Delalutin Side Effects

Generic name: hydroxyprogesterone

Medically reviewed by Drugs.com. Last updated on Oct 8, 2025.

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

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

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.

See also:

For healthcare professionals

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

General adverse events

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

Delalutin 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer