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%-
Cerebral ischaemia17.08.01.005; 24.04.06.0030.000282%
Death08.04.01.0010.003867%
Drug ineffective08.06.01.0060.004403%-
Dysphagia07.01.06.0030.002343%
Graft versus host disease10.02.01.027; 12.02.09.0010.001129%-
Haematochezia07.12.02.003; 24.07.02.0120.000282%-
Ileus07.13.01.0010.000282%
Mouth ulceration07.05.06.0040.000847%-
Mucosal inflammation08.01.06.0020.000282%-
Neutropenia01.02.03.0040.000423%-
Oedema08.01.07.006; 14.05.06.0100.000282%-
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.000621%
Pancreatitis acute07.18.01.0020.001129%-
Pancytopenia01.03.03.0030.000565%-
Renal failure20.01.03.0050.000565%-
Renal tubular necrosis20.01.07.0030.000423%-
Respiratory failure14.01.04.003; 22.02.06.0020.000423%
Thrombocytopenia01.08.01.0020.000423%-
Vomiting07.01.07.0030.000423%
General physical health deterioration08.01.03.0180.000282%-
Drug resistance08.06.01.0050.000706%-
Adverse event08.06.01.0100.002258%-
Acute graft versus host disease10.02.01.028; 12.02.09.0020.000423%-
Treatment failure08.06.01.0170.000565%-
Multiple organ dysfunction syndrome08.01.03.0570.000282%
Acute myeloid leukaemia recurrent01.10.05.004; 16.01.05.0040.000565%-
Graft versus host disease in gastrointestinal tract07.11.01.027; 10.02.01.059; 12.02.09.0280.000423%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.000282%-
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