Rhinocort Aqua Side Effects

Generic name: budesonide nasal

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rhinocort Aqua - for the consumer

Rhinocort Aqua 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 Rhinocort Aqua Spray:

Bad taste; coughing; headache; hoarseness; nasal irritation or dryness; nausea; sore throat; tightness in the lungs.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continuing nose discomfort; increased pressure in the eye; infection (eg, fever, chills, sore throat); nosebleeds or soreness; pounding in the chest.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

For the professional

Rhinocort Aqua

The incidence of common adverse reactions is based upon two U.S. and five non-U.S. controlled clinical trials in 1,526 patients [110 females and 239 males less than 18 years of age, and 635 females and 542 males 18 years of age and older] treated with Rhinocort Aqua Nasal Spray at doses up to 400 mcg once daily for 3-6 weeks. The table below describes adverse events occurring at an incidence of 2% or greater and more common among Rhinocort Aqua Nasal Spray-treated patients than in placebo-treated patients in controlled clinical trials. The overall incidence of adverse events was similar between Rhinocort Aqua and placebo.

A similar adverse event profile was observed in the subgroup of pediatric patients 6 to 12 years of age.

Two to three percent (2-3%) of patients in clinical trials discontinued because of adverse events. Systemic corticosteroid side effects were not reported during controlled clinical studies with Rhinocort Aqua Nasal Spray.

If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism, ie, Cushing’s Syndrome, could occur.

Rare adverse events reported from post-marketing experience include: nasal septum perforation, pharynx disorders (throat irritation, throat pain, swollen throat, burning throat, and itchy throat), angioedema, anosmia, and palpitations.

Cases of growth suppression have been reported for intranasal corticosteroids including Rhinocort Aqua Nasal Spray.

By body system

General side effects

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 side effects

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.

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

Gastrointestinal side effects

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

Nervous system side effects

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 side effects

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.).

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.

Endocrine side effects

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 side effects

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 side effects

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 side effects

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.

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