Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Elagolix
Drug ID BADD_D02496
Description Elagolix has been used in trials studying the basic science and treatment of Endometriosis, Folliculogenesis, Uterine Fibroids, Heavy Uterine Bleeding, and Heavy Menstrual Bleeding. As of 24 July 2018, however, the U.S. Food and Drug Administration (FDA) approved AbbVie's elagolix under the brand name Orilissa as the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain [F815]. It has been determined that endometriosis is one of the most common gynecologic disorders in the United States [A35868, A35869, F801]. In particular, estimates suggest that one in ten women of reproductive age is affected by endometriosis and experience debilitating pain symptoms [A35868, A35869, F801]. Moreover, women who are affected by this condition can suffer for up to six to ten years and visit multiple physicians before receiving a proper diagnosis [A35868, A35869, F801]. Subsequently, as Orilissa (elagolix) was approved by the FDA under priority review [F815], this expedited new approval gives healthcare professionals another valuable option for treating the potentially unmet needs of women who are affected by endometriosis, depending on their specific type and severity of endometriosis pain.
Indications and Usage Elagolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis [FDA Label].
Marketing Status Not Available
ATC Code H01CC03
DrugBank ID DB11979
KEGG ID D09335
MeSH ID C539351
PubChem ID 11250647
TTD Drug ID D0UI3T
NDC Product Code 0074-0039; 68513-0039; 68513-0038; 0074-0038
Synonyms elagolix | R-(+)-4-(2-(5-(2-fluoro-3-methoxyphenyl)-3-(2-fluoro-6-(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl)-1-phenylethylamino)butyrate | elagolix sodium | Orilissa
Chemical Information
Molecular Formula C32H30F5N3O5
CAS Registry Number 834153-87-6
SMILES CC1=C(C(=O)N(C(=O)N1CC2=C(C=CC=C2F)C(F)(F)F)CC(C3=CC=CC=C3)NCCCC(=O)O)C4=C(C(=CC =C4)OC)F
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.0010.003921%
Abdominal pain07.01.05.002--
Abortion spontaneous18.01.04.0010.003921%Not Available
Acne23.02.01.0010.003921%Not Available
Affective disorder19.04.04.0010.003921%Not Available
Alopecia23.02.02.0010.025483%
Amenorrhoea05.05.01.002; 21.01.02.0010.007841%
Anxiety19.06.02.0020.047046%
Arthralgia15.01.02.0010.047046%
Bone disorder15.02.04.0040.003921%Not Available
Bone pain15.02.01.0010.017642%
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.0030.005881%Not Available
Constipation07.02.02.0010.007841%
Crying08.01.03.005; 12.02.11.001; 17.02.05.013; 19.04.02.0020.007841%Not Available
Cyst08.03.05.001; 16.02.02.0020.003921%Not Available
Depressed mood19.15.02.0010.003921%Not Available
Depression19.15.01.0010.066649%
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.0070.031364%
Dry mouth07.06.01.0020.003921%
Dysmenorrhoea21.01.01.0020.007841%
Dyspareunia19.08.05.004; 21.03.02.0160.003921%
Dyspnoea02.01.03.002; 22.02.01.004--
Emotional disorder19.04.02.0050.003921%Not Available
Endometriosis21.07.01.0040.025483%Not Available
Eye swelling06.08.03.0030.003921%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.009801%Not Available
Galactorrhoea05.03.04.002; 21.05.02.0020.003921%Not Available
Headache17.14.01.0010.068609%
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