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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Uterine spasm21.07.03.002-Not Available
Vaginal discharge21.08.02.002-
Vaginal haemorrhage24.07.03.005; 21.08.01.001-
Vaginal odour21.08.02.008-Not Available
Vasodilatation24.03.02.003; 23.06.05.006-Not Available
Vulvovaginal discomfort21.08.02.005-Not Available
Musculoskeletal disorder15.03.05.025-Not Available
Peripheral swelling08.01.03.053; 02.05.04.015-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
Injection site discolouration23.03.03.046; 12.07.03.038; 08.02.03.038-Not Available
Injection site swelling12.07.03.018; 08.02.03.017-Not Available
Nodule08.03.05.002-Not Available
Injection site discomfort08.02.03.018; 12.07.03.019-Not Available
Necrotising enterocolitis neonatal18.04.11.002; 07.08.03.011-Not Available
Foetal death18.01.02.003; 08.04.01.011-
Vulvovaginal pruritus23.03.12.009; 21.08.02.004-Not Available
Urine odour abnormal20.02.01.020-Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008-Not Available
Injection site nodule23.07.04.009; 12.07.03.034; 08.02.03.034-Not Available
Injection site scar12.07.03.050; 08.02.03.050; 23.03.11.016-Not Available
Induration08.01.03.020-Not Available
Limb discomfort15.03.04.014-Not Available
Temperature regulation disorder05.03.04.013; 08.05.01.004-Not Available
Uterine contractions abnormal18.07.02.002; 21.07.03.003-Not Available
Complication of pregnancy18.02.02.003-Not Available
Respiratory disorder neonatal22.11.01.002; 18.04.09.002-Not Available
Pelvic discomfort21.10.01.012; 20.02.03.012; 07.01.06.020-Not Available
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