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Does Rhinocort Aqua (budesonide) cause side effects?
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
Serious side effects of Rhinocort Aqua include
- upper respiratory infections,
- serious allergic reactions,
- increased intraocular pressure,
- 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.
What are the important side effects of Rhinocort Aqua (budesonide)?
The most common side effects associated with nasal budesonide are:
Other side effects include:
Rhinocort Aqua (budesonide) side effects list for healthcare professionals
Systemic and intranasal corticosteroids use may result in the following:
- Epistaxis, Candida albicans infection, nasal septum perforation, and impaired wound healing.
- Hypersensitivity Including Anaphylaxis.
- 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
|Adverse Event|| Rhinocort
AQUA Nasal Spray
|Nasal Irritation||2%||< 1%|
- 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.
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.
What drugs interact with Rhinocort Aqua (budesonide)?
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).
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Related Disease Conditions
What Are the Four Types of Allergic Reactions?
Allergists recognize four types of allergic reactions: Type I or anaphylactic reactions, type II or cytotoxic reactions, type III or immunocomplex reactions and type IV or cell-mediated reactions.
An allergy refers to a misguided reaction by our immune system in response to bodily contact with certain foreign substances. When these allergens come in contact with the body, it causes the immune system to develop an allergic reaction in people who are allergic to it. It is estimated that 50 million North Americans are affected by allergic conditions. The parts of the body that are prone to react to allergies include the eyes, nose, lungs, skin, and stomach. Common allergic disorders include hay fever, asthma, allergic eyes, allergic eczema, hives, and allergic shock.
How Long Does an Allergic Reaction Last?
Allergic reactions may last for varying lengths of time. They may take a few hours to a few days to disappear. If the exposure to the allergen continues, such as during a spring pollen season, allergic reactions may last for longer periods such as a few weeks to months.
Indoor allergens are substances that can cause an allergic reaction in some people. Common sources of indoor allergens include dust mites, cockroaches, molds, pets, and plants. Avoiding indoor allergens is one way to reduce allergy and asthma symptoms.
Hay Fever (Allergic Rhinitis)
Hay fever (allergic rhinitis) is an irritation of the nose caused by pollen and is associated with the following allergic symptoms: nasal congestion, runny nose, sneezing, eye and nose itching, and tearing eyes. Avoidance of known allergens is the recommended treatment, but if this is not possible, antihistamines, decongestants, and nasal sprays may help alleviate symptoms.
Cold, Flu, Allergy Treatments
Before treating a cold, the flu, or allergies with over-the-counter (OTC) medications, it's important to know what's causing the symptoms, which symptoms one wishes to relieve, and the active ingredients in the OTC product. Taking products that only contain the medications needed for relieving your symptoms prevents ingestion of unnecessary medications and reduces the chances of side effects.
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Sinus Infection vs. Allergies
Both sinus infections and allergies (allergic rhinitis) cause symptoms such as runny or stuffy nose and fatigue. Sinus infection (known as sinusitis) is inflammation of the sinuses, caused by infection from bacteria, viruses, and/or fungi (molds). Allergic rhinitis occurs when certain allergies cause nasal symptoms. When a person with allergies breathes in an allergen, such as pollen, dust, or animal dander, symptoms such as runny or stuffy nose, itching, sneezing, and fatigue occur.
The allergic cascade refers to allergic reactions that happen in the body in response to allergens. A variety of immune cells and chemical messengers participate in the allergic cascade. Symptoms of the allergic cascade range from mild swelling and itching to full-blown anaphylactic shock. Allergen avoidance and medications are used to prevent or treat allergies.
Allergy Treatment Begins at Home
Avoiding allergy triggers at home is one of the best ways to prevent allergy symptoms. Controlling temperature, humidity, and ventilation are a few ways to allergy-proof the home. Cleaning, vacuuming, and using HEPA air filters also helps control allergies.
COVID-19 vs. Allergies
Though there is some overlap in allergy and COVID-19 signs and symptoms there are also significant differences. Symptoms that they have in common include headache, fatigue, tiredness, shortness of breath, wheezing, and sore throat. Fever does not occur with allergies but is one of the defining symptoms of COVID-19 infections.
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Treatment & Diagnosis
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Medications & Supplements
- Prednisone vs. Budesonide
- budesonide breath-activated inhaler - oral, Pulmicort
- budesonide - oral, Entocort EC
- budesonide suspension for nebulizer - inhalation
- budesonide liquid spray - nasal, Rhinocort Aqua
- budesonide (oral inhalation, Pulmicort, Pulmicort Flexhaler)
- budesonide nasal inhaler (Rhinocort Allergy, Rhinocort Aqua)
- budesonide (Entocort EC, Uceris)
- budesonide/formoterol hfa inhaler (Symbicort)
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.