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 Daratumumab is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma.[L13290] It is available as a combination product with [hyaluronidase] for the treatment of adults with multiple myeloma as monotherapy or combination therapy and light chain amyloidosis in combination with other drugs.[L13296]
Marketing Status approved
ATC Code L01FC01
DrugBank ID DB09331
KEGG ID D10777
MeSH ID C556306
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 57894-502; 57894-505; 71124-0007
UNII 4Z63YK6E0E
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
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)
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--
Bronchospasm22.03.01.004; 10.01.03.012--
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dyspnoea02.11.05.003; 22.02.01.004--
Fatigue08.01.01.002--
Headache17.14.01.001--
Herpes zoster23.11.05.005; 17.09.03.026; 11.05.02.003--
Hyperglycaemia14.06.02.002; 05.06.02.002--
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; 22.04.02.001; 10.01.05.003--
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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