Important Safety Information: Progesterone | Commercial Oral Capsule
What is this?
This Important Safety Information summarizes key warnings and precautions for oral progesterone, an FDA-approved hormone therapy used to help regulate the menstrual cycle and protect the uterine lining in women receiving estrogen therapy. Progesterone is commonly prescribed in hormone replacement therapy (HRT) during perimenopause and menopause and may also be used to treat certain menstrual disorders. 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 prescription label and FDA-approved patient information before use.
Most Serious Warnings
Product can cause:
Severe allergic reactions, including swelling of the face, lips, tongue, or throat
Blood clots, including deep vein thrombosis, pulmonary embolism, stroke, or heart attack
Increased risk of breast cancer when used with estrogen therapy
Dementia risk in women 65 years and older when used with estrogen
Liver problems, including jaundice
Fluid retention or worsening of heart conditions
Do not use estrogen combined with a progestin to prevent heart disease, heart attacks, strokes, or dementia. Use the lowest effective dose for the shortest duration consistent with treatment goals and individual risk.
Who Should NOT Take Progesterone
Do not take this medication if you:
Have a known allergy to progesterone or any ingredient in the product
Have unexplained vaginal bleeding
Have active or past blood clots, stroke, or heart attack without provider clearance
Have known or suspected breast cancer or other hormone-sensitive cancers unless directed by your provider
Have liver disease or liver dysfunction
Are pregnant
Before Taking Progesterone, Tell Your Healthcare Provider if You:
Have a history of blood clots or clotting disorders
Have heart disease, high blood pressure, or high cholesterol
Have diabetes
Have depression or mood disorders
Experience migraines or vision problems
Have asthma, seizures, or fluid retention disorders
Take any prescription, over-the-counter, vitamin, or herbal medications
Are breastfeeding
Possible Side Effects
Common (mild to moderate):
Drowsiness or dizziness
Headache
Breast tenderness
Bloating or fluid retention
Nausea or stomach discomfort
Irregular vaginal bleeding or spotting
Serious (seek medical care immediately):
Signs of a blood clot such as leg pain, swelling, warmth, redness, chest pain, or shortness of breath
Sudden severe headache, confusion, trouble speaking, or vision changes
Yellowing of the skin or eyes
Severe allergic reaction including swelling or difficulty breathing
New breast lump or nipple discharge
Abnormal vaginal bleeding
While Taking Progesterone
Tell your healthcare provider immediately if you:
Develop swelling, chest pain, or trouble breathing
Experience severe depression or unusual mood changes
Notice persistent or unusual vaginal bleeding
Have vision changes or severe headaches
Experience signs of a blood clot
Pregnancy and Fertility
Progesterone is not a form of birth control and will not prevent pregnancy. Do not use if pregnant unless specifically directed by your healthcare provider. If pregnancy occurs, contact your provider immediately. Discuss risks and benefits if breastfeeding.
Overdose
Symptoms of overdose may include:
Severe drowsiness
Nausea or vomiting
Dizziness
Abnormal bleeding
If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.
Missed Dosage
If you miss a scheduled dose:
Take it as soon as you remember unless it is close to your next scheduled dose
Skip the missed dose if it is near the time for your next dose
Do not take two doses at the same time
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.
