Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Posaconazole
Drug ID BADD_D01804
Description Posaconazole is a triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients.
Indications and Usage For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised as a result of procedures such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD), or due to hematologic malignancies with prolonged neutropenia from chemotherapy. Also for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. Posaconazole is used as an alternative treatment for invasive aspergillosis, Fusarium infections, and zygomycosis in patients who are intolerant of, or whose disease is refractory to, other antifungals.
Marketing Status approved; investigational; vet_approved
ATC Code J02AC04
DrugBank ID DB01263
KEGG ID D02555
MeSH ID C101425
PubChem ID 468595
TTD Drug ID D07ABV
NDC Product Code 14501-0076; 17511-133; 73005-0001; 76397-011; 0254-1016; 70748-258; 12860-0041; 55111-995; 66406-0200; 76397-002; 17856-2133; 31722-677; 43598-470; 0406-7711; 70377-038; 0527-2133; 16714-156; 0085-4331; 42291-919; 60687-523; 76397-024; 14501-0067; 0904-7149; 62227-010; 76397-023; 0085-1328; 0085-4324; 16714-535; 42023-195; 51407-676; 69037-0020; 69367-248; 12860-0133; 65727-059; 58032-1017; 62227-008; 0085-2224; 63629-2236; 69238-1476; 0054-0449; 42765-020; 62227-001; 50268-683; 0254-2045
UNII 6TK1G07BHZ
Synonyms posaconazole | 4-(p-(4-(p-(((3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furyl)methoxy)phenyl)-1-piperazinyl)phenyl)-1-((1S,2S)-1-ethyl-2-hydroxypropyl)-delta(sup 2)-1,2,4-triazolin-5-one | Noxafil | SCH-56592 | SCH 56592 | posaconazole hydrate
Chemical Information
Molecular Formula C37H42F2N8O4
CAS Registry Number 171228-49-2
SMILES CCC(C(C)O)N1C(=O)N(C=N1)C2=CC=C(C=C2)N3CCN(CC3)C4=CC=C(C=C4)OCC5CC(OC5)(CN6C=NC= N6)C7=C(C=C(C=C7)F)F
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)
Hyperlipidaemia14.08.03.001--
Urine analysis abnormal13.13.02.008---
Renal impairment20.01.03.010---
Stem cell transplant25.06.02.003---
Device related infection08.07.01.005; 11.01.08.018--
Haematological malignancy01.13.01.003; 16.21.01.002---
Treatment failure08.06.01.0170.037353%-
Liver injury09.01.07.022; 12.01.17.0120.017494%-
Oral herpes07.05.07.002; 11.05.02.005---
Skin mass23.07.04.014---
Traumatic liver injury09.01.08.010; 12.01.17.027---
Anorectal discomfort07.03.03.003---
Acute kidney injury20.01.03.0160.023641%
Upper-airway cough syndrome22.12.03.036--
Drug-induced liver injury09.01.07.023; 12.03.01.0440.018913%-
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.009456%-
Candida infection11.03.03.021--
Multiple organ dysfunction syndrome08.01.03.0570.022223%
Liver function test increased13.03.04.031---
Hyperadrenalism05.01.01.005; 14.11.01.028; 24.08.04.0030.004728%-
Acute myeloid leukaemia recurrent01.10.05.004; 16.01.05.0040.016549%-
Leukaemia recurrent01.10.03.005; 16.01.03.005---
Acute lymphocytic leukaemia recurrent01.10.01.003; 16.01.01.0030.004728%-
Graft versus host disease in liver09.01.07.033; 10.02.01.060; 12.02.09.029---
Graft versus host disease in lung10.02.01.061; 12.02.09.030; 22.01.01.021---
Graft versus host disease in gastrointestinal tract07.11.01.027; 10.02.01.059; 12.02.09.0280.007092%-
Drug effective for unapproved indication08.06.01.037; 12.09.02.0010.024114%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.004728%-
Gait inability08.01.02.011; 17.02.05.069---
Potentiating drug interaction08.06.03.0150.004728%-
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