Important Safety Information: Progesterone (Women’s Hormone Replacement Therapy) | Oral Capsules

What is this?

This Important Safety Information summarizes key warnings and precautions for Progesterone, a naturally occurring hormone involved in regulation of the menstrual cycle, reproductive health, and balance of estrogen activity in the body. Progesterone is commonly used in women’s hormone replacement therapy (HRT) to support hormonal balance during perimenopause and menopause, help protect the uterine lining when clinically indicated, and support sleep and mood stability. Oral progesterone capsules may be prescribed as part of a personalized hormone care plan. This medication should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions. 

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including rash, swelling, or difficulty breathing

• Blood clots or thromboembolic events, including pain, swelling, warmth, or redness in an arm or leg

• Worsening of mood disorders, including depression or emotional changes

• Drowsiness, dizziness, or impaired alertness

• Fluid retention or swelling

• Potential stimulation of hormone-sensitive conditions, including breast or uterine disorders

Who Should NOT Take Progesterone

Do not take this medication if you:

• Have a known allergy to progesterone or any ingredient in the formulation

• Have a history of hormone-sensitive cancers unless cleared by your provider

• Have unexplained vaginal bleeding

• Have active or prior blood clots, stroke, or thromboembolic disorders without provider clearance

• Have severe liver disease

• Are pregnant unless specifically directed by a healthcare provider

Before Taking Progesterone, Tell Your Healthcare Provider if You:

• Have a history of blood clots, stroke, or cardiovascular disease

• Have liver disease or abnormal liver function tests

• Have a history of breast cancer or uterine conditions

• Have depression, anxiety, or other mood disorders

• Experience migraines or seizure disorders

• Take any prescription, over-the-counter, or herbal medications

• Are breastfeeding or planning pregnancy

Possible Side Effects

Common (mild to moderate):

• Bloating or fluid retention

• Breast tenderness

• Fatigue or drowsiness

• Dizziness or lightheadedness

• Mood changes or irritability

• Nausea or abdominal discomfort

Serious (seek medical care immediately):

• Rash, hives, swelling of the face, lips, or throat, difficulty breathing

• Signs of a blood clot such as leg pain, swelling, warmth, or redness

• Sudden chest pain or shortness of breath

• Severe headache, vision changes, or neurological symptoms

• Yellowing of the skin or eyes (possible liver dysfunction)

While Taking Progesterone

Tell your healthcare provider immediately if you:

• Develop leg swelling, pain, or warmth

• Experience severe mood changes or depression

• Have persistent dizziness or excessive drowsiness

• Notice abnormal vaginal bleeding

• Experience symptoms of an allergic reaction

• Develop chest pain or shortness of breath

Pregnancy and Fertility

Progesterone may have specific clinical uses related to reproductive health. Do not use progesterone during pregnancy or breastfeeding unless explicitly directed by a licensed healthcare provider. Use only under medical supervision when fertility or reproductive outcomes are part of the treatment plan.

Overdose

Symptoms of progesterone overdose may include:

• Severe dizziness or drowsiness

• Nausea or vomiting

• Mood changes or confusion

• Abnormal bleeding

• Difficulty breathing

If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a scheduled dose:

• Do not double the next dose

• Follow your provider’s instructions for resuming therapy

• Contact your pharmacy or provider if you are unsure how to proceed

Storage

• Store at room temperature unless otherwise directed

• Protect from excessive heat and light

• Do not freeze

• Keep out of reach of children

• Use only within the beyond-use date listed on your pharmacy label

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains. Contact your pharmacy for disposal instructions or medication take-back options.

Provider Oversight and Order Review

This medication requires review and oversight by licensed Superior Health & Wellness providers. Dosing and treatment duration are determined based on labs, medical history, symptoms, and clinical goals. Orders may be adjusted to ensure safety and appropriateness.

Telemedicine Disclosure

This prescription was issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about progesterone and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.