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Makena Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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. Common side effects of Makena include itching, nausea, diarrhea, injection site reactions (bruising, itching, swelling, or a hard lump), hives, blood clots, allergic reactions, fluid retention, high blood pressure (hypertension), migraine, depression, and jaundice.
Administered by a health-care provider, Makena is injected intramuscularly at a weekly dose of 250mg. No drug interaction studies have been conducted with Makena. However, the metabolism of certain drugs such as acetaminophen, methadone, and nicotine may be increased during treatment with Makena. Makena is usually started during the 16th week of pregnancy and given once per week until the 37th week or until your baby is born. Makena passes into breast milk, but it is unknown if it could harm a nursing baby. Consult your doctor before breastfeeding.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Makena in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 may include:
- mild itching;
- nausea, diarrhea; or
- pain, bruising, itching, swelling, or a hard lump where the injection was given.
Read the entire detailed patient monograph for Makena (Hydroxyprogesterone Caproate Injection)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Makena Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: dark urine, mental/mood changes (such as depression, nervousness), persistent nausea/vomiting, stomach/abdominal pain, unusual vaginal bleeding, yellowing eyes/skin.
This drug may rarely cause blood clots. Get medical help right away if any of these serious side effects occur: chest/jaw/left arm pain, confusion, pain/swelling/redness/warmth in the leg, slurred speech, sudden shortness of breath, sudden vision changes (such as partial/complete blindness), weakness on one side of the body.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Makena (Hydroxyprogesterone Caproate Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Makena FDA Prescribing 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.1 [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
|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
|Admission for preterm labor1||16||13.8|
|Preeclampsia or gestational hypertension||8.8||4.6|
|1Other than delivery admission.|
Common Adverse Reactions
The most common adverse reaction 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
|Injection site pain||34.8||32.7|
|Injection site swelling||17.1||7.8|
|Injection site pruritus||5.8||3.3|
|Injection site nodule||4.5||2|
In the clinical trial, 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).
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)
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