Drug · FAERS side-effect profile with label screen
Exemestane side effects: what 21,296 FDA adverse event reports show
Who reports
21,296 reports · 77% serious · 2,512 with death outcome · 99% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Exemestane tablets are an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ).
FDA label, Indications and Usage
What it is
Exemestane Tablets, USP for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione.
FDA label, Description section
Boxed warning
None in the current 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 (related wording) 7Likely indication confounding 1Lab value / disease marker 5Not in label — unassessed 27
What the badges mean
- 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.
- 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). 1,122 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 |
|---|---|---|---|---|---|---|
| Pik3ca-activated mutation | 83 | 337.1 262.7–432.6ROR 338.4 · calibrated p 6e-12 ✓ | 236.8 EB05 197.1 · IC025 +6.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.6–0.9) | Not in label — unassessed | serious n=82 | no trial data cached |
| Amaurosis fugax | 229 | 268.8 232.3–311.0ROR 271.7 · calibrated p 3e-11 ✓ | 207.1 EB05 185.5 · IC025 +7.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.0 (0.9–1.2) | Not in label — unassessed | serious n=229 · 93% clinician | no trial data cached |
| Pleural neoplasm | 24 | 167.6 108.7–258.4ROR 167.8 · calibrated p 8e-9 ✓ | 128.7 EB05 91.0 · IC025 +4.5 3/3 methods agree vs other Aromatase Inhibitors: PRR 2.1 (1.3–3.4) | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Bone sequestrum | 19 | 138.7 85.8–224.2ROR 138.8 · calibrated p 5e-8 ✓ | 108.5 EB05 73.4 · IC025 +4.1 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Not in label — unassessed | serious n=19 | no trial data cached |
| Metastases to skin | 124 | 135.7 112.5–163.7ROR 136.5 · calibrated p 1e-8 ✓ | 117.1 EB05 100.8 · IC025 +6.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.4 (1.1–1.7) | Labeled (related wording) related wording | serious n=125 | no trial data cached |
| Carbohydrate antigen 27.29 increased | 18 | 133.4 81.5–218.3ROR 133.5 · calibrated p 7e-8 ✓ | 104.7 EB05 70.0 · IC025 +4.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.1 (0.6–1.8) | Lab value / disease marker | serious n=15 | no trial data cached |
| Hormone receptor positive breast cancer | 31 | 131.4 90.3–191.2ROR 131.6 · calibrated p 4e-8 ✓ | 108.3 EB05 79.9 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.6–1.4) | Labeled (related wording) related wording | serious n=31 | no trial data cached |
| Oestrogen receptor positive breast cancer | 14 | 122.4 70.2–213.4ROR 122.5 · calibrated p 2e-7 ✓ | 95.1 EB05 60.2 · IC025 +3.6 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Likely indication confounding term in indications; also in warnings | serious n=13 | no trial data cached |
| Pseudocirrhosis | 33 | 110.1 76.8–157.7ROR 110.3 · calibrated p 1e-7 ✓ | 93.7 EB05 69.8 · IC025 +4.7 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.5–1.0) | Not in label — unassessed | serious n=33 · 100% clinician | no trial data cached |
| Metastases to chest wall | 34 | 107.2 75.2–152.7ROR 107.3 · calibrated p 2e-7 ✓ | 91.8 EB05 68.7 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.5–1.1) | Not in label — unassessed | serious n=34 | no trial data cached |
| Carbohydrate antigen 15-3 increased | 74 | 105.9 83.4–134.6ROR 106.3 · calibrated p 1e-7 ✓ | 93.4 EB05 76.8 · IC025 +5.5 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.4 (0.3–0.5) | Lab value / disease marker | serious n=73 | no trial data cached |
| Metastases to thorax | 24 | 102.6 67.4–156.3ROR 102.7 · calibrated p 3e-7 ✓ | 86.7 EB05 61.3 · IC025 +4.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.5–1.3) | Not in label — unassessed | serious n=24 | no trial data cached |
| Tumour marker decreased | 15 | 88.8 52.3–150.6ROR 88.8 · calibrated p 1e-6 ✓ | 74.0 EB05 47.6 · IC025 +3.6 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Lab value / disease marker | serious n=15 | no trial data cached |
| Metastases to pleura | 86 | 88.6 71.1–110.5ROR 89.0 · calibrated p 4e-7 ✓ | 79.9 EB05 66.7 · IC025 +5.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.7–1.1) | Not in label — unassessed | serious n=86 | no trial data cached |
| Tumour marker abnormal | 27 | 86.2 58.2–127.8ROR 86.3 · calibrated p 9e-7 ✓ | 75.2 EB05 54.3 · IC025 +4.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.6–1.3) | Lab value / disease marker | serious n=26 | no trial data cached |
| Breast cancer metastatic | 847 | 84.4 78.8–90.4ROR 87.9 · calibrated p 3e-7 ✓ | 77.6 EB05 73.3 · IC025 +6.1 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.7–0.8) | Not in label — unassessed | serious PRR 54.9 | no trial data cached |
| Invasive lobular breast carcinoma | 40 | 83.3 60.3–115.1ROR 83.5 · calibrated p 8e-7 ✓ | 74.2 EB05 56.8 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.9 (0.6–1.3) | Not in label — unassessed | serious n=39 | no trial data cached |
| Anticipatory anxiety | 19 | 74.4 46.7–118.6ROR 74.4 · calibrated p 3e-6 ✓ | 64.8 EB05 43.9 · IC025 +3.9 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Not in label — unassessed | serious n=19 | no trial data cached |
| Metastases to the mediastinum | 28 | 71.2 48.5–104.4ROR 71.2 · calibrated p 3e-6 ✓ | 63.6 EB05 46.2 · IC025 +4.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.4–0.9) | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Metastases to pelvis | 41 | 68.4 49.8–93.8ROR 68.5 · calibrated p 3e-6 ✓ | 62.2 EB05 47.8 · IC025 +4.7 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.5–1.0) | Not in label — unassessed | serious n=41 | no trial data cached |
| Metastases to soft tissue | 16 | 64.2 38.7–106.4ROR 64.2 · calibrated p 1e-5 ✓ | 56.4 EB05 36.8 · IC025 +3.6 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Not in label — unassessed | serious n=16 | no trial data cached |
| Metastases to bone | 922 | 58.8 55.1–62.7ROR 61.4 · calibrated p 4e-6 ✓ | 55.4 EB05 52.5 · IC025 +5.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.6–0.6) | Labeled (related wording) related wording | serious PRR 42.0 | no trial data cached |
| Breast cancer recurrent | 175 | 57.9 49.7–67.4ROR 58.3 · calibrated p 6e-6 ✓ | 54.4 EB05 47.9 · IC025 +5.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.5–0.7) | Not in label — unassessed | serious n=172 | no trial data cached |
| Tumour marker increased | 262 | 56.7 50.1–64.2ROR 57.4 · calibrated p 6e-6 ✓ | 53.4 EB05 48.2 · IC025 +5.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.7–0.9) | Lab value / disease marker | serious n=236 | no trial data cached |
| Primary sequestrum | 49 | 55.5 41.6–74.0ROR 55.6 · calibrated p 1e-5 ✓ | 51.6 EB05 40.5 · IC025 +4.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.6 (1.2–2.3) | Not in label — unassessed | serious n=49 | no trial data cached |
| Oral cavity fistula | 26 | 54.5 36.7–80.9ROR 54.6 · calibrated p 2e-5 ✓ | 49.9 EB05 35.8 · IC025 +4.1 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Not in label — unassessed | serious n=26 | no trial data cached |
| Hormone receptor positive her2 negative breast cancer | 16 | 52.8 31.9–87.4ROR 52.9 · calibrated p 3e-5 ✓ | 47.5 EB05 31.0 · IC025 +3.5 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.2 (0.1–0.4) | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Metastases to ovary | 16 | 52.3 31.6–86.5ROR 52.3 · calibrated p 3e-5 ✓ | 47.1 EB05 30.7 · IC025 +3.5 3/3 methods agree vs other Aromatase Inhibitors: PRR 4.3 (2.1–8.6) | Not in label — unassessed | serious n=16 | no trial data cached |
| Bone marrow infiltration | 19 | 50.9 32.1–80.8ROR 51.0 · calibrated p 3e-5 ✓ | 46.4 EB05 31.4 · IC025 +3.7 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.0 (0.6–1.7) | Not in label — unassessed | serious n=19 | no trial data cached |
| Urinary tract disorder | 211 | 48.4 42.2–55.6ROR 48.9 · calibrated p 2e-5 ✓ | 46.0 EB05 41.0 · IC025 +5.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.0 (0.9–1.2) | Labeled (related wording) related wording | serious n=209 · 94% clinician | no trial data cached |
| Metastases to spine | 153 | 47.1 40.0–55.3ROR 47.4 · calibrated p 2e-5 ✓ | 44.7 EB05 39.1 · IC025 +5.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.5–0.8) | Labeled (related wording) related wording | serious n=152 | no trial data cached |
| Metastases to liver | 753 | 44.2 41.1–47.4ROR 45.7 · calibrated p 2e-5 ✓ | 42.2 EB05 39.8 · IC025 +5.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.7–0.8) | Labeled (related wording) related wording | serious PRR 31.9 | no trial data cached |
| Fibrous histiocytoma | 15 | 43.3 25.8–72.7ROR 43.4 · calibrated p 9e-5 ✓ | 39.6 EB05 25.5 · IC025 +3.3 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Not in label — unassessed | serious n=14 | no trial data cached |
| Metastases to lymph nodes | 276 | 42.2 37.5–47.6ROR 42.8 · calibrated p 4e-5 ✓ | 40.4 EB05 36.6 · IC025 +5.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.7–0.9) | Not in label — unassessed | serious n=275 | no trial data cached |
| Lymphangiosis carcinomatosa | 42 | 41.3 30.3–56.2ROR 41.4 · calibrated p 6e-5 ✓ | 39.0 EB05 30.1 · IC025 +4.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.4 (1.0–1.9) | Not in label — unassessed | serious n=42 · 100% clinician | no trial data cached |
| Nail dystrophy | 22 | 40.6 26.5–62.2ROR 40.6 · calibrated p 1e-4 ✓ | 37.8 EB05 26.3 · IC025 +3.7 3/3 methods agree vs other Aromatase Inhibitors: PRR 3.4 (1.9–6.0) | Not in label — unassessed | serious n=21 | no trial data cached |
| Osteosclerosis | 60 | 38.9 30.1–50.3ROR 39.0 · calibrated p 8e-5 ✓ | 37.0 EB05 29.8 · IC025 +4.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.5–0.9) | Not in label — unassessed | serious n=60 | no trial data cached |
| Wound debridement | 16 | 38.8 23.6–64.0ROR 38.9 · calibrated p 2e-4 ✓ | 35.9 EB05 23.4 · IC025 +3.3 3/3 methods agree vs other Aromatase Inhibitors: only this drug | Not in label — unassessed | serious n=17 | no trial data cached |
| Bone lesion | 137 | 38.8 32.8–46.0ROR 39.1 · calibrated p 7e-5 ✓ | 37.2 EB05 32.3 · IC025 +4.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.6–0.8) | Not in label — unassessed | serious n=135 | no trial data cached |
| Atrophic vulvovaginitis | 27 | 37.9 25.8–55.6ROR 37.9 · calibrated p 1e-4 ✓ | 35.7 EB05 25.7 · IC025 +3.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 1.2 (0.8–1.8) | Not in label — unassessed | serious n=24 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,261 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.597 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.5 (0.5–0.5) | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Malignant neoplasm progression | 1,818 | 17.9 17.1–18.7ROR 19.5 · calibrated p 0.002 ✓ | 17.6 EB05 16.9 · IC025 +4.1 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.7–0.7) | Reporting / coding artifact | serious PRR 13.3 | no trial data cached |
| Nausea | 1,728 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.921 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.5 (0.5–0.5) | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Arthralgia (joint pain) | 1,724 | 4.1 3.9–4.3ROR 4.4 · calibrated p 0.313 | 4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.6–0.6) | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Diarrhoea (diarrhea) | 1,702 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.713 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 1,405 | 2.4 2.3–2.6ROR 2.6 · calibrated p 0.791 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.7–0.7) | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Pain | 1,134 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.867 | 1.8 EB05 1.7 · IC025 +0.8 vs other Aromatase Inhibitors: PRR 0.6 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Asthenia (weakness) | 1,090 | 2.9 2.7–3.0ROR 3.0 · calibrated p 0.640 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Headache | 1,082 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.794 | 1.7 EB05 1.6 · IC025 +0.7 vs other Aromatase Inhibitors: PRR 0.6 (0.6–0.6) | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Malaise (feeling unwell) | 1,078 | 2.4 2.3–2.6ROR 2.5 · calibrated p 0.816 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.7–0.8) | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Cough | 1,036 | 3.7 3.4–3.9ROR 3.8 · calibrated p 0.419 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.7 (0.7–0.8) | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Vomiting | 997 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.977 | 2.1 EB05 2.0 · IC025 +1.0 vs other Aromatase Inhibitors: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Disease progression | 976 | 8.2 7.7–8.7ROR 8.6 · calibrated p 0.054 | 8.1 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.8 (0.7–0.9) | Reporting / coding artifact | serious PRR 5.2 | no trial data cached |
| Death | 938 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.357 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Aromatase Inhibitors: PRR 0.6 (0.6–0.7) | Outcome field, not a reaction | serious PRR 0.8 | no trial data cached |
| Metastases to bone | 922 | 58.8 55.1–62.7ROR 61.4 · calibrated p 4e-6 ✓ | 55.4 EB05 52.5 · IC025 +5.6 3/3 methods agree vs other Aromatase Inhibitors: PRR 0.6 (0.6–0.6) | Labeled (related wording) related wording | serious PRR 42.0 | no trial data cached |
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.
- Pik3ca-activated mutation — n=83, PRR 337.1
- Amaurosis fugax — n=229, PRR 268.8
- Pleural neoplasm — n=24, PRR 167.6
- Pseudocirrhosis — n=33, PRR 110.1
- Metastases to chest wall — n=34, PRR 107.2
- Metastases to thorax — n=24, PRR 102.6
- Metastases to pleura — n=86, PRR 88.6
- Breast cancer metastatic — n=847, PRR 84.4
- Invasive lobular breast carcinoma — n=40, PRR 83.3
- Metastases to the mediastinum — n=28, PRR 71.2
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 Exemestane?
In FDA FAERS, the most frequently co-reported reaction terms for Exemestane are fatigue, nausea, arthralgia, diarrhoea, dyspnoea, pain. 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 Exemestane have an FDA boxed warning?
No. The FDA label retrieved for Exemestane has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Exemestane 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 1841ec12-3f4f-4b87-b719-fd0b4d9eaffb, effective 20240529; matched on
openfda.generic_name.exact:"EXEMESTANE") - 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, 1,162 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
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.