Hyprogesterone Side Effects
Generic name: hydroxyprogesterone
Medically reviewed by Drugs.com. Last updated on Dec 22, 2022.
Note: This document contains side effect information about hydroxyprogesterone. Some dosage forms listed on this page may not apply to the brand name Hyprogesterone.
Applies to hydroxyprogesterone: parenteral injection for im use.
Side effects include:
Injection site reactions (pain, swelling, pruritus, nodule), urticaria, pruritus, nausea, diarrhea.
For Healthcare Professionals
Applies to hydroxyprogesterone: compounding powder, intramuscular solution, subcutaneous solution.
General
The most commonly reported adverse reaction is injection site pain.
Local
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
Postmarketing reports: Local injection site reactions of erythema, urticaria, rash, irritation, hypersensitivity, warmth[Ref]
Endocrine
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%).
Genitourinary
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]
Gastrointestinal
Common (1% to 10%): Nausea, diarrhea
Postmarketing reports: Vomiting[Ref]
Dermatologic
Very common (10% or more): Urticaria (12.3%)
Common (1% to 10%): Pruritus
Postmarketing reports: Rash[Ref]
Nervous system
Postmarketing reports: Headache, dizziness
Respiratory
Pulmonary embolus was reported in 1 patient.
Frequency not reported: Pulmonary embolus
Postmarketing reports: Dyspnea, chest discomfort
Other
Postmarketing reports: Fatigue, fever, hot flashes/flushes
More about Hyprogesterone (hydroxyprogesterone)
Patient resources
Other brands
Professional resources
References
1. "Product Information. Makena (hydroxyprogesterone)." Ther-Rx Corporation (2011):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
