Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gazyva
Drug ID BADD_D01007
Description Obinutuzumab is a humanized monoclonal antibody used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. There is a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Leukoencephalopathy (PML).
Indications and Usage Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.
Marketing Status approved; investigational
ATC Code L01FA03
DrugBank ID DB08935
KEGG ID D09321
MeSH ID C543332
PubChem ID Not Available
TTD Drug ID D0S8WA
NDC Product Code 50242-070
UNII Not Available
Synonyms obinutuzumab | RO 5072759 | RO5072759 | RO-5072759 | R 7159 | R7159 cpd | R-7159 | GA 101 | GA101 antibody | GA-101 | Gazyva | gazyvaro | afutuzumab
Chemical Information
Molecular Formula Not Available
CAS Registry Number 949142-50-1
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)
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Aspartate aminotransferase increased13.03.04.011--
Back pain15.03.04.005--
Blood creatinine increased13.13.01.004--
Cardiac failure02.05.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Hyperkalaemia14.05.03.001--
Hypoalbuminaemia14.10.01.002; 09.01.02.003--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
Hyponatraemia14.05.04.002--
Infection11.01.08.002--Not Available
Leukopenia01.02.02.001--Not Available
Lymphopenia01.02.02.002--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Neutropenia01.02.03.004--Not Available
Pyrexia08.05.02.003--
Thrombocytopenia01.08.01.002--Not Available
Tumour lysis syndrome14.05.01.004; 16.32.03.002--
Urinary tract infection20.08.02.001; 11.01.14.004--
Infusion related reaction12.02.05.009; 10.01.01.017; 08.01.03.002--
Haemorrhage24.07.01.002--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Hepatic enzyme increased13.03.04.028--Not Available
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