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Prodrox Side Effects

Generic Name: hydroxyprogesterone

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 Prodrox.

For the Consumer

Applies to hydroxyprogesterone: intramuscular oil, intramuscular solution

Along with its needed effects, hydroxyprogesterone (the active ingredient contained in Prodrox) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking hydroxyprogesterone:

More Common

  • Pain, itching, or swelling at the injection site

Less Common

  • Small lumps at the injection site

Incidence Not Known

Some side effects of hydroxyprogesterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

For Healthcare Professionals

Applies to hydroxyprogesterone: compounding powder, intramuscular solution, subcutaneous solution


Genitourinary side effects have included admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios. Postmarketing side effects include urinary tract infection, cervical incompetence, premature rupture of membranes, cervical dilation, and shortened cervix.[Ref]


Local side effects have included injection site pain, swelling, pruritus, and nodules. Postmarketing side effects include local injection site reactions of erythema, urticaria, rash, irritation, hypersensitivity, and warmth.[Ref]


Gastrointestinal side effects have included nausea and diarrhea. Postmarketing side effects include vomiting.[Ref]


Dermatologic side effects have included pruritus and urticaria. Postmarketing side effects include rash.[Ref]

Nervous system

Nervous system side effects include postmarketing reports of headache and dizziness.


Respiratory side effects include postmarketing reports of dyspnea and chest discomfort.


Other side effects include postmarketing reports of fatigue, fever, and hot flashes/flushes.


1. "Product Information. Makena (hydroxyprogesterone)." Ther-Rx Corporation, Bridgeton, MO.

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.