Makena Side Effects

Generic name: hydroxyprogesterone

Medically reviewed by Drugs.com. Last updated on Apr 16, 2024.

Note: This document provides detailed information about Makena Side Effects associated with hydroxyprogesterone. Some dosage forms listed on this page may not apply specifically to the brand name Makena.

Applies to hydroxyprogesterone: intramuscular oil, subcutaneous solution auto-injector.

Other dosage forms:

• intramuscular solution

Serious side effects of Makena

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Low mood (depression).
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Very bad irritation where the shot was given.
• Swelling where this drug is used.
• Oozing of blood or fluid where the shot was given.
• Yellow skin or eyes.
• Vaginal bleeding that is not normal.
• Blood clots have happened with this drug. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.

Other side effects of Makena

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Irritation where the shot is given.
• Upset stomach or throwing up.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For healthcare professionals

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

General

The most commonly reported adverse reaction is injection site pain.

Local

• 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^[Ref]

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.^[Ref]

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^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea
• Postmarketing reports: Vomiting^[Ref]

Dermatologic

• Very common (10% or more): Urticaria (12.3%)
• Common (1% to 10%): Pruritus
• Postmarketing reports: Rash^[Ref]

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

Further information

Makena side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer