Skip to Content

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.

In Summary

Common side effects of Makena include: urticaria and swelling at injection site. Other side effects include: pruritus. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to hydroxyprogesterone: intramuscular oil, intramuscular solution

Along with its needed effects, hydroxyprogesterone (the active ingredient contained in Makena) 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
  • Anxiety
  • chest pain
  • cough
  • dizziness or lightheadedness
  • fainting
  • fast heartbeat
  • redness, tenderness, or warmth on the skin
  • sudden shortness of breath or troubled breathing

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


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.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.