Micronized Progesterone vs Medroxyprogesterone: What the FDA Labels Actually Say

Best for / not for you

The FDA Label Diff

We pulled both current prescribing information PDFs from the FDA's own database (accessdata.fda.gov) on July 9, 2026 and read them side by side. As far as we can find, nobody else has published this comparison.

Sources: Prometrium prescribing information, Rev. 02/2026 · Provera prescribing information, Rev. 02/2024 · FDA: Menopausal Hormone Therapies with Updated Prescribing Information (02/12/2026)

Look at the second-to-last row for a moment. Both drugs cut uterine lining overgrowth from roughly 6-in-10 down to roughly 1-in-20. Whatever else is true, on the job these drugs were actually approved to do, they both do it.

Why did one label change in February 2026 and the other didn't?

On February 12, 2026, the FDA approved new labels for six menopause hormone therapy products. It removed the risk statements about heart disease, breast cancer, and probable dementia from the boxed warning — the agency's most serious kind of warning. Prometrium was in that first batch of six. Provera's most recent label on file is dated February 2024 and still carries the boxed warning.

Here's how it happened. In July 2025 the FDA convened an expert panel on menopause hormone therapy. On November 10, 2025, the FDA and HHS announced they would begin pulling the boxed warnings, saying the old warnings rested on a study population whose average age was 63 — more than a decade past the average age of menopause — taking a formulation that isn't in common use anymore. The FDA then asked drug companies to submit new labels. Twenty-nine companies did. Six were approved first.

So what does it mean that Prometrium made the cut and Provera didn't?

Less than you'd hope, because this was a batch, not a verdict. Manufacturers submit on their own schedules. The FDA processes them in order. Provera's label could be updated next month, and if it is, this section goes stale. We re-check monthly.

More than you'd think,because the boxed warning is the loudest thing on a drug label. It's the first thing a pharmacist sees. It's the first thing a cautious primary care doctor sees. For twenty-three years, the box on both of these drugs said the same three frightening words. Now one of them says something different. That changes conversations in exam rooms.

One thing the FDA did notremove: the boxed warning about uterine cancer on estrogen-only products for women who still have a uterus. That warning stands. Which is the entire reason you're reading a page about progestogens in the first place.

Prometrium vs Provera: what actually is the difference between micronized progesterone and medroxyprogesterone?

Micronized progesterone is progesterone — the same hormone your ovaries made, ground into fine particles so your body can absorb it from a capsule. Medroxyprogesterone acetate is a synthetic progestin: a lab-modified molecule that acts like progesterone in the uterus but behaves differently elsewhere. Both protect the uterine lining. They part ways on cholesterol, clotting, sedation, and how they feel.

The vocabulary here is genuinely confusing, and in some corners of the internet it's confusing on purpose. So:

Why does the molecule's structure matter? Two reasons show up in the labels themselves.

Progesterone breaks down into allopregnanolone,a byproduct that acts on the same brain receptor (GABA-A) as sedative medications. That isn't a theory. It's why the Prometrium label tells you to take it at bedtime. It makes people dizzy and drowsy.

Medroxyprogesterone has androgenic activity.Its own label says androgenic and anabolic effects have been noted. Progesterone's label says no such thing.

Same receptor in the uterus. Different everywhere else. That's the whole story in one line.

Want the deeper dive on one drug? We break down Prometrium on its own page, and we compare FDA-approved and compounded HRT here.

Is micronized progesterone the same as “bioidentical” progesterone from a compounding pharmacy?

No — and this is the most expensive confusion in menopause care. Micronized progesterone is a bioidentical hormone and an FDA-approved drug. Compounded progesterone creams, troches, and pellets are not FDA-approved. The American College of Obstetricians and Gynecologists names micronized progesterone specifically as an FDA-approved bioidentical hormone, and states that compounded bioidentical hormone therapy should not be routinely prescribed when FDA-approved formulations exist.

Sit with that for a second, because a lot of marketing depends on you not knowing it.

“Bioidentical” and “FDA-approved” were never opposites. Prometrium is both. So is estradiol. The compounding industry built a business on a false choice — natural versus pharmaceutical — when the most natural progesterone molecule available to you in this country is sitting in an FDA-approved capsule at your regular pharmacy for about fifteen dollars.

What the evidence actually shows about compounded versions:

• The FDA commissioned the National Academies of Sciences, Engineering, and Medicine to study compounded hormone therapy. NASEM reported back on July 1, 2020: there was a lack of rigorous evidence of safety and effectiveness from well-designed, properly controlled studies.
• ACOG's 2023 clinical consensus is blunt: evidence supporting the marketing claims is lacking.
• Compounding pharmacies aren't required to report adverse events to the FDA the way drug manufacturers are.

None of that makes compounded hormones useless. It means you shouldn't accept a compounded product in place of a proven one without a specific reason.

The Menopause Society's carve-out is narrow: compounded hormone therapy may be considered when a woman can't tolerate an approved product because of an ingredient such as an allergen, or when the dose or formulation she needs isn't available as an approved product.

The allergen half comes back when we get to the peanut oil. The “not available” half comes back when we get to the shortage — and it's about to matter more than you'd expect.

What does “on-label” actually mean for your regimen?

Here's the part that surprises most women. The Prometrium label is indicated for menopausal women with a uterus who are receiving conjugated estrogens tablets. The Provera label is indicated for the same thing, in women receiving daily oral conjugated estrogens 0.625 mg tablets.Neither label says “estradiol patch.” Neither says “estradiol gel.” And neither one contains a continuous daily dose at all.

The Regimen Decoder

What “off-label” actually means

It does not mean wrong. It does not mean unsafe. It does not mean unusual. It means the manufacturer never ran a trial for that exact pairing, so the FDA never wrote it into that exact label. Doctors prescribe off-label constantly, legally, and often correctly. Most menopause care in this country runs this way.

But notice what it does to the question you walked in with. You came here asking: did my doctor give me the unapproved one?On the strictest reading of both labels, most American women are off-label on their progestogen either way. Your doctor made a judgment call. That's what doctors do. Now you know the specific question that tests whether it was a good one.

The dose question nobody raises

Your progestogen dose should be proportionate to your estrogen dose. The British Menopause Society's clinician guidance, updated May 2026, notes that women on higher-dose estrogen should consider stepping the progestogen up — for example, micronized progesterone 300 mg for 12 days a month instead of 200 mg, or 200 mg daily continuously instead of 100 mg.

So: did your estrogen dose go up at some point while your progesterone dose stayed the same? That's a real question with a real answer. And it has nothing to do with which molecule you're taking.

What does each one actually feel like to take?

Micronized progesterone makes a meaningful share of women dizzy and drowsy — its label requires bedtime dosing because of it. In its 875-patient placebo-controlled trial, 27% reported breast tenderness (versus 6% on placebo), 15% dizziness (versus 9%), and 12% bloating (versus 5%). Medroxyprogesterone's label lists depression, insomnia, drowsiness, dizziness, and headache among reported reactions, but does not require bedtime dosing.

We're not going to show you testimonials. We can't verify a stranger's account of a prescription drug, and we won't pretend otherwise on a page about your uterus.

What we canshow you is what happened to real women in real placebo-controlled trials, with the placebo numbers sitting right next to them — because “27% got breast tenderness” means nothing until you learn that 6% of women on a sugar pill got it too.

From the Prometrium label's own adverse reaction table

(Women taking progesterone with conjugated estrogens, versus placebo)

Provera's label lists depression, insomnia, somnolence, dizziness, nervousness, and headache among reported reactions. It does not publish a matched placebo-controlled incidence table in the same format — which is itself worth knowing.

The sedation paradox

Here's something strange, and true, and useful.

The Prometrium label treats drowsiness as a problem.It's why you take it at night. Don't drive after.

The Menopause Society's 2022 position statement treats it as a benefit.Micronized progesterone at 300 mg nightly significantly reduces hot flashes and night sweats compared with placebo, and improves sleep.

Both are describing the same molecule doing the same thing to the same receptor. Whether it's a side effect or the entire point depends on whether you're currently sleeping.

If you lie awake at 3 a.m. drenched in sweat, “this drug makes you sleepy” is not a warning. It's a feature.

For more on this specific benefit, see does progesterone help with sleep in menopause?

The peanut oil problem

Prometrium capsules contain peanut oil.The label contraindicates them in women with a peanut allergy. That's not a footnote. It's a hard stop.

Two things to know:

1. Check your specific generic.Manufacturers vary. Look up your exact bottle by its NDC number on DailyMed, or ask your pharmacist to read you the inactive ingredients. Don't assume.
2. Bijuva— the FDA-approved estradiol-and-progesterone combination capsule, also on the FDA's February 2026 updated-label list — lists no peanut oil among its inactive ingredients. It uses medium-chain glycerides instead.

And remember what The Menopause Society said about compounded hormones? Its carve-out covers women who can't tolerate an approved product because of an ingredient like an allergen. If you're peanut-allergic, you are one of the few women for whom that conversation is genuinely appropriate. For most women, it isn't.

What do micronized progesterone and medroxyprogesterone cost in 2026?

Both are inexpensive generics, and medroxyprogesterone is the cheaper of the two. At our July 9, 2026 check, GoodRx listed generic progesterone from $14.10 against an average retail price of $60.75, and generic medroxyprogesterone from $5.20 against an average retail price of $33.26. But the price spread between pharmacies for the identical generic is larger than the difference between the two drugs.

That last sentence is the finding. Let us show you.

The same 30 capsules, the same day, three prices

On July 9, 2026, GoodRx listed three online pharmacies for 30 capsules of generic progesterone, 100 mg — the identical medication:

A 3.4× spread. Same drug. Same dose. Same day. GoodRx put the average retail price at $60.75. SingleCare reported an average retail price of $422.04 for a 90-count of the same 100 mg generic, discounted to $32.86 with their card (SingleCare notes its price chart updates daily). Drugs.com's price guide showed 100 mg capsules from $11.77 per 30. We're not going to pretend we can tell you what you'll pay. Nobody can. What we can tell you is that the first price you're quoted is very often not the only price that exists. Ask.

Count your pills, not your bottles

Nearly every cost article compares “30 capsules” to “30 tablets.” But you don't take these drugs the same way, so that comparison is meaningless.

A 30-count bottle of 200 mg progesterone covers about two and a half cyclic months. Your pharmacy doesn't price it that way, which is why the only number that matters is the one they quote when you hand over the prescription.

Ask for the cash price even if you have insurance. On drugs this cheap, the discount-card price beats the copay more often than you'd guess. If coverage is the sticking point, we walk through the appeal in does insurance cover HRT?

Wait — is there a progesterone shortage right now?

Yes, and it's tangled up with everything else on this page. Reuters reported on June 17, 2026 that U.S. progesterone supplies are tightening, with the American Society of Health-System Pharmacists listing certain oral progesterone capsule products from Amneal and Hikma in its shortage database. The FDA does not list progesterone as being in shortage. Both statements are true, and the gap between them matters.

Here's the part that reframes this entire page.

The FDA took the boxed warning off hormone therapy. Demand exploded. Now women can't fill their prescriptions.

According to Reuters, citing the health analytics company Truveta — whose electronic health record database covers more than 130 million patients across all 50 states — progesterone-containing HRT prescriptions for women aged 45 and older have more than tripled since January 2021, reaching about 12 women per 1,000 in May 2026. Prescribing rates rose more than 19% after the FDA's label change alone.

Amneal told Reuters it has seen increased demand for progesterone capsules in recent months and is expanding manufacturing capacity at its New York facility. A Department of Health and Human Services spokesperson said one manufacturer is experiencing delays while others have product available.

So why does ASHP say shortage and the FDA say no? Because they count different things. ASHP's database is built from reports by the people at the counter — pharmacists, clinicians, patients. The FDA's data comes from manufacturers. When demand outruns supply but every factory is running flat out, the FDA sees full capacity and you see an empty shelf.

Now follow the logic, because this is where it gets uncomfortable

1. The FDA removed the boxed warning, which made micronized progesterone look like the newer, cleaner option.
2. That same label change helped drive a surge in prescriptions.
3. The surge helped push certain oral progesterone capsules into shortage.
4. So the “better” progestogen may be the one your pharmacy can't get.
5. And into that gap step the compounding pharmacies.

Reuters spoke with a director of clinical services at a compounding pharmacy who said providers aren't waiting for the commercial supply chain to sort itself out. Compounding is permitted when the FDA has declared a drug in shortage, or for personalized doses not otherwise available. The FDA has not declared progesterone in shortage.

Dr. Gillian Goddard, adjunct assistant professor of medicine at the NYU Grossman School of Medicine, told Reuters that compounded products aren't subject to the strict regulatory process FDA-approved drugs go through, and could contain too much or too little progesterone — leading to health problems and potentially costly ultrasounds and biopsies. “I always caution against using compounded products,” she said.

What this actually means for you

If you end up on medroxyprogesterone because progesterone isn't on the shelf, you have not been downgraded to a dangerous drug.You've been given a decades-old, FDA-approved medication that reduces uterine lining overgrowth by roughly the same margin, has more randomized trial data behind it than its rival, and costs less. At our July 2026 check, we found no current ASHP or FDA shortage listing for medroxyprogesterone acetate tablets. That is a perfectly reasonable place to be while you wait.

Reuters notes that clinicians consider the progesterone squeeze milder than the estrogen patch shortage, partly because women who've had a hysterectomy don't need a progestogen at all, and partly because alternatives — combination patches, progestin-releasing IUDs, and oral progestins — take pressure off the supply.

Before you leave the pharmacy, ask three things:which manufacturer's generic do you stock, can you check a different manufacturer, and can you check a different strength.

Verification note: Reuters reported the ASHP listings for Amneal and Hikma oral progesterone capsule products on June 17, 2026. Shortage status shifts by manufacturer, strength, and month. We re-check this section monthly — it's the fastest-moving fact on this page.

Can I switch from medroxyprogesterone to micronized progesterone?

Often, yes — but not on your own, and not by converting the dose yourself. These drugs are not milligram-for-milligram equivalent. Ten milligrams of MPA is not “the same as” some amount of progesterone. Switching changes the drug class, the schedule, the side-effect profile, and the plan protecting your uterine lining. It has to be prescribed.

Before you ask for a switch, get clear on why you want one. The answer changes everything.

Notice that three of those six questions aren't about the molecule at all. They're about dose, route, and schedule — the variables that likely matter more, and that nobody argues about online.

What if I can't tolerate either one?

Some women feel genuinely awful on progestogens — foggy, flat, bloated, exhausted. The answer is never to drop the progestogen and keep the estrogen if you have a uterus. The answer is to change the dose, the schedule, the route, or the drug. There are more options than the two on this page.

Things worth asking your clinician about:

• Change the timing.Take it at bedtime, every time. Many women who “can't tolerate progesterone” were taking it in the morning.
• Change the schedule. Cyclic instead of continuous, or the reverse. Cyclic means fewer total days of exposure.
• Change the route.Vaginal micronized progesterone is used off-label for women who can't manage the oral sedation. It's a real option and it needs a real prescriber.
• Change the molecule. There are other progestins besides MPA — norethindrone acetate, drospirenone, and levonorgestrel (via IUD) are among the options clinicians reach for. None of them are identical to each other or to MPA, and none of them are a magic bullet. See best HRT for progesterone intolerance for the full breakdown.
• Consider a progestogen-free option if you have a uterus.Duavee (conjugated estrogens plus bazedoxifene) protects the uterine lining without a progestogen. It's FDA-approved for menopausal symptoms and osteoporosis prevention. Ask whether it fits your profile.
• If you've had a hysterectomy,you don't need a progestogen for endometrial protection at all. Some women still use it for sleep or mood. That's an optional conversation, not a safety requirement.

Frequently asked questions

Is medroxyprogesterone the same as progesterone?

No. Medroxyprogesterone acetate is a synthetic progestin — a lab-modified molecule. Micronized progesterone is progesterone itself, chemically identical to what the ovaries produce, prepared so it can be absorbed as a capsule. Both are FDA-approved progestogens used to protect the uterine lining during estrogen therapy.

Is Prometrium the same as Provera?

No. Prometrium is the brand name for micronized progesterone capsules. Provera is the brand name for medroxyprogesterone acetate tablets. They are different drugs with different labels, different doses, and different side effects. Most patients receive generic versions of one or the other.

Which is safer, micronized progesterone or medroxyprogesterone?

There is no randomized trial comparing them for breast cancer or heart disease. Observational data, including the French E3N cohort, suggests estrogen plus progesterone carries a lower breast cancer signal than estrogen plus other progestins as a group. However, both FDA labels state that studies have not found breast cancer risk to vary significantly among different estrogen-plus-progestin combinations, and reassuring data on micronized progesterone is limited to roughly five years of use.

Is micronized progesterone bioidentical?

Yes. Micronized progesterone is a bioidentical hormone that is also FDA-approved. The American College of Obstetricians and Gynecologists names it specifically as an FDA-approved bioidentical hormone. Bioidentical and FDA-approved are not opposites. Compounded bioidentical products are a separate category that has not been shown to be safe or effective in controlled trials.

Why do I need a progestogen if I take estrogen?

Systemic estrogen stimulates the lining of the uterus to grow. In Prometrium’s three-year trial, 64% of women taking conjugated estrogens alone developed overgrowth of the uterine lining, compared with 6% who also took progesterone. Women who have had a hysterectomy generally do not need a progestogen.

Why is micronized progesterone taken at bedtime?

The Prometrium label states the capsules can cause dizziness and drowsiness, and directs that the dose be taken at bedtime. Progesterone breaks down into allopregnanolone, which acts on the same brain receptor as sedative medications. For women with menopausal insomnia, this effect is sometimes considered a benefit.

Can I switch from Provera to Prometrium?

Only with a prescriber. The two drugs are not milligram-for-milligram equivalent, and switching changes the drug class, schedule, side-effect profile, and the regimen protecting the uterine lining.

Is there a progesterone shortage in 2026?

Reuters reported on June 17, 2026 that U.S. progesterone supplies are tightening, and that the American Society of Health-System Pharmacists lists certain oral progesterone capsule products from Amneal and Hikma in its shortage database. The FDA does not list progesterone as being in shortage; the two organizations draw on different data sources. Availability varies by pharmacy, manufacturer, and month.

Does micronized progesterone cause weight gain?

Weight change is commonly reported by women on hormone therapy but is difficult to attribute to any single medication. The Prometrium label’s placebo-controlled adverse reaction table reports abdominal bloating in 12% of women on progesterone versus 5% on placebo. Bloating and weight gain are not the same thing.

Is compounded progesterone cream as good as an FDA-approved capsule for protecting the uterus?

There is no evidence that it is. The FDA-commissioned NASEM review found a lack of rigorous evidence of safety and effectiveness for compounded bioidentical hormone therapy, and ACOG states that compounded bioidentical hormone therapy should not be routinely prescribed when FDA-approved formulations exist. Protecting the uterine lining is precisely the use case where this distinction matters most.