Please carefully read the following safety information regarding your prescriptions of estrogen and progesterone products:
Risks and Precautions:
- Estrogen and progesterone therapies may increase the risk of blood clots, stroke, heart attack, and breast cancer, most often when used long-term or at higher doses.
- These medications are not recommended if you have a history of blood clots, stroke, heart disease, advanced liver disease, or certain cancers, unless specifically approved by your provider.
- Notify your healthcare provider immediately if you experience symptoms such as unusual 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:
- Compound medications, while regulated, are not FDA approved, and their use is considered off-label.
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
Warning: Risk of breast cancer – The Women’s Health Initiative study reported an increased risk of breast cancer in patients who are taking both estrogen as well as a synthetic progestin. The risk was not specifically for 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. 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) use, it is recommended to use an oral formulation. Progesterone is also available in a topical cream or gel which can be used for symptom management but is not sufficient for endometrial protection. While not progesterone, there are IUDs (intrauterine devices) that contain other progestogens that can provide endometrial protection.
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.
- Stoke and Heart attack – Although very rare, signs would include weakness of one side of the body, difficulty speaking, confusion, chest pain or pressure, and shortness of breath. Any of these symptoms should prompt urgent ED 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.
Black Box Warning Text
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
Cardiovascular Disorders and Probable Dementia
- Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
- The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
- The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Breast Cancer
- The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.
- Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to estrogen-alone therapy.
- However, these studies have not found significant variation in the risk of breast cancer among different estrogen plus progestin combinations, or routes of administration.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
