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 Natalizumab was voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML).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)
Abdominal adhesions07.07.03.001; 12.02.03.006---
Abdominal discomfort07.01.06.001---
Abdominal pain lower07.01.05.010---
Amenorrhoea05.05.01.002; 21.01.02.001--
Aphthous ulcer07.05.06.002---
Arthralgia15.01.02.001--
Back pain15.03.04.005--
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.002---
Chills08.01.09.001; 15.05.03.016--
Cholelithiasis09.03.01.002---
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry skin23.03.03.001--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gastroenteritis07.19.03.001; 11.01.07.004---
Headache17.14.01.001--
Herpes virus infection11.05.02.008---
Hypersensitivity10.01.03.003--
Influenza11.05.03.001; 22.07.02.001---
Influenza like illness08.01.03.010--
Intestinal obstruction07.13.01.002---
Intestinal stenosis07.13.01.003---
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