Rhinocort Aqua Side Effects

Generic name: budesonide nasal

Note: This document contains side effect information about budesonide nasal. Some of the dosage forms listed on this page may not apply to the brand name Rhinocort Aqua.

Some side effects of Rhinocort Aqua 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 budesonide nasal: nasal spray

Get emergency medical help if you have any of these signs of an allergic reaction while taking budesonide nasal (the active ingredient contained in Rhinocort Aqua) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• severe or ongoing nose bleed;

• sores in the nose that won't heal;

• wheezing, trouble breathing;

• vision problems; or

• fever, chills, body aches, flu symptoms.

Less serious side effects of budesonide nasal may include:

• dry or sore throat, cough;

• irritation in your nose;

• pain, swelling, burning, itching, or irritation in your throat;

• sores or white patches inside or around your nose.

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 budesonide nasal: nasal aerosol with adapter, nasal spray

General

Budesonide is generally well tolerated. Due to the nature of its administration, it is not inclined to produce the adverse effects associated with the systemic use of corticosteroids.

Respiratory

Bronchoconstriction has been reported in one patient receiving budesonide inhaled by mouth.

Respiratory side effects have generally been local in nature. Nasal irritation, congestion, bleeding, and sneezing have been most commonly reported. Pharyngitis and coughing are also commonly reported in patients receiving budesonide. Candidiasis has been reported occasionally.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, dyspepsia, or nausea. Budesonide may taste bad to some patients.

Nervous system

Nervous system side effects have included rare reports of behavioral disturbances in pediatric patients. These reactions were characterized by insomnia, hyperactivity, and aggressive behavior. The same reactions have been reported in one adult with a history of psychiatric disturbances.

Hypersensitivity

Hypersensitivity side effects have included contact allergic reactions. These reactions have been characterized by pruritus, burning, worsening of rhinitis, erythematous flares, eczema, and vesicles on the lip, nose, eyelids, and cheeks. Reactions may progress to other sites on the body. Generalized allergic skin eruptions have also been reported.

The reported onset of hypersensitivity reactions has ranged from 2 days to 7 months. Symptoms have resolved upon discontinuation of medication, usually in 7 to 10 days.

Erythema-multiform-like contact dermatitis has been reported with the use of budesonide topical ointment (not available in the U.S.).

Endocrine

Endocrine side effects have included rare suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression is less than that associated with systemic corticosteroids and should only be of concern when using higher than recommended doses.

Immunologic

Immunologic side effects have included concern with immune suppression resulting from inhaled corticosteroids. No conclusive evidence is available to support an increased risk of tuberculosis and viral infections in patients receiving inhaled corticosteroids.

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its labeling decision regarding the use of inhaled corticosteroids during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications from viral infections.

Dermatologic

In one prospective study, patients receiving at least 800 mcg/day of inhaled budesonide (or 1 mg of beclomethasone) for 3 months or more had a higher incidence of ecchymosis than matched controls. In addition, the severity was more pronounced in the treatment group. Older patients were more likely to be affected. The presence of skin bruising was associated with lower urinary cortisol levels, suggesting systemic absorption of the inhaled drug.

Dermatologic side effects have included acne and thinning of the skin. Easy bruising has been associated with budesonide use in some patients.

Ocular

Ocular side effects have included occasional reports of posterior capsular cataracts, especially with long-term use. In addition, one epidemiologic study suggests that prolonged use of high-dose inhaled corticosteroids (1600 mcg or more of budesonide daily) may be associated with increased risk of ocular hypertension and open-angle glaucoma.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.