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)
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.12.04.027; 10.02.02.006--
Vein disorder24.03.02.015--Not Available
Ventricular arrhythmia02.03.04.0060.005345%
Ventricular extrasystoles02.03.04.0070.008017%Not Available
Vertigo17.02.12.002; 04.04.01.0030.008551%
Vision blurred06.02.06.007; 17.17.01.010--
Visual impairment06.02.10.0130.008017%Not Available
Vomiting07.01.07.0030.036076%
Weight decreased13.15.01.005--
Tubulointerstitial nephritis20.05.02.0020.002672%Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.074824%Not Available
Acute generalised exanthematous pustulosis23.03.10.002; 12.03.01.005; 11.07.01.018; 10.01.01.034--Not Available
Hypoacusis04.02.01.006--
Spinal cord haemorrhage24.07.04.010; 17.08.01.030; 12.01.13.0030.004008%Not Available
Left ventricular dysfunction02.04.02.0110.002672%
Lymphatic disorder01.09.01.003--Not Available
Foetor hepaticus09.01.05.006; 07.01.06.026--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Application site swelling12.07.01.027; 08.02.01.0270.004008%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.004008%
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Epidermal necrosis23.03.03.035--Not Available
Blood alkaline phosphatase increased13.04.02.004--
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