Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nivolumab
Drug ID BADD_D01581
Description Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1).[L12129] This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation _S228P_ for additional stability and reduced variability.[A35203] It was developed by Bristol Myers Squibb.[L12129] Nivolumab was granted FDA approval on 22 December 2014.[L12129]
Indications and Usage Nivolumab is indicated for the treatment of unresectable or metastatic melanoma for patients who no longer respond to treatment with other drugs. It is intended for use in patients who have been previously treated with ipilimumab and is used for melanoma patients after treatment with ipilimumab and a BRAF inhibitor in patients whose tumors express BRAF V600 gene mutations. Historically there have been very few effective treatments for advanced melanoma, which is why this product was approved under an FDA accelerated program to allow earlier patient access.
Marketing Status Prescription
ATC Code L01FF01
DrugBank ID DB09035
KEGG ID D10316
MeSH ID D000077594
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 0952-3772; 0003-3734; 71124-0002; 68806-3772; 0003-3756; 70409-7125; 0003-3774; 0003-3772
Synonyms Nivolumab | Opdivo | ONO-4538 | ONO 4538 | ONO4538 | MDX-1106 | MDX 1106 | MDX1106 | BMS-936558 | BMS 936558 | BMS936558
Chemical Information
Molecular Formula Not Available
CAS Registry Number 946414-94-4
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)
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.01.003--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Blood creatinine increased13.13.01.004--
Bronchitis22.07.01.001; 11.01.09.001--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chronic obstructive pulmonary disease22.03.01.007--Not Available
Colitis07.08.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.007--
Dyspnoea22.02.01.004; 02.01.03.002--
Erythema multiforme23.03.01.003; 10.01.03.015--
Fatigue08.01.01.002--
Haemoptysis22.02.03.004; 02.01.02.006; 24.07.01.006--Not Available
Hepatitis09.01.07.004--Not Available
Hypercalcaemia14.04.01.003; 05.04.01.002--
Hyperkalaemia14.05.03.001--
Hyperthyroidism05.02.02.001; 14.11.01.011--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
Hypomagnesaemia14.04.02.001--
Hyponatraemia14.05.04.002--
Hypothyroidism14.11.01.012; 05.02.03.001--
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