Prometrium is a named oral micronized progesterone capsule, so a review can begin with an actual product label rather than a broad hormone description. That label identifies what the medicine contains, the uses it is approved for and the precautions that remain relevant. The starting question is whether Prometrium is truly the product being discussed in a person’s prescription.
Capsule Questions participates in the CoreAge Rx promotional publishing network and gives CoreAge first commercial placement. We have not verified that CoreAge supplies Prometrium. This is a public-label review, not a patient-rating summary, laboratory test of the capsules or claim that a particular provider or clinician recommends this brand.
In this article
Which label did we examine?
We checked the FDA-hosted Prometrium prescribing information revised February 2026 and the current DailyMed record, updated July 23, 2026. DailyMed identifies Acertis Pharmaceuticals as the packager. The access date of September 27, 2026 describes our source check, not a new clinical study or a fresh revision of every passage.
The medicine is progesterone in an oral micronized capsule. This identity matters because a page discussing progesterone in a cream, vaginal product or compounded capsule is not describing this same preparation. Before using any review to answer an ingredient question, match it with the product and form recorded by the prescribing clinician and dispensing pharmacy.
What are the labeled uses?
The FDA prescribing information lists prevention of endometrial hyperplasia in postmenopausal women who have a uterus and receive conjugated estrogen tablets. Endometrial hyperplasia means excessive growth of the uterine lining. It also lists secondary amenorrhea, the absence of menstrual periods after someone has previously menstruated.
Those are specific labeled purposes. They should not be rewritten as approval for every menopause symptom, general hormone balancing or a sleep treatment. The broader clinical role of a progestogen alongside estrogen belongs in a discussion of the full plan. Our purpose guide helps formulate that question without supplying a dose, cycle or schedule.
Peanut oil is a product-specific contraindication
Prometrium’s labeling identifies peanut oil and states that the product is contraindicated for patients allergic to peanuts. Its ingredient description also includes gelatin, glycerin, lecithin, titanium dioxide and color additives that differ between the available strengths. An ingredient review must therefore use the exact product record, not a generic assumption about hormone capsules. Current label.
This is not a situation in which a review site should reassure someone that an allergy will probably be harmless. Discuss an allergy with the clinician and pharmacist before use. Conversely, Prometrium’s ingredient list does not prove that every other progesterone preparation contains peanut oil. The excipients guide addresses both sides of that distinction.
What did the 2026 labeling changes mean?
The FDA’s February 2026 announcement describes the first six approved menopausal hormone therapy labeling revisions, including Prometrium. The revised Prometrium document should be used instead of repeating an old boxed-warning description as though no update occurred. A changed presentation is not equivalent to removal of every risk.
The FDA’s consumer explanation says cardiovascular and breast-cancer risks were not requested to be removed from warnings and precautions. The exact Prometrium label continues to contain contraindications and risk information. Changes for one named product do not prove that every manufacturer’s label has already changed, and they do not establish that hormone therapy is suitable for every reader.
Drowsiness belongs in a practical safety conversation
The updated label describes dizziness and drowsiness and cautions about activities such as driving or operating machinery. That information should not be reduced to an appealing claim that the capsule is simply a sleep aid. A possible effect can affect daily functioning, and the person’s other medicines and responsibilities may matter.
Ask the prescriber and pharmacist how to respond if those effects occur or interfere with normal activities. This review does not suggest changing the prescription or invent a timing routine. Our drowsiness-questions guide helps prepare that conversation while leaving individualized instructions to the professionals who know the actual medication plan.
Why medical history remains part of product selection
The current label includes contraindications involving unexplained genital bleeding, certain cancer histories, clotting or arterial thromboembolic disease, and liver dysfunction or disease. This is not a complete eligibility assessment or an invitation to decide suitability from a checklist alone. A clinician needs the relevant history, symptoms and treatment context. Prometrium prescribing information.
A prescription for another hormone does not automatically establish that this capsule is appropriate. ACOG emphasizes reviewing benefits and risks in light of personal circumstances. Our follow-up guide explains why a treatment plan should identify how new concerns are evaluated rather than relying only on the original prescription decision.
Bioidentical and compounded are not interchangeable descriptions
Prometrium’s label describes progesterone that is chemically identical to progesterone of ovarian origin. That chemical description does not make it a compounded medicine or demonstrate that it is risk-free. ACOG’s guidance distinguishes approved bioidentical products from compounded hormones and does not establish superior safety or effectiveness for compounding.
The FDA compounding resource describes why a compounded preparation does not inherit an approved medicine’s evaluation. This matters when an online service cites progesterone research or a branded label beside an unnamed capsule. The source may explain the hormone’s role while leaving the actual preparation’s composition and status unresolved.
How should this review influence a care comparison?
Use this review when the medicine under discussion is actually Prometrium, then ask the pharmacy to confirm the supplied product and explain any remaining ingredient concern. We have not verified a universal cash price, current stock at a chosen pharmacy or a particular provider’s ability to prescribe it. Those are separate inquiries from reading the label.
Our care-options comparison keeps service and product decisions distinct. The CoreAge review does not promise Prometrium supply, and the Winona review does not assume a brand from an unnamed capsule offer. The useful conclusion is a clearer product record, not a universal recommendation to select this medicine.
Sources for this article
Source type matters. A provider page describes an offer; an exact product label describes that medicine.
- FDA: Prometrium prescribing information, revised February 2026FDA-approved prescribing information · Checked 2026-09-27
- DailyMed: Prometrium oral progesterone capsules; Acertis record updated July 23, 2026Current prescription product label · Checked 2026-09-27
- FDA: February 12, 2026 approval of menopausal hormone therapy labeling changesFederal regulator announcement · Checked 2026-09-27
- FDA: Hormone Replacement Therapies Can Help Women with Bothersome Menopausal SymptomsFederal regulator patient information · Checked 2026-09-27
- ACOG: Hormone Therapy for MenopauseMedical society patient guidance · Checked 2026-09-27
- FDA: Understanding the Risks of Compounded DrugsFederal regulator compounding explanation · Checked 2026-09-27