Note: This document contains side effect information about hydroxyprogesterone. Some dosage forms listed on this page may not apply to the brand name Makena.
Summary
Common side effects of Makena include: urticaria and swelling at injection site. Other side effects include: pruritus. Continue reading for a comprehensive list of adverse effects.
Applies to hydroxyprogesterone: parenteral injection for im use.
Warning
Special Alerts:
A standardized concentration for this drug has been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. The drug is included in a standard concentration list which may apply to an IV or oral compounded liquid formulation. For additional information, see the ASHP website [Web].
DRUG is no longer commercially available in the U.S. See the FDA website ([Web]) for information on drugs that have been discontinued.
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
