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)
Dyskinesia17.01.02.0060.002672%
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.024051%
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.004--
Dysphoria19.04.02.0040.005345%Not Available
Dyspnoea02.11.05.003; 22.02.01.0040.049972%
Dyspnoea exertional02.11.05.005; 22.02.01.0050.006681%Not Available
Ear disorder04.03.01.001--Not Available
Electrocardiogram abnormal13.14.05.001--Not Available
Electrolyte imbalance14.05.01.0020.004008%Not Available
Encephalocele17.19.01.005; 03.10.02.001--Not Available
Erythema23.03.06.0010.019241%Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.002672%
Eye disorder06.08.03.001--Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.002672%Not Available
Face oedema08.01.07.003; 23.04.01.004; 10.01.05.002--
Facial paralysis17.04.03.0080.002672%Not Available
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.0020.008017%
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Fungal infection11.03.05.001--Not Available
Gamma-glutamyltransferase increased13.03.04.024--
Gastritis07.08.02.0010.005879%
Gastroenteritis07.19.03.001; 11.01.07.004--Not Available
Gastrointestinal disorder07.11.01.0010.035007%Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.004--
Gingivitis07.09.10.002; 11.01.04.013--
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