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Hydroxyprogesterone Side Effects

Medically reviewed by Last updated on May 24, 2023.


Commonly reported side effects of hydroxyprogesterone 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.


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.


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

Postmarketing reports: Local injection site reactions of erythema, urticaria, rash, irritation, hypersensitivity, warmth[Ref]


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

Postmarketing reports: Vomiting[Ref]


Very common (10% or more): Urticaria (12.3%)

Common (1% to 10%): Pruritus

Postmarketing reports: Rash[Ref]

Nervous system

Postmarketing reports: Headache, dizziness


Pulmonary embolus was reported in 1 patient.

Frequency not reported: Pulmonary embolus

Postmarketing reports: Dyspnea, chest discomfort


Postmarketing reports: Fatigue, fever, hot flashes/flushes


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.