Duralutin Side Effects
Generic name: hydroxyprogesterone
Medically reviewed by Drugs.com. Last updated on Aug 11, 2020.
Note: This document contains side effect information about hydroxyprogesterone. Some of the dosage forms listed on this page may not apply to the brand name Duralutin.
For the Consumer
Applies to hydroxyprogesterone: parenteral injection for im use
Side effects include:
For Healthcare Professionals
Applies to hydroxyprogesterone: compounding powder, intramuscular solution, subcutaneous solution
The most commonly reported adverse reaction is injection site pain.
Injection site cellulitis was reported in 1 subject. In a study that compared IM injection to subcutaneous auto-injector, injection site pain was reported in 10% of subjects receiving drug via the auto-injector compared with 7% receiving an IM injection. In a second study, 34% reported injection site pain with the auto-injector and 8% with IM injection.[Ref]
Very common (10% or more): Injection site pain (up to 34.8%), injection site swelling (up to 17.1%)
Common (1% to 10%): Injection site pruritus, injection site nodules
Frequency not reported: Injection site cellulitis
Common (1% to 10%): Pregnancy complications
Postmarketing reports: Cervical incompetence, premature rupture of membranes
Certain pregnancy-related fetal and maternal complications or events were numerically increased in patients receiving this drug compared with placebo including miscarriage at less than 20 weeks (5/209 vs 0/107), stillbirth (6/302 vs 2/153), admission for preterm labor (16% vs 13.8%), preeclampsia or gestation hypertension (8.8% vs 4.6%), gestational diabetes (5.6% vs 4.6%), and oligohydramnios (3.6% vs 1.3%).
Frequency not reported: Admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, oligohydramnios
Postmarketing reports: Urinary tract infection, cervical incompetence, premature rupture of membranes, cervical dilation, shortened cervix[Ref]
Common (1% to 10%): Nausea, diarrhea
Very common (10% or more): Urticaria (12.3%)
Common (1% to 10%): Pruritus
Postmarketing reports: Rash[Ref]
Pulmonary embolus was reported in 1 patient.
Frequency not reported: Pulmonary embolus
Postmarketing reports: Dyspnea, chest discomfort
Postmarketing reports: Fatigue, fever, hot flashes/flushes
More about Duralutin (hydroxyprogesterone)
- Other brands
1. "Product Information. Makena (hydroxyprogesterone)." Ther-Rx Corporation, Bridgeton, MO.
Some side effects may not be reported. You may report them to the FDA.