Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Itraconazole
Drug ID BADD_D01217
Description One of the triazole antifungal agents that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ergosterol synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.
Indications and Usage For the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: pulmonary and extrapulmonary blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.
Marketing Status Prescription; Discontinued
ATC Code J02AC02
DrugBank ID DB01167
KEGG ID D00350
MeSH ID D017964
PubChem ID 55283
TTD Drug ID D0V4IB
NDC Product Code 12578-299; 50268-450; 53069-0450; 58032-0110; 0378-5100; 68382-697; 66577-044; 63629-8168; 60687-299; 10147-0150; 70518-3264; 50458-290; 62991-3078; 10147-1700; 71747-002; 65162-630; 67835-5043; 16729-271; 10695-064; 22568-1108; 67877-454; 31722-006; 65162-087; 46708-204; 38779-2759; 62332-204; 60592-318; 72761-019; 70771-1208; 49884-239; 70518-2872; 66039-815; 17511-114; 50458-295; 59349-0012; 13668-463; 0395-8113; 71052-301; 50546-462; 16714-743; 51552-0920; 65015-624; 51862-462
Synonyms Itraconazole | R-51211 | R 51211 | R51211 | Sporanox | Orungal
Chemical Information
Molecular Formula C35H38Cl2N8O4
CAS Registry Number 84625-61-6
SMILES CCC(C)N1C(=O)N(C=N1)C2=CC=C(C=C2)N3CCN(CC3)C4=CC=C(C=C4)OCC5COC(O5)(CN6C=NC=N6)C 7=C(C=C(C=C7)Cl)Cl
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.013924%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.027847%
Abortion spontaneous18.01.04.0010.018565%Not Available
Acute hepatic failure09.01.03.0010.004843%Not Available
Acute lymphocytic leukaemia01.10.01.001; 16.01.01.0010.003632%Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.002421%Not Available
Acute psychosis19.03.01.0010.009282%Not Available
Adrenal insufficiency05.01.02.001; 14.11.01.0040.027847%
Adrenal suppression05.01.02.002; 14.11.01.0050.009282%Not Available
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.0030.037129%
Albuminuria20.02.01.001--Not Available
Alopecia23.02.02.001--
Ammonia increased13.03.01.0230.023206%Not Available
Anaphylactic reaction10.01.07.001; 24.06.03.0060.009282%
Anaphylactic shock10.01.07.002; 24.06.02.0040.013924%Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.007--Not Available
Angioedema10.01.05.009; 23.04.01.0010.013924%Not Available
Anxiety19.06.02.002--
Application site reaction08.02.01.006; 12.07.01.006--Not Available
Arrhythmia02.03.02.0010.041771%Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.0060.027847%
Asthenia08.01.01.0010.055694%Not Available
Atrial fibrillation02.03.03.0020.046412%
Atrial flutter02.03.03.0030.013924%
Atrioventricular block02.03.01.0020.018565%Not Available
Back pain15.03.04.005--
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