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)
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Bone pain15.02.01.001--
Bronchospasm10.01.03.012; 22.03.01.004--
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.007--
Dyspnoea22.02.01.004; 02.01.03.002--
Fatigue08.01.01.002--
Headache17.14.01.001--
Herpes zoster23.09.03.002; 11.05.02.003--
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hypertension24.08.02.001--
Hypokalaemia14.05.03.002--
Hypoxia22.02.02.003--
Insomnia19.02.01.002; 17.15.03.002--
Laryngeal oedema23.04.01.005; 10.01.05.003; 22.04.02.001--
Lymphopenia01.02.02.002--Not Available
Muscle spasms15.05.03.004--
Nasal congestion22.04.04.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neutropenia01.02.03.004--Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Pain08.01.08.004--
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