Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Glatiramer
Drug ID BADD_D01020
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 65370
TTD Drug ID D04CRL
NDC Product Code 0378-6961; 41524-0004
UNII U782C039QP
Synonyms Glatiramer Acetate | Acetate, Glatiramer | Copaxone | Glatiramer | TV 5010 | 5010, TV | TV5010 | TV-5010
Chemical Information
Molecular Formula C23H41N5O11
CAS Registry Number 28704-27-0
SMILES CC(C(=O)O)N.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)
Influenza like illness08.01.03.010--
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 erythema12.07.03.001; 08.02.03.001; 23.03.06.015--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 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 inflammation12.07.03.009; 08.02.03.008--Not Available
Injection site mass12.07.03.010; 08.02.03.009--Not Available
Injection site pain08.02.03.010; 12.07.03.011--Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Laryngospasm22.04.02.002--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Lipoatrophy23.07.01.001; 14.08.04.006--
Lipoma16.18.01.001; 15.09.01.001--Not Available
Local reaction08.01.03.012--Not Available
Loss of consciousness17.02.04.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
Lymphoedema01.09.01.006; 24.09.01.001--
Mania19.16.02.002--
Melaena07.12.02.004; 24.07.02.013--Not Available
Melanosis23.05.01.004--Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Meningitis17.06.03.001; 11.01.03.001--
Micturition urgency20.02.02.006--
Migraine24.03.05.003; 17.14.02.001--Not Available
Monoplegia17.01.04.003--Not Available
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