Xopenex Concentrate Side Effects

Generic Name: levalbuterol

Note: This page contains side effects data for the generic drug levalbuterol. It is possible that some of the dosage forms included below may not apply to the brand name Xopenex Concentrate.

It is possible that some side effects of Xopenex Concentrate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to levalbuterol: inhalation aerosol powder, inhalation solution

As well as its needed effects, levalbuterol (the active ingredient contained in Xopenex Concentrate) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking levalbuterol, check with your doctor immediately:

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 levalbuterol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 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

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 Concentrate) 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 Concentrate) 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 Concentrate) 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.

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