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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Tinnitus17.04.07.004; 04.04.01.002--
Tremor17.01.06.002--
Trisomy 2117.03.07.005; 03.12.01.003; 02.08.02.003; 19.21.06.005-Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001-
Uterine haemorrhage24.07.03.004; 21.07.01.005-
Uterine hypertonus21.07.03.004; 18.07.02.003-Not Available
Uterine leiomyoma21.07.02.004; 16.04.02.001-Not Available
Uterine rupture21.07.01.009; 18.02.02.001; 12.01.15.001-Not Available
Uterine spasm21.07.03.002-Not Available
Vaginal discharge21.08.02.002-
Vaginal haemorrhage24.07.03.005; 21.08.01.001-
Vaginal infection21.14.02.002; 11.01.10.002-
Vaginal odour21.08.02.008-Not Available
Vasodilatation24.03.02.003; 23.06.05.006-Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.003--
Vulvovaginal discomfort21.08.02.005-Not Available
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Musculoskeletal disorder15.03.01.004-Not Available
Peripheral swelling02.05.04.015; 08.01.03.053-Not Available
Emotional distress19.04.02.008--Not Available
Abasia17.02.05.035; 08.01.02.007--Not Available
Muscle tightness15.05.03.007-Not Available
Uterine contractions during pregnancy18.08.02.005-Not Available
Impatience19.05.01.014-Not Available
Cervix haemorrhage uterine24.07.03.011; 21.06.01.005-Not Available
Contusion12.01.06.001; 24.07.06.001; 23.03.11.002; 15.03.01.008-
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