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)
Gastric ulcer haemorrhage24.07.02.003; 07.04.03.005--Not Available
Gastritis07.08.02.001--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal carcinoma16.13.04.001; 07.21.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.004--
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Gingivitis07.09.10.002; 11.01.04.013--
Glaucoma06.03.01.002--
Glossodynia07.14.02.001--Not Available
Goitre05.02.01.001; 14.11.01.008--Not Available
Gout15.01.06.001; 14.09.01.001--Not Available
Haematemesis07.12.02.002; 24.07.02.011--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Hallucination19.10.04.003--
Headache17.14.01.001--
Heart sounds abnormal13.14.01.002--Not Available
Hepatic cirrhosis09.01.04.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.008--Not Available
Hepatomegaly09.01.05.001--Not Available
Hernia08.01.04.001--Not Available
Herpes simplex11.05.02.001; 23.11.05.004--Not Available
Herpes zoster23.11.05.005; 17.09.03.026; 11.05.02.003--
Hostility19.05.01.003--Not Available
Hydrocephalus17.07.01.001--
Hypercholesterolaemia14.08.01.001--Not Available
Hyperhidrosis08.01.03.028; 23.02.03.004--
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