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)
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.004--Not Available
Lung disorder22.02.07.0010.002672%Not Available
Lung infiltration22.01.02.0040.002672%Not Available
Lymphadenopathy01.09.01.0020.004008%Not Available
Malaise08.01.01.003--
Mania19.16.02.0020.002672%
Menopausal symptoms21.02.02.002--Not Available
Menstrual disorder21.01.01.0040.005345%Not Available
Metabolic acidosis14.01.01.0030.009353%Not Available
Metabolic alkalosis14.01.02.0040.004008%Not Available
Mouth ulceration07.05.06.0040.002672%Not Available
Mucosal inflammation08.01.06.002--Not Available
Multiple sclerosis17.16.01.001; 10.04.10.0080.002672%Not Available
Myalgia15.05.02.0010.011224%
Myelitis transverse17.06.02.002; 10.04.10.0060.002672%Not Available
Myocarditis02.04.03.0010.004008%
Myopathy15.05.05.0010.004008%Not Available
Nausea07.01.07.0010.085246%
Nephropathy toxic20.05.03.002; 12.03.01.0100.004008%Not Available
Nervous system disorder17.02.10.0010.012025%Not Available
Neuropathy peripheral17.09.03.0030.020042%Not Available
Neurotoxicity17.02.10.002; 12.03.01.0110.008017%Not Available
Neutropenia01.02.03.004--Not Available
Nocturia20.02.03.0010.004008%Not Available
Oedema14.05.06.010; 08.01.07.0060.068144%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.026723%
Onychomycosis11.03.05.007; 23.11.03.008--Not Available
Orthopnoea02.11.05.010; 22.02.01.0200.004008%Not Available
Orthostatic hypotension17.05.01.020; 24.06.03.004--Not Available
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