Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Letermovir
Drug ID BADD_D02502
Description Letermovir recieved approval from the FDA on November 8th, 2017 for use in prophylaxis of cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients [L1021]. It represents the first entry into a new class of CMV anti-infectives, DNA terminase complex inhibitors [A31290]. Letermovir has recieved both priority and orphan drug status from the FDA. It is currently marketed under the brand name Prevymis [L1021].
Indications and Usage For use in prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) [FDA Label].
Marketing Status approved; investigational
ATC Code J05AX18
DrugBank ID DB12070
KEGG ID D10801
MeSH ID C000588473
PubChem ID 45138674
TTD Drug ID D0G8PA
NDC Product Code 69497-0128; 50473-0126; 50473-0127; 0006-3076; 0006-5004; 0006-5003; 0006-3075
UNII 1H09Y5WO1F
Synonyms letermovir | Prevymis | AIC246
Chemical Information
Molecular Formula C29H28F4N4O4
CAS Registry Number 917389-32-3
SMILES COC1=C(C=C(C=C1)C(F)(F)F)N2C(C3=C(C(=CC=C3)F)N=C2N4CCN(CC4)C5=CC(=CC=C5)OC)CC(=O )O
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)
Cardiac arrest02.03.04.0010.000423%
Cardio-respiratory arrest02.03.04.002; 22.02.06.0070.000423%Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.0050.000282%
Death08.04.01.0010.003867%
Drug ineffective08.06.01.0060.004403%Not Available
Dysphagia07.01.06.0030.002343%
Graft versus host disease12.02.09.001; 10.02.01.0270.001129%Not Available
Haematochezia07.12.02.003; 24.07.02.0120.000282%Not Available
Ileus07.13.01.0010.000282%
Mouth ulceration07.05.06.0040.000847%Not Available
Mucosal inflammation08.01.06.0020.000282%Not Available
Neutropenia01.02.03.0040.000423%Not Available
Oedema08.01.07.006; 14.05.06.0100.000282%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.000621%
Pancreatitis acute07.18.01.0020.001129%Not Available
Pancytopenia01.03.03.0030.000565%Not Available
Renal failure20.01.03.0050.000565%Not Available
Renal tubular necrosis20.01.07.0030.000423%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000423%
Thrombocytopenia01.08.01.0020.000423%Not Available
Vomiting07.01.07.0030.000423%
General physical health deterioration08.01.03.0180.000282%Not Available
Drug resistance08.06.01.0050.000706%Not Available
Adverse event08.06.01.0100.002258%Not Available
Acute graft versus host disease12.02.09.002; 10.02.01.0280.000423%Not Available
Treatment failure08.06.01.0170.000565%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000282%
Acute myeloid leukaemia recurrent16.01.05.004; 01.10.05.0040.000565%Not Available
Graft versus host disease in gastrointestinal tract12.02.09.028; 10.02.01.059; 07.11.01.0270.000423%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.000282%Not Available
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