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--Not Available
Abdominal distension07.01.04.0010.004008%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.013896%
Abortion spontaneous18.01.04.0010.006681%Not Available
Acne23.02.01.0010.004008%Not Available
Acute hepatic failure09.01.03.0010.005345%Not Available
Acute lymphocytic leukaemia16.01.01.001; 01.10.01.0010.004008%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.002672%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.002672%Not Available
Acute psychosis19.03.01.0010.002672%Not Available
Adrenal insufficiency05.01.02.001; 14.11.01.0040.008017%
Adrenal suppression14.11.01.005; 05.01.02.0020.002672%Not Available
Agranulocytosis01.02.03.0010.002672%Not Available
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001--Not Available
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.002672%Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock10.01.07.002; 24.06.02.0040.004008%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Application site reaction12.07.01.006; 08.02.01.006--Not Available
Arrhythmia02.03.02.0010.016034%Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.021378%Not Available
Atrial fibrillation02.03.03.0020.020042%
Atrial flutter02.03.03.0030.004008%
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