Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gemeprost
Drug ID BADD_D01011
Description Gemeprost is a prostaglandin E1 (PGE1) analog and antiprogestogen used for preoperative dilation of the cervix before surgical abortion. It is available as vaginal suppositories and also used in combination with the antiprogestin and mifepristone for termination of 1st- and 2nd-trimester pregnancy [A19726]. It is not FDA-approved but available in Japan marketed as Preglandin.
Indications and Usage Indicated for the softening and dilatation of the cervix uteri prior to transcervical, intrauterine operative procedures in the first trimester of pregnancy or facilitating therapeutic termination of pregnancy in patients in the second trimester of gestation.
Marketing Status approved; withdrawn
ATC Code G02AD03
DrugBank ID DB08964
KEGG ID D02073
MeSH ID C021182
PubChem ID 5282237
TTD Drug ID D0EC5X
NDC Product Code Not Available
UNII 45KZB1FOLS
Synonyms gemeprost | 16,16-dimethyl-delta(2)-PGE1 methyl ester | Preglandin | 16,16-DMTDPGEME | 16,16-dimethyl-delta(2)-prostaglandin E1 methyl ester | Cervagem | Cervagème | gemeprost, (2E,11alpha,13E,15R)-isomer | PG802 | Cergem | 16,16-dimethyl-trans-delta(2)-PGE(1) methyl ester | 16,16-dimethyl-trans-delta(2)-prostaglandin E(1) methyl ester | ONO 802 | ONO-802
Chemical Information
Molecular Formula C23H38O5
CAS Registry Number 64318-79-2
SMILES CCCCC(C)(C)C(C=CC1C(CC(=O)C1CCCCC=CC(=O)OC)O)O
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)
Abdominal pain lower07.01.05.010---
Anaphylactic shock10.01.07.002; 24.06.02.004---
Arteriospasm coronary02.02.02.005; 12.02.01.031; 24.04.04.005---
Back pain15.03.04.005--
Body temperature increased13.15.01.001---
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Chills08.01.09.001; 15.05.03.016--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysmenorrhoea21.01.01.002--
Dyspnoea02.11.05.003; 22.02.01.004--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Headache17.14.01.001--
Hypotension24.06.03.002--
Muscular weakness15.05.06.001; 17.05.03.005--
Myocardial infarction02.02.02.007; 24.04.04.009--
Nausea07.01.07.001--
Palpitations02.11.04.012--
Surgery25.01.02.003---
Tachycardia02.03.02.007---
Uterine pain21.07.01.008--
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Vomiting07.01.07.003--
Acute coronary syndrome02.02.02.015; 24.04.04.011---
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