Albuterol / ipratropium Side Effects

Some side effects of 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.

For the Consumer

Applies to albuterol / ipratropium: inhalation aerosol, inhalation solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking albuterol / ipratropium: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using albuterol and ipratropium and call your doctor at once if you have a serious side effect such as:

• wheezing, choking, or other breathing problems (especially after starting a new canister of this medicine);

• chest pain, pounding heartbeats or fluttering in your chest;

• dangerously high blood pressure (severe headache, anxiety, uneven heartbeats);

• swelling of your ankles or feet;

• eye pain, or seeing halos around lights;

• painful or difficult urination; or

• low potassium (confusion, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Other common side effects may include:

• mild headache; or

• cold symptoms such as stuffy nose, sneezing, cough, or sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to albuterol / ipratropium: inhalation aerosol, inhalation solution

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 (up to 12.3%), upper respiratory tract infection (up to 10.9%), lung disease (6.4%), cough (up to 6.4%), dyspnea (up to 4.5%), pharyngitis (up to 4.4%), nasopharyngitis (up to 4%), respiratory disorders (2.5%), sinusitis (2.3%), pneumonia (up to 1.4%), rhinitis (1.1%), and voice alterations (more than 1%). Dysphonia, increased sputum, pharyngolaryngeal pain, wheezing, and bronchospasm have been reported in less than 2% of patients. Hoarseness, throat irritation, bronchospasm (including paradoxical bronchospasm), wheezing, exacerbation of COPD symptoms, upper respiratory tract infection, sinusitis, sore throat, nasal congestion, and pharyngeal edema have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (up to 5.6%). Dizziness, paresthesia, tremor, taste perversion, and insomnia have been reported in less than 2% of patients. Drowsiness, coordination difficulty, and taste perversion have been reported during postmarketing experience.

Other

Other side effects have included chest pain (up to 2.6%), pain (up to 2.5%), and influenza (1.4%). Asthenia, influenza-like illness, chest discomfort, edema, and fatigue have been reported in less than 2% of patients. Mucosal ulcers, irritation from aerosol, flushing, edema, back pain, aching, and asthenia have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included hypertension, palpitations, tachycardia, angina, and arrhythmia in less than 2% of patients. Palpitations, hypotension, elevated heart rate, myocardial ischemia, decreased diastolic blood pressure, and increased systolic blood pressure have been reported during postmarketing experience. 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 inhalation aerosol.

Hypersensitivity

Hypersensitivity side effects associated with the inhalation solution have included immediate hypersensitivity reactions as demonstrated by rare cases of rash, urticaria, angioedema, pruritus, bronchospasm, anaphylaxis, and oropharyngeal edema. Allergic-type reactions such as skin reactions including rash, pruritus, urticaria (including giant urticaria), angioedema (including that of tongue, lips, and face), laryngospasm, and anaphylactic reaction have been reported with the inhalation aerosol. Hypersensitivity has been reported during postmarketing experience.

Ocular

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.

Ocular side effects have included eye pain (less than 2%), acute angle-closure glaucoma, and aggravation of narrow-angle glaucoma. Glaucoma, precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, conjunctival hyperemia, halo vision, accommodation disorder, ocular irritation, corneal edema, increased intraocular pressure, and mydriasis have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea (greater than or equal to 2%). Diarrhea, dry mouth, constipation, dyspepsia, and vomiting have been reported in less than 2% of patients. Drying of secretions, gastrointestinal motility disorder, stomatitis, dry throat, heartburn, gastrointestinal distress (diarrhea, nausea, vomiting), constipation, and mouth edema have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, muscle spasms, and myalgia in less than 2% of patients. Leg cramps (1.4%) have been reported. Muscle spasms, muscular weakness, and myalgia have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included nervousness (less than 2%). Central nervous system stimulation and mental disorder have been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hypokalemia (less than 2%). Hypokalemia and metabolic acidosis have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included pruritus and rash in less than 2% of patients. Angioedema, hyperhidrosis, alopecia, and skin reaction have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included urinary tract infection and dysuria in less than 2% of patients. Urinary retention has been reported during postmarketing experience.

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