Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Palivizumab
Drug ID BADD_D01658
Description Humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human lightchain sequence was derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4. Palivizumab is expressed from a stable murine (mouse) myeloma cell line (NS0). Palivizumab is composed of to heavy chains (50.6 kDa each) and two light chains (27.6 kDa each), contains 1-2% carbohydrate by weight and has a molecular weight of 147.7 kDa +/- 1 kDa (MALDI-TOF)
Indications and Usage For prophylaxis of respiratory diseases casued by respiratory syncytial virus.
Marketing Status approved; investigational
ATC Code J06BD01
DrugBank ID DB00110
KEGG ID D02737
MeSH ID D000069455
PubChem ID Not Available
TTD Drug ID D0A1AS
NDC Product Code 66658-230; 0310-4113; 66658-231
UNII DQ448MW7KS
Synonyms Palivizumab | MEDI 493 | Monoclonal Antibody MEDI-493 | Monoclonal Antibody MEDI 493 | Monoclonal Antibody MEDI493 | MEDI-493 | MEDI493 | Synagis
Chemical Information
Molecular Formula Not Available
CAS Registry Number 188039-54-5
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)
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Aspartate aminotransferase increased13.03.04.011--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Drug specific antibody present13.17.01.001---
Gastroenteritis07.19.03.001; 11.01.07.004---
Hernia08.01.04.001---
Hypersensitivity10.01.03.003--
Injection site reaction08.02.03.014; 12.07.03.015--
Otitis media04.05.01.001; 11.01.05.004--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Rhinitis11.01.13.004; 22.07.03.006--
Thrombocytopenia01.08.01.002---
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Vomiting07.01.07.003--
Wheezing22.03.01.009--
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