Note: This document contains side effect information about levalbuterol. Some dosage forms listed on this page may not apply to the brand name Xopenex HFA.
Applies to levalbuterol: inhalation aerosol powder, inhalation solution.
Serious side effects of Xopenex HFA
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 immediately if any of the following side effects occur while taking levalbuterol:
More common
- Fast heartbeat
Less common
- Chest pain or tightness
- dizziness
- feeling “faint”
- lightheadedness
- troubled breathing
Incidence not known
- Confusion
- cough
- difficult or labored breathing
- difficulty swallowing
- drowsiness
- extra heartbeat
- fainting
- fast, pounding, slow, or irregular heartbeat or pulse
- hives, welts, itching, or rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- nausea
- noisy breathing
- rapid, deep breathing
- redness of the skin
- restlessness
- stomach cramps
- unusual tiredness or weakness
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur while taking levalbuterol:
Symptoms of overdose
- Chest pain
- dizziness
- dry mouth
- general feeling of discomfort or illness
- headache
- impaired consciousness
- irregular or fast heartbeat
- lightheadedness
- nausea
- nervousness
- seizures
- sleeplessness
- sweating
- tremor
Other side effects of Xopenex HFA
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
- dryness or soreness of the 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
- Abnormal growth filled with fluid or semisolid material
- blemishes on the skin
- blood in the urine
- bloody nose
- burning, dry, or itching eyes
- burning or stinging of the skin
- cough producing mucus
- cramps
- diarrhea
- difficulty having a bowel movement
- discharge from the eye
- dry mouth or throat
- ear pain
- excessive tearing
- eye itch
- heavy menstrual bleeding
- muscle pain
- night sweats
- numbness or decreased sensitivity of the hand
- pain
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pimples
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- stomach pain
- tingling sensation in the arms or legs
- vaginal yeast infection
- weight loss
For Healthcare Professionals
Applies to levalbuterol: inhalation aerosol, inhalation solution.
General
This drug has been associated with paradoxical bronchospasm, cardiovascular effects, immediate hypersensitivity reactions, and hypokalemia.[Ref]
Cardiovascular
ECG abnormal, ECG change, hypotension, and syncope occurred in less than 2%.[Ref]
Common (1% to 10%): Hypertension, tachycardia
Frequency not reported: ECG abnormal, ECG change, hypotension, syncope
Postmarketing reports: Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)[Ref]
Musculoskeletal
Common (1% to 10%): Leg cramps
Frequency not reported: Myalgia[Ref]
Myalgia occurred in less than 2%.[Ref]
Metabolic
Metabolic acidosis occurred in less than 2%.[Ref]
Frequency not reported: Changes in plasma glucose and serum potassium; metabolic acidosis[Ref]
Nervous system
Common (1% to 10%): Dizziness, migraine, tremor, nervousness
Frequency not reported: Central nervous system stimulation, hyperesthesia of the hand[Ref]
Central nervous system stimulation and hyperesthesia of the hand occurred in less than 2%.[Ref]
Other
Common (1% to 10%): Pain, flu syndrome, accidental injury, asthenia, fever
Frequency not reported: Ear pain, herpes simplex, chills, cyst[Ref]
Ear pain, herpes simplex, chills, and cyst occurred in less than 2%.[Ref]
Gastrointestinal
Common (1% to 10%): Dyspepsia
Frequency not reported: Diarrhea, dry mouth, dry throat, nausea, gastroenteritis, vomiting, constipation
Postmarketing reports: Gastroesophageal reflux disease (GERD), nausea
Diarrhea, dry mouth, dry throat, nausea, gastroenteritis, vomiting, and constipation occurred in less than 2%.
Respiratory
Common (1% to 10%): Asthma, pharyngitis, rhinitis, bronchitis, sinusitis, turbinate edema, cough increased, viral infection
Frequency not reported: Epistaxis, lung disorder, asthma exacerbation, wheezing
Postmarketing reports: Chest pain, dysphonia, dyspnea
Viral infection, epistaxis, lung disorder, asthma exacerbation, and wheezing occurred in less than 2%.
Dermatologic
Frequency not reported: Acne, sweating
Postmarketing reports: Rash, urticaria
Acne and sweating occurred less than 2%.
Hypersensitivity
Common (1% to 10%): Allergic reactions
Postmarketing reports: Angioedema, anaphylaxis
Genitourinary
Frequency not reported: Hematuria, dysmenorrhea, vaginal moniliasis
Hematuria, dysmenorrhea, vaginal moniliasis occurred in less than 2%.
Immunologic
Frequency not reported: Lymphadenopathy
Lymphadenopathy occurred in less than 2%.
Ocular
Frequency not reported: Eye itch
Eye itch occurred in less than 2%.
Psychiatric
Insomnia occurred in less than 2%.
Common (1% to 10%): Anxiety
Frequency not reported: Insomnia
