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Hylutin Side Effects

Generic name: hydroxyprogesterone

Medically reviewed by Drugs.com. Last updated on Jan 28, 2024.

Note: This document contains side effect information about hydroxyprogesterone. Some dosage forms listed on this page may not apply to the brand name Hylutin.

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

Serious side effects of Hylutin

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:

Other side effects of Hylutin

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:

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

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]

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]

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

Pulmonary embolus was reported in 1 patient.

Frequency not reported: Pulmonary embolus

Postmarketing reports: Dyspnea, chest discomfort

Other

Postmarketing reports: Fatigue, fever, hot flashes/flushes

More about Hylutin (hydroxyprogesterone)

Patient resources

Other brands

Makena

Professional resources

Other brands

Makena

References

1. Product Information. Makena (hydroxyprogesterone). Ther-Rx Corporation. 2011.

Further information

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.