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)
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Myelitis17.06.02.001; 11.01.03.007--
Myocardial infarction02.02.02.007; 24.04.04.009--
Myoclonus17.02.05.008--Not Available
Myopathy15.05.05.001--Not Available
Nail disorder23.02.05.002--
Nausea07.01.07.001--
Neck pain15.03.04.009--
Neoplasm16.16.02.001--Not Available
Nephrolithiasis20.04.01.002--
Nephrotic syndrome20.05.01.002--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Neuralgia17.02.07.005--
Nocturia20.02.03.001--Not Available
Nystagmus06.05.02.006; 17.02.02.006--
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophageal ulcer07.04.05.002--
Oesophagitis07.08.05.001--
Optic neuritis10.02.01.097; 17.04.05.001; 06.04.08.002--Not Available
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteomalacia14.04.04.001; 20.01.01.002; 15.02.03.001--Not Available
Osteomyelitis15.02.05.001; 11.01.01.001--
Otitis externa11.01.05.003; 04.01.02.001--
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