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)
Large intestinal stenosis07.13.03.004--
Gastrointestinal wall thickening07.01.06.032---
End stage renal disease20.01.03.0190.000186%-
Behaviour disorder19.01.01.0050.000326%-
Cortisol decreased13.10.09.013---
Cross sensitivity reaction10.01.01.0360.000093%-
Drug effect less than expected08.06.01.036---
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.000577%-
Eosinophilic granulomatosis with polyangiitis01.02.04.022; 10.02.02.031; 22.01.01.025; 24.12.04.010---
Fear of injection19.06.03.016---
Gait inability08.01.02.011; 17.02.05.069---
Gastrointestinal scarring07.13.01.015---
Growth failure05.03.02.006; 14.03.02.030; 15.03.05.0150.002884%-
Idiopathic intracranial hypertension17.07.02.011---
Illness08.01.03.091---
Intermenstrual bleeding21.01.01.0150.000363%-
Loss of therapeutic response08.06.01.041---
NSAID exacerbated respiratory disease10.01.01.039; 22.03.01.0270.000093%-
Oesophageal carcinoma recurrent07.21.06.005; 16.13.06.0050.000140%-
Pharyngeal swelling22.04.05.028---
Precursor B-lymphoblastic lymphoma01.15.10.001; 16.28.10.0010.000093%-
Reaction to excipient10.01.01.0420.000251%-
Spinal stenosis15.10.04.014; 17.10.01.0310.000093%-
Therapeutic product effect decreased08.06.01.0500.000567%-
Therapeutic product effect delayed08.06.01.051---
Therapeutic product effect incomplete08.06.01.0520.000660%-
Therapeutic product effective for unapproved indication08.06.01.056; 12.09.02.0040.000205%-
Therapeutic product ineffective08.06.01.057---
Therapeutic response shortened08.06.01.062---
Therapy non-responder08.06.01.0630.000642%-
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