Rhinocort Aqua
- Generic Name: budesonide
- Brand Name: Rhinocort Aqua
- Drug Class: Corticosteroids, Intranasal
Rhinocort Aqua (Budesonide) side effects drug center
Rhinocort Aqua (budesonide) nasal spray is a steroid used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Rhinocort Aqua nasal spray is also used to keep nasal polyps from returning after surgical removal. Common side effects of Rhinocort Aqua nasal spray include:
- nose/throat dryness or irritation,
- sore throat,
- cough,
- sneezing,
- nosebleeds,
- unpleasant taste/smell,
- sores or white patches inside or around your nose, or
- pain, swelling, burning, itching, or irritation around your nose.
Tell your doctor if you have rare but serious side effects of Rhinocort Aqua nasal spray including:
- loss of taste or smell, or
- pain or sores in your nose.
In adults and in children older than 6 years, the recommended starting dose of Rhinocort Aqua is 2-4 sprays in each nostril in the morning and in the evening, or 4 sprays in each nostril only in the morning. Rhinocort Aqua may interact with HIV /AIDS medicine, antibiotics, antifungals, or antidepressants. Tell your doctor all medications you are taking. Tell your doctor if you are pregnant before using Rhinocort Aqua. Rarely, infants born to mothers using corticosteroids (including budesonide) may have low levels of corticosteroid hormone. Tell your doctor if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. It is unknown if Rhinocort Aqua passes into breast milk. This medication might also pass into breast milk in very small amounts that are unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Our Rhinocort Aqua (budesonide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe or ongoing nosebleeds;
- sores in the nose that won't heal;
- wheezing, trouble breathing;
- vision problems; or
- fever, chills, body aches, flu symptoms.
Common side effects 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Rhinocort Aqua (Budesonide)
SIDE EFFECTS
Systemic and intranasal corticosteroids use may result in the following:
- Epistaxis, Candida albicans infection, nasal septum perforation, and impaired wound healing [see WARNINGS AND PRECAUTIONS].
- Hypersensitivity Including Anaphylaxis [see WARNINGS AND PRECAUTIONS].
- Immunosuppression [see WARNINGS AND PRECAUTIONS].
- Hypercorticism and Adrenal Suppression [see WARNINGS AND PRECAUTIONS].
- Growth Effect [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
- Glaucoma and Cataracts [see WARNINGS AND PRECAUTIONS].
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 |
Placebo Vehicle |
| Epistaxis | 8% | 5% |
| Pharyngitis | 4% | 3% |
| Bronchospasm | 2% | 1% |
| Coughing | 2% | < 1% |
| 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.
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), [see WARNINGS AND PRECAUTIONS and CONTRAINDICATIONS]
Eye disorders: glaucoma, increased intraocular pressure, cataracts [see WARNINGS AND PRECAUTIONS]
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 [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]
Read the entire FDA prescribing information for Rhinocort Aqua (Budesonide)
© Rhinocort Aqua Patient Information is supplied by Cerner Multum, Inc. and Rhinocort Aqua Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
