Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Glasdegib
Drug ID BADD_D02559
Description Glasdegib, also known as PF-04449913, is a small-molecule hedgehog signaling inhibitor selected under the group of the benzimidazoles. In early research, benzimidazoles attracted large interest as they represented a class of inhibitors with a low molecular weight, potent inhibitory activity and lacking unstable functionality. The great lipophilicity of this group of compounds brought interest to further modification. This analysis concluded that the presence of p-cyano ureas presented good physicochemical and pharmacokinetic properties from which glasdegib was developed.[A40310] Glasdegib was developed by Pfizer Inc and approved on November 21, 2018, by the FDA for the treatment of Acute Myeloid Leukemia.[L11935]
Indications and Usage Glasdegib, in combination with cytarabine, is indicated for the treatment of newly diagnosed acute myeloid leukemia in adult patients who are over 75 years old or that have co-morbidities that preclude intensive induction chemotherapy.[L5080] Acute myeloid leukemia is characterized by abnormal production of myeloblasts, red cells, or platelets. It is considered a cancer of blood and bone marrow and it is the most common type of acute leukemia in adults.[L4832]
Marketing Status approved; investigational
ATC Code L01XJ03
DrugBank ID DB11978
KEGG ID D10636
MeSH ID C000592580
PubChem ID 25166913
TTD Drug ID D0S5LO
NDC Product Code 0069-0298; 0069-1531
UNII K673DMO5H9
Synonyms glasdegib | Daurismo | 1-(2-(1H-benzo(d)imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea | PF-04449913
Chemical Information
Molecular Formula C21H22N6O
CAS Registry Number 1095173-27-5
SMILES CN1CCC(CC1C2=NC3=CC=CC=C3N2)NC(=O)NC4=CC=C(C=C4)C#N
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)
Constipation07.02.02.0010.000112%
Death08.04.01.0010.002462%
Dysgeusia17.02.07.003; 07.14.03.0010.000246%
Dysphagia07.01.06.0030.000246%
Febrile neutropenia08.05.02.004; 01.02.03.0020.000168%
Myalgia15.05.02.0010.000112%
Pyrexia08.05.02.0030.000112%
General physical health deterioration08.01.03.0180.000168%Not Available
Neoplasm progression16.16.02.0050.000772%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000302%
Acute kidney injury20.01.03.0160.000112%
Taste disorder17.02.07.029; 07.14.03.0040.000112%Not Available
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