Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Hydroxyprogesterone caproate
Drug ID BADD_D01107
Description Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid). Hydroxyprogesterone caproate was previously marketed under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999. The U.S. FDA approved Makena from KV Pharmaceutical (previously named as Gestiva) on February 4, 2011 for prevention of preterm delivery in women with a history of preterm delivery, sparking a pricing controversy.
Indications and Usage Hydroxyprogesterone caproate is indicated for the prevention of spontaneous preterm births in singleton pregnancies in women who have previously had a spontaneous preterm birth. (1)
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB06789
KEGG ID D00949
MeSH ID D000077713
PubChem ID 169870
TTD Drug ID Not Available
NDC Product Code 51927-2733; 71052-200; 64011-247; 69238-1797; 62756-303; 64011-243; 22552-0045; 64025-0003; 71225-105; 67457-967; 0517-1767; 71225-104; 51552-1028; 18124-016; 47335-037; 67457-886; 64011-301; 0517-1791; 60870-0408; 55150-311
UNII 276F2O42F5
Synonyms 17 alpha-Hydroxyprogesterone Caproate | 17 alpha Hydroxyprogesterone Caproate | 17-alpha-Hydroxy-Progesterone Caproate | 17 alpha Hydroxy Progesterone Caproate | Caproate, 17-alpha-Hydroxy-Progesterone | Oxyprogesterone Caproate | Hydroxyprogesterone Caproate | Hydroxyprogesterone Hexanoate | 17 alpha-Oxyprogesterone Capronate | 17 alpha Oxyprogesterone Capronate | 17-Hydroxyprogesterone Capronate | 17 Hydroxyprogesterone Capronate | Prolutin Depot | Proluton Depot | Neolutin | Makena | Delalutin
Chemical Information
Molecular Formula C27H40O4
CAS Registry Number 630-56-8
SMILES CCCCCC(=O)OC1(CCC2C1(CCC3C2CCC4=CC(=O)CCC34C)C)C(=O)C
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)
Joint instability15.01.08.007--
Adverse reaction08.06.01.018--
Low birth weight baby18.04.02.003--
Shortened cervix21.06.01.009--
Oropharyngeal discomfort07.05.05.008; 22.12.03.015--
Vulvovaginal pain21.08.02.009-
Foetal growth restriction18.03.01.002-
Gestational hypertension18.02.03.004; 24.08.07.004--
Vulvovaginal swelling21.08.02.016--
Foetal heart rate deceleration abnormality02.03.02.022; 18.03.02.012--
Cyanosis neonatal18.04.09.006; 22.11.02.003--
Hyperbilirubinaemia neonatal09.01.01.014; 14.11.01.038; 17.13.01.009; 18.04.08.003--
Induced labour18.07.01.007--
Intraventricular haemorrhage neonatal17.08.01.053; 18.04.16.002; 24.07.04.029--
Large for dates baby18.04.02.004--
Macrosomia08.01.03.073--
Neonatal respiratory distress syndrome18.04.10.003; 22.11.02.010--
Placenta praevia18.05.02.004--
Placenta praevia haemorrhage18.02.01.005; 24.07.03.026--
Placental insufficiency18.05.02.006; 24.04.12.002--
Retained products of conception12.02.14.006; 18.01.03.006--
Shoulder dystocia18.03.04.002--
Small for dates baby18.04.02.002--
Threatened labour18.07.01.009--
Transient tachypnoea of the newborn18.04.09.010; 22.11.01.010--
Umbilical cord around neck18.04.14.004--
Umbilical cord prolapse18.04.14.005--
Umbilical cord abnormality18.04.14.003--
Cholestasis of pregnancy09.01.01.013; 18.02.04.003--
Laziness19.04.04.005--
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