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Atrovent Nasal Spray

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Atrovent Nasal Spray

Atrovent Nasal Spray

Atrovent Nasal Spray Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Atrovent (ipratropium bromide) Nasal Spray is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Atrovent Nasal Spray may cause headache, nasal dryness, and nasal irritation. Other side effects may occur. Consult your physician if you experience any possible side effects.

The recommended dose of Atrovent Nasal Spray is two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day). Safe use of Atrovent Nasal Spray for use by Children under 6 years of age has not been established. Atrovent nasal spray should only be used by pregnant women if clearly needed. It is not known whether Atrovent Nasal Spray 0.06% is excreted in human milk, so caution should be exercised when Atrovent Nasal Spray 0.06% is administered to a nursing mother.

Our Atrovent Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Atrovent Nasal Spray in Detail - Patient Information: Side Effects

Stop using ipratropium nasal and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a fast, pounding heartbeat.

Less serious side effects may include:

  • headache;
  • dry nose;
  • nosebleeds; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Atrovent Nasal Spray (Ipratropium Bromide Nasal Spray) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Atrovent Nasal Spray Overview - Patient Information: Side Effects

SIDE EFFECTS: See also How to Use section.

Dry/bloody nose, dry mouth/throat, throat irritation, bad taste in mouth, nausea, dizziness, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: eye pain, vision changes (such as blurred vision, seeing halos), difficult/painful urination, fast/pounding heartbeat.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Atrovent Nasal Spray (Ipratropium Bromide Nasal Spray)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Atrovent Nasal Spray FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 (ipratropium bromide nasal spray) 0.03% three times daily, for eight weeks. In the other trial, ATROVENT Nasal Spray (ipratropium bromide 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 (ipratropium bromide 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.

Table 1 - % of Patients Reporting Events +

  Atrovent®
(ipratropium bromide)
Nasal Spray 0.03%
(n=356)
Vehicle Control
(n=347)
Incidence % Discontinued % Incidence % Discontinued %
Headache 9.8 0.6 9.2 0.0
Upper respiratory tract infection 9.8 1.4 7.2 1.4
Epistaxis1 9.0 0.3 4.6 0.3
Rhinitis*
   Nasal dryness 5.1 0.0 0.9 0.3
   Nasal irritation2 2.0 0.0 1.7 0.6
   Other nasal symptoms3 3.1 1.1 1.7 0.3
Pharyngitis 8.1 0.3 4.6 0.0
Nausea 2.2 0.3 0.9 0.0
+ This table includes adverse events which occurred at an incidence rate of at least 2.0% in the ATROVENT group and more frequently in the ATROVENT group than in the vehicle group.
1 Epistaxis reported by 7.0% of ATROVENT patients and 2.3% of vehicle patients, blood-tinged mucus by 2.0% of ATROVENT patients and 2.3% of vehicle patients.
2Nasal irritation includes reports of nasal itching, nasal burning, nasal irritation, and ulcerative rhinitis.
3 Other nasal symptoms include reports of nasal congestion, increased rhinorrhea, increased rhinitis, posterior nasal drip, sneezing, nasal polyps, and nasal edema.
*All events are listed by their WHO term; rhinitis has been presented by descriptive terms for clarification.

ATROVENT Nasal Spray (ipratropium bromide 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.

Read the entire FDA prescribing information for Atrovent Nasal Spray (Ipratropium Bromide Nasal Spray) »

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Atrovent Nasal Spray - User Reviews

Atrovent Nasal Spray User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Atrovent Nasal Spray sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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