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)
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hyperthyroidism05.02.02.001; 14.11.01.011--
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Hyperventilation22.02.01.006; 19.01.02.004--Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypokinesia17.01.02.009--Not Available
Hypotension24.06.03.002--
Hypothyroidism14.11.01.012; 05.02.03.001--
Hypoventilation22.02.01.007--Not Available
Hypoxia22.02.02.003--
Immune system disorder10.02.01.001--Not Available
Impaired healing08.03.02.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza11.05.03.001; 22.07.02.001--Not Available
Injection site abscess12.07.03.021; 11.01.08.023; 08.02.03.021--Not Available
Injection site atrophy12.07.03.022; 08.02.03.022--Not Available
Injection site bruising24.07.06.017; 23.03.11.015; 12.07.03.042; 08.02.03.042--Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001--Not Available
Injection site fibrosis12.07.03.025; 08.02.03.025--Not Available
Injection site haematoma24.07.01.009; 12.07.03.004; 08.02.03.004--Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005--Not Available
Injection site hypersensitivity10.01.03.017; 08.02.03.006; 12.07.03.006--Not Available
Injection site hypertrophy12.07.03.026; 08.02.03.026--Not Available
Injection site induration12.07.03.007; 08.02.03.007--Not Available
Injection site inflammation12.07.03.009; 08.02.03.008--Not Available
Injection site mass08.02.03.009; 12.07.03.010--Not Available
Injection site oedema12.07.03.024; 08.02.03.024--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
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