Makena 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 Makena.

Some side effects of Makena may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to hydroxyprogesterone: intramuscular solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking hydroxyprogesterone (the active ingredient contained in Makena) 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 of hydroxyprogesterone 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.

For Healthcare Professionals

Applies to hydroxyprogesterone: compounding powder, intramuscular solution

Genitourinary

Genitourinary side effects have included admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios.

Local

Local side effects have included injection site pain, swelling, pruritus, and nodules.

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.

Dermatologic

Dermatologic side effects have included pruritus and urticaria.

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