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Duralutin Side Effects

Generic Name: hydroxyprogesterone

Note: This page contains information about the side effects of hydroxyprogesterone. Some of the dosage forms included on this document may not apply to the brand name Duralutin.

For the Consumer

Applies to hydroxyprogesterone: intramuscular oil, intramuscular solution

In addition to its needed effects, some unwanted effects may be caused by hydroxyprogesterone (the active ingredient contained in Duralutin). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking hydroxyprogesterone, check with your doctor or nurse immediately:

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

Minor Side Effects

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

More common:
  • Hives or welts
  • itching
  • nausea
  • skin rash
Less common:
  • Diarrhea

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.

Not all side effects for Duralutin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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.