Patient Information is supplied by Cerner Multum, Inc. and Xopenex HFA Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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