Vandetanib side effects: what 1,794 FDA adverse event reports show
Brand names
Caprelsa
Who reports
1,794 reports · 67% serious · 161 with death outcome · 47% female
Used for
CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
What it is
Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine. The structural and molecular formulas are: C 22 H 24 BrFN 4 O 2 Vandetanib has a molecular weight of 475.36 g/mol.
Boxed warning
QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome.
Causality screen of the 40 strongest signals
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 15 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Electrocardiogram qt prolonged | 142 | 46.3 39.5–54.2ROR 50.2 · χ² 6,233 / p <1e-300 | 45.8 EB05 39.9 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 39.8 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 40 | 28.5 21.0–38.7ROR 29.1 · χ² 1,031 / p 1e-226 | 28.1 EB05 21.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.2 | no trial data cached |
| Myoclonus | 26 | 25.5 17.4–37.4ROR 25.9 · χ² 588 / p 4e-130 | 25.1 EB05 18.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 91% (drug 47%) · 100% clinician | no trial data cached |
| Ataxia | 25 | 24.6 16.6–36.3ROR 24.9 · χ² 541 / p 6e-120 | 24.1 EB05 17.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · ♀ 95% (drug 47%) · 100% clinician | no trial data cached |
| Blood thyroid stimulating hormone increased | 18 | 22.8 14.4–36.2ROR 23.0 · χ² 354 / p 3e-79 | 22.3 EB05 14.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Metastases to liver | 34 | 22.7 16.3–31.7ROR 23.1 · χ² 683 / p 7e-151 | 22.4 EB05 16.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 · ♀ 87% (drug 47%) | no trial data cached |
| Metastases to central nervous system | 24 | 21.9 14.7–32.7ROR 22.2 · χ² 458 / p 6e-102 | 21.5 EB05 15.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 · ♀ 96% (drug 47%) | no trial data cached |
| Metastases to bone | 29 | 20.8 14.5–29.8ROR 21.1 · χ² 525 / p 2e-116 | 20.5 EB05 14.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · ♀ 86% (drug 47%) | no trial data cached |
| Lymphocyte count decreased | 28 | 18.5 12.8–26.8ROR 18.8 · χ² 447 / p 2e-99 | 18.2 EB05 13.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 19.5 · ♀ 92% (drug 47%) | no trial data cached |
| Blood calcium decreased | 17 | 17.6 11.0–28.3ROR 17.8 · χ² 250 / p 1e-56 | 17.1 EB05 10.9 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.5 | no trial data cached |
| Blood triglycerides increased | 25 | 16.5 11.2–24.4ROR 16.7 · χ² 349 / p 4e-78 | 16.1 EB05 11.3 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 21.4 · ♀ 95% (drug 47%) · 96% clinician | no trial data cached |
| Hemiparesis | 24 | 16.5 11.1–24.5ROR 16.7 · χ² 333 / p 9e-75 | 16.1 EB05 11.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Acne | 97 | 14.9 12.3–18.1ROR 15.7 · χ² 1,247 / p 2e-273 | 14.8 EB05 12.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.5 | no trial data cached |
| Hypocalcaemia (low calcium) | 23 | 14.3 9.5–21.4ROR 14.4 · χ² 270 / p 5e-61 | 13.7 EB05 9.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Hypophagia | 28 | 12.9 8.9–18.7ROR 13.1 · χ² 296 / p 1e-66 | 12.4 EB05 8.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 100% (drug 47%) · 93% clinician | no trial data cached |
| Thyroid cancer | 13 | 12.6 7.3–21.6ROR 12.6 · χ² 127 / p 1e-29 | 11.1 EB05 6.2 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.8 | no trial data cached |
| Neoplasm | 10 | 10.2 5.5–18.8ROR 10.2 · χ² 74 / p 5e-18 | 8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 20 | 10.0 6.5–15.5ROR 10.1 · χ² 153 / p 2e-35 | 9.0 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Mucosal inflammation | 22 | 9.9 6.5–15.0ROR 10.0 · χ² 167 / p 2e-38 | 8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 100% clinician | no trial data cached |
| Oral pain | 17 | 8.8 5.5–14.2ROR 8.9 · χ² 111 / p 3e-26 | 7.6 EB05 4.9 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Blood creatinine increased | 48 | 8.6 6.5–11.3ROR 8.8 · χ² 315 / p 1e-70 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 69% (drug 47%) | no trial data cached |
| Musculoskeletal chest pain | 11 | 8.3 4.6–15.0ROR 8.3 · χ² 64 / p 8e-16 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Blood pressure abnormal | 14 | 8.3 4.9–13.9ROR 8.3 · χ² 82 / p 6e-20 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Disease progression | 81 | 8.0 6.5–9.9ROR 8.4 · χ² 494 / p 9e-110 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Neutrophil count decreased | 27 | 7.8 5.4–11.3ROR 7.9 · χ² 153 / p 2e-35 | 7.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Stomatitis (mouth sores) | 36 | 6.9 5.0–9.6ROR 7.1 · χ² 178 / p 8e-41 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 82% (drug 47%) | no trial data cached |
| Blood cholesterol increased | 27 | 6.8 4.7–9.8ROR 6.9 · χ² 127 / p 8e-30 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 · ♀ 96% (drug 47%) · 93% clinician | no trial data cached |
| Alanine aminotransferase increased | 35 | 6.7 4.8–9.3ROR 6.8 · χ² 163 / p 1e-37 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 · ♀ 86% (drug 47%) · 97% clinician | no trial data cached |
| Neoplasm progression | 20 | 6.7 4.3–10.3ROR 6.7 · χ² 91 / p 8e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 85% (drug 47%) | no trial data cached |
| Malignant neoplasm progression | 58 | 6.7 5.2–8.6ROR 6.8 · χ² 274 / p 6e-62 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Flatulence (gas) | 32 | 6.6 4.7–9.3ROR 6.7 · χ² 147 / p 4e-34 | 6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · ♀ 79% (drug 47%) · 90% clinician | no trial data cached |
| Ocular hyperaemia | 25 | 6.3 4.2–9.2ROR 6.3 · χ² 105 / p 5e-25 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 · ♀ 100% (drug 47%) · 100% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 329 | 6.0 5.4–6.6ROR 7.1 · χ² 1,402 / p <1e-300 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 | no trial data cached |
| Blood pressure increased | 78 | 6.0 4.8–7.4ROR 6.2 · χ² 319 / p 1e-71 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.7 · 74% consumer | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 5.8 3.2–10.4ROR 5.8 · χ² 39 / p 3e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Pancytopenia (all blood cells low) | 27 | 5.7 3.9–8.2ROR 5.7 · χ² 99 / p 1e-23 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · ♀ 96% (drug 47%) | no trial data cached |
| Product dose omission in error | 13 | 5.7 3.3–9.7ROR 5.7 · χ² 45 / p 8e-12 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Epistaxis (nosebleed) | 32 | 5.0 3.5–7.0ROR 5.1 · χ² 99 / p 2e-23 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Skin exfoliation | 30 | 4.2 3.0–6.0ROR 4.3 · χ² 71 / p 2e-17 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 17% (drug 47%) | no trial data cached |
| Dry skin | 41 | 3.6 2.7–4.9ROR 3.7 · χ² 76 / p 1e-18 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 329 | 6.0 5.4–6.6ROR 7.1 · χ² 1,402 / p <1e-300 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 | no trial data cached |
| Electrocardiogram qt prolonged | 142 | 46.3 39.5–54.2ROR 50.2 · χ² 6,233 / p <1e-300 | 45.8 EB05 39.9 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 39.8 | no trial data cached |
| Acne | 97 | 14.9 12.3–18.1ROR 15.7 · χ² 1,247 / p 2e-273 | 14.8 EB05 12.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.5 | no trial data cached |
| Disease progression | 81 | 8.0 6.5–9.9ROR 8.4 · χ² 494 / p 9e-110 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Blood pressure increased | 78 | 6.0 4.8–7.4ROR 6.2 · χ² 319 / p 1e-71 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.7 · 74% consumer | no trial data cached |
| Malignant neoplasm progression | 58 | 6.7 5.2–8.6ROR 6.8 · χ² 274 / p 6e-62 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Blood creatinine increased | 48 | 8.6 6.5–11.3ROR 8.8 · χ² 315 / p 1e-70 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · ♀ 69% (drug 47%) | no trial data cached |
| Dry skin | 41 | 3.6 2.7–4.9ROR 3.7 · χ² 76 / p 1e-18 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 40 | 28.5 21.0–38.7ROR 29.1 · χ² 1,031 / p 1e-226 | 28.1 EB05 21.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.2 | no trial data cached |
| Stomatitis (mouth sores) | 36 | 6.9 5.0–9.6ROR 7.1 · χ² 178 / p 8e-41 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 82% (drug 47%) | no trial data cached |
| Alanine aminotransferase increased | 35 | 6.7 4.8–9.3ROR 6.8 · χ² 163 / p 1e-37 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 · ♀ 86% (drug 47%) · 97% clinician | no trial data cached |
| Metastases to liver | 34 | 22.7 16.3–31.7ROR 23.1 · χ² 683 / p 7e-151 | 22.4 EB05 16.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 · ♀ 87% (drug 47%) | no trial data cached |
| Epistaxis (nosebleed) | 32 | 5.0 3.5–7.0ROR 5.1 · χ² 99 / p 2e-23 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Flatulence (gas) | 32 | 6.6 4.7–9.3ROR 6.7 · χ² 147 / p 4e-34 | 6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · ♀ 79% (drug 47%) · 90% clinician | no trial data cached |
| Skin exfoliation | 30 | 4.2 3.0–6.0ROR 4.3 · χ² 71 / p 2e-17 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 17% (drug 47%) | 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.
- Myoclonus — n=26, PRR 25.5
- Ataxia — n=25, PRR 24.6
- Metastases to liver — n=34, PRR 22.7
- Metastases to central nervous system — n=24, PRR 21.9
- Metastases to bone — n=29, PRR 20.8
- Hemiparesis — n=24, PRR 16.5
- Hypocalcaemia — n=23, PRR 14.3
- Hypophagia — n=28, PRR 12.9
- Palmar-plantar erythrodysaesthesia syndrome — n=20, PRR 10.0
- Mucosal inflammation — n=22, PRR 9.9
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 Vandetanib?
In FDA FAERS, the most frequently co-reported reaction terms for Vandetanib are diarrhoea, electrocardiogram qt prolonged, acne, blood pressure increased, blood creatinine increased, dry skin. 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 Vandetanib have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome.
Do FAERS signals prove that Vandetanib 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 e5721cb8-4185-47b9-bbb3-1c587e558a03, effective 20260423; matched on
openfda.generic_name.exact:"VANDETANIB") - 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, 55 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 2026-10-08. 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.