What are the possible side effects of Budanase AQ?
Get emergency medical help if you have signs of an allergic reaction to Budanase AQ: hives, rash, severe itching; chest pain, difficult breathing, feeling anxious; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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worsening asthma symptoms;
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wheezing, choking, or other breathing problems after using this medication;
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white patches or sores inside your mouth or on your lips;
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blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
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signs of infection - fever, chills, body aches, ear pain, nausea, vomiting; or
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signs of low adrenal gland hormones - worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.
Common Budanase AQ side effects may include:
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runny or stuffy nose, sneezing;
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red, itchy, and watery eyes;
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fever, sore throat, cough;
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nausea, vomiting, diarrhea, stomach pain, loss of appetite;
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nosebleed; or
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headache, back pain.
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.
Side effects of Budanase AQ in details
The following adverse reactions were reported in patients treated with Budanase AQ (Budanase AQ).
The incidence of common adverse events is based upon double-blind, placebo-controlled US clinical trials in which 1116 adult and pediatric patients age 6-70 years (472 females and 644 males) were treated with Budanase AQ (Budanase AQ) (200 to 800 mcg twice daily for 12 to 20 weeks) or placebo.
The following table shows the incidence of adverse events in patients previously receiving bronchodilators and/or inhaled corticosteroids in US controlled clinical trials. This population included 232 male and 62 female pediatric patients (age 6 to 17 years) and 332 male and 331 female adult patients (age 18 years and greater).
Adverse Events with ≥ 3% Incidence reported by Patients on Budanase AQ (Budanase AQ)
| Budanase AQ | ||||
| Adverse Event | Placebo N=284 % | 200 mcg twice daily N=286 % | 400 mcg twice daily N=289 % | 800 mcg twice daily N=98 % |
| Respiratory System | ||||
| Respiratory infection | 17 | 20 | 24 | 19 |
| Pharyngitis | 9 | 10 | 9 | 5 |
| Sinusitis | 7 | 11 | 7 | 2 |
| Voice alteration | 0 | 1 | 2 | 6 |
| Body As A Whole | ||||
| Headache | 7 | 14 | 13 | 14 |
| Flu syndrome | 6 | 6 | 6 | 14 |
| Pain | 2 | 5 | 5 | 5 |
| Back pain | 1 | 2 | 3 | 6 |
| Fever | 2 | 2 | 4 | 0 |
| Digestive System | ||||
Oral candidiasis | 2 | 2 | 4 | 4 |
| Dyspepsia | 2 | 1 | 2 | 4 |
| Gastroenteritis | 1 | 1 | 2 | 3 |
| Nausea | 2 | 2 | 1 | 3 |
| Average Duration of Exposure (days) | 59 | 79 | 80 | 80 |
The table above includes all events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of ≥3% in any one Budanase AQ (Budanase AQ) group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for Budanase AQ (Budanase AQ) patients should be taken into account.
The following other adverse events occurred in these clinical trials using Budanase AQ (Budanase AQ) with an incidence of 1 to 3% and were more common on Budanase AQ (Budanase AQ) than on placebo.
Body As A Whole:neck pain
Cardiovascular: syncope
Digestive: abdominal pain, dry mouth, vomiting
Metabolic and Nutritional: weight gain
Musculoskeletal: fracture, myalgia
Nervous: hypertonia, migraine
Platelet, Bleeding and Clotting: ecchymosis
Psychiatric: insomnia
Resistance Mechanisms: infection
Special Senses: taste perversion
In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the effects of Budanase AQ (Budanase AQ) 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) were compared with placebo (N=53) on the frequency of reported adverse events. Adverse events, whether considered drug-related or non-drug-related by the investigators, reported in more than five patients in the Budanase AQ (Budanase AQ) group and which occurred more frequently with Budanase AQ (Budanase AQ) than placebo are shown below (% Budanase AQ (Budanase AQ) and % placebo). In considering these data, the increased average duration of exposure for Budanase AQ (Budanase AQ) patients (78 days for Budanase AQ (Budanase AQ) vs. 41 days for placebo) should be taken into account.
| Body As A Whole: | asthenia (9% and 2%) headache (12% and 2%) pain (10% and 2%) |
| Digestive: | dyspepsia (8% and 0%)nausea (6% and 0%)oral candidiasis (10% and 0%) |
| Musculoskeletal: | arthralgia (6% and 0%) |
| Respiratory: | cough increased (6% and 2%) respiratory infection (32% and 13%) rhinitis (6% and 2%) sinusitis (16% and 11%) |
Patients Receiving Budanase AQ (Budanase AQ) Once Daily
The adverse event profile of once-daily administration of Budanase AQ (Budanase AQ) 200 mcg and 400 mcg, and placebo, was evaluated in 309 adult asthmatic patients in an 18-week study. The study population included both patients previously treated with inhaled corticosteroids, and patients not previously receiving corticosteroid therapy. There was no clinically relevant difference in the pattern of adverse events following once-daily administration of Budanase AQ (Budanase AQ) when compared with twice-daily dosing.
Pediatric Studies: In a 12-week placebo-controlled trial in 404 pediatric patients 6 to 18 years of age previously maintained on inhaled corticosteroids, the frequency of adverse events for each age category (6 to 12 years, 13 to 18 years) was comparable for Budanase AQ (Budanase AQ) (at 100, 200 and 400 mcg twice daily) and placebo. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.
Adverse Event Reports From Other Sources: Rare adverse events reported in the published literature or from worldwide marketing experience with any formulation of inhaled Budanase AQ include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis.
What is the most important information I should know about Budanase AQ?
- Budanase AQ sustained-release capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Take Budanase AQ sustained-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tell your doctor or dentist that you take Budanase AQ sustained-release capsules before you receive any medical or dental care, emergency care, or surgery.
- Budanase AQ sustained-release capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Budanase AQ sustained-release capsules. Talk with your doctor before you receive any vaccine.
- Diabetes patients - Budanase AQ sustained-release capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including adrenal function assessment, may be performed while you use Budanase AQ sustained-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Budanase AQ sustained-release capsules should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budanase AQ sustained-release capsules while you are pregnant. Budanase AQ sustained-release capsules is found in breast milk. Do not breast-feed while taking Budanase AQ sustained-release capsules.
Budanase AQ contraindications
Before using Budanase AQ, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have liver disease, glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.
It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.
To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.
Budanase AQ nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Budanase AQ nasal.
Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.
Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using Budanase AQ nasal.
References
- DailyMed. "BUDESONIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Budesonide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "Budesonide". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Budanase AQ are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Budanase AQ. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
