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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Hypersensitivity10.01.03.003-
Hypoaesthesia23.03.03.081; 17.02.06.023-Not Available
Hypoglycaemia neonatal18.04.06.003; 14.06.03.006; 05.06.03.006-Not Available
Injection site bruising24.07.06.017; 23.03.11.015; 12.07.03.042; 08.02.03.042-Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001-Not Available
Injection site extravasation08.02.03.002; 12.07.03.002-Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005-Not Available
Injection site hypersensitivity12.07.03.006; 10.01.03.017; 08.02.03.006-Not Available
Injection site induration08.02.03.007; 12.07.03.007-Not Available
Injection site inflammation12.07.03.009; 08.02.03.008-Not Available
Injection site irritation12.07.03.027; 08.02.03.027-Not Available
Injection site mass12.07.03.010; 08.02.03.009-Not Available
Injection site oedema12.07.03.024; 08.02.03.024-Not Available
Injection site pain12.07.03.011; 08.02.03.010-Not Available
Injection site paraesthesia17.02.06.029; 12.07.03.049; 08.02.03.049-Not Available
Injection site pruritus08.02.03.013; 23.03.12.007; 12.07.03.014-Not Available
Injection site rash23.03.13.010; 12.07.03.032; 08.02.03.032-Not Available
Injection site reaction12.07.03.015; 08.02.03.014-
Injection site urticaria10.01.06.003; 08.02.03.029; 23.04.02.003; 12.07.03.029-Not Available
Injection site vesicles23.03.01.024; 12.07.03.051; 08.02.03.051-Not Available
Injection site warmth12.07.03.036; 08.02.03.036-Not Available
Jaundice neonatal18.04.08.001; 09.01.01.008; 01.06.04.006-Not Available
Mass08.03.05.003-Not Available
Migraine17.14.02.001; 24.03.05.003-Not Available
Migraine with aura24.03.05.005; 17.14.02.002-Not Available
Mood swings19.04.03.001-Not Available
Muscle contractions involuntary17.05.03.001; 15.05.03.008-Not Available
Muscle spasms15.05.03.004-
Nausea07.01.07.001--
Oligohydramnios18.05.01.001-Not Available
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