Drug · FAERS side-effect profile with label screen
Lenvatinib side effects: what 32,604 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
32,604 reports · 88% serious · 4,443 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Lab value / disease marker 2No label text to screen 38
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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). 1,024 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 |
|---|---|---|---|---|---|---|
| Tracheal fistula | 39 | 216.7 150.7–311.7ROR 217.0 · calibrated p 7e-10 ✓ | 150.0 EB05 114.5 · IC025 +5.2 3/3 methods agree | No label text to screen | serious n=39 · 100% clinician | no trial data cached |
| Liver carcinoma ruptured | 49 | 155.2 113.6–212.1ROR 155.4 · calibrated p 8e-9 ✓ | 119.2 EB05 93.7 · IC025 +5.3 3/3 methods agree | No label text to screen | serious n=49 · ♀ 10% (drug 51%) · 100% clinician | no trial data cached |
| Primary adrenal insufficiency | 38 | 94.0 66.9–132.2ROR 94.1 · calibrated p 4e-7 ✓ | 78.9 EB05 60.0 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=38 · 100% clinician | no trial data cached |
| Thyroglobulin increased | 21 | 90.5 57.3–142.9ROR 90.6 · calibrated p 8e-7 ✓ | 74.2 EB05 51.2 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=21 | no trial data cached |
| Immune-mediated adrenal insufficiency | 91 | 88.1 70.8–109.7ROR 88.4 · calibrated p 4e-7 ✓ | 76.3 EB05 64.0 · IC025 +5.4 3/3 methods agree | No label text to screen | serious n=91 · ♀ 72% (drug 51%) · 100% clinician | no trial data cached |
| Silent thyroiditis | 17 | 86.2 51.9–143.0ROR 86.2 · calibrated p 2e-6 ✓ | 70.2 EB05 46.4 · IC025 +3.8 3/3 methods agree | No label text to screen | serious n=17 | no trial data cached |
| Immune-mediated encephalitis | 52 | 75.4 56.6–100.5ROR 75.5 · calibrated p 1e-6 ✓ | 65.9 EB05 52.2 · IC025 +4.9 3/3 methods agree | No label text to screen | serious n=52 · 100% clinician | no trial data cached |
| Oesophageal fistula | 33 | 74.4 51.9–106.7ROR 74.5 · calibrated p 2e-6 ✓ | 64.3 EB05 47.9 · IC025 +4.5 3/3 methods agree | No label text to screen | serious n=33 | no trial data cached |
| Immune-mediated hypothyroidism | 94 | 61.6 49.8–76.1ROR 61.8 · calibrated p 4e-6 ✓ | 55.6 EB05 46.8 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=94 · ♀ 78% (drug 51%) · 100% clinician | no trial data cached |
| Immune-mediated pancreatitis | 29 | 54.8 37.5–80.1ROR 54.9 · calibrated p 1e-5 ✓ | 49.0 EB05 35.8 · IC025 +4.2 3/3 methods agree | No label text to screen | serious n=29 · 100% clinician | no trial data cached |
| Primary hypothyroidism | 15 | 50.5 29.9–85.5ROR 50.6 · calibrated p 4e-5 ✓ | 44.4 EB05 28.6 · IC025 +3.4 3/3 methods agree | No label text to screen | serious n=14 | no trial data cached |
| Tracheal haemorrhage | 24 | 47.2 31.2–71.5ROR 47.2 · calibrated p 4e-5 ✓ | 42.6 EB05 30.1 · IC025 +3.9 3/3 methods agree | No label text to screen | serious n=24 | no trial data cached |
| Urogenital fistula | 16 | 47.1 28.4–78.3ROR 47.2 · calibrated p 6e-5 ✓ | 41.9 EB05 27.4 · IC025 +3.4 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Immune-mediated thyroiditis | 31 | 45.5 31.6–65.4ROR 45.5 · calibrated p 4e-5 ✓ | 41.5 EB05 30.6 · IC025 +4.1 3/3 methods agree | No label text to screen | serious n=30 · ♀ 77% (drug 51%) · 100% clinician | no trial data cached |
| Tumour rupture | 36 | 44.7 31.9–62.7ROR 44.8 · calibrated p 4e-5 ✓ | 41.0 EB05 30.9 · IC025 +4.2 3/3 methods agree | No label text to screen | serious n=36 · ♀ 23% (drug 51%) · 100% clinician | no trial data cached |
| Immune-mediated cholangitis | 22 | 44.4 28.8–68.4ROR 44.4 · calibrated p 6e-5 ✓ | 40.2 EB05 28.0 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=22 · 100% clinician | no trial data cached |
| Tumour haemorrhage | 180 | 43.3 37.2–50.3ROR 43.5 · calibrated p 3e-5 ✓ | 40.4 EB05 35.7 · IC025 +4.9 3/3 methods agree | No label text to screen | serious n=176 · ♀ 28% (drug 51%) | no trial data cached |
| Immune-mediated myasthenia gravis | 18 | 40.3 25.0–64.9ROR 40.3 · calibrated p 1e-4 ✓ | 36.6 EB05 24.5 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=18 | no trial data cached |
| Proteinuria | 1,053 | 38.0 35.7–40.4ROR 39.2 · calibrated p 6e-5 ✓ | 35.9 EB05 34.1 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 24.3 · 95% clinician | no trial data cached |
| Hepatic encephalopathy | 518 | 37.7 34.5–41.2ROR 38.3 · calibrated p 7e-5 ✓ | 35.6 EB05 33.1 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 22.9 · ♀ 24% (drug 51%) · 93% clinician | no trial data cached |
| Immune-mediated lung disease | 90 | 34.9 28.2–43.1ROR 35.0 · calibrated p 1e-4 ✓ | 32.9 EB05 27.6 · IC025 +4.5 3/3 methods agree | No label text to screen | serious n=90 · 93% clinician | no trial data cached |
| Immune-mediated hepatitis | 96 | 33.0 26.9–40.5ROR 33.1 · calibrated p 2e-4 ✓ | 31.3 EB05 26.3 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=95 · 100% clinician | no trial data cached |
| Haemobilia | 20 | 32.7 20.9–51.3ROR 32.8 · calibrated p 3e-4 ✓ | 30.4 EB05 20.8 · IC025 +3.4 3/3 methods agree | No label text to screen | serious n=20 | no trial data cached |
| Kl-6 increased | 10 | 31.5 16.7–59.5ROR 31.5 · calibrated p 7e-4 ✓ | 28.5 EB05 16.4 · IC025 +2.6 3/3 methods agree | No label text to screen | serious n=10 | no trial data cached |
| Thrombophlebitis migrans | 15 | 31.2 18.6–52.3ROR 31.2 · calibrated p 5e-4 ✓ | 28.8 EB05 18.5 · IC025 +3.1 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Adrenal insufficiency | 536 | 30.1 27.6–32.8ROR 30.6 · calibrated p 2e-4 ✓ | 28.8 EB05 26.8 · IC025 +4.7 3/3 methods agree | No label text to screen | serious PRR 19.1 · 93% clinician | no trial data cached |
| Oesophageal varices haemorrhage | 97 | 30.0 24.5–36.7ROR 30.1 · calibrated p 3e-4 ✓ | 28.5 EB05 24.1 · IC025 +4.3 3/3 methods agree | No label text to screen | serious n=97 · ♀ 13% (drug 51%) | no trial data cached |
| Gallbladder rupture | 20 | 29.8 19.0–46.7ROR 29.8 · calibrated p 5e-4 ✓ | 27.8 EB05 19.0 · IC025 +3.3 3/3 methods agree | No label text to screen | serious n=20 | no trial data cached |
| Thyroiditis | 131 | 29.5 24.8–35.2ROR 29.6 · calibrated p 3e-4 ✓ | 28.2 EB05 24.3 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=126 · 95% clinician | no trial data cached |
| Ammonia increased | 219 | 28.8 25.2–33.0ROR 29.0 · calibrated p 3e-4 ✓ | 27.5 EB05 24.6 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=213 · ♀ 24% (drug 51%) · 70% consumer | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 980 | 28.1 26.4–29.9ROR 28.9 · calibrated p 3e-4 ✓ | 26.9 EB05 25.5 · IC025 +4.6 3/3 methods agree | No label text to screen | serious PRR 20.7 | no trial data cached |
| Immune-mediated renal disorder | 16 | 27.4 16.6–45.2ROR 27.4 · calibrated p 9e-4 ✓ | 25.6 EB05 16.6 · IC025 +3.1 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Duodenal perforation | 39 | 26.8 19.5–36.9ROR 26.9 · calibrated p 6e-4 ✓ | 25.5 EB05 19.5 · IC025 +3.8 3/3 methods agree | No label text to screen | serious n=38 · 100% clinician | no trial data cached |
| Immune-mediated enterocolitis | 139 | 26.4 22.3–31.2ROR 26.5 · calibrated p 5e-4 ✓ | 25.3 EB05 21.9 · IC025 +4.3 3/3 methods agree | No label text to screen | serious n=137 · 100% clinician | no trial data cached |
| Immune-mediated dermatitis | 36 | 25.7 18.4–35.8ROR 25.7 · calibrated p 8e-4 ✓ | 24.4 EB05 18.4 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=36 · ♀ 77% (drug 51%) · 100% clinician | no trial data cached |
| Immune-mediated myocarditis | 59 | 25.6 19.7–33.2ROR 25.6 · calibrated p 7e-4 ✓ | 24.5 EB05 19.7 · IC025 +3.9 3/3 methods agree | No label text to screen | serious n=59 · 100% clinician | no trial data cached |
| Tracheo-oesophageal fistula | 24 | 24.9 16.6–37.5ROR 24.9 · calibrated p 0.001 ✓ | 23.6 EB05 16.7 · IC025 +3.3 3/3 methods agree | No label text to screen | serious n=24 · 100% clinician | no trial data cached |
| Cholangitis acute | 27 | 24.5 16.7–36.0ROR 24.6 · calibrated p 0.001 ✓ | 23.3 EB05 16.8 · IC025 +3.4 3/3 methods agree | No label text to screen | serious n=27 · 100% clinician | no trial data cached |
| Small intestinal perforation | 68 | 24.1 18.9–30.7ROR 24.2 · calibrated p 9e-4 ✓ | 23.1 EB05 18.9 · IC025 +3.9 3/3 methods agree | No label text to screen | serious n=68 · ♀ 72% (drug 51%) | no trial data cached |
| Adrenocorticotropic hormone deficiency | 31 | 23.7 16.5–33.9ROR 23.7 · calibrated p 0.001 ✓ | 22.6 EB05 16.6 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=30 · 100% clinician | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 4,133 | 4.2 4.0–4.3ROR 4.6 · calibrated p 0.281 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree | No label text to screen | serious PRR 4.0 | no trial data cached |
| Hypertension (high blood pressure) | 3,703 | 11.4 11.1–11.8ROR 12.7 · calibrated p 0.013 ✓ | 11.2 EB05 10.9 · IC025 +3.4 3/3 methods agree | No label text to screen | serious PRR 8.3 | no trial data cached |
| Fatigue (tiredness) | 3,333 | 2.8 2.7–2.9ROR 3.0 · calibrated p 0.637 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 2.7 | no trial data cached |
| Decreased appetite (loss of appetite) | 3,112 | 8.7 8.5–9.0ROR 9.6 · calibrated p 0.038 ✓ | 8.6 EB05 8.4 · IC025 +3.0 3/3 methods agree | No label text to screen | serious PRR 7.8 | no trial data cached |
| Nausea | 2,464 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.994 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen | serious PRR 2.1 | no trial data cached |
| Malignant neoplasm progression | 2,433 | 15.7 15.1–16.3ROR 16.9 · calibrated p 0.004 ✓ | 15.4 EB05 14.8 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Blood pressure increased | 2,133 | 9.1 8.7–9.4ROR 9.6 · calibrated p 0.037 ✓ | 8.9 EB05 8.6 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 · 74% consumer | no trial data cached |
| Vomiting | 1,994 | 2.7 2.6–2.9ROR 2.9 · calibrated p 0.675 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 2.4 | no trial data cached |
| Asthenia (weakness) | 1,610 | 2.8 2.6–2.9ROR 2.9 · calibrated p 0.676 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 2.3 | no trial data cached |
| Dehydration | 1,513 | 7.4 7.0–7.7ROR 7.7 · calibrated p 0.076 | 7.3 EB05 7.0 · IC025 +2.8 3/3 methods agree | No label text to screen | serious PRR 5.3 · 72% consumer | no trial data cached |
| Weight decreased (weight loss) | 1,431 | 3.3 3.1–3.5ROR 3.4 · calibrated p 0.506 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen | serious PRR 2.8 | no trial data cached |
| Malaise (feeling unwell) | 1,315 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.925 | 1.9 EB05 1.8 · IC025 +0.9 | No label text to screen | serious PRR 2.0 | no trial data cached |
| Pyrexia (fever) | 1,265 | 2.4 2.2–2.5ROR 2.4 · calibrated p 0.853 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen | serious PRR 1.8 | no trial data cached |
| Headache | 1,194 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.464 | 1.2 EB05 1.2 · IC025 +0.2 | No label text to screen | serious PRR 1.4 · 72% consumer | no trial data cached |
| Hypothyroidism | 1,093 | 22.8 21.5–24.2ROR 23.6 · calibrated p 9e-4 ✓ | 22.1 EB05 21.0 · IC025 +4.4 3/3 methods agree | No label text to screen | serious PRR 15.1 · 93% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Lenvatinib?
In FDA FAERS, the most frequently co-reported reaction terms for Lenvatinib are diarrhoea, hypertension, fatigue, decreased appetite, nausea, blood pressure increased. 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 Lenvatinib have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Lenvatinib 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 1,064 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.