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)
Rash pustular23.03.10.003; 11.01.12.002--
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal failure20.01.03.005--Not Available
Renal pain20.02.03.003--Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Rheumatoid arthritis15.01.03.001; 10.04.06.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Rhinitis allergic22.04.04.003; 10.01.04.003--
Salivary gland enlargement07.06.03.002--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Serum sickness12.02.08.004; 10.01.03.004--
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Sinusitis11.01.13.005; 22.07.03.007--
Skin atrophy23.01.05.001--
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin hypertrophy23.01.04.002--Not Available
Skin necrosis23.03.03.011--Not Available
Skin papilloma23.10.01.002; 16.26.01.002; 11.05.07.001--
Skin striae23.01.05.002--Not Available
Sleep disorder19.02.04.001--Not Available
Smear cervix abnormal13.20.02.001--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Speech disorder22.12.03.027; 17.02.08.003; 19.19.02.002--Not Available
Splenomegaly01.09.02.001--Not Available
Stomatitis07.05.06.005--
Stupor19.02.05.004; 17.02.04.007--Not Available
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