Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Glatiramer
Drug ID BADD_D01020
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 65370
TTD Drug ID D04CRL
NDC Product Code 0378-6961; 41524-0004
UNII U782C039QP
Synonyms Glatiramer Acetate | Acetate, Glatiramer | Copaxone | Glatiramer | TV 5010 | 5010, TV | TV5010 | TV-5010
Chemical Information
Molecular Formula C23H41N5O11
CAS Registry Number 28704-27-0
SMILES CC(C(=O)O)N.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)
Malnutrition14.03.02.004---
Mediastinal disorder22.09.03.001---
Mental disorder19.07.01.002---
Erectile dysfunction19.08.04.001; 21.03.01.007--
Polyp08.01.06.010; 16.02.02.005---
Blood disorder01.05.01.004---
Cervix carcinoma stage 016.12.01.002; 21.06.02.002---
Respiratory tract infection viral11.05.04.003; 22.07.07.002---
Urine analysis abnormal13.13.02.008---
Urethritis noninfective20.07.02.002---
Vulvovaginal mycotic infection11.03.05.004; 21.14.02.004---
Ulcerative keratitis06.04.02.004; 10.02.01.021--
Tendon pain15.07.01.009---
Liver injury09.01.07.022; 12.01.17.012---
Anorectal discomfort07.03.03.003---
Candida infection11.03.03.021--
Depersonalisation/derealisation disorder19.14.01.004---
Heavy menstrual bleeding21.01.03.005---
Vulvovaginal inflammation21.14.02.014---
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