Atrovent HFA Side Effects

Generic Name: ipratropium

Please note - some side effects for Atrovent HFA 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).

Atrovent HFA Side Effects - for the Professional

Atrovent HFA

The adverse reaction information concerning Atrovent HFA Inhalation Aerosol is derived from two 12-week, double-blind, parallel group studies and one open-label, parallel group study that compared Atrovent HFA Inhalation Aerosol, ATROVENT Inhalation Aerosol CFC, and placebo (in one study only) in 1,010 COPD patients. The following table lists the incidence of adverse events that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group. Overall, the incidence and nature of the adverse events reported for Atrovent HFA Inhalation Aerosol, ATROVENT Inhalation Aerosol CFC, and placebo were comparable.

In the one open label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol and Atrovent® (ipratropium bromide) Inhalation Aerosol CFC formulations.

Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg Atrovent HFA Inhalation Aerosol and 8.7% of the patients taking 42 mcg ATROVENT Inhalation Aerosol CFC reported at least one adverse event that was considered by the investigator to be related to the study drug. The most common drug-related adverse events were dry mouth (1.6% of Atrovent HFA Inhalation Aerosol and 0.9% of ATROVENT Inhalation Aerosol CFC patients), and taste perversion (bitter taste) (0.9% of Atrovent HFA Inhalation Aerosol and 0.3% of ATROVENT Inhalation Aerosol CFC patients).

As an anticholinergic drug, cases of precipitation or worsening of narrow-angle glaucoma, mydriasis, acute eye pain, hypotension, palpitations, urinary retention, tachycardia, constipation, bronchospasm, including paradoxical bronchospasm have been reported.

Allergic-type reactions such as skin rash, pruritus, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported.

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 Inhalation Aerosol CFC.

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

Additionally, urinary retention, mydriasis, gastrointestinal distress (diarrhea, nausea, vomiting), and bronchospasm, including paradoxical bronchospasm, have been reported during the post-marketing period with use of ATROVENT Inhalation Aerosol CFC.

Side Effects by Body System

General

Ipratropium has been generally well tolerated, and void of systemic effects when administered by oral inhalation.

Local

Local side effects have included dry mouth, bitter taste, and scratchy throat in up to 25% of patients treated.

Nervous system

Nervous system side effects have included headache in approximately 2% of patients treated. Dizziness has occurred infrequently.

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, rash, bronchospasm, pruritis, and oropharyngeal edema.

Ocular

Ocular side effects have included changes in intraocular pressure and changes in pupil size or accommodation with long-term therapy. Blurred vision and conjunctivitis have occurred when the medication came in contact with the eyes.

Genitourinary

Genitourinary side effects have included urinary retention in patients receiving higher dosages by nebulizer but not with the lower doses given by metered-dose inhaler Caution is warranted when using ipratropium in men with prostatic hypertrophy.

Respiratory

Respiratory side effects have included rare reports of paradoxical bronchoconstriction.

Cardiovascular

Cardiovascular side effects including tachycardia and palpitations have been rare. Supraventricular tachycardia has occurred in patients treated with high dosages by nebulizer but has not been reproduced with lower dosages given by metered-dose inhaler.

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