Drug · FAERS side-effect profile with label screen
Everolimus side effects: what 49,204 FDA adverse event reports show
Drug class
Kinase Inhibitor, mTOR Inhibitor Immunosuppressant
FDA label (Established Pharmacologic Class) · compare the class
Who reports
49,204 reports · 77% serious · 10,666 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
1. INDICATIONS AND USAGE Everolimus tablets are a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
FDA label, Indications and Usage
What it is
11. DESCRIPTION Everolimus Tablets and Everolimus Tablets for Oral Suspension are kinase inhibitors.
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 adverse reaction 2Labeled (related wording) 1Likely indication confounding 8Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 23
What the badges mean
- 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). 1,175 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 |
|---|---|---|---|---|---|---|
| Pancreatic neuroendocrine tumour metastatic | 96 | 279.8 215.8–362.7ROR 280.3 · calibrated p 4e-11 ✓ | 161.1 EB05 135.8 · IC025 +6.1 3/3 methods agree vs other Kinase Inhibitors: PRR 445.9 (249.9–795.7) | Likely indication confounding term in indications; also in warnings | serious n=96 · ♀ 34% (drug 60%) | not reported in cached trials |
| Angiofibroma | 26 | 221.0 137.2–356.2ROR 221.1 · calibrated p 1e-9 ✓ | 130.2 EB05 93.4 · IC025 +4.6 3/3 methods agree vs other Kinase Inhibitors: only this drug | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Pancreatic neuroendocrine tumour | 175 | 155.9 131.0–185.5ROR 156.5 · calibrated p 4e-9 ✓ | 111.7 EB05 98.5 · IC025 +6.2 3/3 methods agree vs other Kinase Inhibitors: PRR 199.4 (146.7–271.0) | Labeled adverse reaction exact term | serious n=173 | not reported in cached trials |
| Brain stem glioma | 32 | 111.6 75.5–165.0ROR 111.7 · calibrated p 1e-7 ✓ | 83.6 EB05 62.0 · IC025 +4.6 3/3 methods agree vs other Kinase Inhibitors: PRR 84.0 (49.2–143.5) | Not in label — unassessed | serious n=32 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Pik3ca-activated mutation | 68 | 109.2 83.6–142.7ROR 109.4 · calibrated p 9e-8 ✓ | 84.4 EB05 68.9 · IC025 +5.3 3/3 methods agree vs other Kinase Inhibitors: PRR 26.0 (19.6–34.5) | Not in label — unassessed | serious n=67 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Polyomavirus viraemia | 180 | 91.0 77.5–107.0ROR 91.3 · calibrated p 3e-7 ✓ | 74.0 EB05 65.4 · IC025 +5.7 3/3 methods agree vs other Kinase Inhibitors: PRR 60.4 (49.1–74.2) | Not in label — unassessed | serious n=180 · ♀ 25% (drug 60%) · 95% clinician | not reported in cached trials |
| Accidental exposure to product packaging | 42 | 89.7 64.3–125.3ROR 89.8 · calibrated p 5e-7 ✓ | 71.4 EB05 55.1 · IC025 +4.8 3/3 methods agree vs other Kinase Inhibitors: PRR 60.4 (39.4–92.6) | Reporting / coding artifact | ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Neuroendocrine tumour | 227 | 78.5 68.1–90.5ROR 78.8 · calibrated p 7e-7 ✓ | 65.6 EB05 58.8 · IC025 +5.6 3/3 methods agree vs other Kinase Inhibitors: PRR 217.6 (164.6–287.5) | Likely indication confounding term in indications; also in warnings | serious n=227 | not reported in cached trials |
| Blood chromogranin a increased | 67 | 71.4 55.1–92.5ROR 71.5 · calibrated p 2e-6 ✓ | 59.9 EB05 48.8 · IC025 +5.0 3/3 methods agree vs other Kinase Inhibitors: PRR 202.3 (122.8–333.3) | Lab value / disease marker | serious n=59 | not reported in cached trials |
| Insulinoma | 26 | 70.7 46.6–107.2ROR 70.8 · calibrated p 4e-6 ✓ | 58.0 EB05 41.6 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: PRR 74.8 (42.1–132.8) | Labeled adverse reaction exact term | serious n=26 · 100% clinician | not reported in cached trials |
| Carcinoid tumour pulmonary | 33 | 65.4 45.3–94.4ROR 65.4 · calibrated p 5e-6 ✓ | 54.8 EB05 40.8 · IC025 +4.4 3/3 methods agree vs other Kinase Inhibitors: PRR 76.6 (45.8–128.1) | Not in label — unassessed | serious n=33 · 100% clinician | not reported in cached trials |
| Metastases to skin | 134 | 62.3 52.0–74.8ROR 62.5 · calibrated p 4e-6 ✓ | 53.8 EB05 46.6 · IC025 +5.2 3/3 methods agree vs other Kinase Inhibitors: PRR 49.3 (39.3–62.0) | Not in label — unassessed | serious n=134 · ♀ 84% (drug 60%) | not reported in cached trials |
| Polyomavirus-associated nephropathy | 302 | 61.8 54.8–69.8ROR 62.2 · calibrated p 4e-6 ✓ | 53.7 EB05 48.8 · IC025 +5.4 3/3 methods agree vs other Kinase Inhibitors: PRR 50.7 (43.5–59.0) | Not in label — unassessed | serious n=302 · ♀ 23% (drug 60%) · 96% clinician | not reported in cached trials |
| Gamma-glutamyltransferase decreased | 25 | 61.5 40.4–93.6ROR 61.5 · calibrated p 9e-6 ✓ | 51.6 EB05 36.7 · IC025 +4.1 3/3 methods agree vs other Kinase Inhibitors: only this drug | Lab value / disease marker | serious n=25 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Carcinoid crisis | 29 | 60.4 40.9–89.2ROR 60.4 · calibrated p 9e-6 ✓ | 51.1 EB05 37.3 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: only this drug | Not in label — unassessed | serious n=29 | not reported in cached trials |
| Angiomyolipoma | 26 | 56.7 37.6–85.5ROR 56.8 · calibrated p 1e-5 ✓ | 48.3 EB05 34.6 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: only this drug | Likely indication confounding term in indications; also in warnings | serious n=25 | not reported in cached trials |
| Metastases to the mediastinum | 45 | 50.3 36.9–68.6ROR 50.4 · calibrated p 2e-5 ✓ | 44.1 EB05 34.3 · IC025 +4.4 3/3 methods agree vs other Kinase Inhibitors: PRR 41.2 (28.2–60.1) | Not in label — unassessed | serious n=45 | not reported in cached trials |
| Metastases to thorax | 27 | 49.2 33.0–73.3ROR 49.2 · calibrated p 3e-5 ✓ | 42.8 EB05 30.9 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: PRR 163.0 (78.9–336.8) | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Metastases to chest wall | 36 | 48.0 34.0–67.8ROR 48.0 · calibrated p 3e-5 ✓ | 42.2 EB05 31.8 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: PRR 48.3 (31.2–74.9) | Not in label — unassessed | serious n=36 · ♀ 100% (drug 60%) | not reported in cached trials |
| Hormone receptor positive breast cancer | 27 | 47.3 31.7–70.4ROR 47.3 · calibrated p 4e-5 ✓ | 41.3 EB05 29.8 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: PRR 70.9 (40.7–123.6) | Likely indication confounding term in indications; also in warnings | serious n=27 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Mycobacterium haemophilum infection | 26 | 47.2 31.4–70.8ROR 47.2 · calibrated p 4e-5 ✓ | 41.2 EB05 29.5 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: PRR 60.4 (35.1–104.0) | Not in label — unassessed | serious n=26 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Metastases to pleura | 102 | 44.9 36.6–55.1ROR 45.0 · calibrated p 3e-5 ✓ | 40.3 EB05 34.2 · IC025 +4.8 3/3 methods agree vs other Kinase Inhibitors: PRR 35.8 (28.0–45.7) | Not in label — unassessed | serious n=102 · ♀ 82% (drug 60%) · 91% clinician | not reported in cached trials |
| Microsporidia infection | 34 | 43.8 30.7–62.3ROR 43.8 · calibrated p 5e-5 ✓ | 38.8 EB05 29.1 · IC025 +4.1 3/3 methods agree vs other Kinase Inhibitors: PRR 24.4 (16.4–36.4) | Not in label — unassessed | serious n=34 · ♀ 0% (drug 60%) · 100% consumer | not reported in cached trials |
| Bk virus infection | 304 | 41.3 36.7–46.5ROR 41.6 · calibrated p 4e-5 ✓ | 37.5 EB05 34.1 · IC025 +5.0 3/3 methods agree vs other Kinase Inhibitors: PRR 45.5 (39.3–52.8) | Labeled (related wording) related wording | serious n=291 · ♀ 33% (drug 60%) · 97% clinician | not reported in cached trials |
| Viraemia | 125 | 40.8 34.0–49.1ROR 40.9 · calibrated p 5e-5 ✓ | 37.0 EB05 31.9 · IC025 +4.7 3/3 methods agree vs other Kinase Inhibitors: PRR 46.0 (36.5–58.1) | Not in label — unassessed | serious n=118 · ♀ 38% (drug 60%) · 100% clinician | not reported in cached trials |
| Nephritic syndrome | 27 | 39.6 26.7–58.8ROR 39.7 · calibrated p 1e-4 ✓ | 35.4 EB05 25.5 · IC025 +3.8 3/3 methods agree vs other Kinase Inhibitors: only this drug | Not in label — unassessed | serious n=27 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Carbohydrate antigen 15-3 increased | 66 | 39.3 30.5–50.5ROR 39.3 · calibrated p 7e-5 ✓ | 35.6 EB05 28.9 · IC025 +4.4 3/3 methods agree vs other Kinase Inhibitors: PRR 19.9 (15.1–26.3) | Lab value / disease marker | serious n=65 · ♀ 100% (drug 60%) | not reported in cached trials |
| Human polyomavirus infection | 43 | 37.3 27.3–51.0ROR 37.4 · calibrated p 1e-4 ✓ | 33.8 EB05 26.2 · IC025 +4.1 3/3 methods agree vs other Kinase Inhibitors: PRR 60.4 (39.6–92.1) | Not in label — unassessed | serious n=43 · 100% clinician | not reported in cached trials |
| Metastases to pancreas | 36 | 36.5 26.0–51.4ROR 36.6 · calibrated p 1e-4 ✓ | 33.1 EB05 25.0 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: PRR 36.8 (24.3–55.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=36 | not reported in cached trials |
| Metastatic renal cell carcinoma | 143 | 34.6 29.2–41.0ROR 34.7 · calibrated p 1e-4 ✓ | 31.8 EB05 27.7 · IC025 +4.6 3/3 methods agree vs other Kinase Inhibitors: PRR 16.2 (13.5–19.4) | Likely indication confounding term in indications; also in warnings | serious n=140 · ♀ 32% (drug 60%) | not reported in cached trials |
| Metastases to abdominal cavity | 37 | 33.5 23.9–46.8ROR 33.5 · calibrated p 2e-4 ✓ | 30.6 EB05 23.2 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: PRR 62.1 (39.2–98.2) | Not in label — unassessed | serious n=36 · ♀ 100% (drug 60%) | not reported in cached trials |
| Metastases to liver | 1,254 | 31.9 30.1–33.7ROR 32.7 · calibrated p 2e-4 ✓ | 29.6 EB05 28.3 · IC025 +4.8 3/3 methods agree vs other Kinase Inhibitors: PRR 34.4 (32.2–36.9) | Not in label — unassessed | serious PRR 22.7 | not reported in cached trials |
| Lymphangiosis carcinomatosa | 74 | 31.6 25.0–40.0ROR 31.7 · calibrated p 2e-4 ✓ | 29.2 EB05 24.0 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: PRR 42.6 (31.6–57.3) | Not in label — unassessed | serious n=74 · 90% clinician | not reported in cached trials |
| Cell marker increased | 34 | 30.9 21.8–43.8ROR 30.9 · calibrated p 3e-4 ✓ | 28.4 EB05 21.2 · IC025 +3.8 3/3 methods agree vs other Kinase Inhibitors: only this drug | Lab value / disease marker | serious n=33 · 100% clinician | not reported in cached trials |
| Breast cancer metastatic | 726 | 30.0 27.9–32.4ROR 30.5 · calibrated p 2e-4 ✓ | 28.0 EB05 26.4 · IC025 +4.7 3/3 methods agree vs other Kinase Inhibitors: PRR 29.8 (27.3–32.6) | Likely indication confounding term in indications; also in warnings | serious PRR 21.2 · ♀ 100% (drug 60%) | not reported in cached trials |
| Immunosuppressant drug level decreased | 78 | 29.0 23.1–36.5ROR 29.1 · calibrated p 4e-4 ✓ | 27.0 EB05 22.3 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: PRR 62.8 (45.7–86.2) | Lab value / disease marker | serious n=75 · ♀ 0% (drug 60%) | not reported in cached trials |
| Carcinoid tumour | 48 | 28.1 21.0–37.7ROR 28.2 · calibrated p 5e-4 ✓ | 26.2 EB05 20.5 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: PRR 289.8 (146.7–572.8) | Likely indication confounding term in indications | serious n=46 | NCT00307047: 1/2,436 (0.0%) on Everolimus (serious AE) |
| Metastases to bone | 1,039 | 28.1 26.4–29.9ROR 28.6 · calibrated p 3e-4 ✓ | 26.3 EB05 25.0 · IC025 +4.6 3/3 methods agree vs other Kinase Inhibitors: PRR 25.6 (23.9–27.5) | Not in label — unassessed | serious PRR 20.3 · ♀ 83% (drug 60%) | not reported in cached trials |
| Parvovirus b19 infection | 55 | 27.5 21.0–36.2ROR 27.6 · calibrated p 5e-4 ✓ | 25.7 EB05 20.5 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: PRR 61.5 (42.3–89.5) | Not in label — unassessed | serious n=54 · 100% clinician | not reported in cached trials |
| Metastases to adrenals | 57 | 27.4 20.9–35.8ROR 27.4 · calibrated p 5e-4 ✓ | 25.5 EB05 20.4 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: PRR 21.0 (15.5–28.4) | Not in label — unassessed | serious n=56 | 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 Everolimus 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 (1 of 40 signal terms matched).
- NCT00676520 — XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1) (N=8053, phase n/a; 242 AE terms posted; arms: Subjects Receiving the XIENCE V EECSS)
- NCT00307047 — SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System (N=3687, PHASE3; 497 AE terms posted; arms: XIENCE V®; TAXUS™ EXPRESS 2™)
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 |
|---|---|---|---|---|---|---|
| Death | 6,349 | 3.1 3.0–3.1ROR 3.4 · calibrated p 0.518 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Kinase Inhibitors: PRR 9.0 (8.8–9.2) | Outcome field, not a reaction | serious PRR 2.3 | NCT00676520: 2/4,952 (0.0%) on Everolimus (serious AE) |
| Malignant neoplasm progression | 4,683 | 19.9 19.4–20.5ROR 21.9 · calibrated p 0.001 ✓ | 19.1 EB05 18.6 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: PRR 24.1 (23.3–24.8) | Reporting / coding artifact | serious PRR 14.4 | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,073 | 2.6 2.6–2.7ROR 2.8 · calibrated p 0.703 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Kinase Inhibitors: PRR 8.4 (8.1–8.6) | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00307047: 6/2,436 (0.2%) on Everolimus (serious AE) |
| Fatigue (tiredness) | 3,811 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.990 | 2.0 EB05 2.0 · IC025 +1.0 vs other Kinase Inhibitors: PRR 6.0 (5.8–6.2) | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00676520: 4/4,952 (0.1%) on Everolimus (serious AE) |
| Stomatitis (mouth sores) | 3,189 | 23.0 22.2–23.8ROR 24.4 · calibrated p 8e-4 ✓ | 21.8 EB05 21.2 · IC025 +4.4 3/3 methods agree vs other Kinase Inhibitors: PRR 28.6 (27.4–29.7) | Labeled adverse reaction exact term | serious PRR 15.4 | not reported in cached trials |
| Nausea | 2,853 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.662 | 1.5 EB05 1.5 · IC025 +0.5 vs other Kinase Inhibitors: PRR 7.8 (7.5–8.1) | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00307047: 3/2,436 (0.1%) on Everolimus (serious AE) |
| Dyspnoea (shortness of breath) | 2,637 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.938 | 1.9 EB05 1.9 · IC025 +0.9 vs other Kinase Inhibitors: PRR 14.5 (13.9–15.1) | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00676520: 91/4,952 (1.8%) on Everolimus (serious AE) |
| Drug ineffective (drug did not work) | 2,356 | 0.7 0.7–0.8ROR 0.7 · calibrated p 0.145 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other Kinase Inhibitors: PRR 15.7 (15.1–16.4) | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Pyrexia (fever) | 2,141 | 2.6 2.5–2.7ROR 2.6 · calibrated p 0.754 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Kinase Inhibitors: PRR 14.1 (13.5–14.8) | Labeled adverse reaction exact term | serious PRR 2.2 | NCT00676520: 9/4,952 (0.2%) on Everolimus (serious AE) |
| Vomiting | 2,138 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.907 | 1.9 EB05 1.8 · IC025 +0.8 vs other Kinase Inhibitors: PRR 11.5 (11.0–12.0) | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00307047: 2/2,436 (0.1%) on Everolimus (serious AE) |
| Decreased appetite (loss of appetite) | 2,125 | 3.8 3.7–4.0ROR 4.0 · calibrated p 0.386 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Kinase Inhibitors: PRR 10.7 (10.3–11.2) | Labeled adverse reaction exact term | serious PRR 3.5 | not reported in cached trials |
| Rash | 1,978 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.906 | 1.9 EB05 1.8 · IC025 +0.8 vs other Kinase Inhibitors: PRR 10.5 (10.0–11.0) | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00307047: 2/2,436 (0.1%) on Everolimus (serious AE) |
| Weight decreased (weight loss) | 1,937 | 2.9 2.8–3.0ROR 3.0 · calibrated p 0.637 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree vs other Kinase Inhibitors: PRR 13.9 (13.2–14.5) | Labeled (related wording) related wording | serious PRR 2.6 | NCT00307047: 1/2,436 (0.0%) on Everolimus (serious AE) |
| Asthenia (weakness) | 1,900 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.980 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Kinase Inhibitors: PRR 8.3 (7.9–8.7) | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00676520: 6/4,952 (0.1%) on Everolimus (serious AE) |
| Cough | 1,894 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.663 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Kinase Inhibitors: PRR 17.3 (16.4–18.1) | Labeled adverse reaction exact term | serious PRR 3.1 | NCT00676520: 1/4,952 (0.0%) on Everolimus (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.
- Angiofibroma — n=26, PRR 221.0
- Brain stem glioma — n=32, PRR 111.6
- Pik3ca-activated mutation — n=68, PRR 109.2
- Polyomavirus viraemia — n=180, PRR 91.0
- Carcinoid tumour pulmonary — n=33, PRR 65.4
- Metastases to skin — n=134, PRR 62.3
- Polyomavirus-associated nephropathy — n=302, PRR 61.8
- Carcinoid crisis — n=29, PRR 60.4
- Metastases to the mediastinum — n=45, PRR 50.3
- Metastases to thorax — n=27, PRR 49.2
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 Everolimus?
In FDA FAERS, the most frequently co-reported reaction terms for Everolimus are diarrhoea, fatigue, stomatitis, nausea, dyspnoea, pyrexia. 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 Everolimus have an FDA boxed warning?
No. The FDA label retrieved for Everolimus has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Everolimus 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 01f7b5fb-be0d-4adf-acd2-6899018de966, effective 20250905; matched on
openfda.generic_name.exact:"EVEROLIMUS") - 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, 1,215 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
EVEROLIMUS, 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.