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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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-Not Available
Adverse reaction08.06.01.018-Not Available
Low birth weight baby18.04.02.003-Not Available
Shortened cervix21.06.01.009-Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.008-Not Available
Vulvovaginal pain21.08.02.009-
Foetal growth restriction18.03.01.002-
Gestational hypertension24.08.07.004; 18.02.03.004-Not Available
Vulvovaginal swelling21.08.02.016-Not Available
Foetal heart rate deceleration abnormality18.03.02.012; 02.03.02.022-Not Available
Cyanosis neonatal22.11.02.003; 18.04.09.006-Not Available
Hyperbilirubinaemia neonatal18.04.08.003; 17.13.01.009; 14.11.01.038; 09.01.01.014-Not Available
Induced labour18.07.01.007-Not Available
Intraventricular haemorrhage neonatal24.07.04.029; 18.04.16.002; 17.08.01.053-Not Available
Large for dates baby18.04.02.004-Not Available
Macrosomia08.01.03.073-Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.003-Not Available
Placenta praevia18.05.02.004-Not Available
Placenta praevia haemorrhage24.07.03.026; 18.02.01.005-Not Available
Placental insufficiency24.04.12.002; 18.05.02.006-Not Available
Retained products of conception12.02.14.006; 18.01.03.006-Not Available
Shoulder dystocia18.03.04.002-Not Available
Small for dates baby18.04.02.002-Not Available
Threatened labour18.07.01.009-Not Available
Transient tachypnoea of the newborn22.11.01.010; 18.04.09.010-Not Available
Umbilical cord around neck18.04.14.004-Not Available
Umbilical cord prolapse18.04.14.005-Not Available
Umbilical cord abnormality18.04.14.003-Not Available
Cholestasis of pregnancy18.02.04.003; 09.01.01.013-Not Available
Laziness19.04.04.005-Not Available
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