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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Foetal cardiac disorder02.11.01.013; 18.03.02.013--
Foetal macrosomia18.03.01.003--
Bradycardia neonatal02.03.02.019; 18.04.07.004--
Cervix enlargement21.06.01.010--
Head deformity15.10.05.005--
Placenta accreta18.05.02.003--
Anaemia of pregnancy01.03.01.006; 14.13.02.003; 18.02.02.012--
Amniorrhoea18.05.01.005--
Delivery18.08.02.006--
Foetal hypokinesia18.03.02.015--
Preterm premature rupture of membranes18.02.02.016--
Nonreassuring foetal heart rate pattern02.03.02.027; 18.03.02.017--
Poor feeding infant14.03.02.022; 18.04.06.006--
ABO incompatibility01.06.01.005; 10.02.04.002; 12.02.08.008; 18.04.18.001--
Allergic reaction to excipient10.01.01.035--
Cervical dilatation18.08.02.008--
Foetal malpresentation18.03.04.005--
High risk pregnancy18.08.04.001--
Injection site hypoaesthesia08.02.03.060; 12.07.03.060; 17.02.06.051--
Injection site laceration08.02.03.063; 12.07.03.063; 23.03.11.036--
Injection site movement impairment08.02.03.065; 12.07.03.065--
Injection site scab08.02.03.069; 12.07.03.069; 23.03.03.088--
Labia enlarged21.08.02.020--
Limb mass15.03.05.019--
Morning sickness07.01.07.018; 18.02.02.022--
Neonatal dyspnoea02.11.05.008; 18.04.09.012; 22.11.01.012--
Neonatal respiratory distress18.04.10.004; 22.11.02.015--
Placental transfusion syndrome01.05.01.031; 18.05.02.010--
Polymorphic eruption of pregnancy18.02.02.023; 23.03.04.049--
Pubic pain15.02.01.009--
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