Drug · FAERS side-effect profile with label screen
Everolimus Tablets side effects: what 16,669 FDA adverse event reports show
Drug class
Kinase Inhibitor, mTOR Inhibitor Immunosuppressant
FDA label (Established Pharmacologic Class) · compare the class
Who reports
16,669 reports · 89% serious · 2,572 with death outcome · 49% 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) 4Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 27
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,049 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 |
|---|---|---|---|---|---|---|
| Granulomatous rosacea | 14 | 496.1 267.0–921.9ROR 496.5 · χ² 4,594 / p <1e-300 | 239.2 EB05 151.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Adenovirus interstitial nephritis | 14 | 482.3 260.2–894.1ROR 482.7 · χ² 4,501 / p <1e-300 | 235.9 EB05 149.4 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | not reported in cached trials |
| Biphasic mesothelioma | 11 | 440.1 221.3–875.4ROR 440.4 · χ² 3,240 / p <1e-300 | 208.2 EB05 124.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Acanthoma | 10 | 295.3 148.2–588.5ROR 295.5 · χ² 2,137 / p <1e-300 | 164.5 EB05 95.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Polyomavirus viraemia | 180 | 276.6 235.5–324.9ROR 279.7 · χ² 40,198 / p <1e-300 | 221.1 EB05 195.3 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=180 · ♀ 25% (drug 49%) · 95% clinician | not reported in cached trials |
| Accidental exposure to product packaging | 42 | 272.7 195.4–380.8ROR 273.4 · χ² 9,100 / p <1e-300 | 203.2 EB05 156.6 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | ♀ 73% (drug 49%) | not reported in cached trials |
| Pik3ca-activated mutation | 56 | 261.1 195.8–348.2ROR 262.0 · χ² 11,773 / p <1e-300 | 201.1 EB05 160.7 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 49%) · 94% clinician | not reported in cached trials |
| Brain stem glioma | 23 | 226.4 145.2–353.0ROR 226.7 · χ² 4,176 / p <1e-300 | 165.5 EB05 116.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 49%) · 100% clinician | not reported in cached trials |
| Isosporiasis | 12 | 225.5 121.9–417.1ROR 225.7 · χ² 2,083 / p <1e-300 | 146.9 EB05 89.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Polyomavirus test positive | 18 | 223.3 135.2–368.7ROR 223.5 · χ² 3,189 / p <1e-300 | 157.9 EB05 105.7 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=18 | not reported in cached trials |
| Vascular hyalinosis | 11 | 200.6 106.1–379.3ROR 200.8 · χ² 1,713 / p <1e-300 | 133.4 EB05 79.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Hepatic angiosarcoma | 10 | 196.9 101.0–383.6ROR 197.0 · χ² 1,517 / p <1e-300 | 128.9 EB05 74.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Polyomavirus-associated nephropathy | 302 | 187.9 166.7–211.9ROR 191.4 · χ² 48,610 / p <1e-300 | 161.7 EB05 147.0 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=302 · ♀ 23% (drug 49%) · 96% clinician | not reported in cached trials |
| Insulinoma | 21 | 168.0 106.6–265.0ROR 168.3 · χ² 2,926 / p <1e-300 | 130.8 EB05 90.2 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=21 · ♀ 71% (drug 49%) · 100% clinician | not reported in cached trials |
| Carcinoid tumour pulmonary | 26 | 151.4 100.8–227.4ROR 151.6 · χ² 3,329 / p <1e-300 | 123.0 EB05 88.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 | not reported in cached trials |
| Mycobacterium haemophilum infection | 26 | 143.3 95.5–215.0ROR 143.5 · χ² 3,168 / p <1e-300 | 117.7 EB05 84.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 49%) · 100% clinician | not reported in cached trials |
| Chordoma | 10 | 136.3 71.0–261.8ROR 136.4 · χ² 1,091 / p 1e-239 | 100.0 EB05 58.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Microsporidia infection | 34 | 133.0 93.4–189.4ROR 133.3 · χ² 3,905 / p <1e-300 | 112.8 EB05 84.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 49%) | not reported in cached trials |
| Congenital coronary artery malformation | 16 | 132.3 79.0–221.5ROR 132.4 · χ² 1,767 / p <1e-300 | 105.0 EB05 68.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Pleural neoplasm | 15 | 125.7 73.9–213.8ROR 125.8 · χ² 1,574 / p <1e-300 | 100.0 EB05 64.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Viraemia | 125 | 124.1 103.3–149.1ROR 125.1 · χ² 13,768 / p <1e-300 | 111.1 EB05 95.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=118 · 100% clinician | not reported in cached trials |
| Bk virus infection | 298 | 122.9 109.2–138.3ROR 125.1 · χ² 32,671 / p <1e-300 | 111.1 EB05 100.9 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=289 · 98% clinician | not reported in cached trials |
| Hormone receptor positive breast cancer | 23 | 120.4 78.5–184.6ROR 120.5 · χ² 2,374 / p <1e-300 | 100.8 EB05 70.8 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=23 · ♀ 100% (drug 49%) | not reported in cached trials |
| Cytomegalovirus gastritis | 21 | 117.9 75.4–184.3ROR 118.0 · χ² 2,117 / p <1e-300 | 98.3 EB05 67.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Complications of transplanted heart | 18 | 114.5 70.7–185.5ROR 114.6 · χ² 1,751 / p <1e-300 | 94.6 EB05 63.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Human polyomavirus infection | 43 | 113.5 83.1–155.0ROR 113.8 · χ² 4,290 / p <1e-300 | 99.6 EB05 77.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=43 · 90% clinician | not reported in cached trials |
| Pancreatic neuroendocrine tumour | 53 | 113.3 85.6–150.1ROR 113.7 · χ² 5,305 / p <1e-300 | 100.3 EB05 79.6 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=53 · ♀ 18% (drug 49%) | not reported in cached trials |
| Blood gastrin increased | 10 | 105.1 55.1–200.4ROR 105.2 · χ² 857 / p 1e-188 | 82.3 EB05 47.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=9 | not reported in cached trials |
| Metastases to skin | 74 | 98.0 77.3–124.1ROR 98.4 · χ² 6,492 / p <1e-300 | 88.8 EB05 73.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 87% (drug 49%) · 92% clinician | not reported in cached trials |
| Cytomegalovirus gastrointestinal infection | 21 | 94.7 60.8–147.6ROR 94.8 · χ² 1,723 / p <1e-300 | 81.7 EB05 56.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | not reported in cached trials |
| Pseudocirrhosis | 22 | 90.4 58.6–139.3ROR 90.5 · χ² 1,730 / p <1e-300 | 78.7 EB05 54.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 49%) · 90% clinician | not reported in cached trials |
| Post transplant distal limb syndrome | 13 | 84.9 48.4–148.8ROR 84.9 · χ² 931 / p 7e-205 | 71.5 EB05 44.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Immunosuppressant drug level decreased | 75 | 84.6 67.0–106.8ROR 84.9 · χ² 5,720 / p <1e-300 | 77.7 EB05 64.0 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=75 · ♀ 18% (drug 49%) | not reported in cached trials |
| Parvovirus b19 infection | 54 | 82.1 62.3–108.1ROR 82.3 · χ² 3,981 / p <1e-300 | 75.1 EB05 59.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=53 · 100% clinician | not reported in cached trials |
| Pancreatic steatosis | 16 | 80.3 48.5–133.2ROR 80.4 · χ² 1,104 / p 2e-242 | 69.5 EB05 45.4 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | not reported in cached trials |
| Parasitic gastroenteritis | 11 | 78.0 42.4–143.4ROR 78.0 · χ² 716 / p 6e-158 | 65.5 EB05 39.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Lymphocele | 38 | 75.8 54.6–105.1ROR 75.9 · χ² 2,573 / p <1e-300 | 69.1 EB05 52.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=38 · 100% clinician | not reported in cached trials |
| Pancreatic neuroendocrine tumour metastatic | 13 | 72.3 41.3–126.5ROR 72.4 · χ² 798 / p 9e-176 | 62.4 EB05 38.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=13 | not reported in cached trials |
| Metastases to the mediastinum | 22 | 70.3 45.8–108.0ROR 70.4 · χ² 1,358 / p 1e-297 | 63.1 EB05 43.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | not reported in cached trials |
| Enterocolitis viral | 16 | 70.1 42.4–116.0ROR 70.2 · χ² 967 / p 1e-212 | 61.8 EB05 40.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | 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 (0 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 1,539 | 19.3 18.4–20.2ROR 21.1 · χ² 26,382 / p <1e-300 | 19.0 EB05 18.2 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.3 | not reported in cached trials |
| Off label use (used outside approved label) | 1,305 | 1.9 1.8–2.0ROR 2.0 · χ² 572 / p 1e-126 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.1 · 91% clinician | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,213 | 2.4 2.2–2.5ROR 2.5 · χ² 993 / p 3e-218 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | NCT00307047: 6/2,436 (0.2%) on Everolimus (serious AE) |
| Drug ineffective (drug did not work) | 997 | 1.0 0.9–1.0ROR 0.9 · χ² 2 / p 0.058 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Fatigue (tiredness) | 839 | 1.4 1.3–1.5ROR 1.4 · χ² 82 / p 6e-20 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00676520: 4/4,952 (0.1%) on Everolimus (serious AE) |
| Nausea | 768 | 1.2 1.1–1.3ROR 1.2 · χ² 33 / p 6e-9 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT00307047: 3/2,436 (0.1%) on Everolimus (serious AE) |
| Disease progression | 752 | 8.1 7.5–8.7ROR 8.4 · χ² 4,645 / p <1e-300 | 8.0 EB05 7.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | not reported in cached trials |
| Death | 743 | 1.1 1.0–1.2ROR 1.1 · χ² 5 / p 0.012 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.7 | NCT00676520: 2/4,952 (0.0%) on Everolimus (serious AE) |
| Product use in unapproved indication | 742 | 3.8 3.6–4.1ROR 4.0 · χ² 1,562 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 94% clinician | not reported in cached trials |
| Dyspnoea (shortness of breath) | 653 | 1.5 1.3–1.6ROR 1.5 · χ² 94 / p 1e-22 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT00676520: 91/4,952 (1.8%) on Everolimus (serious AE) |
| Pyrexia (fever) | 614 | 2.2 2.1–2.4ROR 2.3 · χ² 423 / p 3e-94 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00676520: 9/4,952 (0.2%) on Everolimus (serious AE) |
| Vomiting | 611 | 1.6 1.5–1.8ROR 1.7 · χ² 155 / p 6e-36 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00307047: 2/2,436 (0.1%) on Everolimus (serious AE) |
| Pneumonia (lung infection) | 593 | 2.3 2.1–2.5ROR 2.4 · χ² 445 / p 4e-99 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 | NCT00676520: 5/4,952 (0.1%) on Everolimus (serious AE) |
| Anaemia (low red blood cells) | 544 | 3.6 3.3–3.9ROR 3.7 · χ² 1,022 / p 2e-224 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00307047: 17/2,436 (0.7%) on Everolimus (serious AE) |
| Drug interaction | 542 | 4.3 4.0–4.7ROR 4.4 · χ² 1,379 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 96% clinician | not reported in cached trials |
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.
- Polyomavirus viraemia — n=180, PRR 276.6
- Pik3ca-activated mutation — n=56, PRR 261.1
- Brain stem glioma — n=23, PRR 226.4
- Polyomavirus-associated nephropathy — n=302, PRR 187.9
- Carcinoid tumour pulmonary — n=26, PRR 151.4
- Mycobacterium haemophilum infection — n=26, PRR 143.3
- Microsporidia infection — n=34, PRR 133.0
- Viraemia — n=125, PRR 124.1
- Cytomegalovirus gastritis — n=21, PRR 117.9
- Human polyomavirus infection — n=43, PRR 113.5
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, nausea, dyspnoea, pyrexia, vomiting. 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, 1,089 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 2026-10-08. 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.