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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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-Not Available
Foetal macrosomia18.03.01.003-Not Available
Bradycardia neonatal18.04.07.004; 02.03.02.019-Not Available
Cervix enlargement21.06.01.010-Not Available
Head deformity15.10.05.005-Not Available
Placenta accreta18.05.02.003-Not Available
Anaemia of pregnancy01.03.01.006; 18.02.02.012; 14.13.02.003-Not Available
Amniorrhoea18.05.01.005-Not Available
Delivery18.08.02.006-Not Available
Foetal hypokinesia18.03.02.015-Not Available
Preterm premature rupture of membranes18.02.02.016-Not Available
Nonreassuring foetal heart rate pattern18.03.02.017; 02.03.02.027-Not Available
Poor feeding infant18.04.06.006; 14.03.02.022-Not Available
ABO incompatibility18.04.18.001; 12.02.08.008; 10.02.04.002; 01.06.01.005-Not Available
Allergic reaction to excipient10.01.01.035-Not Available
Cervical dilatation18.08.02.008-Not Available
Foetal malpresentation18.03.04.005-Not Available
High risk pregnancy18.08.04.001-Not Available
Injection site hypoaesthesia17.02.06.051; 12.07.03.060; 08.02.03.060-Not Available
Injection site laceration23.03.11.036; 12.07.03.063; 08.02.03.063-Not Available
Injection site movement impairment12.07.03.065; 08.02.03.065-Not Available
Injection site scab08.02.03.069; 23.03.03.088; 12.07.03.069-Not Available
Labia enlarged21.08.02.020-Not Available
Limb mass15.03.05.019-Not Available
Morning sickness18.02.02.022; 07.01.07.018-Not Available
Neonatal dyspnoea22.11.01.012; 18.04.09.012; 02.11.05.008-Not Available
Neonatal respiratory distress22.11.02.015; 18.04.10.004-Not Available
Placental transfusion syndrome18.05.02.010; 01.05.01.031-Not Available
Polymorphic eruption of pregnancy23.03.04.049; 18.02.02.023-Not Available
Pubic pain15.02.01.009-Not Available
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