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)
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Myocarditis02.04.03.0010.000512%
Myopathy15.05.05.0010.000093%Not Available
Nasal congestion22.04.04.0010.000251%
Nasal obstruction22.12.03.013--Not Available
Nasal oedema22.04.03.0120.000233%Not Available
Nasal polyps22.04.03.010; 16.38.01.0010.000093%Not Available
Nasal septum perforation22.04.03.003--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neck pain15.03.04.009--
Necrosis24.04.02.006; 08.03.03.0010.000140%Not Available
Necrosis ischaemic24.04.02.018--Not Available
Neoplasm16.16.02.0010.000093%Not Available
Nephrolithiasis20.04.01.002--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.0030.000251%Not Available
Nocturia20.02.03.001--Not Available
Non-Hodgkin's lymphoma16.35.01.001; 01.17.01.0010.000093%Not Available
Ocular hyperaemia06.04.05.0040.000363%Not Available
Oedema14.05.06.010; 08.01.07.0060.000186%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophageal carcinoma16.13.06.001; 07.21.06.0010.000140%Not Available
Oesophageal ulcer07.04.05.0020.000140%
Oesophagitis07.08.05.001--
Oligohydramnios18.05.01.0010.000093%Not Available
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Orthopnoea02.11.05.010; 22.02.01.0200.000140%Not Available
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