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)
Genitourinary tract neoplasm16.15.01.001; 21.10.02.004; 20.08.01.003--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Polyp08.01.06.010; 16.02.02.005--Not Available
Blood disorder01.05.01.004--Not Available
Cervix carcinoma stage 021.06.02.002; 16.12.01.002--Not Available
Pigmentation disorder23.05.03.001--Not Available
Urine analysis abnormal13.13.02.008--Not Available
Urethritis noninfective20.07.02.002--Not Available
Cystitis noninfective20.03.02.001--
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Ulcerative keratitis10.02.01.021; 06.04.02.004--
Tendon pain15.07.01.009--Not Available
Liver injury12.01.17.012; 09.01.07.022--Not Available
Immediate post-injection reaction10.01.03.032; 08.06.01.019--Not Available
Skin mass23.07.04.014--Not Available
Nail atrophy23.02.05.010--Not Available
Anorectal discomfort07.03.03.003--Not Available
Candida infection11.03.03.021--
Anal incontinence17.05.01.021; 07.01.06.029--
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Dilated cardiomyopathy02.04.01.017--Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Intermenstrual bleeding21.01.01.015--Not Available
Vulvovaginal inflammation21.14.02.014--Not Available
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