Drug · FAERS side-effect profile with label screen
Conjugated Estrogens side effects: what 57,948 FDA adverse event reports show
Brand names
Premarin Vaginal
openFDA label
Who reports
57,948 reports · 71% serious · 1,780 with death outcome · 100% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
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.
FDA label, Description section
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.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 2Labeled adverse reaction 3Labeled (related wording) 9Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 20
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,181 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Contralateral breast cancer | 133 | 648.7 487.7–863.0ROR 650.2 · calibrated p 1e-14 ✓ | 223.2 EB05 193.1 · IC025 +6.7 3/3 methods agree vs other Estrogens: PRR 14.7 (11.3–19.2) | Not in label — unassessed | serious n=133 · 100% consumer | not reported in cached trials |
| Progesterone receptor assay positive | 598 | 635.6 556.2–726.4ROR 642.2 · calibrated p 5e-15 ✓ | 227.2 EB05 212.3 · IC025 +7.5 3/3 methods agree vs other Estrogens: PRR 13.7 (12.1–15.5) | Lab value / disease marker | serious n=591 · 74% consumer | not reported in cached trials |
| Oestrogen receptor assay positive | 693 | 562.1 498.9–633.3ROR 568.9 · calibrated p 2e-14 ✓ | 217.3 EB05 204.0 · IC025 +7.4 3/3 methods agree vs other Estrogens: PRR 13.6 (12.1–15.2) | Lab value / disease marker | serious n=685 | not reported in cached trials |
| Breast cancer in situ | 492 | 224.9 200.9–251.7ROR 226.8 · calibrated p 1e-10 ✓ | 137.5 EB05 127.6 · IC025 +6.8 3/3 methods agree vs other Estrogens: PRR 11.5 (10.1–13.1) | Not in label — unassessed | serious n=488 | not reported in cached trials |
| Biopsy breast abnormal | 33 | 192.6 126.1–294.2ROR 192.7 · calibrated p 3e-9 ✓ | 117.0 EB05 87.2 · IC025 +4.9 3/3 methods agree vs other Estrogens: PRR 13.7 (8.1–23.2) | Not in label — unassessed | serious n=33 | not reported in cached trials |
| Malignant breast lump removal | 47 | 192.4 134.9–274.3ROR 192.5 · calibrated p 2e-9 ✓ | 119.3 EB05 93.3 · IC025 +5.3 3/3 methods agree vs other Estrogens: PRR 11.7 (7.7–17.9) | Not in label — unassessed | serious n=47 | not reported in cached trials |
| Breast cancer female | 8,862 | 178.4 174.2–182.8ROR 210.5 · calibrated p 2e-10 ✓ | 119.2 EB05 117.1 · IC025 +6.9 3/3 methods agree vs other Estrogens: PRR 8.0 (7.8–8.2) | Not in label — unassessed | serious PRR 96.5 · 89% consumer | not reported in cached trials |
| Breast microcalcification | 30 | 118.7 78.5–179.4ROR 118.7 · calibrated p 1e-7 ✓ | 84.6 EB05 62.1 · IC025 +4.6 3/3 methods agree vs other Estrogens: PRR 13.0 (7.6–22.4) | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Bronchial neoplasm | 33 | 115.2 77.8–170.6ROR 115.3 · calibrated p 1e-7 ✓ | 83.2 EB05 62.0 · IC025 +4.7 3/3 methods agree vs other Estrogens: only this drug | Not in label — unassessed | serious n=33 | not reported in cached trials |
| Ovarian cancer metastatic | 164 | 87.7 73.9–104.0ROR 87.9 · calibrated p 4e-7 ✓ | 70.0 EB05 61.5 · IC025 +5.6 3/3 methods agree vs other Estrogens: PRR 16.4 (12.8–21.0) | Labeled (related wording) related wording | serious n=164 · 100% consumer | not reported in cached trials |
| Breast cancer metastatic | 1,681 | 67.2 63.8–70.7ROR 69.2 · calibrated p 2e-6 ✓ | 56.7 EB05 54.4 · IC025 +5.7 3/3 methods agree vs other Estrogens: PRR 9.5 (8.9–10.2) | Labeled (related wording) related wording | serious PRR 46.6 · 96% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens (serious AE) |
| Breast operation | 105 | 53.6 43.6–65.7ROR 53.7 · calibrated p 1e-5 ✓ | 46.3 EB05 39.4 · IC025 +4.9 3/3 methods agree vs other Estrogens: PRR 10.2 (7.7–13.3) | Reporting / coding artifact | serious n=105 | not reported in cached trials |
| Fibrocystic breast disease | 91 | 50.2 40.3–62.6ROR 50.3 · calibrated p 2e-5 ✓ | 43.8 EB05 36.7 · IC025 +4.8 3/3 methods agree vs other Estrogens: PRR 15.9 (11.4–22.2) | Labeled (related wording) related wording | serious n=90 | NCT00242710: 1/179 (0.6%) on Conjugated Estrogens (serious AE) |
| Breast cancer | 9,624 | 41.2 40.4–42.0ROR 49.2 · calibrated p 1e-5 ✓ | 37.0 EB05 36.4 · IC025 +5.2 3/3 methods agree vs other Estrogens: PRR 9.7 (9.5–10.0) | Labeled — boxed warning exact term | serious PRR 29.9 · 90% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens; 1/474 (0.2%) control (serious AE) |
| Bronchial haemorrhage | 32 | 40.8 28.3–58.9ROR 40.9 · calibrated p 8e-5 ✓ | 36.0 EB05 26.7 · IC025 +4.0 3/3 methods agree vs other Estrogens: only this drug | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Sinus rhythm | 44 | 40.3 29.5–55.0ROR 40.3 · calibrated p 7e-5 ✓ | 35.8 EB05 27.7 · IC025 +4.2 3/3 methods agree vs other Estrogens: PRR 5.2 (3.6–7.5) | Not in label — unassessed | serious n=44 · 100% clinician | not reported in cached trials |
| Schizoaffective disorder | 176 | 39.3 33.7–45.9ROR 39.4 · calibrated p 6e-5 ✓ | 35.4 EB05 31.2 · IC025 +4.8 3/3 methods agree vs other Estrogens: PRR 5.8 (4.8–6.9) | Not in label — unassessed | serious n=176 | not reported in cached trials |
| Atrophic vulvovaginitis | 69 | 37.8 29.5–48.4ROR 37.8 · calibrated p 9e-5 ✓ | 34.0 EB05 27.8 · IC025 +4.4 3/3 methods agree vs other Estrogens: PRR 10.0 (7.1–13.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=47 | not reported in cached trials |
| Nasal turbinate hypertrophy | 34 | 35.9 25.2–51.1ROR 35.9 · calibrated p 2e-4 ✓ | 32.2 EB05 24.1 · IC025 +3.9 3/3 methods agree vs other Estrogens: only this drug | Not in label — unassessed | serious n=34 | not reported in cached trials |
| Endometrial ablation | 31 | 34.6 23.9–50.0ROR 34.6 · calibrated p 2e-4 ✓ | 31.1 EB05 22.9 · IC025 +3.8 3/3 methods agree vs other Estrogens: only this drug | Not in label — unassessed | serious n=31 | not reported in cached trials |
| Mammogram abnormal | 58 | 34.0 26.0–44.5ROR 34.1 · calibrated p 2e-4 ✓ | 30.9 EB05 24.8 · IC025 +4.2 3/3 methods agree vs other Estrogens: PRR 16.1 (10.6–24.3) | Lab value / disease marker | serious n=54 | not reported in cached trials |
| Cystocele | 66 | 29.9 23.2–38.4ROR 29.9 · calibrated p 3e-4 ✓ | 27.4 EB05 22.3 · IC025 +4.1 3/3 methods agree vs other Estrogens: PRR 65.8 (33.8–128.0) | Not in label — unassessed | serious n=59 | NCT00242710: 1/179 (0.6%) on Conjugated Estrogens (serious AE) |
| Rectocele | 45 | 29.0 21.4–39.3ROR 29.0 · calibrated p 4e-4 ✓ | 26.6 EB05 20.7 · IC025 +3.9 3/3 methods agree vs other Estrogens: only this drug | Not in label — unassessed | serious n=43 | NCT00242710: 1/361 (0.3%) on Conjugated Estrogens (serious AE) |
| Vulvovaginal burning sensation | 441 | 28.2 25.6–31.0ROR 28.4 · calibrated p 4e-4 ✓ | 26.1 EB05 24.2 · IC025 +4.5 3/3 methods agree vs other Estrogens: PRR 10.6 (9.3–12.2) | Labeled (related wording) related wording | serious n=88 · 77% consumer | not reported in cached trials |
| Breast calcifications | 56 | 27.1 20.6–35.5ROR 27.1 · calibrated p 6e-4 ✓ | 25.1 EB05 20.0 · IC025 +3.9 3/3 methods agree vs other Estrogens: PRR 13.3 (8.9–19.8) | Not in label — unassessed | serious n=50 | not reported in cached trials |
| Vaginal disorder | 66 | 26.6 20.8–34.2ROR 26.7 · calibrated p 6e-4 ✓ | 24.7 EB05 20.1 · IC025 +4.0 3/3 methods agree vs other Estrogens: PRR 94.0 (43.1–204.9) | Labeled adverse reaction exact term | serious n=31 · 77% consumer | NCT00808132: 4/220 (1.8%) on Conjugated Estrogens; 11/474 (2.3%) control |
| Vulvovaginal dryness | 219 | 26.4 23.0–30.3ROR 26.5 · calibrated p 5e-4 ✓ | 24.6 EB05 22.0 · IC025 +4.3 3/3 methods agree vs other Estrogens: PRR 9.0 (7.5–10.8) | Not in label — unassessed | serious n=86 | not reported in cached trials |
| Ovarian cancer | 611 | 25.5 23.5–27.7ROR 25.8 · calibrated p 6e-4 ✓ | 23.9 EB05 22.3 · IC025 +4.4 3/3 methods agree vs other Estrogens: PRR 11.8 (10.5–13.2) | Labeled adverse reaction exact term | serious PRR 19.2 · 87% consumer | not reported in cached trials |
| Vulvovaginal discomfort | 288 | 25.3 22.4–28.5ROR 25.4 · calibrated p 6e-4 ✓ | 23.6 EB05 21.4 · IC025 +4.3 3/3 methods agree vs other Estrogens: PRR 8.5 (7.2–9.9) | Labeled adverse reaction exact term | serious n=58 · 73% consumer | not reported in cached trials |
| Mastectomy | 112 | 24.8 20.4–30.0ROR 24.8 · calibrated p 8e-4 ✓ | 23.1 EB05 19.8 · IC025 +4.1 3/3 methods agree vs other Estrogens: PRR 12.1 (9.2–16.0) | Not in label — unassessed | serious n=112 | not reported in cached trials |
| Benign breast neoplasm | 63 | 23.6 18.3–30.5ROR 23.6 · calibrated p 0.001 ✓ | 22.1 EB05 17.9 · IC025 +3.8 3/3 methods agree vs other Estrogens: PRR 37.0 (21.6–63.1) | Not in label — unassessed | serious n=58 | not reported in cached trials |
| Vulvovaginal erythema | 49 | 22.6 17.0–30.2ROR 22.6 · calibrated p 0.001 ✓ | 21.2 EB05 16.6 · IC025 +3.7 3/3 methods agree vs other Estrogens: PRR 9.0 (6.1–13.3) | Labeled (related wording) related wording | 100% consumer | not reported in cached trials |
| Bladder prolapse | 71 | 21.9 17.3–27.9ROR 22.0 · calibrated p 0.001 ✓ | 20.6 EB05 16.9 · IC025 +3.8 3/3 methods agree vs other Estrogens: only this drug | Not in label — unassessed | serious n=60 | not reported in cached trials |
| Vulvovaginal pain | 235 | 18.7 16.4–21.3ROR 18.7 · calibrated p 0.003 ✓ | 17.8 EB05 15.9 · IC025 +3.9 3/3 methods agree vs other Estrogens: PRR 11.5 (9.5–13.8) | Labeled (related wording) related wording | serious n=70 · 77% consumer | not reported in cached trials |
| Breast cancer recurrent | 151 | 18.2 15.4–21.4ROR 18.2 · calibrated p 0.003 ✓ | 17.3 EB05 15.1 · IC025 +3.8 3/3 methods agree vs other Estrogens: PRR 15.2 (11.8–19.6) | Not in label — unassessed | serious n=151 · 100% consumer | not reported in cached trials |
| Blood oestrogen decreased | 31 | 17.2 12.0–24.7ROR 17.2 · calibrated p 0.005 ✓ | 16.2 EB05 11.8 · IC025 +3.1 3/3 methods agree vs other Estrogens: PRR 1.9 (1.3–2.8) | Likely indication confounding term in indications; also in warnings | – | not reported in cached trials |
| Breast cyst | 81 | 17.2 13.8–21.5ROR 17.2 · calibrated p 0.004 ✓ | 16.4 EB05 13.6 · IC025 +3.5 3/3 methods agree vs other Estrogens: PRR 7.8 (5.9–10.5) | Labeled (related wording) related wording | serious n=74 | not reported in cached trials |
| Vulvovaginal pruritus | 228 | 17.1 15.0–19.5ROR 17.1 · calibrated p 0.004 ✓ | 16.3 EB05 14.6 · IC025 +3.8 3/3 methods agree vs other Estrogens: PRR 10.4 (8.7–12.5) | Labeled (related wording) related wording | serious n=57 · 80% consumer | NCT00242710: 6/179 (3.4%) on Conjugated Estrogens; 1/172 (0.6%) control |
| Endometrial cancer | 89 | 15.2 12.3–18.8ROR 15.2 · calibrated p 0.007 ✓ | 14.5 EB05 12.1 · IC025 +3.4 3/3 methods agree vs other Estrogens: PRR 14.8 (10.7–20.5) | Labeled — boxed warning exact term | serious n=89 · 100% consumer | not reported in cached trials |
| Breast neoplasm | 41 | 15.0 10.9–20.4ROR 15.0 · calibrated p 0.008 ✓ | 14.2 EB05 10.8 · IC025 +3.1 3/3 methods agree vs other Estrogens: PRR 27.3 (15.1–49.2) | Labeled (related wording) related wording | serious n=39 | 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 (7 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 | 9,624 | 41.2 40.4–42.0ROR 49.2 · calibrated p 1e-5 ✓ | 37.0 EB05 36.4 · IC025 +5.2 3/3 methods agree vs other Estrogens: PRR 9.7 (9.5–10.0) | Labeled — boxed warning exact term | serious PRR 29.9 · 90% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens; 1/474 (0.2%) control (serious AE) |
| Breast cancer female | 8,862 | 178.4 174.2–182.8ROR 210.5 · calibrated p 2e-10 ✓ | 119.2 EB05 117.1 · IC025 +6.9 3/3 methods agree vs other Estrogens: PRR 8.0 (7.8–8.2) | Not in label — unassessed | serious PRR 96.5 · 89% consumer | not reported in cached trials |
| Drug ineffective (drug did not work) | 3,310 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.245 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Estrogens: PRR 2.8 (2.7–2.9) | Reporting / coding artifact | serious PRR 0.8 | not reported in cached trials |
| Nausea | 2,379 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.369 | 1.1 EB05 1.1 · IC025 +0.1 vs other Estrogens: PRR 2.7 (2.6–2.8) | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00808132: 11/220 (5.0%) on Conjugated Estrogens; 26/474 (5.5%) control |
| Headache | 2,304 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.539 | 1.3 EB05 1.3 · IC025 +0.3 vs other Estrogens: PRR 2.6 (2.5–2.8) | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00808132: 54/220 (24.5%) on Conjugated Estrogens; 122/474 (25.7%) control |
| Pain | 2,265 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.540 | 1.3 EB05 1.3 · IC025 +0.3 vs other Estrogens: PRR 3.5 (3.4–3.7) | Labeled adverse reaction exact term | serious PRR 1.2 | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens; 1/474 (0.2%) control (serious AE) |
| Fatigue (tiredness) | 2,219 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.329 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Estrogens: PRR 2.6 (2.4–2.7) | Not in label — unassessed | serious PRR 1.0 | NCT00808132: 4/220 (1.8%) on Conjugated Estrogens; 12/474 (2.5%) control |
| Off label use (used outside approved label) | 2,184 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.247 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Estrogens: PRR 3.0 (2.9–3.2) | Reporting / coding artifact | serious PRR 0.7 | not reported in cached trials |
| Breast cancer metastatic | 1,681 | 67.2 63.8–70.7ROR 69.2 · calibrated p 2e-6 ✓ | 56.7 EB05 54.4 · IC025 +5.7 3/3 methods agree vs other Estrogens: PRR 9.5 (8.9–10.2) | Labeled (related wording) related wording | serious PRR 46.6 · 96% consumer | NCT00808132: 1/445 (0.2%) on Conjugated Estrogens (serious AE) |
| Dizziness | 1,646 | 1.2 1.1–1.3ROR 1.2 · calibrated p 0.442 | 1.2 EB05 1.1 · IC025 +0.2 vs other Estrogens: PRR 3.1 (3.0–3.3) | Labeled adverse reaction exact term | serious PRR 1.1 | NCT00808132: 9/220 (4.1%) on Conjugated Estrogens; 11/474 (2.3%) control |
| Dyspnoea (shortness of breath) | 1,630 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.336 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Estrogens: PRR 3.5 (3.3–3.7) | Not in label — unassessed | serious PRR 0.9 | not reported in cached trials |
| Malaise (feeling unwell) | 1,585 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.518 | 1.3 EB05 1.3 · IC025 +0.3 vs other Estrogens: PRR 4.0 (3.8–4.2) | Not in label — unassessed | serious PRR 1.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,531 | 0.9 0.8–0.9ROR 0.9 · calibrated p 0.217 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Estrogens: PRR 2.6 (2.5–2.7) | Not in label — unassessed | serious PRR 0.8 | NCT00808132: 13/220 (5.9%) on Conjugated Estrogens; 24/474 (5.1%) control |
| Arthralgia (joint pain) | 1,453 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.492 | 1.3 EB05 1.2 · IC025 +0.3 vs other Estrogens: PRR 2.9 (2.7–3.1) | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00808132: 19/220 (8.6%) on Conjugated Estrogens; 47/474 (9.9%) control |
| Anxiety | 1,428 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.851 | 1.8 EB05 1.7 · IC025 +0.8 vs other Estrogens: PRR 3.5 (3.3–3.8) | Not in label — unassessed | serious PRR 1.7 | NCT00808132: 1/474 (0.2%) on Conjugated Estrogens (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=133, PRR 648.7
- Breast cancer in situ — n=492, PRR 224.9
- Biopsy breast abnormal — n=33, PRR 192.6
- Malignant breast lump removal — n=47, PRR 192.4
- Breast cancer female — n=8,862, PRR 178.4
- Breast microcalcification — n=30, PRR 118.7
- Bronchial neoplasm — n=33, PRR 115.2
- Bronchial haemorrhage — n=32, PRR 40.8
- Sinus rhythm — n=44, PRR 40.3
- Schizoaffective disorder — n=176, PRR 39.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Conjugated Estrogens And Medroxyprogesterone Acetate ↔ Breast Cancer.
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, nausea, headache, pain, fatigue. 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, 1,221 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 2026-10-14. 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.