Drug · FAERS side-effect profile with label screen
Fruquintinib side effects: what 3,767 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Brand names
Fruzaqla
openFDA label
Who reports
3,767 reports · 96% serious · 1,245 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
FDA label, Indications and Usage
What it is
11. DESCRIPTION Fruquintinib is a kinase inhibitor with the chemical name 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]- N ,2-dimethyl-1-benzofuran-3-carboxamide.
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 11Labeled (related wording) 3Lab value / disease marker 4Outcome field, not a reaction 1Not in label — unassessed 21
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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 46 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 |
|---|---|---|---|---|---|---|
| Colon cancer | 371 | 141.7 128.5–156.3ROR 157.1 · χ² 50,433 / p <1e-300 | 137.2 EB05 125.9 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 83.4 | no trial data cached |
| Myelosuppression | 217 | 35.7 31.4–40.6ROR 37.8 · χ² 7,249 / p <1e-300 | 35.4 EB05 31.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · 99% clinician | no trial data cached |
| Proteinuria | 101 | 29.9 24.7–36.3ROR 30.7 · χ² 2,785 / p <1e-300 | 29.6 EB05 25.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.1 · 90% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 124 | 29.6 24.9–35.3ROR 30.6 · χ² 3,388 / p <1e-300 | 29.4 EB05 25.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.9 | no trial data cached |
| Metastases to liver | 67 | 21.3 16.8–27.1ROR 21.7 · χ² 1,274 / p 2e-279 | 21.1 EB05 17.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Metastases to lung | 44 | 21.3 15.9–28.6ROR 21.5 · χ² 827 / p 3e-182 | 21.0 EB05 16.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Dysphonia | 209 | 20.0 17.5–22.8ROR 21.1 · χ² 3,743 / p <1e-300 | 19.9 EB05 17.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.8 · 72% consumer | no trial data cached |
| Posterior reversible encephalopathy syndrome | 27 | 15.8 10.9–23.0ROR 15.9 · χ² 359 / p 2e-80 | 15.5 EB05 10.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 · 100% clinician | no trial data cached |
| Aphonia | 30 | 12.0 8.4–17.1ROR 12.1 · χ² 291 / p 2e-65 | 11.4 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Oral pain | 46 | 11.4 8.6–15.2ROR 11.5 · χ² 426 / p 6e-95 | 11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 83% consumer | no trial data cached |
| Blood pressure increased | 269 | 9.8 8.7–11.0ROR 10.5 · χ² 2,124 / p <1e-300 | 9.7 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 · 74% consumer | no trial data cached |
| Stomatitis (mouth sores) | 102 | 9.4 7.7–11.3ROR 9.6 · χ² 755 / p 2e-166 | 9.2 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Hypothyroidism | 53 | 9.3 7.1–12.1ROR 9.4 · χ² 383 / p 2e-85 | 8.9 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 94% clinician | no trial data cached |
| Ascites | 40 | 7.6 5.6–10.3ROR 7.6 · χ² 222 / p 2e-50 | 7.1 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Blood bilirubin increased | 31 | 6.4 4.5–9.0ROR 6.4 · χ² 135 / p 2e-31 | 5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 | no trial data cached |
| Blood pressure abnormal | 22 | 6.2 4.1–9.4ROR 6.2 · χ² 90 / p 9e-22 | 5.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · 86% consumer | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 98 | 5.8 4.7–7.0ROR 5.9 · χ² 383 / p 1e-85 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 73% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 239 | 5.7 5.1–6.5ROR 6.1 · χ² 941 / p 5e-207 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Metastases to central nervous system | 13 | 5.6 3.3–9.7ROR 5.7 · χ² 45 / p 9e-12 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Death | 850 | 5.5 5.2–5.8ROR 6.8 · χ² 3,251 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.3 | no trial data cached |
| Metastases to bone | 16 | 5.4 3.3–8.9ROR 5.5 · χ² 54 / p 1e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Ileus | 12 | 5.4 3.1–9.6ROR 5.4 · χ² 39 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Mucosal inflammation | 24 | 5.1 3.4–7.6ROR 5.2 · χ² 76 / p 2e-18 | 4.7 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Hypertension (high blood pressure) | 193 | 5.1 4.4–5.8ROR 5.3 · χ² 632 / p 1e-139 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Taste disorder | 18 | 5.0 3.2–7.9ROR 5.0 · χ² 54 / p 1e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Brain fog | 13 | 5.0 2.9–8.5ROR 5.0 · χ² 37 / p 5e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Hepatic failure | 25 | 4.6 3.1–6.8ROR 4.6 · χ² 67 / p 1e-16 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Neutrophil count decreased | 32 | 4.4 3.1–6.2ROR 4.4 · χ² 81 / p 1e-19 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.1 · 97% clinician | no trial data cached |
| Hypophagia | 20 | 4.4 2.8–6.8ROR 4.4 · χ² 49 / p 1e-12 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Blood urine present | 15 | 4.4 2.6–7.3ROR 4.4 · χ² 36 / p 1e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 | no trial data cached |
| Hepatic function abnormal | 28 | 4.2 2.9–6.1ROR 4.2 · χ² 65 / p 3e-16 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 93% clinician | no trial data cached |
| Blister | 42 | 4.2 3.1–5.6ROR 4.2 · χ² 98 / p 2e-23 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 76% consumer | no trial data cached |
| Oral discomfort | 10 | 4.0 2.2–7.4ROR 4.0 · χ² 20 / p 5e-6 | 3.5 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mouth ulceration | 14 | 3.7 2.2–6.2ROR 3.7 · χ² 25 / p 3e-7 | 3.4 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Renal impairment | 55 | 3.7 2.8–4.8ROR 3.7 · χ² 104 / p 1e-24 | 3.6 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Thyroid disorder | 10 | 3.6 1.9–6.7ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Platelet count decreased | 68 | 3.6 2.8–4.5ROR 3.6 · χ² 123 / p 8e-29 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Asthenia (weakness) | 233 | 3.4 3.0–3.9ROR 3.6 · χ² 410 / p 2e-91 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Fatigue (tiredness) | 470 | 3.4 3.1–3.7ROR 3.7 · χ² 809 / p 3e-178 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 72% consumer | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 16 | 3.3 2.0–5.4ROR 3.3 · χ² 23 / p 7e-7 | 3.1 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | 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 |
|---|---|---|---|---|---|---|
| Death | 850 | 5.5 5.2–5.8ROR 6.8 · χ² 3,251 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.3 | no trial data cached |
| Fatigue (tiredness) | 470 | 3.4 3.1–3.7ROR 3.7 · χ² 809 / p 3e-178 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 72% consumer | no trial data cached |
| Colon cancer | 371 | 141.7 128.5–156.3ROR 157.1 · χ² 50,433 / p <1e-300 | 137.2 EB05 125.9 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 83.4 | no trial data cached |
| Blood pressure increased | 269 | 9.8 8.7–11.0ROR 10.5 · χ² 2,124 / p <1e-300 | 9.7 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 · 74% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 239 | 5.7 5.1–6.5ROR 6.1 · χ² 941 / p 5e-207 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Asthenia (weakness) | 233 | 3.4 3.0–3.9ROR 3.6 · χ² 410 / p 2e-91 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Myelosuppression | 217 | 35.7 31.4–40.6ROR 37.8 · χ² 7,249 / p <1e-300 | 35.4 EB05 31.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · 99% clinician | no trial data cached |
| Dysphonia | 209 | 20.0 17.5–22.8ROR 21.1 · χ² 3,743 / p <1e-300 | 19.9 EB05 17.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.8 · 72% consumer | no trial data cached |
| Hypertension (high blood pressure) | 193 | 5.1 4.4–5.8ROR 5.3 · χ² 632 / p 1e-139 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Product dose omission issue | 126 | 2.5 2.1–2.9ROR 2.5 · χ² 109 / p 7e-26 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 82% consumer | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 124 | 29.6 24.9–35.3ROR 30.6 · χ² 3,388 / p <1e-300 | 29.4 EB05 25.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.9 | no trial data cached |
| Stomatitis (mouth sores) | 102 | 9.4 7.7–11.3ROR 9.6 · χ² 755 / p 2e-166 | 9.2 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Proteinuria | 101 | 29.9 24.7–36.3ROR 30.7 · χ² 2,785 / p <1e-300 | 29.6 EB05 25.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.1 · 90% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 98 | 5.8 4.7–7.0ROR 5.9 · χ² 383 / p 1e-85 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 73% consumer | no trial data cached |
| Dehydration | 75 | 3.1 2.5–3.9ROR 3.2 · χ² 107 / p 2e-25 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | 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.
- Colon cancer — n=371, PRR 141.7
- Myelosuppression — n=217, PRR 35.7
- Palmar-plantar erythrodysaesthesia syndrome — n=124, PRR 29.6
- Metastases to liver — n=67, PRR 21.3
- Metastases to lung — n=44, PRR 21.3
- Aphonia — n=30, PRR 12.0
- Oral pain — n=46, PRR 11.4
- Ascites — n=40, PRR 7.6
- Neuropathy peripheral — n=98, PRR 5.8
- Decreased appetite — n=239, PRR 5.7
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 Fruquintinib?
In FDA FAERS, the most frequently co-reported reaction terms for Fruquintinib are fatigue, colon cancer, blood pressure increased, decreased appetite, asthenia, myelosuppression. 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 Fruquintinib have an FDA boxed warning?
No. The FDA label retrieved for Fruquintinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fruquintinib 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 186d786e-dc8a-45f2-b5e1-01ac0201879f, effective 20260731; matched on
openfda.generic_name.exact:"FRUQUINTINIB") - 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, 86 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.