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)
Seizure17.12.03.001--
Sepsis11.01.11.003--
Serum sickness12.02.08.004; 10.01.03.004--
Sexual dysfunction19.08.05.002; 21.03.02.003--Not Available
Shock24.06.02.002--Not Available
Skin atrophy23.01.05.001--
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Skin hypertrophy23.01.04.002--Not Available
Skin papilloma16.26.01.002; 11.05.07.001; 23.10.01.002--
Skin striae23.01.05.002--Not Available
Smear cervix abnormal13.20.02.001--Not Available
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003--Not Available
Splenomegaly01.09.02.001--Not Available
Stomatitis07.05.06.005--
Stupor19.02.05.004; 17.02.04.007--Not Available
Suicide attempt19.12.01.004--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tenosynovitis15.07.01.004--Not Available
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Thrombosis24.01.01.006--Not Available
Tongue discolouration07.14.02.006--Not Available
Tongue disorder07.14.01.002--Not Available
Tongue oedema07.14.02.007; 23.04.01.009; 10.01.05.008--Not Available
Tremor17.01.06.002--
Urethral disorder20.07.01.002--Not Available
Urethritis20.07.02.001; 11.01.14.008--
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