{"id":"budesonide","rwe":[{"pmid":"41889597","year":"2026","title":"Sickle Cell Lung Disease in a 9-year-Old Presenting with Wheezing: Investigating Causal Relationships, Asthma or Acute Chest Syndrome.","finding":"","journal":"International medical case reports journal","studyType":"Clinical Study"},{"pmid":"41874708","year":"2026","title":"The Effect of the Novel Macrolide Glasmacinal (EP395) on Allergen-Induced Eosinophil Infiltration into the Lung.","finding":"","journal":"Lung","studyType":"Clinical Study"},{"pmid":"41872545","year":"2026","title":"Dose-dependent effects of Alveofact with and without steroids on neutrophil extracellular traps in neonatal respiratory distress syndrome.","finding":"","journal":"Pediatric research","studyType":"Clinical Study"},{"pmid":"41868882","year":"2026","title":"Efficacy of current therapeutic strategies for immune checkpoint inhibitor-related esophagitis.","finding":"","journal":"Annals of gastroenterology","studyType":"Clinical Study"},{"pmid":"41865696","year":"2026","title":"Callicarpa nudiflora-derived extracellular vesicle-like particles loaded with budesonide enhance the treatment of ulcerative colitis by regulating M1/M2 macrophage polarization.","finding":"","journal":"Biomaterials advances","studyType":"Clinical Study"}],"_fda":{"id":"ce26c1bb-c50d-7731-6877-0b8a5fda98df","set_id":"04eb9e98-1323-353f-3fd7-2d317dfac526","openfda":{"nui":["N0000175576","N0000175450"],"unii":["Q3OKS62Q6X"],"route":["NASAL"],"rxcui":["1797929"],"spl_id":["ce26c1bb-c50d-7731-6877-0b8a5fda98df"],"brand_name":["Budesonide"],"spl_set_id":["04eb9e98-1323-353f-3fd7-2d317dfac526"],"package_ndc":["0536-1112-40","0536-1112-48"],"product_ndc":["0536-1112"],"generic_name":["BUDESONIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["BUDESONIDE"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"manufacturer_name":["Rugby Laboratories"],"application_number":["ANDA078949"],"is_original_packager":[true]},"purpose":["Purpose Nasal allergy symptom reliever"],"version":"12","stop_use":["Stop use and ask a doctor if you have, or come into contact with someone who has, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision you have severe or frequent nosebleeds"],"warnings":["Warnings Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. do not share this bottle with anyone else as this may spread germs remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if you have, or come into contact with someone who has, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision you have severe or frequent nosebleeds If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"questions":["Questions or comments? call toll free 1-800-645-2158"],"ask_doctor":["Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts"],"do_not_use":["Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients"],"when_using":["When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. do not share this bottle with anyone else as this may spread germs remember to tell your doctor about all the medicines you take, including this one"],"effective_time":"20260227","active_ingredient":["Active ingredient (in each spray) Budesonide (glucocorticoid) 32 mcg"],"inactive_ingredient":["Inactive ingredients carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water"],"indications_and_usage":["Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing"],"spl_unclassified_section":["Other information do not use if the safety seal labeled \"sealed for your protection\" is broken or missing. keep package and insert. They contain important information. store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light."],"dosage_and_administration":["Directions Read insert (inside package) on how to: get a new bottle ready (primed) before first use prime bottle again if not used for two days use the spray clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older once daily, spray 2 times into each nostril while sniffing gently once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 6 TO UNDER 12 YEARS OF AGE the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year children 6 to under 12 years of age an adult should supervise use once daily, spray 1 time into each nostril while sniffing gently if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day children under 6 years of age do not use do not use more than directed if you forget a dose, do not double the next dose do not spray into eyes or mouth if allergy symptoms do not improve after two weeks, stop using and talk to a doctor do not use for the common cold shake well before each use"],"spl_product_data_elements":["Budesonide Budesonide BUDESONIDE Budesonide EDETATE DISODIUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED MICROCRYSTALLINE CELLULOSE DEXTROSE, UNSPECIFIED FORM POTASSIUM SORBATE POLYSORBATE 80 HYDROCHLORIC ACID WATER Bottle-label-120ms Carton-label-120ms"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"dosage_and_administration_table":["<table frame=\"below\" width=\"50%\"><tbody><tr><td colspan=\"2\"><paragraph><content styleCode=\"bold\">ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER</content></paragraph><paragraph/></td></tr><tr><td><paragraph>adults and children 12 years of age and older</paragraph></td><td><list><item>once daily, spray 2 times into each nostril while sniffing gently</item><item>once your allergy symptoms improve, reduce to 1 spray in each nostril per day</item></list></td></tr><tr><td colspan=\"2\" scope=\"row\"><content styleCode=\"bold\">CHILDREN 6 TO UNDER 12 YEARS OF AGE</content></td></tr><tr><td colspan=\"2\" scope=\"row\"><list><item>the growth rate of some children may be slower while using this product. Talk to your child&#x2019;s doctor if your child needs to use the spray for longer than two months a year</item></list></td></tr><tr><td scope=\"row\">children 6 to under 12 years of age</td><td><list><item>an adult should supervise use</item><item>once daily, spray 1 time into each nostril while sniffing gently</item><item>if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day</item></list></td></tr><tr><td scope=\"row\">children under 6 years of age</td><td><list><item>do not use</item></list><paragraph/></td></tr><tr><td colspan=\"2\" scope=\"row\"><list><item><content styleCode=\"bold\">do not use more than directed</content></item><item>if you forget a dose, do<content styleCode=\"bold\"> not</content> double the next dose</item><item>do <content styleCode=\"bold\">not</content> spray into eyes or mouth</item><item>if allergy symptoms do not improve after two weeks, stop using and talk to a doctor</item><item>do not use for the common cold</item><item>shake well before each use</item></list></td></tr></tbody></table>"],"package_label_principal_display_panel":["Principal Display Panel - Carton 120ms CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray Rugby Laboratories NDC 0536-1112-48 Budesonide Nasal Spray Allergy Spray 120 sprays Relief of: Nasal Congestion Runny Nose Itchy Nose Sneezing","Principal Display Panel - Bottle 120ms BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray Rugby Laboratories NDC 0536-1112-48 Budesonide Nasal Spray Allergy Spray 120 sprays"]},"tags":[{"label":"Corticosteroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"IL5","category":"gene"},{"label":"IFNG","category":"gene"},{"label":"A07EA06","category":"atc"},{"label":"Oral","category":"route"},{"label":"Rectal","category":"route"},{"label":"Respiratory (Inhalation)","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Allergic Rhinitis Prevention","category":"indication"},{"label":"Allergic rhinitis","category":"indication"},{"label":"Asthma","category":"indication"},{"label":"Asthma management","category":"indication"},{"label":"Chronic Non-Allergic Rhinitis","category":"indication"},{"label":"Crohn's disease","category":"indication"},{"label":"AstraZeneca K.K.","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Bronchodilator Agents","category":"pharmacology"},{"label":"Glucocorticoids","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"24560 reports"},{"date":"","signal":"ASTHMA","source":"FDA FAERS","actionTaken":"16117 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"12889 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"11581 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"11123 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"8728 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"8298 reports"},{"date":"","signal":"WHEEZING","source":"FDA FAERS","actionTaken":"7682 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"7477 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"6727 reports"}],"drugInteractions":[{"url":"/drug/aripiprazole","drug":"aripiprazole","action":"Monitor closely","effect":"May interact with Aripiprazole","source":"DrugCentral","drugSlug":"aripiprazole"},{"url":"/drug/boceprevir","drug":"boceprevir","action":"Avoid combination","effect":"May interact with Boceprevir","source":"DrugCentral","drugSlug":"boceprevir"},{"url":"/drug/quetiapine","drug":"quetiapine","action":"Monitor closely","effect":"May interact with Quetiapine Fumarate","source":"DrugCentral","drugSlug":"quetiapine"},{"url":"/drug/risperidone","drug":"risperidone","action":"Monitor closely","effect":"May interact with Risperidone","source":"DrugCentral","drugSlug":"risperidone"},{"url":"/drug/telaprevir","drug":"telaprevir","action":"Avoid combination","effect":"May interact with Telaprevir","source":"DrugCentral","drugSlug":"telaprevir"},{"url":"/drug/warfarin","drug":"warfarin","action":"Monitor closely","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"Headache","drugRate":"21%","severity":"common","organSystem":""},{"effect":"Respiratory Infection","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Back Pain","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Abdominal Pain","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Flatulence","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Pain","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Acne","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Bruising Easily","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Moon Face","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Swollen Ankles","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Hirsutism","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Buffalo Hump","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Skin Striae","drugRate":"1%","severity":"common","organSystem":""}],"contraindications":["Acute tuberculosis","Adrenal cortical hypofunction","Anastomosis of intestine","Arginase deficiency","Arginosuccinate Lyase Deficiency","Avascular necrosis of bone","Bacterial infectious disease","Bilateral cataracts","Cerebral malaria","Cerebral trauma","Chronic heart failure","Cirrhosis of liver","Citrullinemia","Congenital hyperammonemia, type I","Diabetes mellitus","Disease caused by parasite","Disease of liver","Disorder of muscle","Diverticulitis of gastrointestinal tract","Edema","Epistaxis","Exposure to varicella","Gastritis","Glaucoma","Herpes simplex"],"specialPopulations":{"Pregnancy":"Based on animal data, may cause fetal harm. Limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform drug-associated risk for major birth defects and miscarriage. There are clinical considerations. In animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.5 times or 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. Maternal toxicity was observed in both rats and rabbits at these dose levels. The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Teratogenic Effects:Pregnancy Category C: As with other corticosteroids, budesonide was teratogenic and embryocidal in rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on body surface area basis) and 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose on body surface area basis).","Geriatric use":"Clinical studies of ENTOCORT EC did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"AstraZeneca K.K.","patents":[{"type":"Formulation","number":"9192581","applicant":"SALIX PHARMACEUTICALS INC","territory":"US","tradeName":"UCERIS","expiryDate":"2031-09-07"},{"type":"Formulation","number":"9707182","applicant":"SUN PHARMACEUTICAL INDUSTRIES INC","territory":"US","tradeName":"ORTIKOS","expiryDate":"2036-09-09"},{"type":"Method of Use","number":"10172802","applicant":"SUN PHARMACEUTICAL INDUSTRIES INC","territory":"US","tradeName":"ORTIKOS","expiryDate":"2036-09-09"},{"type":"Method of Use","number":"11896719","applicant":"CALLIDITAS THERAPEUTICS AB","territory":"US","tradeName":"TARPEYO","expiryDate":"2043-01-23"},{"type":"Method of Use","number":"12171882","applicant":"CALLIDITAS THERAPEUTICS AB","territory":"US","tradeName":"TARPEYO","expiryDate":"2043-01-23"},{"type":"Formulation","number":"12311057","applicant":"CALLIDITAS THERAPEUTICS AB","territory":"US","tradeName":"TARPEYO","expiryDate":"2043-01-23"},{"type":"Method of Use","number":"9119863","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2026-11-09"},{"type":"Method of Use","number":"8975243","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2026-11-09"},{"type":"Method of Use","number":"8497258","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2026-11-09"},{"type":"Method of Use","number":"8324192","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2029-08-03"},{"type":"Formulation","number":"8491932","applicant":"CALLIDITAS THERAPEUTICS AB","territory":"US","tradeName":"TARPEYO","expiryDate":"2029-05-07"},{"type":"Method of Use","number":"11564934","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2039-01-10"},{"type":"Method of Use","number":"11357859","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2028-11-12"},{"type":"Formulation","number":"8895064","applicant":"SALIX PHARMACEUTICALS INC","territory":"US","tradeName":"UCERIS","expiryDate":"2031-09-07"},{"type":"Formulation","number":"11197822","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2026-11-09"},{"type":"Formulation","number":"11413296","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2026-11-09"},{"type":"Formulation","number":"10660858","applicant":"SALIX PHARMACEUTICALS INC","territory":"US","tradeName":"UCERIS","expiryDate":"2031-09-07"},{"type":"Formulation","number":"10307375","applicant":"SALIX PHARMACEUTICALS INC","territory":"US","tradeName":"UCERIS","expiryDate":"2031-09-07"},{"type":"Formulation","number":"10293052","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2028-11-22"},{"type":"Formulation","number":"9132093","applicant":"SALIX PHARMACEUTICALS INC","territory":"US","tradeName":"UCERIS","expiryDate":"2031-09-07"},{"type":"Formulation","number":"11260064","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2039-01-10"},{"type":"Formulation","number":"8679545","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2026-11-09"},{"type":"Formulation","number":"9050368","applicant":"TAKEDA PHARMACEUTICALS USA INC","territory":"US","tradeName":"EOHILIA","expiryDate":"2029-08-01"},{"type":"Formulation","number":"12171883","applicant":"CALLIDITAS THERAPEUTICS AB","territory":"US","tradeName":"TARPEYO","expiryDate":"2043-01-23"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.9298/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$335","description":"BUDESONIDE 0.25 MG/2 ML SUSP","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BUDESONIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:28:49.815216+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T01:28:49.814898+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Budesonide","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:28:58.070106+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:28:56.754560+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:28:49.838621+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:28:48.400373+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BUDESONIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:28:57.503447+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:28:46.848047+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:28:46.848087+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:28:46.848096+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:28:59.045026+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucocorticoid receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:28:58.069685+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1370/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:28:57.974073+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA078949","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:28:46.848101+00:00"}},"allNames":"pulmicort respules","offLabel":[],"synonyms":["budesonide","barazone","budesomide","budeson"],"timeline":[{"date":"1994-02-14","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1997-06-24","type":"positive","source":"FDA Orange Book","milestone":"Pulmicort approved — 0.16MG/INH"},{"date":"2001-10-02","type":"positive","source":"FDA Orange Book","milestone":"Entocort Ec approved — 3MG"},{"date":"2006-07-12","type":"positive","source":"FDA Orange Book","milestone":"Pulmicort Flexhaler approved — 0.08MG/INH"},{"date":"2013-01-14","type":"positive","source":"FDA Orange Book","milestone":"Uceris approved — 9MG"},{"date":"2014-10-07","type":"positive","source":"FDA Orange Book","milestone":"Uceris approved — 2MG/ACTUATION"},{"date":"2015-03-23","type":"positive","source":"FDA Orange Book","milestone":"Rhinocort Allergy approved — 0.032MG/SPRAY"},{"date":"2018-08-01","type":"positive","source":"DrugCentral","milestone":"EMA approval (Dr. Falk Pharma GmbH)"},{"date":"2019-06-13","type":"positive","source":"FDA Orange Book","milestone":"Ortikos approved — 6MG"},{"date":"2021-12-15","type":"positive","source":"FDA Orange Book","milestone":"Tarpeyo approved — 4MG"},{"date":"2023-04-12","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 20 manufacturers approved"},{"date":"2024-02-09","type":"positive","source":"FDA Orange Book","milestone":"Eohilia approved — 2MG/10ML"}],"aiSummary":"Pulmicort Respules (Budesonide) is a corticosteroid medication developed by AstraZeneca K.K. and currently owned by Astrazeneca. It targets the glucocorticoid receptor to treat various respiratory and gastrointestinal conditions, including asthma, allergic rhinitis, and Crohn's disease. Pulmicort Respules is a small molecule modality with a 2.8-hour half-life and 37% bioavailability. The medication is off-patent, with 21 generic manufacturers available. Key safety considerations include potential side effects such as oral thrush and adrenal suppression.","brandName":"Pulmicort Respules","ecosystem":[{"indication":"Allergic Rhinitis Prevention","otherDrugs":[{"name":"desonide","slug":"desonide","company":"Perrigo New York"},{"name":"flunisolide","slug":"flunisolide","company":""},{"name":"mometasone furoate","slug":"mometasone-furoate","company":"Merck Sharp Dohme"},{"name":"triamcinolone","slug":"triamcinolone","company":""}],"globalPrevalence":null},{"indication":"Allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"astemizole","slug":"astemizole","company":""}],"globalPrevalence":null},{"indication":"Asthma","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"}],"globalPrevalence":262000000},{"indication":"Asthma management","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"},{"name":"ciclesonide","slug":"ciclesonide","company":"Takeda Gmbh"},{"name":"cromoglicic acid","slug":"cromoglicic-acid","company":"King Pharms"}],"globalPrevalence":262000000},{"indication":"Chronic Non-Allergic Rhinitis","otherDrugs":[{"name":"desonide","slug":"desonide","company":"Perrigo New York"},{"name":"flunisolide","slug":"flunisolide","company":""},{"name":"fluticasone furoate","slug":"fluticasone-furoate","company":"Glaxosmithkline"},{"name":"fluticasone propionate","slug":"fluticasone-propionate","company":"Fougera Pharms"}],"globalPrevalence":null},{"indication":"Crohn's disease","otherDrugs":[{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"},{"name":"azathioprine","slug":"azathioprine","company":"Prometheus Labs"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""}],"globalPrevalence":5000000},{"indication":"Crohn's disease in remission","otherDrugs":[{"name":"desonide","slug":"desonide","company":"Perrigo New York"}],"globalPrevalence":5000000},{"indication":"Eosinophilic esophagitis","otherDrugs":[{"name":"dupilumab","slug":"dupilumab","company":"Regeneron Pharmaceuticals"}],"globalPrevalence":null}],"mechanism":{"target":"Glucocorticoid receptor","novelty":"Follow-on","targets":[{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"},{"gene":"IL5","source":"DrugCentral","target":"Interleukin-5","protein":"Interleukin-5"},{"gene":"IFNG","source":"DrugCentral","target":"Interferon gamma","protein":"Interferon gamma"},{"gene":"NR3C2","source":"DrugCentral","target":"Mineralocorticoid receptor","protein":"Mineralocorticoid receptor"},{"gene":"PGR","source":"DrugCentral","target":"Progesterone receptor","protein":"Progesterone receptor"},{"gene":"MMP9","source":"DrugCentral","target":"Matrix metalloproteinase-9","protein":"Matrix metalloproteinase-9"},{"gene":"ABCB1","source":"DrugCentral","target":"Multidrug resistance protein 1","protein":"Multidrug resistance protein 1"}],"moaClass":"Corticosteroid Hormone Receptor Agonists","modality":"Small Molecule","drugClass":"Corticosteroid [EPC]","explanation":"","oneSentence":"","technicalDetail":"Pulmicort Respules (Budesonide) is a synthetic corticosteroid that selectively binds to the glucocorticoid receptor (GR), leading to the inhibition of transcription factors and subsequent reduction in the expression of pro-inflammatory genes, resulting in decreased inflammation and immune response."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Budesonide","title":"Budesonide","extract":"Budesonide, sold under the brand name Pulmicort, among others, is a steroid medication. It is available as an inhaler, nebulization solution, pill, nasal spray, and rectal foam. The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease (COPD). The nasal spray is used for allergic rhinitis and nasal polyps. Modified-release pills or capsules and rectal forms may be used for inflammatory bowel disease including Crohn's disease, ulcerative colitis, and microscopic colitis.","wiki_society_and_culture":"==Society and culture==\nthumb|Dry powder inhaler that contains a combination of budesonide and [[formoterol.]]\n\n===Brand names===\nBudesonide is marketed under various brand and generic names internationally. Notable examples for each formulation include:\n\nInhalation: Pulmicort, Pulmicort Flexhaler, Pulmicort Nebuamp, Pulmicort Turbuhaler, TARO-Budesonide, TEVA-Budesonide, Novolizer budesonid meda, Budenova.\n\nTopical: Entocort, Uceris, Budenofalk."},"commercial":{"launchDate":"1994","revenueYear":2024,"_launchSource":"DrugCentral (FDA 1994-02-14, )","annualRevenue":2800,"revenueSource":"Verified: AstraZeneca AR","revenueCurrency":"USD","revenueConfidence":"verified"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/419","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BUDESONIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BUDESONIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Budesonide","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T09:07:57.412373","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:29:00.759361+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"prednisolone","drugSlug":"prednisolone","fdaApproval":"1955-06-21","genericCount":42,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"hydrocortisone","drugSlug":"hydrocortisone","fdaApproval":"1952-08-05","patentExpiry":"Nov 19, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prednisone","drugSlug":"prednisone","fdaApproval":"1955-02-21","patentExpiry":"Jan 7, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"betamethasone","drugSlug":"betamethasone","fdaApproval":"1961-04-17","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"beclometasone dipropionate","drugSlug":"beclometasone-dipropionate","fdaApproval":"1976-05-12","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"budesonide","indications":{"approved":[{"name":"Allergic Rhinitis Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Allergic rhinitis","source":"DrugCentral","snomedId":61582004,"regulator":"FDA","eligibility":null},{"name":"Asthma","source":"DrugCentral","snomedId":195967001,"regulator":"FDA","eligibility":null,"usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Asthma management","source":"DrugCentral","snomedId":406162001,"regulator":"FDA","eligibility":null,"usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Chronic Non-Allergic Rhinitis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Crohn's disease","source":"DrugCentral","snomedId":34000006,"regulator":"FDA","eligibility":null,"usPrevalence":780000,"globalPrevalence":5000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Gastroenterology, 2023"},{"name":"Crohn's disease in remission","source":"DrugCentral","snomedId":426549001,"regulator":"FDA","eligibility":null,"usPrevalence":780000,"globalPrevalence":5000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Gastroenterology, 2023"},{"name":"Eosinophilic esophagitis","source":"DrugCentral","snomedId":235599003,"regulator":"FDA","eligibility":null},{"name":"Primary immunoglobulin A nephropathy","source":"DrugCentral","snomedId":68779003,"regulator":"FDA","eligibility":null},{"name":"Severe chronic obstructive pulmonary disease","source":"DrugCentral","snomedId":313299006,"regulator":"FDA","eligibility":null,"usPrevalence":16000000,"globalPrevalence":392000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"}],"offLabel":[],"pipeline":[]},"currentOwner":"Astrazeneca","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"prednisolone","brandName":"prednisolone","genericName":"prednisolone","approvalYear":"1955","relationship":"same-class"},{"drugId":"hydrocortisone","brandName":"hydrocortisone","genericName":"hydrocortisone","approvalYear":"1952","relationship":"same-class"},{"drugId":"prednisone","brandName":"prednisone","genericName":"prednisone","approvalYear":"1955","relationship":"same-class"},{"drugId":"betamethasone","brandName":"betamethasone","genericName":"betamethasone","approvalYear":"1961","relationship":"same-class"},{"drugId":"beclometasone-dipropionate","brandName":"beclometasone dipropionate","genericName":"beclometasone dipropionate","approvalYear":"1976","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07491991","phase":"PHASE4","title":"Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery","status":"COMPLETED","sponsor":"Qianfoshan Hospital","startDate":"2025-03-02","conditions":["Postoperative Pain","NEBULIZATION","Thyroid Surgery"],"enrollment":96,"completionDate":"2026-03-01"},{"nctId":"NCT06676319","phase":"PHASE2","title":"Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma","status":"RECRUITING","sponsor":"Sanofi","startDate":"2024-11-07","conditions":["Asthma"],"enrollment":1147,"completionDate":"2027-10-15"},{"nctId":"NCT06712563","phase":"","title":"Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-04-17","conditions":["Pulmonary 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Asthma.","status":"ACTIVE_NOT_RECRUITING","sponsor":"AstraZeneca","startDate":"2024-09-30","conditions":["Severe Asthma"],"enrollment":326,"completionDate":"2027-06-25"},{"nctId":"NCT06596252","phase":"PHASE3","title":"Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE","status":"RECRUITING","sponsor":"Dr. Falk Pharma GmbH","startDate":"2021-05-21","conditions":["Eosinophilic Esophagitis"],"enrollment":308,"completionDate":"2027-03"},{"nctId":"NCT07267130","phase":"PHASE1","title":"A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects","status":"RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.","startDate":"2025-11-25","conditions":["Chronic Obstructive Pulmonary Disease"],"enrollment":57,"completionDate":"2026-12"},{"nctId":"NCT06307665","phase":"PHASE3","title":"Evaluating the Efficacy and Safety of PT027 Compared With PT007 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Adults With Mild Asthma","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-09-11","conditions":["Mild Asthma"],"enrollment":101,"completionDate":"2026-02-24"},{"nctId":"NCT07156175","phase":"PHASE2","title":"A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission","status":"RECRUITING","sponsor":"Sanofi","startDate":"2025-10-14","conditions":["Microscopic Colitis"],"enrollment":54,"completionDate":"2027-05-06"},{"nctId":"NCT05562466","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2023-05-11","conditions":["Asthma"],"enrollment":200,"completionDate":"2028-05-30"},{"nctId":"NCT05839756","phase":"NA","title":"Predicting Post Extubation Stridor After Maxillomandibular 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Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy","status":"RECRUITING","sponsor":"Calliditas Therapeutics AB","startDate":"2024-12-17","conditions":["IgA Nephropathy"],"enrollment":60,"completionDate":"2027-11"},{"nctId":"NCT07386873","phase":"NA","title":"The Efficacy of Olfactory Cleft Steroid Drops in Patients With CRS With Olfactory Cleft Obstruction","status":"NOT_YET_RECRUITING","sponsor":"Peking University Third Hospital","startDate":"2026-03-01","conditions":["Chronic Rhinosinusitis (CRS)","Smell Dysfunction"],"enrollment":54,"completionDate":"2028-12-31"},{"nctId":"NCT07386860","phase":"NA","title":"The Effectiveness of Steroid Nasal Drops in the Olfactory Cleft Combined With Olfactory Training for Patients With PIOD","status":"NOT_YET_RECRUITING","sponsor":"Peking University Third Hospital","startDate":"2026-03-01","conditions":["Smell 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(LITHOS)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-02-27","conditions":["Asthma"],"enrollment":374,"completionDate":"2024-11-19"},{"nctId":"NCT05555290","phase":"PHASE3","title":"PT027 Compared to PT007 in Patients With Asthma With Mannitol-induced Acute Airway Obstruction","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2022-09-28","conditions":["Asthma"],"enrollment":190,"completionDate":"2024-11-18"},{"nctId":"NCT06855043","phase":"PHASE1,PHASE2","title":"Little Lungs Study","status":"NOT_YET_RECRUITING","sponsor":"University of Wisconsin, Madison","startDate":"2026-09","conditions":["Invasive Mechanical Ventilation","Severe Respiratory Distress Syndrome"],"enrollment":24,"completionDate":"2029-03"},{"nctId":"NCT04545866","phase":"PHASE3","title":"The Budesonide in Babies (BiB) Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"NICHD Neonatal Research Network","startDate":"2021-04-01","conditions":["Bronchopulmonary Dysplasia (BPD)","Respiratory 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