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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Ear infection04.03.01.006; 11.01.05.001--Not Available
Emotional disorder19.04.02.005-Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.001-Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.003--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Feeling hot08.01.09.009-Not Available
Flatulence07.01.04.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Foetal distress syndrome18.03.02.003-Not Available
Fungal infection11.03.05.001-Not Available
Gait disturbance17.02.05.016; 08.01.02.002-
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis viral11.05.04.005; 07.19.03.005--Not Available
Gestational diabetes18.02.04.001; 14.06.01.008; 05.06.01.008-Not Available
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haemorrhage in pregnancy18.02.01.003; 24.07.03.015-Not Available
Headache17.14.01.001-
Heart disease congenital02.01.01.009; 03.07.07.001--Not Available
Heart rate increased13.14.04.002-Not Available
Hepatic failure09.01.03.002--
Herpes simplex23.09.03.001; 11.05.02.001-Not Available
Hunger14.03.02.012; 08.01.09.003-Not Available
Hyperemesis gravidarum18.02.02.010; 07.01.07.009-Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003-
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023-Not Available
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