Side Effects of Rhinocort Aqua (budesonide)

Rhinocort Aqua (budesonide) is a synthetic steroid belonging to the glucocorticoid family, a family in which cortisol (hydrocortisone) is the naturally occurring steroid, used to manage symptoms of allergic rhinitis, a condition in which fluid accumulates within the lining of the nose leading to obstruction to the flow of air. Fluid also is released into the nasal passages.

In addition, budesonide is used to treat and prevent nasal polyps. Hydrocortisone is produced in the adrenal glands. Glucocorticoid steroids have potent anti-inflammatory actions. When used as a nasal inhaler or spray, budesonide travels directly to the lining of the nose, and only 20% of the administered dose is absorbed into the body. 

The brand name Rhinocort Aqua is discontinued in the U.S.

Common side effects of Rhinocort Aqua include

• nasal irritation,
• sore throat,
• cough,
• bronchospasm, and
• nosebleed.

Serious side effects of Rhinocort Aqua include

• upper respiratory infections,
• serious allergic reactions,
• increased intraocular pressure,
• cataracts,
• glaucoma, and
• growth suppression.

Drug interactions of Rhinocort Aqua include ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, and telithromycin, because these drugs may increase the concentration in blood of budesonide by decreasing the elimination of budesonide from the body. This may lead to an increase in the side effects of budesonide. 

Studies of pregnant women using inhaled Rhinocort Aqua during early pregnancy do not show an increase in the rate of fetal abnormalities. Nevertheless, since these studies cannot completely exclude rare abnormalities, Rhinocort Aqua should only be used during pregnancy if it clearly is needed. 

Budesonide is secreted in breast milk at concentrations of 0.3% to 1% of the inhaled dose. Rhinocort Aqua should only be used by breastfeeding mothers when clearly needed, and the lowest effective dose and other strategies to reduce infant exposure should be used.

The most common side effects associated with nasal budesonide are:

• Nasal irritation
• Sore throat
• Cough
• Bronchospasm
• Nasal bleeding

Other side effects include:

• Upper respiratory infections
• Serious allergic reactions
• Increased intraocular pressure
• Cataracts
• Glaucoma
• Growth suppression

Systemic and intranasal corticosteroids use may result in the following:

• Epistaxis, Candida albicans infection, nasal septum perforation, and impaired wound healing.
• Hypersensitivity Including Anaphylaxis.
• Immunosuppression.
• Hypercorticism and Adrenal Suppression.
• Growth Effect.
• Glaucoma and Cataracts.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• The incidence of common adverse reactions in Table 1 is based upon two U.S. and five non-U.S. controlled clinical trials in 1,526 patients with seasonal or perennial rhinitis in adults and children ≥ 6 years treated with Rhinocort Aqua (budesonide) Nasal Spray at doses up to 400 mcg once daily for 3-6 weeks.
• This population included 745 females and 781 males with a mean age of 31 years (range of 6-85 years, 349 were 6 < 18 years).
• The racial distribution of patients receiving Rhinocort Aqua (budesonide) Nasal Spray was 93% white, 3% black and 4% other.
• Table 1 describes adverse reactions occurring at an incidence of 2% or greater and more commonly among Rhinocort Aqua (budesonide) Nasal Spray-treated patients than in placebo-treated patients in controlled clinical trials.

Table 1. Adverse Reactions occurring at an incidence ≥ 2% and more commonly than placebo in the Rhinocort Aqua (budesonide) Nasal Spray group in patients 6 years and older

• A similar adverse reaction profile was observed in the subgroup of pediatric patients 6 to 12 years of age. These patients are included in Table 1.
• Two to three percent (2-3%) of patients in clinical trials discontinued because of adverse reactions. Systemic corticosteroid side effects were not reported during controlled clinical studies with Rhinocort Aqua (budesonide) Nasal Spray.
• If recommended doses are exceeded, or if individuals are particularly sensitive, symptoms of hypercorticism, ie, Gushing's Syndrome, and adrenal suppression could occur.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use of Rhinocort Aqua (budesonide) Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Immune system disorders: immediate and delayed hypersensitivity reactions (including anaphylactic reaction, urticaria, rash, dermatitis, angioedema and pruritus).
• Eye disorders: glaucoma, increased intraocular pressure, cataracts.
• Respiratory, thoracic, and mediastinal disorders: nasal septum perforation, anosmia, pharynx disorders (throat irritation, throat pain, swollen throat, burning throat, and itchy throat), and wheezing
• Cardiac disorders: palpitations
• Musculoskeletal and connective tissue disorders: growth suppression.

Inhibitors of Cytochrome P450 3A4

• The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4).
• After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased.
• Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide.
• Caution should be exercised when considering the co-administration of Rhinocort Aqua (budesonide) Nasal Spray with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir clarithromycin, indinavir itraconazole, nefazodone nelfinavir-saquinavir, telithromycin).