Medications and Drugs

Brand Names: Makena, Prodrox

Generic Name: hydroxyprogesterone (Pronunciation: hye DROX ee pro JES te rone)

What is hydroxyprogesterone (Makena, Prodrox)?

Hydroxyprogesterone is a form of progestin, a manmade form of a female hormone called progesterone.

Hydroxyprogesterone is used to lower the risk of premature birth in a woman who has already had one premature baby. This medication will not stop premature labor that has already begun.

Hydroxyprogesterone is not for use in women who have had more than one pregnancy.

Hydroxyprogesterone may also be used for purposes not listed in this medication guide.

What are the possible side effects of hydroxyprogesterone (Makena, Prodrox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;
swelling, oozing, bleeding, or worsening pain where the injection was given;
sudden severe headache, confusion, problems with vision, speech, or balance;
pain, swelling, warmth, or redness in one or both legs;
jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet; or
symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild itching;
nausea, diarrhea; or
pain, bruising, itching, swelling, or a hard lump where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hydroxyprogesterone (Makena, Prodrox)?

You should not use this medication if you are allergic to hydroxyprogesterone or castor oil, or if you have unusual vaginal bleeding, liver disease or liver cancer, breast cancer, uterine cancer, uncontrolled high blood pressure, a history of jaundice caused by pregnancy, or a history of stroke, blood clot, or circulation problems.

Before you receive hydroxyprogesterone, tell your doctor if you have eclampsia or preeclampsia, kidney disease, high blood pressure, heart disease, migraine headaches, a personal or family history of diabetes, asthma, seizures, depression, or fluid retention.

Your doctor will need to check your progress on a regular basis while you are using this medication. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

Call your doctor at once if you have sudden numbness or weakness, confusion, problems with vision or speech, jaundice (yellowing of the skin or eyes), swelling in your hands or feet, pain or redness in one or both legs, or symptoms of depression (sleep problems, weakness, mood changes).

There are many other drugs that may interact with hydroxyprogesterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.

What should I discuss with my healthcare provider before receiving hydroxyprogesterone (Makena, Prodrox)?»

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.