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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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-
Hypoaesthesia17.02.06.023; 23.03.03.081--
Hypoglycaemia neonatal05.06.03.006; 14.06.03.006; 18.04.06.003--
Injection site bruising08.02.03.042; 12.07.03.042; 23.03.11.015; 24.07.06.017--
Injection site erythema08.02.03.001; 12.07.03.001; 23.03.06.015--
Injection site extravasation08.02.03.002; 12.07.03.002--
Injection site haemorrhage08.02.03.005; 12.07.03.005; 24.07.01.010--
Injection site hypersensitivity08.02.03.006; 10.01.03.017; 12.07.03.006--
Injection site induration08.02.03.007; 12.07.03.007--
Injection site inflammation08.02.03.008; 12.07.03.009--
Injection site irritation08.02.03.027; 12.07.03.027--
Injection site mass08.02.03.009; 12.07.03.010--
Injection site oedema08.02.03.024; 12.07.03.024--
Injection site pain08.02.03.010; 12.07.03.011--
Injection site paraesthesia08.02.03.049; 12.07.03.049; 17.02.06.029--
Injection site pruritus08.02.03.013; 12.07.03.014; 23.03.12.007--
Injection site rash08.02.03.032; 12.07.03.032; 23.03.13.010--
Injection site reaction08.02.03.014; 12.07.03.015-
Injection site urticaria08.02.03.029; 10.01.06.003; 12.07.03.029; 23.04.02.003--
Injection site vesicles08.02.03.051; 12.07.03.051; 23.03.01.024--
Injection site warmth08.02.03.036; 12.07.03.036--
Jaundice neonatal01.06.04.006; 09.01.01.008; 18.04.08.001--
Mass08.03.05.003--
Migraine17.14.02.001; 24.03.05.003--
Migraine with aura17.14.02.002; 24.03.05.005--
Mood swings19.04.03.001--
Muscle contractions involuntary15.05.03.008; 17.05.03.001--
Muscle spasms15.05.03.004-
Nausea07.01.07.001--
Oligohydramnios18.05.01.001--
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