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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Foetal heart rate decreased13.21.01.003-Not Available
Foetal heart rate abnormal13.21.01.001-Not Available
Pruritus generalised23.03.12.003-Not Available
Musculoskeletal stiffness15.03.01.005--Not Available
Musculoskeletal discomfort15.03.04.001-Not Available
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
Trisomy 1819.21.06.004; 17.03.07.004; 03.12.01.002; 02.08.01.003-Not Available
Nodule08.03.05.002-Not Available
Affect lability19.04.01.001--Not Available
Foetal death18.01.02.003; 08.04.01.011-
Haemorrhage24.07.01.002--Not Available
Vulvovaginal pruritus21.08.02.004; 23.03.12.009-Not Available
Urine odour abnormal20.02.01.020-Not Available
Paraesthesia oral17.02.06.008; 07.05.03.003-Not Available
Bipolar disorder19.16.01.003-Not Available
Injection site nodule12.07.03.034; 08.02.03.034; 23.07.04.009--Not Available
Hepatic enzyme increased13.03.01.019--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027-
Amniotic cavity infection18.05.01.004; 11.01.10.014-Not Available
Hormone level abnormal13.10.10.001-Not Available
Limb discomfort15.03.04.014-Not Available
Uterine contractions abnormal21.07.03.003; 18.07.02.002-Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Respiratory disorder neonatal22.11.01.002; 18.04.09.002-Not Available
Sensation of foreign body08.01.09.002-Not Available
Unevaluable event08.01.03.051--Not Available
Pelvic discomfort21.10.01.012; 20.02.03.012; 07.01.06.020-Not Available
Joint instability15.01.08.007-Not Available
Treatment failure08.06.01.017--Not Available
Shortened cervix21.06.01.009-Not Available
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