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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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)
Abortion18.01.01.001-Not Available
Abortion missed18.01.01.002-Not Available
Abortion spontaneous18.01.04.001-Not Available
Anaemia neonatal18.04.03.002; 01.03.02.011-Not Available
Aneurysm24.02.01.001-Not Available
Asthma22.03.01.002; 10.01.03.010-Not Available
Back pain15.03.04.005-
Bradycardia foetal18.03.02.006; 02.03.02.018-Not Available
Breast pain21.05.05.003-
Breech presentation18.03.04.001-Not Available
Burning sensation17.02.06.001; 08.01.09.029-Not Available
Carpal tunnel syndrome17.09.02.001-Not Available
Cervical incompetence18.02.02.009; 21.06.01.008-Not Available
Cervix disorder21.06.01.003-Not Available
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.009-Not Available
Cough22.02.03.001-
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.005-Not Available
Death neonatal18.04.01.002; 08.04.01.002-
Diarrhoea07.02.01.001--
Discomfort08.01.08.003-Not Available
Dry throat22.12.03.005; 07.06.01.005-Not Available
Emotional disorder19.04.02.005-Not Available
Erythema23.03.06.001-Not Available
Feeling hot08.01.09.009-Not Available
Foetal distress syndrome18.03.02.003-Not Available
Gestational diabetes18.02.04.001; 14.06.01.008; 05.06.01.008-Not Available
Haemorrhage in pregnancy24.07.03.015; 18.02.01.003-Not Available
Hunger14.03.02.012; 08.01.09.003-Not Available
Hydrops foetalis18.03.02.008-Not Available
Hyperemesis gravidarum18.02.02.010; 07.01.07.009-Not Available
The 1th Page    1 2 3 4 5    Next   Last    Total 7 Pages