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 abscess08.02.03.021; 11.01.08.023; 12.07.03.021---
Injection site atrophy08.02.03.022; 12.07.03.022---
Injection site erythema08.02.03.001; 12.07.03.001; 23.03.06.015---
Injection site fibrosis08.02.03.025; 12.07.03.025---
Injection site haematoma08.02.03.004; 12.07.03.004; 24.07.01.009---
Injection site hypersensitivity08.02.03.006; 10.01.03.017; 12.07.03.006---
Injection site hypertrophy08.02.03.026; 12.07.03.026---
Injection site inflammation08.02.03.008; 12.07.03.009---
Injection site mass08.02.03.009; 12.07.03.010---
Injection site pain08.02.03.010; 12.07.03.011---
Injection site pruritus08.02.03.013; 12.07.03.014; 23.03.12.007---
Injection site reaction08.02.03.014; 12.07.03.015--
Laryngospasm22.04.02.002--
Leukopenia01.02.02.001---
Libido decreased19.08.03.001; 21.03.02.005--
Lipoatrophy14.08.04.006; 23.07.01.001--
Lipoma15.09.01.001; 16.18.01.001---
Local reaction08.01.03.012---
Loss of consciousness17.02.04.004---
Lymphadenopathy01.09.01.002---
Lymphoedema01.09.01.006; 24.09.01.001--
Mania19.16.02.002--
Melaena07.12.02.004; 24.07.02.013---
Melanosis23.05.01.004---
Memory impairment17.03.02.003; 19.20.01.003--
Meningitis11.01.03.001; 17.06.03.001--
Micturition urgency20.02.02.006--
Migraine17.14.02.001; 24.03.05.003---
Monoplegia17.01.04.003---
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