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)
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.000061%
Vaginal infection21.14.02.002; 11.01.10.002--
Vertigo17.02.12.002; 04.04.01.0030.000041%
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Vulvitis11.01.10.007; 21.14.02.006--
Vulvovaginal discomfort21.08.02.0050.000346%Not Available
Vulvovaginal dryness21.08.02.0030.000207%
Wheezing22.03.01.009--
Hypoacusis04.02.01.006--
Uterine contractions during pregnancy18.08.02.005--Not Available
Foetal acidosis18.03.02.0020.000061%Not Available
Foetal heart rate13.21.01.004--Not Available
Foetal heart rate abnormal13.21.01.001--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Foetal death18.01.02.003; 08.04.01.0110.000142%
Haemorrhage24.07.01.0020.000041%Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.0040.000207%Not Available
Nuchal rigidity15.05.04.005; 17.05.02.006--Not Available
Angiopathy24.03.02.007--Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.005--
Amniotic cavity infection18.05.01.004; 11.01.10.014--Not Available
Bladder disorder20.03.01.002--Not Available
Foetal disorder18.03.02.001--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Uterine contractions abnormal21.07.03.003; 18.07.02.0020.000110%Not Available
Vaginal disorder21.08.01.005--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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