Important Safety Information for Progesterone Products
Please carefully read the following safety information regarding your prescriptions of progesterone products:
Risks and Precautions:
- Progesterone therapy may not be appropriate for individuals with unexplained vaginal bleeding, liver disease, certain hormone-sensitive cancers, or a history of allergic reaction to progesterone products unless specifically approved by your healthcare provider.
- Patients with a history of blood clots, stroke, or cardiovascular disease should discuss their individual risk factors and treatment options with their healthcare provider prior to starting hormone therapy.
- Notify your healthcare provider immediately if you experience symptoms such as chest pain, shortness of breath, severe headaches, vision changes, significant swelling, or unexpected vaginal bleeding.
Usage Guidelines:
- Take your medications exactly as prescribed by your healthcare provider.
- Do not share your medications with others.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential interactions.
Off Label:
- The use of these compounded medications for this indication is off-label. Compounded medications are not FDA-approved and do not undergo the same safety, effectiveness, or manufacturing review as FDA-approved drugs.
For any questions or concerns regarding your medication, contact our support team immediately.
This statement does not replace individual medical advice provided by your healthcare professional. Always follow the specific instructions given by your provider.
Important Progesterone Safety Information
Black Box Warning Update
In February 2026, the FDA updated boxed warning language for many menopause hormone therapy products, including micronized progesterone products. Previous boxed warnings related to breast cancer, cardiovascular disease, and probable dementia were removed from many hormone therapy products after review of newer research and safety data.
Earlier Women’s Health Initiative (WHI) research reported increased risks of breast cancer, blood clots, stroke, heart attack, and probable dementia in patients using a specific combination of oral estrogen and a synthetic progestin. These findings were not specific to micronized progesterone.
Note regarding compounded medications: Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review by the FDA. Your Ivim Health provider may recommend certain doses of compounded medications based on your medical evaluation.
What is the FDA-approved use of progesterone?
Progesterone is FDA approved for prevention of endometrial hyperplasia in postmenopausal women who still have a uterus and are receiving treatment with estrogen. It is also indicated in secondary amenorrhea.
Who should not use progesterone?
You should not take progesterone if you have undiagnosed vaginal bleeding, a history of breast cancer, active DVT, uncontrolled cardiovascular disease, or you are pregnant.
How should progesterone be administered?
Progesterone is available in multiple forms. For systemic (whole body) hormone therapy and endometrial protection, oral progesterone is the preferred formulation used by Ivím Health.
Some healthcare providers may also prescribe topical progesterone creams or gels for symptom management. However, topical progesterone products are not considered reliable for endometrial protection when used alongside systemic estrogen therapy.
Some intrauterine devices (IUDs) contain other progestogens that may also provide endometrial protection in certain patients. Patients should discuss the most appropriate progesterone option with their healthcare provider based on their medical history and treatment goals.
What should I tell my IVIM provider before starting progesterone?
Progesterone has certain drug interactions. It’s important to tell your Ivim provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, herbal and dietary supplements.
Medications to watch out for (interactions): Please note, this is not an exhaustive list, and interactions are not limited to the following medications.
- Clarithromycin
- Edoxaban
- Erythromycin
- Lamotrigine
- Rifampin
- Telithromycin
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:
- Undiagnosed abnormal vaginal bleeding.
- Known or suspected history of breast cancer.
- Active deep vein thrombosis, pulmonary embolism or history of these conditions.
- Active cardiovascular disease (stroke, heart attack)
- Known liver dysfunction
- Known or suspected pregnancy.
What are the most serious side effects that I or a caregiver should monitor for?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These following serious side effects can occur with progesterone. You or a caregiver should carefully monitor for these side effects.
- Stroke and Heart attack – Although very rare, signs would include weakness or numbness of one side of the body, slurred speech, difficulty speaking, confusion, chest pain or pressure, and/or shortness of breath. Any of these symptoms should prompt emergent evaluation.
- Serious Allergic Reactions: Stop using progesterone right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
What are the most common side effects of estrogen and progesterone?
- drowsiness, dizziness
- breast pain
- mood changes
- headache
- constipation, diarrhea, heartburn
- bloating, swelling in your hands or feet
- joint pain
- hot flashes
- vaginal discharge
This information is not comprehensive. Please see the full prescribing information for oral progesterone therapy.
Disclaimer: Progesterone is available as a compounded medication through licensed compounding pharmacies. Compounded medications are not FDA-approved but are prepared by pharmacists to meet individual patient needs based on a valid prescription. The safety, efficacy, and quality of compounded progesterone may vary depending on the pharmacy and formulation. Always consult with a licensed healthcare provider before starting any compounded therapy.
This document may include information about the use of medications, supplements, or therapies that are not approved by the U.S. Food and Drug Administration (FDA) for the specific indication discussed. Such “off-label” use is based on clinical judgment, emerging research, or standard of care guidelines and is intended to support safe, evidence-informed decision-making.
