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 approved; investigational
ATC Code J02AC02
DrugBank ID DB01167
KEGG ID D00350
MeSH ID D017964
PubChem ID 55283
TTD Drug ID D0V4IB
NDC Product Code 22568-1108; 53069-0450; 59349-0012; 65015-624; 65162-630; 60592-318; 62991-3078; 72761-019; 50268-450; 50458-290; 10147-0150; 67835-5043; 46708-204; 49884-239; 60687-299; 49452-3845; 51552-0920; 70771-1208; 17511-114; 71747-002; 13668-463; 67877-454; 12578-299; 38779-2759; 58032-0110; 66039-815; 62332-204; 65162-087; 69339-159; 10147-1700; 71052-301; 70518-2872; 70518-3559; 10695-064; 50546-462; 31722-006; 51862-462; 68382-697; 70518-3264; 66577-044; 16714-743; 16729-271; 50458-295
UNII 304NUG5GF4
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
*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)
Hepatic enzyme abnormal13.03.04.026--Not Available
Cystitis noninfective20.03.02.001--
Immune reconstitution inflammatory syndrome08.06.02.014; 10.02.01.0430.004008%Not Available
Bronchial hyperreactivity22.03.01.016--Not Available
Treatment failure08.06.01.0170.031533%Not Available
Liver injury12.01.17.012; 09.01.07.0220.009353%Not Available
Adverse reaction08.06.01.0180.005345%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.008--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Drug-induced liver injury12.03.01.044; 09.01.07.0230.029395%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.002672%Not Available
Pneumocystis jirovecii infection11.03.07.004--Not Available
Multiple organ dysfunction syndrome08.01.03.0570.010689%
Cardiac failure chronic02.05.01.0090.002672%Not Available
Faeces pale07.01.03.0050.004008%Not Available
Acute left ventricular failure02.05.02.0050.006681%Not Available
Unmasking of previously unidentified disease08.01.03.0800.002672%Not Available
Acquired apparent mineralocorticoid excess24.08.04.008; 14.05.01.012; 05.01.01.0080.004008%Not Available
Bell's palsy17.04.03.011--Not Available
Dilated cardiomyopathy02.04.01.017--Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.005345%Not Available
Hepatic cytolysis09.01.07.0360.004008%Not Available
Myelosuppression01.03.03.0150.002672%Not Available
Primary amyloidosis10.02.05.009--Not Available
Pseudoaldosteronism14.05.04.013; 05.01.01.009; 24.08.04.0100.012025%Not Available
Pseudohyponatraemia14.05.04.0140.009353%Not Available
SJS-TEN overlap12.03.01.069; 11.07.01.030; 10.01.01.043; 23.03.01.0410.002672%Not Available
Symmetrical drug-related intertriginous and flexural exanthema23.03.05.012; 10.01.01.0460.050774%Not Available
Therapeutic product effect decreased08.06.01.0500.011758%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.019241%Not Available
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