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Makena

Generic Name: hydroxyprogesterone injection (hye DROX ee pro JES te rone)
Brand Names: Makena
Makena (hydroxyprogesterone) is used to lower the risk of premature birth in women who have already had one premature baby. Includes Makena side effects, interactions and indications.
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Drug Information:
Makena (hydroxyProgesterone) is a form of progestin, a manmade form of a female hormone called Progesterone. Makena is used to lower the risk of premature birth in a woman who has already had one premature baby. Makena will not stop premature labor that has already begun. Makena is not for use in women who are pregnant with more than one baby (twins, triplets, etc). HydroxyProgesterone may also be used for purposes not listed in this medication guide. You should not use Makena if you have: uncontrolled high blood pressure, unusual vaginal bleeding, liver disease or liver cancer, jaundice caused by your pregnancy, or if you have ever had circulation problems, a stroke or blood clot, or cancer of the breast, uterus/cervix, or vagina. Learn more

Makena Side Effects

Makena Side Effects

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: parenteral injection for im use

Side effects include:

Injection site reactions (pain, swelling, pruritus, nodule), urticaria, pruritus, nausea, diarrhea.

For Healthcare Professionals

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

General

The most commonly reported adverse reaction is injection site pain.

Local

Injection site cellulitis was reported in 1 subject. In a study that compared IM injection to subcutaneous auto-injector, injection site pain was reported in 10% of subjects receiving drug via the auto-injector compared with 7% receiving an IM injection. In a second study, 34% reported injection site pain with the auto-injector and 8% with IM injection.

Very common (10% or more): Injection site pain (up to 34.8%), injection site swelling (up to 17.1%)

Common (1% to 10%): Injection site pruritus, injection site nodules

Frequency not reported: Injection site cellulitis

Postmarketing reports: Local injection site reactions of erythema, urticaria, rash, irritation, hypersensitivity, warmth

Endocrine

Common (1% to 10%): Pregnancy complications

Postmarketing reports: Cervical incompetence, premature rupture of membranes

Certain pregnancy-related fetal and maternal complications or events were numerically increased in patients receiving this drug compared with placebo including miscarriage at less than 20 weeks (5/209 vs 0/107), stillbirth (6/302 vs 2/153), admission for preterm labor (16% vs 13.8%), preeclampsia or gestation hypertension (8.8% vs 4.6%), gestational diabetes (5.6% vs 4.6%), and oligohydramnios (3.6% vs 1.3%).

Genitourinary

Frequency not reported: Admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, oligohydramnios

Postmarketing reports: Urinary tract infection, cervical incompetence, premature rupture of membranes, cervical dilation, shortened cervix

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea

Postmarketing reports: Vomiting

Dermatologic

Very common (10% or more): Urticaria (12.3%)

Common (1% to 10%): Pruritus

Postmarketing reports: Rash

Nervous system

Postmarketing reports: Headache, dizziness

Respiratory

Frequency not reported: Pulmonary embolus

Postmarketing reports: Dyspnea, chest discomfort

Pulmonary embolus was reported in 1 patient.

Other

Postmarketing reports: Fatigue, fever, hot flashes/flushes

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Makena (www.drugs.com/makena.html).