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 Natalizumab was voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML).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--Not Available
Laryngeal pain22.12.03.010--
Liver function test abnormal13.03.04.030--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Menstruation irregular21.01.01.005; 05.05.01.008--
Muscle spasms15.05.03.004--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Night sweats23.02.03.006; 08.01.03.031--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Ovarian cyst21.11.01.002; 16.04.03.001--Not Available
Pain in extremity15.03.04.010--
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Somnolence19.02.05.003; 17.02.04.006--
Tonsillitis22.07.03.008; 11.01.13.006--Not Available
Toothache07.09.06.001--
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Vertigo17.02.12.002; 04.04.01.003--
Viral infection11.05.04.001--Not Available
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Tooth infection11.01.04.004; 07.09.01.004--
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