Conjugated Estrogens and Medroxyprogesterone side effects: what 23,463 FDA adverse event reports show
Brand names
Premarin Vaginal
Who reports
23,463 reports · 85% serious · 647 with death outcome · 100% female
Used for
PREMARIN (conjugated estrogens) vaginal cream is a mixture of estrogens indicated for: • Treatment of Atrophic Vaginitis and Kraurosis Vulvae ( 1.1 ) • Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopau.
What it is
Each gram of PREMARIN (CE) vaginal cream contains 0.625 mg CE, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil.
Boxed warning
ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,031 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Contralateral breast cancer | 90 | 683.4 519.1–899.7ROR 686.0 · χ² 34,149 / p <1e-300 | 356.0 EB05 298.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=90 · 100% consumer | not reported in cached trials |
| Progesterone receptor assay positive | 333 | 488.9 427.8–558.6ROR 495.9 · χ² 103,950 / p <1e-300 | 309.1 EB05 282.3 · IC025 +7.6 3/3 methods agree | Lab value / disease marker | serious n=329 · 75% consumer | not reported in cached trials |
| Oestrogen receptor assay positive | 374 | 434.6 384.2–491.6ROR 441.6 · χ² 108,053 / p <1e-300 | 287.1 EB05 263.5 · IC025 +7.5 3/3 methods agree | Lab value / disease marker | serious n=369 · 73% consumer | not reported in cached trials |
| Malignant breast lump removal | 40 | 374.8 259.0–542.5ROR 375.5 · χ² 10,200 / p <1e-300 | 233.9 EB05 179.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=40 | not reported in cached trials |
| Breast cancer in situ | 331 | 310.2 273.8–351.3ROR 314.6 · χ² 75,214 / p <1e-300 | 226.7 EB05 206.9 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=328 | not reported in cached trials |
| Biopsy breast abnormal | 24 | 302.0 190.0–480.0ROR 302.3 · χ² 5,140 / p <1e-300 | 191.1 EB05 135.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Breast cancer female | 5,790 | 245.7 239.4–252.2ROR 325.9 · χ² 1,104,544 / p <1e-300 | 192.2 EB05 188.1 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 131.5 · 90% consumer | not reported in cached trials |
| Breast microcalcification | 23 | 208.9 132.6–329.0ROR 209.1 · χ² 3,679 / p <1e-300 | 148.4 EB05 104.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Breast cancer metastatic | 1,506 | 146.1 138.5–154.0ROR 156.0 · χ² 186,074 / p <1e-300 | 125.2 EB05 120.0 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 87.2 · 96% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens (serious AE) |
| Breast operation | 103 | 129.6 105.4–159.3ROR 130.2 · χ² 11,347 / p <1e-300 | 110.8 EB05 94.0 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious n=103 | not reported in cached trials |
| Ovarian cancer metastatic | 100 | 120.7 97.9–148.6ROR 121.2 · χ² 10,332 / p <1e-300 | 104.2 EB05 88.1 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=100 · 100% consumer | not reported in cached trials |
| Breast lump removal | 22 | 92.7 59.8–143.8ROR 92.8 · χ² 1,724 / p <1e-300 | 78.5 EB05 54.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Breast cancer | 7,888 | 81.8 80.3–83.4ROR 122.7 · χ² 578,642 / p <1e-300 | 74.9 EB05 73.6 · IC025 +6.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 51.2 · 93% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens; 1/474 (0.2%) control (serious AE) |
| Breast hyperplasia | 29 | 79.8 54.6–116.7ROR 79.9 · χ² 1,998 / p <1e-300 | 70.0 EB05 51.1 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=29 | not reported in cached trials |
| Fibrocystic breast disease | 57 | 73.9 56.4–96.9ROR 74.1 · χ² 3,717 / p <1e-300 | 66.8 EB05 53.5 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=57 | NCT00242710: 1/179 (0.6%) on Conjugated Estrogens (serious AE) |
| Inflammatory carcinoma of the breast | 10 | 65.2 34.3–124.0ROR 65.3 · χ² 531 / p 1e-117 | 54.8 EB05 31.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Mammogram abnormal | 36 | 50.4 36.0–70.5ROR 50.5 · χ² 1,603 / p <1e-300 | 46.6 EB05 35.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=35 | not reported in cached trials |
| Mastectomy | 92 | 49.7 40.3–61.3ROR 49.9 · χ² 4,109 / p <1e-300 | 46.7 EB05 39.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=92 | not reported in cached trials |
| Breast calcifications | 42 | 49.3 36.2–67.3ROR 49.4 · χ² 1,838 / p <1e-300 | 45.9 EB05 35.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=38 | not reported in cached trials |
| Biopsy breast | 16 | 47.8 28.9–79.0ROR 47.8 · χ² 651 / p 6e-144 | 43.2 EB05 28.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Lymphadenectomy | 34 | 32.1 22.8–45.2ROR 32.2 · χ² 960 / p 5e-211 | 30.6 EB05 22.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=34 | not reported in cached trials |
| Ovarian cancer | 307 | 30.6 27.3–34.3ROR 31.0 · χ² 8,473 / p <1e-300 | 29.6 EB05 26.9 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.2 · 92% consumer | not reported in cached trials |
| Endometrial hypertrophy | 13 | 29.7 17.1–51.5ROR 29.7 · χ² 321 / p 4e-72 | 27.7 EB05 17.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00242710: 4/179 (2.2%) on Conjugated Estrogens; 1/172 (0.6%) control |
| Breast cancer recurrent | 99 | 29.0 23.7–35.4ROR 29.1 · χ² 2,560 / p <1e-300 | 27.9 EB05 23.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=99 · 96% consumer | not reported in cached trials |
| Wrong strength | 10 | 27.9 14.9–52.3ROR 27.9 · χ² 226 / p 3e-51 | 25.7 EB05 14.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Breast reconstruction | 11 | 26.8 14.7–48.9ROR 26.9 · χ² 241 / p 1e-54 | 24.9 EB05 14.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Postmenopausal haemorrhage | 72 | 25.6 20.3–32.4ROR 25.7 · χ² 1,633 / p <1e-300 | 24.8 EB05 20.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=64 | not reported in cached trials |
| Endometrial cancer | 60 | 25.0 19.3–32.3ROR 25.0 · χ² 1,319 / p 4e-289 | 24.1 EB05 19.4 · IC025 +3.9 3/3 methods agree | Labeled — boxed warning exact term | serious n=60 | not reported in cached trials |
| Breast cyst | 47 | 24.2 18.1–32.3ROR 24.2 · χ² 995 / p 1e-218 | 23.4 EB05 18.3 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=43 | not reported in cached trials |
| Atrophic vulvovaginitis | 19 | 23.9 15.2–37.7ROR 23.9 · χ² 384 / p 8e-86 | 22.8 EB05 15.4 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Invasive ductal breast carcinoma | 62 | 20.8 16.2–26.8ROR 20.9 · χ² 1,123 / p 2e-246 | 20.2 EB05 16.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=62 | not reported in cached trials |
| Fracture nonunion | 29 | 19.2 13.3–27.8ROR 19.2 · χ² 473 / p 4e-105 | 18.6 EB05 13.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=29 | not reported in cached trials |
| Uterine dilation and curettage | 19 | 19.0 12.1–30.0ROR 19.1 · χ² 300 / p 1e-67 | 18.2 EB05 12.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | not reported in cached trials |
| Intramedullary rod insertion | 43 | 18.8 13.9–25.5ROR 18.9 · χ² 694 / p 3e-153 | 18.3 EB05 14.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Radiotherapy | 37 | 17.6 12.7–24.3ROR 17.6 · χ² 551 / p 3e-122 | 17.1 EB05 12.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=37 | not reported in cached trials |
| Open reduction of fracture | 22 | 17.3 11.3–26.3ROR 17.3 · χ² 315 / p 1e-70 | 16.6 EB05 11.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Smear cervix abnormal | 24 | 15.2 10.2–22.8ROR 15.2 · χ² 300 / p 2e-67 | 14.6 EB05 10.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Benign breast neoplasm | 17 | 15.0 9.3–24.3ROR 15.0 · χ² 205 / p 7e-47 | 14.1 EB05 8.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Bunion | 12 | 15.0 8.5–26.4ROR 15.0 · χ² 140 / p 1e-32 | 13.4 EB05 7.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Breast mass | 102 | 13.7 11.3–16.7ROR 13.8 · χ² 1,174 / p 1e-257 | 13.5 EB05 11.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=91 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Conjugated Estrogens as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).
- NCT00808132 — Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Ost (N=1886, PHASE3; 144 AE terms posted; arms: Bazedoxifene 20 mg / Conjugated Estrogen; Bazedoxifene 20 mg / Conjugated Estrogen; Bazedoxifene 20 mg; Conjugated Estrogens 0.45mg/Medroxyproge)
- NCT00242710 — Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women (N=1083, PHASE3; 154 AE terms posted; arms: Bazedoxifene 20 mg/Conjugated Estrogen 0; Bazedoxifene 20 mg/Conjugated Estrogen 0; Conjugated Estrogen 0.45 mg/Medroxyproge; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Breast cancer | 7,888 | 81.8 80.3–83.4ROR 122.7 · χ² 578,642 / p <1e-300 | 74.9 EB05 73.6 · IC025 +6.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 51.2 · 93% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens; 1/474 (0.2%) control (serious AE) |
| Breast cancer female | 5,790 | 245.7 239.4–252.2ROR 325.9 · χ² 1,104,544 / p <1e-300 | 192.2 EB05 188.1 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 131.5 · 90% consumer | not reported in cached trials |
| Breast cancer metastatic | 1,506 | 146.1 138.5–154.0ROR 156.0 · χ² 186,074 / p <1e-300 | 125.2 EB05 120.0 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 87.2 · 96% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens (serious AE) |
| Drug ineffective (drug did not work) | 733 | 0.5 0.5–0.5ROR 0.5 · χ² 397 / p 1e-88 | 0.5 EB05 0.5 · IC025 -1.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.3 · 72% consumer | not reported in cached trials |
| Cerebrovascular accident (stroke) | 502 | 2.6 2.4–2.9ROR 2.7 · χ² 514 / p 5e-114 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 1.8 | NCT00808132: 1/474 (0.2%) on Conjugated Estrogens (serious AE) |
| Depression | 478 | 1.9 1.7–2.0ROR 1.9 · χ² 195 / p 2e-44 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00808132: 1/474 (0.2%) on Conjugated Estrogens (serious AE) |
| Headache | 423 | 0.6 0.5–0.7ROR 0.6 · χ² 113 / p 1e-26 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.4 | NCT00808132: 54/220 (24.5%) on Conjugated Estrogens; 122/474 (25.7%) control |
| Anxiety | 418 | 1.3 1.2–1.4ROR 1.3 · χ² 31 / p 2e-8 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.0 | NCT00808132: 1/474 (0.2%) on Conjugated Estrogens (serious AE) |
| Nausea | 413 | 0.5 0.4–0.5ROR 0.5 · χ² 260 / p 1e-58 | 0.5 EB05 0.4 · IC025 -1.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.3 | NCT00808132: 11/220 (5.0%) on Conjugated Estrogens; 26/474 (5.5%) control |
| Deep vein thrombosis (leg blood clot) | 397 | 5.5 4.9–6.0ROR 5.5 · χ² 1,437 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.8 | NCT00808132: 1/220 (0.5%) on Conjugated Estrogens (serious AE) |
| Fatigue (tiredness) | 393 | 0.5 0.4–0.5ROR 0.4 · χ² 271 / p 4e-61 | 0.5 EB05 0.4 · IC025 -1.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.3 | NCT00808132: 4/220 (1.8%) on Conjugated Estrogens; 12/474 (2.5%) control |
| Hot flush (hot flashes) | 388 | 4.6 4.2–5.1ROR 4.7 · χ² 1,094 / p 3e-240 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 75% consumer | NCT00808132: 11/220 (5.0%) on Conjugated Estrogens; 40/474 (8.4%) control |
| Pain | 383 | 0.6 0.5–0.6ROR 0.5 · χ² 139 / p 2e-32 | 0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.4 | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens; 1/474 (0.2%) control (serious AE) |
| Insomnia (trouble sleeping) | 380 | 1.3 1.2–1.4ROR 1.3 · χ² 22 / p 1e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 0.7 · 71% consumer | NCT00808132: 12/220 (5.5%) on Conjugated Estrogens; 32/474 (6.8%) control |
| Myocardial infarction (heart attack) | 378 | 1.9 1.7–2.1ROR 1.9 · χ² 168 / p 1e-38 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled — boxed warning exact term | serious PRR 1.3 | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens; 1/474 (0.2%) control (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Contralateral breast cancer — n=90, PRR 683.4
- Malignant breast lump removal — n=40, PRR 374.8
- Breast cancer in situ — n=331, PRR 310.2
- Biopsy breast abnormal — n=24, PRR 302.0
- Breast cancer female — n=5,790, PRR 245.7
- Breast microcalcification — n=23, PRR 208.9
- Breast lump removal — n=22, PRR 92.7
- Mastectomy — n=92, PRR 49.7
- Breast calcifications — n=42, PRR 49.3
- Lymphadenectomy — n=34, PRR 32.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Conjugated Estrogens?
In FDA FAERS, the most frequently co-reported reaction terms for Conjugated Estrogens are breast cancer, breast cancer female, breast cancer metastatic, cerebrovascular accident, depression, headache. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Conjugated Estrogens have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.
Do FAERS signals prove that Conjugated Estrogens causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 96609623-528e-4aba-cabe-7254aed816d5, effective 20250530; matched on
openfda.generic_name.exact:"CONJUGATED ESTROGENS") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,071 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
CONJUGATED ESTROGENS, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.