Atrovent Side Effects

Generic Name: ipratropium

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

Atrovent HFA Aerosol Suspension

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 Atrovent HFA Aerosol Suspension:

Cough; dizziness; dry mouth; dry nose or nose irritation; flu-like symptoms; headache; nausea; nervousness; pain; runny nose; sinus infection; sore throat; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; eye pain; nosebleeds; trouble urinating; visual halos or colored rings.

Atrovent Aerosol Suspension

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 Atrovent Aerosol Suspension:

Cough; dizziness; dry mouth; dry nose or nose irritation; flu-like symptoms; headache; nausea; nervousness; pain; runny nose; sinus infection; sore throat; upper respiratory tract infection.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; eye pain; nosebleeds; trouble urinating; visual halos or colored rings.

Atrovent Spray

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 Atrovent Spray:

Dry nose or nose irritation; mild nosebleed; nausea; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; eye pain; fast heartbeat; hoarseness; severe constipation; severe or recurring nosebleeds; severe nasal dryness; sinus infection; trouble urinating; visual halos or colored rings.

Atrovent Side Effects - for the Professional

Atrovent Nasal Spray

Adverse reaction information on Atrovent Nasal Spray 0.03% in patients with perennial rhinitis was derived from four multicenter, vehicle-controlled clinical trials involving 703 patients (356 patients on Atrovent and 347 patients on vehicle), and a one-year, open-label, follow-up trial.  In three of the trials, patients received Atrovent Nasal Spray 0.03% three times daily, for eight weeks. In the other trial, Atrovent Nasal Spray 0.03% was given to patients two times daily for four weeks. Of the 285 patients who entered the open-label, follow-up trial, 232 were treated for 3 months, 200 for 6 months, and 159 up to one year. The majority (>86%) of patients treated for one year were maintained on 42 mcg per nostril, two or three times daily, of Atrovent Nasal Spray 0.03%.

Table 1 shows adverse events, and the frequency that these adverse events led to the discontinuation of treatment, reported for patients who received Atrovent Nasal Spray 0.03% at the recommended dose of 42 mcg per nostril, or vehicle two or three times daily for four or eight weeks. Only adverse events reported with an incidence of at least 2.0% in the Atrovent group and higher in the Atrovent group than in the vehicle group are shown.

Atrovent Nasal Spray 0.03% was well tolerated by most patients. The most frequently reported nasal adverse events were transient episodes of nasal dryness or epistaxis. These adverse events were mild or moderate in nature, none was considered serious, none resulted in hospitalization and most resolved spontaneously or following a dose reduction. Treatment for nasal dryness and epistaxis was required infrequently (2% or less) and consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly or saline nasal spray). Patient discontinuation for epistaxis or nasal dryness was infrequent in both the controlled (0.3% or less) and one-year, open-label (2% or less) trials. There was no evidence of nasal rebound (i.e., a clinically significant increase in rhinorrhea, posterior nasal drip, sneezing or nasal congestion severity compared to baseline) upon discontinuation of double-blind therapy in these trials.

Adverse events reported by less than 2% of the patients receiving Atrovent Nasal Spray 0.03% during the controlled clinical trials or during the open-label follow-up trial, which are potentially related to Atrovent’s local effects or systemic anticholinergic effects include: dry mouth/throat, dizziness, ocular irritation, blurred vision, conjunctivitis, hoarseness, cough, and taste perversion.

There were infrequent reports of skin rash in both the controlled and uncontrolled clinical studies.

Post-Marketing Experience

Allergic-type reactions such as skin rash, angioedema of the throat, tongue, lips and face, generalized urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported with Atrovent® (ipratropium bromide) Nasal Spray 0.03% and for other ipratropium bromide-containing products, with positive rechallenge in some cases.

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, prostatic disorders, mydriasis, cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, wheezing, dryness of the oropharynx, sinusitis, tachycardia, palpitations, pain, edema, gastrointestinal distress (diarrhea, nausea, vomiting), bowel obstruction, and constipation.

After oral inhalation of ipratropium bromide in patients suffering from COPD/Asthma supraventricular tachycardia and atrial fibrillation have been reported.

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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