Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dinoprostone
Drug ID BADD_D00684
Description Dinoprostone is a naturally occurring prostaglandin E2 (PGE2). It has important effects in labour. It also stimulates osteoblasts to release factors which stimualtes bone resorption by osteoclasts. As a prescription drug it is used as a vaginal suppository, to prepare the cervix for labour and to induce labour.
Indications and Usage For the termination of pregnancy during the second trimester (from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period), as well as for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. Also used in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). Other indications include improving the cervical inducibility (cervical "ripening") in pregnant women at or near term with a medical or obstetrical need for labor induction, and the management of postpartum hemorrhage.
Marketing Status approved
ATC Code G02AD02
DrugBank ID DB00917
KEGG ID D00079
MeSH ID D015232
PubChem ID 5280360
TTD Drug ID D06FEA
NDC Product Code 0009-0058; 55566-2800; 82231-104; 68245-0015; 40016-012; 12079-0485; 45542-1153; 0009-3359
UNII K7Q1JQR04M
Synonyms Dinoprostone | PGE2 alpha | alpha, PGE2 | Prostaglandin E2alpha | E2alpha, Prostaglandin | Prostaglandin E2 | E2, Prostaglandin | Prostaglandin E2 alpha | E2 alpha, Prostaglandin | alpha, Prostaglandin E2 | PGE2 | PGE2alpha | Prepidil Gel | Gel, Prepidil | Prostenon
Chemical Information
Molecular Formula C20H32O5
CAS Registry Number 363-24-6
SMILES CCCCCC(C=CC1C(CC(=O)C1CC=CCCCC(=O)O)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)
Blood disorder01.05.01.004---
Vaginal oedema21.08.02.0100.000207%-
Uterine hyperstimulation18.07.02.008; 21.07.03.0060.000500%-
Anaphylactoid syndrome of pregnancy01.01.02.010; 10.01.07.005; 18.02.02.006; 22.06.02.004; 24.01.06.0040.000102%-
Post procedural infection11.01.08.019; 12.02.05.010---
Low birth weight baby18.04.02.0030.000041%-
Vulvovaginal burning sensation21.08.02.0070.000130%-
Vulvovaginal pain21.08.02.0090.000138%
Vulvovaginal erythema21.08.02.011; 23.03.06.0170.000110%-
Hypoxic-ischaemic encephalopathy17.13.02.006; 22.02.02.011; 24.04.06.0210.000061%-
Vulvovaginal swelling21.08.02.0160.000455%-
Foetal heart rate deceleration abnormality02.03.02.022; 18.03.02.0120.000211%-
Genito-pelvic pain/penetration disorder19.08.05.006; 21.03.02.022---
Abnormal labour affecting foetus18.03.03.003---
Neonatal asphyxia18.04.15.005; 22.11.02.0060.000305%-
Neonatal respiratory distress syndrome18.04.10.003; 22.11.02.010---
Transient tachypnoea of the newborn18.04.09.010; 22.11.01.0100.000041%-
Meconium in amniotic fluid18.05.01.007---
Meconium stain18.05.01.0080.000041%-
Nonreassuring foetal heart rate pattern02.03.02.027; 18.03.02.0170.000061%-
Encephalopathy neonatal17.13.02.014; 18.04.04.015---
Therapeutic product effect incomplete08.06.01.052---
Uterine tachysystole18.07.02.013; 21.07.03.0070.000289%-
Vulvovaginal inflammation21.14.02.014---
Labour pain18.08.02.009---
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ADReCS-Target
Drug Name ADR Term Target
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