Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Budesonide
Drug ID BADD_D00306
Description Budesonide is a glucocorticoid that is a mix of the 22R and 22S epimer used to treat inflammatory conditions of the lungs and intestines such as asthma, COPD, Crohn's disease, and ulcerative colitis.[A188529,A188532] Budesonide was granted FDA approval on 14 February 1994.[L10598]
Indications and Usage Budesonide extended release capsules are indicated for the treatment and maintenance of mild to moderate Crohn’s disease.[L10601,L10604] Various inhaled budesonide products are indicated for prophylactic therapy in asthma[L10607,L10613,L10619] and reducing exacerbations of COPD.[L10619] A budesonide nasal spray is available over the counter for symptoms of hay fever and upper respiratory allergies.[L10616] Extended-release capsules are indicated to induce remission of mild to moderate ulcerative colitis[L10622] and a rectal foam is used for mild to moderate distal ulcerative colitis.[L10625] In addition, a delayed-release capsule formulation of budesonide is indicated to reduce proteinuria in adults with IgA nephropathy at risk of rapid disease progression.[L39479]
Marketing Status approved
ATC Code A07EA06; D07AC09; R01AD05; R03BA02
DrugBank ID DB01222
KEGG ID D00246
MeSH ID D019819
PubChem ID 5281004
TTD Drug ID D0Y7IU
NDC Product Code 46439-8719; 49076-6111; 53104-7617; 16714-019; 0115-1689; 46122-389; 50090-2239; 51407-366; 68788-7290; 0536-1112; 70771-1075; 0904-7166; 0591-2510; 38779-3097; 64918-0204; 0093-6816; 0186-1989; 49035-703; 63629-8294; 68012-309; 0487-9601; 55154-4849; 0378-4500; 76282-641; 49452-1291; 52128-133; 65089-0024; 16714-829; 0093-6815; 45802-627; 47335-633; 68682-658; 69097-321; 69842-001; 0781-7516; 15308-0100; 52221-117; 16714-020; 0115-1687; 0186-1988; 60687-596; 68682-309; 68788-7314; 76282-640; 81749-004; 46439-8737; 60870-0466; 63190-0060; 63592-0187; 64918-0205; 66412-0393; 68743-309; 73377-076; 11822-1700; 0186-1990; 51862-580; 55566-1002; 55566-1020; 68788-8429; 0574-9855; 51552-1365; 21130-710; 0093-6817; 47335-632; 0186-0916; 0186-0917; 60505-6129; 63629-9093; 65162-778; 68382-720; 69097-318; 69097-319; 0781-7517; 49452-1292; 68981-017; 47335-631; 0363-0048; 64980-255; 65649-651; 49927-0004; 0487-9701; 76282-642; 0781-7515; 10695-124; 50546-580; 51508-004; 53183-6310; 65089-0005; 71052-270; 16714-018; 50580-646; 51407-128
UNII Q3OKS62Q6X
Synonyms Budesonide | Budesonide, (S)-Isomer | Pulmicort | Rhinocort | Budesonide, (R)-Isomer | Horacort
Chemical Information
Molecular Formula C25H34O6
CAS Registry Number 51333-22-3
SMILES CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C4C(CC3(C2(O1)C(=O)CO)C)O)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Inner ear disorder04.04.02.002--Not Available
Polyp16.02.02.005; 08.01.06.0100.000093%Not Available
Vocal cord disorder22.04.01.0030.000205%Not Available
Blood disorder01.05.01.004--Not Available
Adverse drug reaction08.06.01.009--Not Available
Disease recurrence08.01.03.0500.000233%Not Available
Drug intolerance08.06.01.0130.001116%Not Available
Neoplasm recurrence16.16.02.0040.000140%Not Available
Neutrophil morphology abnormal13.01.06.024--Not Available
Obstruction08.01.03.023--Not Available
Obstructive airways disorder22.03.01.0110.000251%Not Available
Psychotic disorder19.03.01.002--
Gastrointestinal obstruction07.13.01.005--Not Available
Renal impairment20.01.03.010--Not Available
Lipohypertrophy23.07.01.005; 14.08.04.009--
Respiratory tract infection11.01.08.017; 22.07.07.001--Not Available
Unevaluable event08.01.03.051--Not Available
Poor quality sleep19.02.05.005; 17.15.04.002--Not Available
Chorioretinopathy06.09.01.0060.000530%Not Available
Bowel movement irregularity07.02.03.003--Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000093%Not Available
Gastrointestinal inflammation07.08.03.007--Not Available
Infusion site extravasation08.02.05.007; 12.07.05.008--
Soft tissue necrosis24.04.02.007; 15.03.02.002--
Bronchial hyperreactivity22.03.01.0160.000093%Not Available
Bronchial secretion retention22.03.02.008--Not Available
Treatment failure08.06.01.0170.000958%Not Available
Pharyngeal disorder22.04.05.007--Not Available
Adverse reaction08.06.01.0180.000205%Not Available
Gastrointestinal sounds abnormal07.01.01.002--Not Available
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