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)
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.018--Not Available
Poor venous access24.03.02.017--Not Available
Hypoacusis04.02.01.0060.000316%
Weight fluctuation14.03.02.002--Not Available
Rectal discharge07.03.03.005--Not Available
Red blood cell sedimentation rate increased13.01.03.001--Not Available
General physical health deterioration08.01.03.0180.000372%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.012--Not Available
Intervertebral disc protrusion15.10.01.004--Not Available
Oropharyngeal candidiasis22.07.03.003; 11.03.03.006; 07.05.07.003--Not Available
Contusion12.01.06.001; 15.03.05.007; 24.07.06.001; 23.03.11.002--
Plantar erythema23.03.06.0120.000140%Not Available
Viral diarrhoea11.05.04.012; 07.19.02.008--Not Available
Conjunctival hyperaemia06.04.01.0040.000093%Not Available
Haemodynamic instability24.03.02.0060.000140%Not Available
Ear discomfort04.03.01.005--Not Available
Ear pruritus04.03.01.011--Not Available
Respiratory tract congestion22.02.07.003--Not Available
Lymphatic disorder01.09.01.003--Not Available
Nasal discomfort22.12.03.0120.000521%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Epigastric discomfort07.01.02.004--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Organ failure08.01.03.0410.000093%Not Available
Secretion discharge08.01.03.0190.000186%Not Available
Infusion site pain12.07.05.002; 08.02.05.014--Not Available
Infusion site swelling12.07.05.003; 08.02.05.002--Not Available
Type IV hypersensitivity reaction10.01.03.0220.000140%Not Available
Growth retardation15.03.05.016; 14.03.02.031; 05.03.02.0070.000326%
Affect lability19.04.01.001--Not Available
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