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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Pain in extremity15.03.04.010-
Panic attack19.06.04.001-Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012-
Petechiae01.01.03.002; 24.07.06.004; 23.06.01.003-Not Available
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.016-Not Available
Placental disorder18.05.02.001-Not Available
Polyhydramnios18.05.01.002-Not Available
Pre-eclampsia24.08.07.002; 20.01.08.002; 18.02.03.002-Not Available
Premature baby18.04.02.001-Not Available
Premature delivery18.07.01.006-
Premature labour18.07.01.002-Not Available
Premature rupture of membranes18.07.01.003-Not Available
Premature separation of placenta24.07.03.019; 18.02.01.004-Not Available
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.009-
Prolonged labour18.07.01.001-Not Available
Pruritus23.03.12.001-
Rash papular23.03.13.017-Not Available
Rash pruritic23.03.13.030-Not Available
Retained placenta or membranes18.07.04.004-Not Available
Sciatica17.10.03.001; 15.10.01.001-Not Available
Skin warm23.03.03.014-Not Available
Sluggishness08.01.01.004-Not Available
Stillbirth18.01.02.002; 08.04.01.006-Not Available
Swelling08.01.03.015-Not Available
Tenderness08.01.08.005-Not Available
Throat irritation22.12.03.029; 07.05.05.037-Not Available
Throat tightness22.12.03.031; 19.01.02.005-Not Available
Urticaria10.01.06.001; 23.04.02.001-
Uterine hypertonus21.07.03.004; 18.07.02.003-Not Available
Uterine leiomyoma21.07.02.004; 16.04.02.001-Not Available
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