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)
Joint swelling15.01.02.004--Not Available
Lacrimation increased06.08.02.0040.000363%
Lactose intolerance14.02.02.001; 07.17.01.0030.000474%Not Available
Laryngeal oedema10.01.05.003; 23.04.01.005; 22.04.02.0010.000093%
Left ventricular failure02.05.02.0010.000093%Not Available
Leukocytosis01.02.01.002--
Lip oedema23.04.01.006; 10.01.05.004; 07.05.04.0040.000140%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005--Not Available
Listless19.04.04.003; 08.01.01.0120.000093%Not Available
Local reaction08.01.03.0120.000093%Not Available
Logorrhoea19.19.02.001; 17.02.08.0060.000186%Not Available
Loss of consciousness17.02.04.0040.000326%Not Available
Lung disorder22.02.07.0010.000456%Not Available
Lymph node pain01.09.01.007--
Lymphadenopathy01.09.01.0020.000251%Not Available
Lymphoma16.20.01.001; 01.12.01.0010.000140%Not Available
Macule23.03.03.0370.000093%Not Available
Malaise08.01.01.0030.003535%
Menstrual disorder21.01.01.004--Not Available
Menstruation delayed21.01.02.003; 05.05.01.010--Not Available
Metabolic acidosis14.01.01.0030.000140%Not Available
Micturition urgency20.02.02.006--
Middle insomnia19.02.01.003; 17.15.03.003--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.004--Not Available
Movement disorder17.01.02.010--Not Available
Mucous stools07.01.03.006--Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Muscle spasms15.05.03.004--
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