Progesterone | Compounded Oral Capsule
Important Safety Information: Progesterone | Compounded Oral Capsule
Progesterone is a hormone your body naturally makes to help regulate your period, support a healthy uterus, and keep estrogen levels balanced. As you move through perimenopause and menopause, progesterone levels can drop. This shift may lead to irregular cycles, trouble sleeping, mood swings, or simply not feeling like yourself.
When used as part of hormone replacement therapy, progesterone is often paired with estrogen to help protect the lining of the uterus in women who still have one. Your treatment plan is personalized based on your symptoms, health history, and lab results. Your Superior provider will determine the right type, dose, and duration of therapy and will monitor you to ensure it continues to be appropriate and well tolerated.
This product may be dispensed as either an FDA-approved commercial medication or a compounded formulation prepared by a licensed compounding pharmacy. Compounded medications have not been reviewed by the FDA for safety or efficacy. Review important medication safety information: compounded capsules and commercial capsules
What is this?
This Important Safety Information summarizes key warnings and precautions for Progesterone 100mg Sustained-Release (SR) Capsule, a compounded oral hormone therapy used in women’s hormone replacement therapy (HRT). Progesterone is a naturally occurring hormone that helps regulate the menstrual cycle, support uterine health, and balance estrogen activity. It may be prescribed to lower the chance of endometrial changes in postmenopausal individuals receiving estrogen therapy or to treat certain menstrual irregularities. This compounded formulation has not been evaluated or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy and 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 swelling of the face, lips, tongue, or throat
Blood clots, including heart attack, stroke, or clots in the leg, lung, or eye
Increased risk of certain cancers when used with estrogen therapy
Liver problems, including yellowing of the skin or eyes
Fluid retention or swelling
Depression or significant mood changes
Do not use progesterone with estrogen to prevent heart disease or dementia. Studies of estrogen combined with a progestin have shown an increased risk of heart attack, stroke, blood clots, breast cancer, and dementia. Use the lowest effective dose for the shortest duration needed.
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 peanut allergy, as some capsules may contain peanut oil
Have unexplained vaginal bleeding
Have a history of blood clots, stroke, or heart attack without provider clearance
Have liver disease
Have or have had breast cancer or other hormone-sensitive cancers unless cleared by your provider
Are pregnant or may be pregnant unless specifically directed by your provider
Before Taking Progesterone, Tell Your Healthcare Provider if You:
Have a history of blood clots or risk factors for clotting
Have diabetes or high blood sugar
Have depression or other mood disorders
Have migraines or vision problems
Have liver problems
Will be immobile for long periods, such as long travel or bedrest after surgery
Have a nut or seed allergy
Take any prescription, over the counter, vitamin, or herbal medications
Are breastfeeding or planning pregnancy
Possible Side Effects
Common (mild to moderate):
Dizziness, drowsiness, or fatigue
Headache
Nausea, vomiting, constipation, or diarrhea
Stomach pain or bloating
Breast tenderness or enlargement
Weight gain
Vaginal spotting or irregular bleeding
Decreased interest in sex
Serious (seek medical care immediately):
Signs of an allergic reaction such as rash, hives, swelling, or difficulty breathing
Chest pain, coughing up blood, or sudden shortness of breath
Weakness on one side of the body, trouble speaking, or vision changes
Severe dizziness or fainting
Signs of liver problems such as dark urine or yellowing of the skin or eyes
A lump in the breast or nipple discharge
Abnormal vaginal bleeding
Signs of a blood clot including swelling, warmth, pain, numbness, or color change in an arm or leg
While Taking Progesterone
Tell your healthcare provider immediately if you:
Develop swelling, rapid weight gain, or trouble breathing
Experience severe mood changes or depression
Notice abnormal vaginal bleeding
Have vision changes or severe headaches
Develop symptoms of a blood clot
Do not notice improvement in symptoms or develop new symptoms
Pregnancy and Fertility
Progesterone is not a form of birth control and will not prevent pregnancy. Do not use this medication if you are 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 or dizziness
Nausea or vomiting
Confusion
Abnormal bleeding
If overdose is suspected, seek emergency medical attention or contact Poison Control right away.
Missed Dosage
If you miss a scheduled dose:
Take the missed dose as soon as you remember unless it is close to the next scheduled dose
Skip the missed dose if it is near the time of your next dose
Do not double the next dose
Storage
Store at room temperature
Do not refrigerate or freeze
Store in a dry place away from moisture
Keep out of reach of children and pets
Medication Disposal
Dispose of unused or expired medication according to local hazardous waste regulations. Do not flush medication down the toilet or pour down a drain unless instructed to do so.
Provider Oversight and Order Review
This compounded medication requires review and oversight by licensed Superior Health and Wellness providers. Dosing and duration of therapy are determined based on symptoms, medical history, and laboratory findings. Orders may be adjusted to ensure safety and clinical appropriateness.
Telemedicine Disclosure
This prescription may have been 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. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
