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)
Saliva altered07.06.01.004---
Sarcoidosis10.02.06.001---
Sciatica15.10.01.001; 17.10.03.001---
Seborrhoeic dermatitis23.03.04.018---
Secondary hypertension24.08.02.0150.004728%-
Seizure17.12.03.001--
Sepsis11.01.11.003--
Shock24.06.02.002---
Sinus tachycardia02.03.03.010--
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007---
Skin reaction10.01.03.019; 23.03.03.0130.010402%-
Sleep disorder19.02.04.001---
Somnolence17.02.04.006; 19.02.05.003--
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.027---
Splenomegaly01.09.02.001---
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Stomatitis07.05.06.005--
Stupor17.02.04.007; 19.02.05.004---
Sudden death02.03.04.013; 08.04.01.003--
Supraventricular extrasystoles02.03.03.011---
Supraventricular tachycardia02.03.03.012--
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Tachycardia02.03.02.007---
Tendonitis12.01.07.007; 15.07.01.0030.004728%-
Therapeutic response decreased08.06.01.0160.018440%-
Thirst08.01.09.021; 14.03.02.007---
Thrombocytopenia01.08.01.0020.016549%-
Thrombocytopenic purpura01.08.01.003; 23.06.01.0070.004728%-
Thrombocytosis01.08.02.001---
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