Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Glatiramer acetate
Drug ID BADD_D01021
Description Glatiramer acetate consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000-9,000 daltons. It is an immunomodulator, licensed in much of the world for reduced frequency of relapses in relapsing-remitting multiple sclerosis.
Indications and Usage For reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.
Marketing Status approved; investigational
ATC Code L03AX13
DrugBank ID DB05259
KEGG ID D04318
MeSH ID D000068717
PubChem ID 3081884
TTD Drug ID D04CRL
NDC Product Code 0781-3234; 63629-8815; 0441-3642; 14403-0008; 68546-325; 59651-517; 68546-317; 0781-3250; 55111-945; 0378-6960; 53104-7715; 65129-1181; 63850-4035; 63629-8816; 65727-038
UNII 5M691HL4BO
Synonyms Glatiramer Acetate | Acetate, Glatiramer | Copaxone | Glatiramer | TV 5010 | 5010, TV | TV5010 | TV-5010
Chemical Information
Molecular Formula C25H45N5O13
CAS Registry Number 147245-92-9
SMILES CC(C(=O)O)N.CC(=O)O.C1=CC(=CC=C1CC(C(=O)O)N)O.C(CCN)CC(C(=O)O)N.C(CC(=O)O)C(C(=O )O)N
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)
Visual field defect06.02.07.003; 17.17.01.001--Not Available
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Xanthoma23.03.03.047; 14.08.04.010--Not Available
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.013--Not Available
Brain oedema17.07.02.003; 12.01.10.010--
Lhermitte's sign17.02.06.014--Not Available
Deep vein thrombosis24.01.02.003--Not Available
Injection site discolouration23.03.03.046; 12.07.03.038; 08.02.03.038--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
Affect lability19.04.01.001--Not Available
Haemorrhage24.07.01.002--Not Available
Rectal tenesmus15.05.03.011; 07.03.03.001--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
Major depression19.15.01.003--Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.001--Not Available
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Vasodilation procedure25.03.01.001--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Bacterial infection11.02.01.005--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
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