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)
Monoplegia17.01.04.003--Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.0040.015130%Not Available
Mucosal inflammation08.01.06.002--Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.009456%
Musculoskeletal pain15.03.04.0070.004728%
Myalgia15.05.02.001--
Myelodysplastic syndrome16.01.04.001; 01.10.04.0010.007092%
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neoplasm16.16.02.001--Not Available
Neoplasm malignant16.16.01.001--Not Available
Nephrolithiasis20.04.01.002--
Nervous system disorder17.02.10.001--Not Available
Neuralgia17.02.07.0050.007092%
Neuritis17.09.03.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Neurotoxicity17.02.10.002; 12.03.01.0110.011820%Not Available
Neutropenia01.02.03.0040.047282%Not Available
Neutrophil count decreased13.01.06.010--
Neutrophilia01.02.01.005--Not Available
Night sweats23.02.03.006; 08.01.03.031--Not Available
Nightmare19.02.03.003--Not Available
Nocturia20.02.03.001--Not Available
Odynophagia07.01.06.036--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
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