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)
Rhabdomyolysis15.05.05.0020.016034%
Rhinitis22.07.03.006; 11.01.13.004--
Right ventricular failure02.05.03.0020.004008%Not Available
Secondary adrenocortical insufficiency05.03.04.012; 14.11.01.0140.004008%Not Available
Sensory disturbance17.02.07.0060.002672%Not Available
Serum sickness10.01.03.004; 12.02.08.004--
Shock24.06.02.0020.002672%Not Available
Sinus bradycardia02.03.03.0090.002672%
Sinusitis22.07.03.007; 11.01.13.005--
Skin atrophy23.01.05.0010.002672%
Skin disorder23.03.03.0070.004008%Not Available
Skin exfoliation23.03.07.0030.014698%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.002672%Not Available
Sputum increased22.02.03.007--Not Available
Stevens-Johnson syndrome10.01.01.045; 12.03.01.014; 23.03.01.007; 11.07.01.005--
Stridor22.04.02.0030.002672%
Supraventricular extrasystoles02.03.03.0110.004008%Not Available
Swelling08.01.03.015--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.009353%
Tachycardia02.03.02.007--Not Available
Tachypnoea22.02.01.0140.002672%Not Available
Tendonitis15.07.01.003; 12.01.07.0070.006681%Not Available
Teratogenicity03.02.01.004; 12.03.01.032--Not Available
Therapeutic response unexpected08.06.01.0010.016301%Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.0020.005879%
Torsade de pointes02.03.04.0050.010689%Not Available
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.006--
Tremor17.01.06.0020.015767%
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