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Prometrium Missed Dose: What the Label Says About Bedtime Dosing

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4 linked public sourcesEditorial, sourcing, and corrections policy

HealthRX.com

The label gives no missed-dose rule for Prometrium

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Key numbers

  • 200 mgEndometrial-protection dose: 200 mg at bedtime, 12 days per 28-day cycle, with conjugated estrogensSource: dailymed.nlm.nih.gov, as cited Nov 8, 2026
  • 400 mgSecondary amenorrhea dose: 400 mg at bedtime for 10 days, a separate regimen from the endometrial doseSource: dailymed.nlm.nih.gov, as cited Nov 8, 2026
  • 3 hoursTime until maximum serum progesterone concentration after an oral doseSource: accessdata.fda.gov, as cited Nov 8, 2026

From the public record

Missed dose and timing terms in FDA adverse event reports for Prometrium

Of 3,513 adverse event reports FDA had received for Prometrium through 2026-10-28, 299 (8.5%) name at least one missed dose or timing term. The terms named most often are product use issue (147), product dose omission issue (31) and incorrect dose administered (31). Across every medicine in the database the same terms appear in 6.6% of reports.

Missed dose and timing terms in FDA adverse event reports for Prometrium: the figures
MeasureValueNote
Reports naming at least one missed dose or timing term299
Share of all reports for Prometrium8.5%of 3,513 reports
Same terms across every medicine in FAERS6.6%share of all reports in the database, for context
Product use issue147 reports
Product dose omission issue31 reports
Incorrect dose administered31 reports
Inappropriate schedule of product administration30 reports
Drug dose omission24 reports

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports for this medicine that name any of 16 reaction terms about missed dose and timing, then each term on its own. A report can name several terms. Reports are unverified and do not show cause.

Scope: Reports with the product name recorded as Prometrium naming any of 16 MedDRA missed dose or timing terms, all years to 2026-10-28

Download the data (CSV)

At a glance

  • Drug / oral micronized progesterone, Prometrium 100 mg and 200 mg capsules [1]
  • Endometrial regimen / 200 mg at bedtime, 12 days per 28-day cycle, with conjugated estrogens [1]
  • Amenorrhea regimen / 400 mg at bedtime for 10 days [1]
  • Bedtime dosing / label cites transient dizziness and drowsiness and cautions about driving [1]
  • Food effect / food increased bioavailability at the 200 mg dose [2]
  • Peanut oil / peanut allergy is a contraindication [1]

What the label covers

Prometrium is oral micronized progesterone, approved for prevention of endometrial hyperplasia in postmenopausal women with a uterus who are taking conjugated estrogens tablets, and for secondary amenorrhea [1]. For endometrial protection the label directs 200 mg orally as a single daily dose at bedtime for 12 days sequentially per 28-day cycle [1]. For secondary amenorrhea it directs 400 mg at bedtime for 10 days [1]. Women who have trouble swallowing a capsule are told to take it with a glass of water while standing [1].

The endometrial regimen is written for conjugated estrogens; the label does not describe use with estradiol [1].

Questions worth asking

Choose the questions you want to keep

Why the dose is at bedtime

The label states that Prometrium 'may cause transient dizziness and drowsiness and should be used with caution when driving a motor vehicle or operating machinery,' and directs a single daily dose at bedtime [1]. The patient leaflet says to take it at bedtime because some women become very drowsy or dizzy [2]. During initial therapy, a few women had extreme dizziness or drowsiness, blurred vision, slurred speech, difficulty walking, loss of consciousness, vertigo, confusion, disorientation, feeling drunk and shortness of breath [1][2]. Maximum serum concentrations are reached within 3 hours of an oral dose [2].

Taking the capsule with food increased progesterone bioavailability compared with fasting in postmenopausal women at the 200 mg dose [2].

What people on Reddit report

Accounts from Reddit users who forgot or shifted a progesterone dose, including daytime drowsiness after a morning dose and bleeding after a missed dose.

No_Okra_4783 · hrt

Didn't have best sleep. Not sure what to do this morning, so decided to take progesterone when I got up to hopefully lessen crazy spotting/ bleeding that will surely happen.

Forgot the bedtime dose, took it the next morning, and felt drugged and sleepy at work.

Read the source discussion

No_Okra_4783 · hrt

The drugged feeling only lasted about an hour or hour and a half. Still not at my best but getting through my day.

The original poster reports the sleepy, drugged feeling faded within a short time.

Read the source discussion

Jeterjane123 · hrt

I use a 7 day pill holder thingie to make sure I don't forget. Plus it has vitamin. If I do forget I just skip it it.

Uses a weekly pill organizer and says they skip a dose they forget.

Read the source discussion

What the label says about taking too much

The overdosage section says that in the case of overdosage, Prometrium should be discontinued and the patient treated symptomatically [1]. The label's 400 mg bedtime dose is for 10 days in secondary amenorrhea, not the endometrial-protection regimen [1].

What the label trial showed

In the label's 36-month trial, 358 postmenopausal women with a uterus received cyclic Prometrium 200 mg plus conjugated estrogens 0.625 mg (n=120), conjugated estrogens alone (n=119), or placebo (n=119) [1]. Endometrial hyperplasia was found in 6% (7 of 117) of the combination group, 64% (74 of 115) of the estrogen-alone group and 3% (3 of 116) of the placebo group; atypical hyperplasia occurred in 1%, 12% and 0% respectively [1].

Check what you know

Think you have it? Try 5 quick questions and see what the article says.

1. How many days per 28-day cycle does the label direct 200 mg at bedtime for endometrial protection?

Question 1 of 5

Score: 0 right, 0 of 5 answered

Frequently asked questions

What does the label say about the Prometrium schedule?
For endometrial protection, 200 mg at bedtime for 12 days sequentially per 28-day cycle with conjugated estrogens. For secondary amenorrhea, 400 mg at bedtime for 10 days [1].
Should I take two capsules after a missed one?
The label's dosage section does not describe doubling. Its 400 mg bedtime dose is the 10-day secondary-amenorrhea regimen, not the endometrial-protection dose [1]. The overdosage section says that in the case of overdosage Prometrium should be discontinued and the patient treated symptomatically [1].
Can I take Prometrium at a different time of day?
The label directs a single daily dose at bedtime and says Prometrium may cause transient dizziness and drowsiness, with caution for driving or operating machinery [1].
Does food change absorption?
At the 200 mg dose in postmenopausal women, taking the capsule with food increased bioavailability compared with a fasting dose [2].
What did the label trial show about endometrial hyperplasia?
Over 36 months, hyperplasia occurred in 6% of women taking cyclic Prometrium 200 mg with conjugated estrogens, 64% taking estrogen alone and 3% on placebo [1].
Is peanut allergy a problem with Prometrium?
Yes. The capsules contain peanut oil, and peanut allergy is one of the label contraindications [1].

References

Show all 4 referencesHide references
  1. U.S. National Library of Medicine, DailyMed. Prometrium progesterone capsules (Acertis), Rev. 02/2026 prescribing information. Prometrium progesterone capsules (Acertis), Rev. 02/2026 label
  2. U.S. Food and Drug Administration.
  3. Reddit participants. Forgot 200 mg progesterone at bedtime. Took in morning today. At work and struggling, sleepy. (r/hrt). Accessed 2026-11-11.
  4. Reddit participants. Help! Missed one dose of progesterone and have been bleeding for 9 days! (r/Menopause). Accessed 2026-11-11.
Evidence overview for Prometrium Missed Dose: What the Label Says About Bedtime Dosing