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)
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Injection site urticaria23.04.02.003; 12.07.03.029; 10.01.06.003; 08.02.03.029--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Laryngitis22.07.03.001; 11.01.13.001--
Laryngospasm22.04.02.002--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Lipoatrophy23.07.01.001; 14.08.04.006--
Lipoma15.09.01.001; 16.18.01.001--Not Available
Liver function test abnormal13.03.04.030--Not Available
Local reaction08.01.03.012--Not Available
Loss of consciousness17.02.04.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
Lymphoedema24.09.01.001; 01.09.01.006--
Malaise08.01.01.003--
Mania19.16.02.002--
Melaena24.07.02.013; 07.12.02.004--Not Available
Melanosis23.05.01.004--Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Meningitis17.06.03.001; 11.01.03.001--
Mental disability26.01.01.001--Not Available
Micturition urgency20.02.02.006--
Migraine24.03.05.003; 17.14.02.001--Not Available
Monoplegia17.01.04.003--Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.004--Not Available
Muscle atrophy15.05.03.003; 17.05.03.004--Not Available
Muscle disorder15.05.03.014--Not Available
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