Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Natalizumab
Drug ID BADD_D01537
Description Humanized IgG4k monoclonal antibody produced in murine myeloma cells. Natalizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to a4-integrin. Natalizumab was voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). It was returned to market July, 2006.
Indications and Usage For treatment of multiple sclerosis.
Marketing Status approved; investigational
ATC Code L04AA23
DrugBank ID DB00108
KEGG ID D06886
MeSH ID D000069442
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 64406-008
UNII 3JB47N2Q2P
Synonyms Natalizumab | Tysabri | Antegren
Chemical Information
Molecular Formula Not Available
CAS Registry Number 189261-10-7
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)
Joint swelling15.01.02.004---
Laryngeal pain22.12.03.010--
Liver function test abnormal13.03.04.030---
Lower respiratory tract infection11.01.09.002; 22.07.01.002---
Menstruation irregular05.05.01.008; 21.01.01.005--
Muscle spasms15.05.03.004--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Night sweats08.01.03.031; 23.02.03.006---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Ovarian cyst16.04.03.001; 21.11.01.002---
Pain in extremity15.03.04.010--
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Rash23.03.13.001---
Sinusitis11.01.13.005; 22.07.03.007--
Somnolence17.02.04.006; 19.02.05.003--
Tonsillitis11.01.13.006; 22.07.03.008---
Toothache07.09.06.001--
Tremor17.01.06.002--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary incontinence17.05.01.008; 20.02.02.010--
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria10.01.06.001; 23.04.02.001--
Vaginal infection11.01.10.002; 21.14.02.002--
Vertigo04.04.01.003; 17.02.12.002--
Viral infection11.05.04.001---
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Tooth infection07.09.01.004; 11.01.04.004--
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