Hormones & endocrine · Steroid hormone
Also known as micronized progesterone, Prometrium
A steroid hormone found in FDA-approved products, including oral micronized progesterone. It is distinct from synthetic progestins.[1]
Human studies and labelled product evidence are available in specific contexts. This is not a ranking of suitability or a guarantee that every product or use has the same evidence.
Reviewed Jul 22, 2026 · U.S.-focused reference profile
Read the context, not only the compound name. Evidence and status can change with the form, route, population, and use. This profile does not assess individual suitability.
Orientation
Start with identity and research context. Similar names do not establish equivalent products or evidence.
Published research or product contexts. These are not personal indications.
Evidence can change with chemical form, formulation, route, ingredients, and manufacturing. A brand, salt, fragment, or cosmetic ingredient may not represent the same evidence.
What is known
Human studies and labelled product evidence are available in specific contexts. This is not a ranking of suitability or a guarantee that every product or use has the same evidence. This is a description, not a rating or recommendation.
Hormone-related and clinician-directed
Clinical evidence and FDA labeling support product-specific uses of oral micronized progesterone, including use with estrogen in defined postmenopausal contexts and treatment of certain amenorrhea presentations.
Progesterone and synthetic progestins should not be conflated. Formulation, route, combined hormone use, and compounded-product quality can materially change the evidence and risk context.
Nonclinical reproductive and hormone-response studies inform the label. These data are contextual and cannot establish individual suitability.[1]
More human evidence does not automatically transfer to a different product, route, population, or purpose. Limited evidence does not prove no biological activity; it means the relevant clinical question is not established by the reviewed material.
What needs caution
Known published concerns and unanswered questions are kept separate so absence of evidence is never presented as reassurance.
Labels describe risks including thromboembolic, cardiovascular, neurologic, breast, hypersensitivity, and sedation-related concerns, with context influenced by concomitant estrogen and patient factors.
The cited product label describes risks for a specific approved product and use. It is not a complete guide to every product or individual situation.Source [1]Progesterone and synthetic progestins should not be conflated. Formulation, route, combined hormone use, and compounded-product quality can materially change the evidence and risk context.
The answer can change with the product, formulation, route, population, duration, and use being discussed.Source [1]Common effects, important warnings, product-quality concerns, and evidence gaps are different kinds of information. A risk in one product label may not apply to every formulation; an uncertainty proves neither safety nor harm.
Match the product
Form describes the specific product; route describes how it reaches the body. These are sourced descriptions, not instructions.
This publication set uses the oral micronized progesterone label; other progesterone products require their own route- and product-specific interpretation.
Routes shown apply only to the named published or investigational formulation; they are not instructions for use.
U.S. product context
At least one FDA-approved product exists, but approval applies only to the named product, formulation, route, population, and use in its label.
Status applies to a product, formulation, route, population, and use. It does not apply to a name in the abstract.
Micronized progesterone is FDA approved in product-specific oral capsule indications. This does not make all compounded progesterone formulations equivalent to the approved product.
Specific form or route not separately published in this record.View sourceTake it forward
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Each source supports the section that cites it; publication does not imply endorsement or suitability.
PROMETRIUM prescribing information
DailyMed. PROMETRIUM (progesterone) capsules prescribing information. Revised February 2026.
National Library of Medicine / Acertis Pharmaceuticals · Published Feb 26, 2026 · Accessed Jul 22, 2026 · Prescribing information
Open sourceIdentity, human evidence, laboratory and animal findings, risks, uncertainty, and U.S. product status are shown separately. Missing information stays marked as unpublished instead of being inferred.
