DuoNeb Side Effects

Please note - some side effects for DuoNeb may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of DuoNeb - for the Consumer

DuoNeb Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using DuoNeb Solution:

Coughing; dizziness; dry mouth; headache; nausea; nervousness; sinus inflammation; sore throat; trouble sleeping; unusual taste in mouth.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; clammy skin; difficulty urinating; fast or irregular heartbeat; new or worsening breathing problems; numbness of an arm or leg; pain, tightness, or pressure in the jaw, neck, or chest; pounding in the chest; severe headache, nausea, vomiting, or dizziness; severe stomach pain; shortness of breath; swelling of the arms or legs; tremors; vision changes; wheezing.

DuoNeb Side Effects - for the Professional

DuoNeb

Adverse reaction information concerning DuoNeb was derived from the 12-week controlled clinical trial.

Additional adverse reactions reported in more than 1% of patients treated with DuoNeb included constipation and voice alterations.

In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritus, and urticaria.

Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain and sore throat.

Side Effects by Body System

General

The combination of ipratropium and albuterol has been generally well tolerated. Systemic effects have occurred with albuterol; however, due to the poor oral and mucosal absorption of ipratropium, it typically has not exhibited systemic effects when administered by oral inhalation.

Respiratory

Respiratory side effects have included bronchitis (12.3%), upper respiratory tract infection (10.9%), dyspnea (4.5%), and cough (4.2%). Other reported events included pharyngitis (2.2%), sinusitis (2.3%), and rhinitis (1.1%). Paradoxical bronchospasm has occurred infrequently. Postmarketing experience has included hoarseness.

Nervous system

Nervous system side effects have included headache which was reported in 5.6% of patients. Dizziness, nervousness, tremor, and insomnia were reported in less than 2% of patients.

Local

Local side effects have been common when ipratropium was administered alone as an oral inhalation, and occurred in up to 25% of patients. Such effects were noted in less than 2% of patients taking the combined product in clinical trials and included dry mouth and taste perversion.

Cardiovascular

Cardiovascular side effects have included hypertension, edema, palpitations and arrhythmia which were reported in less than 2% of patients treated with albuterol-ipratropium. Postmarketing experience has included a 5-year placebo-controlled trial, in which hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving ipratropium by inhalation aerosol.

Hypersensitivity

Hypersensitivity side effects have been manifested as rash, urticaria, angioedemas, and laryngospasm.

Ocular

Ocular side effects have included acute angle closure glaucoma and aggravation of narrow angle glaucoma. Postmarketing experience has included ocular irritation and mydriasis.

There are numerous case reports in the literature of precipitation of glaucoma with the use of ipratropium and albuterol via nebulized solution. This is thought to occur through direct contact with the eyes, and is seen with the combination since both beta agonists and anticholinergics can increase intraocular pressure. There is one report of glaucoma associated with the use of nebulized albuterol and ipratropium aerosol in an emergency department. Caution is warranted when the combination is used in patients predisposed to glaucoma. Extra care should be taken to avoid contact with the eyes.

Musculoskeletal

Musculoskeletal side effects have included postmarketing reports of muscle spasms, muscular weakness, myalgia, and asthenia.

Psychiatric

Psychiatric side effects have included postmarketing reports of mental disorder.

Metabolic

Metabolic side effects have included hypokalemia.

Dermatologic

Dermatologic side effects have included postmarketing reports of hyperhidrosis.

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