Prometrium is a useful example of why the words on a medicine label deserve separate attention. Progesterone identifies the active hormone, micronized describes its processing, and capsules for oral administration specify the product form and route. The brand connects those terms to a particular label. None of them, read alone, tells you everything about the treatment a clinician might propose.
This product review examines the current FDA label and DailyMed record, not patient ratings or medicines we have tested. Progesterone Particulars is part of the CoreAge Rx promotional publishing network; CoreAge receives first commercial placement in our comparisons. Prometrium is reviewed as a distinct named medicine, without implying CoreAge supplies it or that the brand is the best clinical choice for a reader.
Read this article by section
Start with the exact record and its date
We checked the FDA Prometrium label revised February 2026 and the DailyMed record updated July 23, 2026. The latter identifies Acertis Pharmaceuticals as the packager. A page describing an older package or an old repackaged label may show different warning language; matching the actual record matters before interpreting a screenshot.
The current label describes micronized progesterone capsules for oral use. It is not a label for a cream, vaginal insert, or custom compounded capsule. A brand reference in an advertisement is not enough to identify what would be dispensed. The offers comparison separates that medicine record from prescribing and pharmacy services.
Micronized has a specific, limited meaning
The label states that micronization increases the oral bioavailability of progesterone. In its absorption discussion, it also says absolute bioavailability is unknown. Both statements belong in an accurate account: a formulation process can affect absorption without guaranteeing a particular blood level or a predictable experience for every patient.
This evidence concerns the labeled oral capsule. It does not prove that any preparation called micronized has the same finished formulation, nor establish superiority for every treatment goal. Our micronized terminology guide explains the word without treating it as a quality score. Product-specific evidence is stronger when the name, form, and route all match the medicine being discussed.
Plant starting material does not mean an herbal supplement
The Prometrium description states that its progesterone is synthesized from a plant starting material and is chemically identical to progesterone of human ovarian origin. That identifies the hormone's chemistry. It does not make the capsule an unprocessed plant product, an over-the-counter supplement, or a risk-free alternative to medication.
The finished medicine remains a prescription product with ingredients and clinical restrictions. Bioidentical is therefore not the opposite of manufactured, and it is not synonymous with compounded. The approval guide explains how an approved medicine can contain a hormone with that molecular identity while a separately compounded preparation has a different regulatory status.
An approved indication is more precise than general wellness
The label includes prevention of endometrial hyperplasia in postmenopausal women who have not had a hysterectomy and are receiving conjugated estrogen tablets. It separately includes secondary amenorrhea. Those are specific indications. They are not an approval for every menopause symptom, every estrogen combination, or a general sleep, anti-aging, or wellness promise.
A clinician may discuss a treatment question that requires interpretation beyond a marketing description. Ask which purpose applies to the proposed prescription and what evidence supports that plan. Do not convert the label's specific use into instructions for yourself. Our route guide explains why changing the way a hormone is delivered requires more than recognizing the same ingredient name.
The inactive ingredients are part of the product identity
The current label lists peanut oil in Prometrium and specifically contraindicates the medicine for patients allergic to peanuts. It also lists gelatin, glycerin, lecithin, titanium dioxide, and color ingredients that differ by strength. A capsule's active hormone is only one part of the information needed for an allergy or ingredient question.
These details do not establish the composition of every generic or compounded progesterone capsule. FDA allows certain differences in inactive ingredients in approved generics. If the manufacturer or product changes, ask the pharmacist to check its exact record. Neither similar appearance nor a familiar brand used as a comparison name settles that question.
Updated warnings still require careful reading
FDA announced initial approvals of revised labels for six menopausal hormone-therapy products in February 2026. Its current consumer explanation says cardiovascular and breast cancer risk information remains in warnings and precautions. This review uses the revised Prometrium record rather than assuming every older boxed-warning statement remains the current presentation.
Prometrium still has substantial contraindications and warnings, including issues involving unexplained genital bleeding, certain cancer history, clotting conditions, and liver disease. Its label also discusses drowsiness and dizziness. A change in where risk information appears is not a declaration that all risks disappeared or that an individual can start treatment without assessment.
A trial about another progestogen is not a direct product trial
The current label discusses Women's Health Initiative findings from a regimen using conjugated estrogens and medroxyprogesterone acetate. Medroxyprogesterone acetate is not micronized progesterone. The label explains uncertainty about applying those findings to other products and also states that risks cannot definitively be excluded without the relevant data.
That creates two boundaries: do not call the trial a direct test of Prometrium, and do not use the different ingredient as proof of no risk. The progesterone versus progestin guide helps preserve exact names when reading a study summary. The treatment decision still needs the full history and the proposed formulation.
What this label review cannot establish
A verified label does not establish your pharmacy's stock, your price, insurance coverage, or which product an online clinician would select. Cost Plus's listing is for a generic reference; its pharmacy review explains why the manufacturer remains an order-specific question. The CoreAge review addresses a separately advertised compounded offer.
Use the named label to make questions more precise: which product, which route, which ingredients, and which intended purpose? Keep the answer attached to the actual prescription. That is the value of a product evidence review; it describes what the record supports without claiming a personal treatment outcome or a universal winner.
Documents behind the details
Read the source for the product, use and context it actually describes. A source type is not a rating of a provider.
- FDA: Prometrium prescribing information, revised February 2026Prescribing information · Checked 2026-09-27
- DailyMed: Prometrium, Acertis Pharmaceuticals, updated July 23, 2026Prescribing information · Checked 2026-09-27
- FDA: Generic drugs questions and answersRegulatory guidance · Checked 2026-09-27
- FDA: Hormone replacement therapies and current label changesRegulatory guidance · Checked 2026-09-27
- FDA: First six menopausal hormone therapy label changes, February 12, 2026Regulatory announcement · Checked 2026-09-27