"The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the f"...
Rhinocort Aqua Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Rhinocort Aqua (budesonide) nasal spray is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. It is also used to keep nasal polyps from returning after surgical removal. Rhinocort Aqua is a steroid. Common side effects include nose/throat dryness or irritation, cough, sneezing, nosebleeds, and unpleasant taste/smell.
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 breast-feeding.
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.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Rhinocort Aqua in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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.
Read the entire detailed patient monograph for Rhinocort Aqua (Budesonide) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Rhinocort Aqua Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these rare but serious side effects occur: loss of taste or smell, pain/sores in your nose.
Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.
Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as budesonide). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor immediately if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Rhinocort Aqua (Budesonide)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Rhinocort Aqua FDA Prescribing Information: 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
|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), [see WARNINGS AND PRECAUTIONS and CONTRAINDICATIONS]
Eye disorders: glaucoma, increased intraocular pressure, cataracts [see WARNINGS AND PRECAUTIONS]
Cardiac disorders: palpitations
Read the entire FDA prescribing information for Rhinocort Aqua (Budesonide) »
Additional Rhinocort Aqua Information
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