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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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 Prescription; Discontinued
ATC Code G03DA03
DrugBank ID DB06789
KEGG ID D00949
MeSH ID D000077713
PubChem ID 169870
TTD Drug ID Not Available
NDC Product Code 71225-104; 0517-1767; 71052-200; 69238-1797; 55150-309; 67457-886; 55150-310; 66993-039; 73301-001; 67457-967; 55150-311; 64011-301; 51927-2733; 51552-1028; 60870-0408; 18124-016; 64011-243; 64025-0003; 71225-105; 0517-1791; 62756-303; 22552-0045; 47335-037; 66993-038; 64011-247
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypoglycaemia neonatal18.04.06.003; 05.06.03.006; 14.06.03.006-Not Available
Hypotension24.06.03.002--
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.010--
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Irritability19.04.02.013; 08.01.03.011--
Jaundice neonatal18.04.08.001; 09.01.01.008; 01.06.04.006-Not Available
Joint stiffness15.01.02.003--Not Available
Joint swelling15.01.02.004--Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Lip swelling10.01.05.005; 07.05.04.005; 23.04.01.007--Not Available
Listeriosis11.02.11.001-Not Available
Liver disorder09.01.08.001--Not Available
Loss of consciousness17.02.04.004--Not Available
Malaise08.01.01.003--
Migraine24.03.05.003; 17.14.02.001-Not Available
Migraine with aura24.03.05.005; 17.14.02.002-Not Available
Miosis17.02.11.002; 06.05.03.003--Not Available
Mood altered19.04.02.007-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-
Muscular weakness17.05.03.005; 15.05.06.001--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nasal congestion22.04.04.001--
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