Albuterol/Ipratropium Side Effects

Please note - some side effects for Albuterol/Ipratropium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Albuterol/Ipratropium - for the Consumer

Albuterol/Ipratropium 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 Albuterol/Ipratropium 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); burning, numbness, or tingling; clammy skin; difficult or painful urination; fainting; 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Albuterol/Ipratropium 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 Albuterol/Ipratropium 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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.
Also, decreased diastolic blood pressure, and increased systolic blood pressure have been reported.

Hypersensitivity

Hypersensitivity side effects have been manifested as rash, urticaria, angioedemas, laryngospasm, bronchospasm, anaphylaxis, and oropharyngeal edema.

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.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal distress (diarrhea, nausea, vomiting), and constipation.

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. Additional reports have included pruritus.

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