Makena Side Effects Center

Last updated on RxList: 10/13/2021
Makena Side Effects Center

What Is Makena?

Makena (hydroxyprogesterone caproate) is a prescription hormone medicine (progestin) used in women who are pregnant with only one baby and who have delivered a premature baby in the past. Makena is used in these women to help lower the risk of having a preterm baby again. Makena is not intended for use to stop active preterm labor.

What Are Side Effects of Makena?

Common side effects of Makena include:

Tell your doctor if you have serious side effects of Makena including sudden numbness or weakness, especially on one side of the body; 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; yellowing of the skin or eyes (jaundice); swelling in your hands, ankles, or feet; or symptoms of depression (sleep problems, weakness, mood changes).

Additional Information

Our Makena (hydroxyprogesterone caproate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

16 Early Signs & Symptoms of Pregnancy: Could You Be Pregnant? See Slideshow
Makena Consumer Information

1 pharmacies near 20147 have coupons for Makena (Brand Names:Makena for 1ML of 250MG/ML)

Wegmans Food Markets Inc
Wegmans Food Markets Inc
$1023.83

Est. Regular Price

$131.98

with free coupon

View Coupon

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

Call your doctor at once if you have:

  • swelling, oozing, bleeding, or worsening pain where the injection was given;
  • jaundice (yellowing of the skin or eyes);
  • symptoms of depression (sleep problems, weakness, mood changes);
  • swelling in your hands, ankles, or feet;
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

  • pain, swelling, itching, rash, or a lump where the medicine was injected;
  • nausea; or
  • diarrhea.

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.

Read the entire detailed patient monograph for Makena (Hydroxyprogesterone Caproate Injection)

QUESTION

The first sign of pregnancy is most often: See Answer
Makena Professional Information

SIDE EFFECTS

For the most serious adverse reactions to the use of progestins, see WARNINGS AND PRECAUTIONS.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a vehicle (placebo)-controlled clinical trial of 463 pregnant women at risk for spontaneous preterm delivery based on obstetrical history, 310 received 250 mg of Makena and 153 received a vehicle formulation containing no drug by a weekly intramuscular injection beginning at 16 to 20 weeks of gestation and continuing until 37 weeks of gestation or delivery, whichever occurred first. [See Clinical Studies]

Certain pregnancy-related fetal and maternal complications or events were numerically increased in the Makena-treated subjects as compared to control subjects, including miscarriage and stillbirth, admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios (Tables 1 and 2).

Table 1 Selected Fetal Complications

Pregnancy Complication Makena
n/N
Control
n/N
Miscarriage (< 20 weeks)1 5/209 0/107
Stillbirth (≥ 20 weeks)2 6/305 2/153
1N = Total number of subjects enrolled prior to 20 weeks 0 days
2N = Total number of subjects at risk ≥ 20 weeks

Table 2 Selected Maternal Complications

Pregnancy Complication Makena
N=310
%
Control
N=153
%
Admission for preterm labor1 16.0 13.8
Preeclampsia or gestational hypertension 8.8 4.6
Gestational diabetes 5.6 4.6
Oligohydramnios 3.6 1.3
1 Other than delivery admission.

Common Adverse Reactions

The most common adverse reaction with intramuscular injection was injection site pain, which was reported after at least one injection by 34.8% of the Makena group and 32.7% of the control group. Table 3 lists adverse reactions that occurred in ≥ 2% of subjects and at a higher rate in the Makena group than in the control group.

Table 3 Adverse Reactions Occurring in ≥ 2% of Makena-Treated Subjects and at a Higher Rate than Control Subjects

Preferred Term Makena
N=310
%
Control
N=153
%
Injection site pain 34.8 32.7
Injection site swelling 17.1 7.8
Urticaria 12.3 11.1
Pruritus 7.7 5.9
Injection site pruritus 5.8 3.3
Nausea 5.8 4.6
Injection site nodule 4.5 2.0
Diarrhea 2.3 0.7

In the clinical trial using intramuscular injection, 2.2% of subjects receiving Makena were reported as discontinuing therapy due to adverse reactions compared to 2.6% of control subjects. The most common adverse reactions that led to discontinuation in both groups were urticaria and injection site pain/swelling (1% each).

Pulmonary embolus in one subject and injection site cellulitis in another subject were reported as serious adverse reactions in Makena-treated subjects.

Two clinical studies were conducted in healthy post-menopausal women, comparing Makena administered via subcutaneous auto-injector to Makena administered as an intramuscular injection. In the first study, injection site pain occurred in 3/30 (10%) of subjects who used the subcutaneous auto-injector vs. 2/30 (7%) of subjects receiving intramuscular injection. In the second study, injection site pain occurred in 20/59 (34%) of subjects who used the subcutaneous auto-injector vs. 5/61 (8%) of subjects receiving intramuscular injection.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Makena. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Body as a whole: Local injection site reactions (including erythema, urticaria, rash, irritation, hypersensitivity, warmth); fatigue; fever; hot flashes/flushes
  • Digestive disorders: Vomiting
  • Infections: Urinary tract infection
  • Nervous system disorders: Headache, dizziness
  • Pregnancy, puerperium and perinatal conditions: Cervical incompetence, premature rupture of membranes
  • Reproductive system and breast disorders: Cervical dilation, shortened cervix
  • Respiratory disorders: Dyspnea, chest discomfort
  • Skin: Rash

Read the entire FDA prescribing information for Makena (Hydroxyprogesterone Caproate Injection)

© Makena Patient Information is supplied by Cerner Multum, Inc. and Makena Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors