Combivent Side Effects

Please note - some side effects for Combivent 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 Combivent - for the Consumer

Combivent Aerosol

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 Combivent Aerosol:

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.

Combivent Side Effects - for the Professional

Combivent

Adverse reaction information concerning Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol is derived from two 12-week controlled clinical trials (N=358 for Combivent Inhalation Aerosol) as seen in Table 1.

Additional adverse reactions, reported in less than two percent of the patients in the Combivent Inhalation Aerosol treatment group include edema, fatigue, hypertension, dizziness, nervousness, paresthesia, tremor, dysphonia, insomnia, diarrhea, dry mouth, dyspepsia, vomiting, arrhythmia, palpitation, tachycardia, arthralgia, angina, increased sputum, taste perversion, and urinary tract infection/dysuria.

Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reaction have been reported with Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, with positive rechallenge in some cases. Many of these patients had a history of allergies to other drugs and/or foods including soybean.

Post-Marketing Experience

In a 5-year placebo-controlled trial, hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving Atrovent® (ipratropium bromide) Inhalation Aerosol CFC.

Additional side effects identified from the published literature and/or post-marketing surveillance on the use of ipratropium bromide-containing products (singly or in combination with albuterol), include: urinary retention, mydriasis, bronchospasm (including paradoxical bronchospasm), cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, ocular irritation, nasal congestion, drying of secretions, mucosal ulcers, irritation from aerosol, wheezing, exacerbation of COPD symptoms, hoarseness, palpitations, heartburn, drowsiness, CNS stimulation, coordination difficulty, flushing, alopecia, itching, hypotension, edema, gastrointestinal distress (diarrhea, nausea, vomiting), constipation, hypokalemia, mental disorder, hyperhidrosis, muscle spasms, muscular weakness, myalgia, and asthenia.

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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