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Levalbuterol Side Effects

Not all side effects for levalbuterol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to levalbuterol: inhalation aerosol powder, inhalation solution

In addition to its needed effects, some unwanted effects may be caused by levalbuterol. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking levalbuterol:

More common
  • Fast heartbeat
Less common or rare
  • Chest pain or tightness
  • dizziness
  • feeling “faint”
  • lightheadedness
  • troubled breathing
Incidence not known
  • Cough
  • difficult or labored breathing
  • difficulty swallowing
  • extra heartbeats
  • 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 sex organs
  • noisy breathing
  • redness of the skin
  • tightness in the chest
  • unusual tiredness or weakness

If any of the following symptoms of overdose occur while taking levalbuterol, get emergency help immediately:

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

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

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 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 or rare
  • Abdominal or stomach pain
  • 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 (stool)
  • 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
  • sleeplessness
  • 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

Myalgia occurred in less than 2%.[Ref]

Common (1% to 10%): Leg cramps
Frequency not reported: Myalgia[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

Central nervous system stimulation and hyperesthesia of the hand occurred in less than 2%.[Ref]

Common (1% to 10%): Dizziness, migraine, tremor, nervousness
Frequency not reported: Central nervous system stimulation, hyperesthesia of the hand[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

Diarrhea, dry mouth, dry throat, nausea, gastroenteritis, vomiting, and constipation occurred in less than 2%.

Common (1% to 10%): Dyspepsia
Frequency not reported: Diarrhea, dry mouth, dry throat, nausea, gastroenteritis, vomiting, constipation
Postmarketing reports: Gastroesophageal reflux disease (GERD), nausea

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

Eye itch occurred in less than 2%.

Frequency not reported: Eye itch

Psychiatric

Insomnia occurred in less than 2%.

Common (1% to 10%): Anxiety
Frequency not reported: Insomnia

References

1. Nelson HS, Bensch G, Pleskow WW, DiSantostefano R, DeGraw S, Reasner DS, Rollins TE, Rubin PD "Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma." J Allergy Clin Immunol 102 (1998): 943-52

2. "Product Information. Xopenex (levalbuterol)." Sepracor, Marlborough, MA.

3. Gawchik SM, Saccar CL, Noonan M, Reasner DS, DeGraw SS "The safety and efficacy of nebulized levalbuterol compared with racemic albuterol and placebo in the treatment of asthma in pediatric patients." J Allerg Clin Immunol 103 (1999): 615-21

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