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)
Abdominal discomfort07.01.06.001---
Abdominal distension07.01.04.0010.004008%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.013896%
Abortion spontaneous18.01.04.0010.006681%-
Acne23.02.01.0010.004008%-
Acute hepatic failure09.01.03.0010.005345%-
Acute lymphocytic leukaemia01.10.01.001; 16.01.01.0010.004008%-
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.002672%-
Acute myocardial infarction02.02.02.001; 24.04.04.0010.002672%-
Acute psychosis19.03.01.0010.002672%-
Adrenal insufficiency05.01.02.001; 14.11.01.0040.008017%
Adrenal suppression05.01.02.002; 14.11.01.0050.002672%-
Agranulocytosis01.02.03.0010.002672%-
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001---
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.002672%-
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock10.01.07.002; 24.06.02.0040.004008%-
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Anxiety19.06.02.002--
Application site reaction08.02.01.006; 12.07.01.006---
Arrhythmia02.03.02.0010.016034%-
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.021378%-
Atrial fibrillation02.03.03.0020.020042%
Atrial flutter02.03.03.0030.004008%
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