Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Daratumumab
Drug ID BADD_D00582
Description Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab.[A7935] It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind.[A199002] Daratumumab was granted FDA approval on 16 November 2015.[L13290] It is approved for the treatment of multiple myeloma as monotherapy or combination therapy and light chain (AL) amyloidosis in combination with other drugs.[L13290,L13296]
Indications and Usage For the treatment of patients with multiple myeloma who have received at least three prior lines of therapy (a proteasome inhibitor (PI) and an immunomodulatory agent) or who are double-refractory to a PI and an immunomodulatory agent. This indication was approved by accelerated approval based on response rate.
Marketing Status Prescription
ATC Code L01FC01
DrugBank ID DB09331
KEGG ID D10777
MeSH ID C556306
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 71124-0007; 57894-505; 57894-502
Synonyms daratumumab | humax-CD38 | humax-CD 38 | Darzalex
Chemical Information
Molecular Formula Not Available
CAS Registry Number 945721-28-8
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pain in extremity15.03.04.010--
Peripheral sensory neuropathy17.09.03.005--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pyrexia08.05.02.003--
Sepsis11.01.11.003--
Throat irritation22.02.05.013; 07.05.03.004--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Vomiting07.01.07.003--
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Infusion related reaction12.02.05.009; 10.01.01.017; 08.01.03.002--
Decreased appetite14.03.01.005; 08.01.09.028--
Non-cardiac chest pain22.02.08.007; 08.01.08.006--
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