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---
Cystitis noninfective20.03.02.001--
Immune reconstitution inflammatory syndrome08.06.02.014; 10.02.01.0430.004008%-
Bronchial hyperreactivity22.03.01.016---
Treatment failure08.06.01.0170.031533%-
Liver injury09.01.07.022; 12.01.17.0120.009353%-
Adverse reaction08.06.01.0180.005345%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.015---
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Drug-induced liver injury09.01.07.023; 12.03.01.0440.029395%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.002672%-
Pneumocystis jirovecii infection11.03.07.004---
Multiple organ dysfunction syndrome08.01.03.0570.010689%
Cardiac failure chronic02.05.01.0090.002672%-
Faeces pale07.01.03.0050.004008%-
Acute left ventricular failure02.05.02.0050.006681%-
Unmasking of previously unidentified disease08.01.03.0800.002672%-
Acquired apparent mineralocorticoid excess05.01.01.008; 14.05.01.012; 24.08.04.0080.004008%-
Bell's palsy17.04.03.011---
Dilated cardiomyopathy02.04.01.017---
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.005345%-
Hepatic cytolysis09.01.07.0360.004008%-
Myelosuppression01.03.03.0150.002672%-
Primary amyloidosis10.02.05.009---
Pseudoaldosteronism05.01.01.009; 14.05.04.013; 24.08.04.0100.012025%-
Pseudohyponatraemia14.05.04.0140.009353%-
SJS-TEN overlap10.01.01.043; 11.07.01.030; 12.03.01.069; 23.03.01.0410.002672%-
Symmetrical drug-related intertriginous and flexural exanthema10.01.01.046; 23.03.05.0120.050774%-
Therapeutic product effect decreased08.06.01.0500.011758%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.019241%-
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