Xopenex HFA Side Effects

Generic Name: levalbuterol

Note: This document contains side effect information about levalbuterol. Some of the dosage forms listed on this page may not apply to the brand name Xopenex HFA.

Some side effects of Xopenex HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to levalbuterol: inhalation aerosol powder, inhalation solution

Along with its needed effects, levalbuterol (the active ingredient contained in Xopenex HFA) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking levalbuterol:

More common
  • Fast heartbeat
Less common or rare
  • Chest pain or tightness
  • dizziness
  • feeling “faint”
  • high or low blood pressure
  • hives
  • light-headedness
  • shortness of breath
  • troubled breathing
  • wheezing
Incidence not known
  • Cough
  • Difficult or labored breathing
  • difficulty swallowing
  • extra heartbeats
  • fainting
  • fast, pounding, slow, or irregular heartbeat or pulse
  • hives or welts
  • itching
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • noisy breathing
  • palpitations
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • redness of skin
  • tightness in chest
  • unusual tiredness or weakness
Symptoms of overdose
  • Chest pain
  • dizziness
  • dry mouth
  • fatigue
  • general feeling of discomfort or illness
  • headache
  • high blood pressure
  • impaired consciousness
  • irregular or fast heartbeat
  • light-headedness
  • nausea
  • nervousness
  • seizures
  • sleeplessness
  • sweating
  • tremor

Some side effects of levalbuterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Accidental injury (in children 4 to 11 years of age)
  • anxiety
  • body aches or pain
  • chills
  • congestion
  • cough or hoarseness
  • dryness or soreness of throat
  • fever
  • general aches and pains
  • headache
  • hoarseness
  • increased cough
  • leg cramps
  • loss of appetite
  • migraines or other headaches
  • muscle tightness
  • nervousness
  • runny or stuffy nose
Less common or rare
  • Abdominal or stomach pain
  • abnormal growth filled with fluid or semisolid material
  • blemishes on the skin
  • blood in urine
  • bloody nose
  • burning, dry or itching eyes
  • burning or stinging of skin
  • cough producing mucus
  • cramps
  • diarrhea
  • difficulty breathing
  • difficulty having a bowel movement (stool)
  • discharge from the eye
  • dry mouth or throat
  • ear pain
  • excessive tearing
  • eye itch
  • heavy menstrual bleeding
  • muscle pain
  • nausea
  • night sweats
  • numbness or decreased sensitivity of the hand
  • pain
  • painful cold sores or blisters on lips, nose, eyes, or genitals
  • pimples
  • redness, pain, swelling of eye, eyelid, or inner lining of eyelid
  • sleeplessness
  • tingling sensation in extremities
  • vaginal yeast infection
  • weight loss

For Healthcare Professionals

Applies to levalbuterol: inhalation aerosol, inhalation solution

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 (the active ingredient contained in Xopenex HFA) compared to racemic albuterol remains to be established.

Cardiovascular

Adverse cardiovascular effects may be due to significant hypokalemia produced by levalbuterol (the active ingredient contained in Xopenex HFA) 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 (the active ingredient contained in Xopenex HFA) 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. Postmarketing reports have included metabolic acidosis.

Nervous system

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

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.

Gastrointestinal

Gastrointestinal side effects include dyspepsia, diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, and nausea. Postmarketing side effects include gastroesophageal reflux disease (GERD).

Respiratory

Respiratory side effects include increased cough, viral infection, rhinitis, sinusitis, turbinate edema, asthma, and pharyngitis. Postmarketing side effects include dysphonia and dyspnea.

Dermatologic

Dermatologic side effects include postmarketing reports for rash and urticaria.

Hypersensitivity

Hypersensitivity side effects include postmarketing reports of angioedema and anaphylaxis.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)