Drug · FAERS side-effect profile with label screen
Ripretinib side effects: what 5,185 FDA adverse event reports show
Brand names
Qinlock
openFDA label
Who reports
5,185 reports · 44% serious · 494 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ( 1 )
FDA label, Indications and Usage
What it is
Ripretinib is a kinase inhibitor.
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 5Labeled (related wording) 3Reporting / coding artifact 10Lab value / disease marker 4Not in label — unassessed 18
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.
- 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. 99 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 |
|---|---|---|---|---|---|---|
| Extra dose administered | 357 | 36.3 32.8–40.1ROR 38.9 · χ² 12,126 / p <1e-300 | 35.9 EB05 32.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=142 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 186 | 32.2 28.0–37.1ROR 33.4 · χ² 5,555 / p <1e-300 | 31.9 EB05 28.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 | no trial data cached |
| Neoplasm progression | 265 | 30.6 27.2–34.4ROR 32.1 · χ² 7,504 / p <1e-300 | 30.3 EB05 27.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.0 · 74% consumer | no trial data cached |
| Underdose | 373 | 20.6 18.7–22.7ROR 22.1 · χ² 6,932 / p <1e-300 | 20.5 EB05 18.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 40.2 | no trial data cached |
| Hair texture abnormal | 57 | 17.0 13.2–22.1ROR 17.2 · χ² 842 / p 2e-185 | 16.9 EB05 13.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 · 72% consumer | no trial data cached |
| Metastases to liver | 62 | 14.3 11.1–18.3ROR 14.4 · χ² 749 / p 3e-165 | 14.1 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 | no trial data cached |
| Product dose omission in error | 88 | 13.2 10.7–16.3ROR 13.4 · χ² 979 / p 3e-215 | 13.1 EB05 10.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 22.0 · 89% consumer | no trial data cached |
| Gingival bleeding | 42 | 12.4 9.2–16.7ROR 12.5 · χ² 427 / p 4e-95 | 12.0 EB05 9.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 68% (drug 44%) · 81% consumer | no trial data cached |
| Alopecia (hair loss) | 592 | 12.1 11.2–13.1ROR 13.6 · χ² 6,071 / p <1e-300 | 12.1 EB05 11.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 · 73% consumer | no trial data cached |
| Blood iron decreased | 34 | 11.6 8.3–16.3ROR 11.7 · χ² 319 / p 1e-71 | 11.1 EB05 8.1 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 · 79% consumer | no trial data cached |
| Disease progression | 297 | 10.1 9.1–11.3ROR 10.7 · χ² 2,447 / p <1e-300 | 10.1 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 | no trial data cached |
| Adverse event | 219 | 9.6 8.4–10.9ROR 9.9 · χ² 1,676 / p <1e-300 | 9.5 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Malignant neoplasm progression | 226 | 8.9 7.9–10.2ROR 9.3 · χ² 1,589 / p <1e-300 | 8.8 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.1 | no trial data cached |
| Neoplasm | 25 | 8.7 5.9–12.9ROR 8.8 · χ² 163 / p 1e-37 | 7.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 80% consumer | no trial data cached |
| Hospitalisation | 319 | 8.4 7.6–9.4ROR 8.9 · χ² 2,093 / p <1e-300 | 8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 · 75% consumer | no trial data cached |
| Surgery | 115 | 8.0 6.7–9.6ROR 8.1 · χ² 697 / p 8e-154 | 7.8 EB05 6.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.1 · 75% consumer | no trial data cached |
| Hospice care | 17 | 6.9 4.3–11.2ROR 7.0 · χ² 81 / p 1e-19 | 6.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Dry skin | 220 | 6.7 5.9–7.7ROR 7.0 · χ² 1,073 / p 1e-235 | 6.6 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · 83% consumer | no trial data cached |
| Inappropriate schedule of product administration | 276 | 6.3 5.6–7.0ROR 6.6 · χ² 1,229 / p 1e-269 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Blood pressure abnormal | 30 | 6.1 4.3–8.7ROR 6.1 · χ² 123 / p 8e-29 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.3 · 83% consumer | no trial data cached |
| Pain of skin | 39 | 5.8 4.3–7.9ROR 5.8 · χ² 151 / p 6e-35 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 · 72% consumer | no trial data cached |
| Tenderness | 15 | 5.8 3.5–9.6ROR 5.8 · χ² 55 / p 8e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Hair colour changes | 18 | 5.8 3.6–9.1ROR 5.8 · χ² 66 / p 2e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Muscle spasms | 259 | 5.7 5.0–6.4ROR 5.9 · χ² 1,001 / p 6e-220 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 78% consumer | no trial data cached |
| Blister | 78 | 5.6 4.5–7.0ROR 5.7 · χ² 291 / p 2e-65 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 83% consumer | no trial data cached |
| Prescribed underdose | 27 | 5.4 3.7–7.9ROR 5.5 · χ² 94 / p 2e-22 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Constipation | 292 | 5.4 4.9–6.1ROR 5.7 · χ² 1,060 / p 7e-233 | 5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 76% consumer | no trial data cached |
| Loss of personal independence in daily activities | 58 | 4.9 3.8–6.3ROR 5.0 · χ² 177 / p 1e-40 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 76% consumer | no trial data cached |
| Blood bilirubin increased | 33 | 4.9 3.5–6.9ROR 4.9 · χ² 99 / p 2e-23 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 2.7 | no trial data cached |
| Blood pressure fluctuation | 29 | 4.8 3.4–7.0ROR 4.9 · χ² 85 / p 2e-20 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.1 · 90% consumer | no trial data cached |
| Muscle atrophy | 15 | 4.8 2.9–8.0ROR 4.8 · χ² 41 / p 6e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Myalgia (muscle pain) | 200 | 4.7 4.1–5.4ROR 4.9 · χ² 589 / p 2e-130 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Thyroid disorder | 18 | 4.7 3.0–7.5ROR 4.7 · χ² 49 / p 1e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Skin cancer | 25 | 4.7 3.2–6.9ROR 4.7 · χ² 68 / p 7e-17 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 · 92% consumer | no trial data cached |
| Seasonal allergy | 16 | 4.6 2.8–7.4ROR 4.6 · χ² 41 / p 8e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Illness | 113 | 4.5 3.8–5.4ROR 4.6 · χ² 308 / p 3e-69 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 76% consumer | no trial data cached |
| Tooth extraction | 14 | 4.5 2.7–7.6ROR 4.5 · χ² 35 / p 2e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Product use in unapproved indication | 267 | 4.4 3.9–4.9ROR 4.6 · χ² 705 / p 1e-155 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 83% consumer | no trial data cached |
| Increased tendency to bruise | 10 | 4.4 2.3–8.1ROR 4.4 · χ² 23 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Skin disorder | 36 | 4.4 3.1–6.0ROR 4.4 · χ² 90 / p 1e-21 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 78% consumer | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 687 | 3.6 3.3–3.8ROR 3.9 · χ² 1,307 / p 1e-286 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Alopecia (hair loss) | 592 | 12.1 11.2–13.1ROR 13.6 · χ² 6,071 / p <1e-300 | 12.1 EB05 11.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 · 73% consumer | no trial data cached |
| Death | 380 | 1.8 1.6–2.0ROR 1.8 · χ² 133 / p 5e-31 | 1.8 EB05 1.6 · IC025 +0.7 | Outcome field, not a reaction | serious PRR 2.4 | no trial data cached |
| Underdose | 373 | 20.6 18.7–22.7ROR 22.1 · χ² 6,932 / p <1e-300 | 20.5 EB05 18.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 40.2 | no trial data cached |
| Extra dose administered | 357 | 36.3 32.8–40.1ROR 38.9 · χ² 12,126 / p <1e-300 | 35.9 EB05 32.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=142 | no trial data cached |
| Hospitalisation | 319 | 8.4 7.6–9.4ROR 8.9 · χ² 2,093 / p <1e-300 | 8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 · 75% consumer | no trial data cached |
| Disease progression | 297 | 10.1 9.1–11.3ROR 10.7 · χ² 2,447 / p <1e-300 | 10.1 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 | no trial data cached |
| Pain | 295 | 1.9 1.7–2.2ROR 2.0 · χ² 135 / p 2e-31 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.6 · 79% consumer | no trial data cached |
| Constipation | 292 | 5.4 4.9–6.1ROR 5.7 · χ² 1,060 / p 7e-233 | 5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 76% consumer | no trial data cached |
| Inappropriate schedule of product administration | 276 | 6.3 5.6–7.0ROR 6.6 · χ² 1,229 / p 1e-269 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Product use in unapproved indication | 267 | 4.4 3.9–4.9ROR 4.6 · χ² 705 / p 1e-155 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 83% consumer | no trial data cached |
| Neoplasm progression | 265 | 30.6 27.2–34.4ROR 32.1 · χ² 7,504 / p <1e-300 | 30.3 EB05 27.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.0 · 74% consumer | no trial data cached |
| Muscle spasms | 259 | 5.7 5.0–6.4ROR 5.9 · χ² 1,001 / p 6e-220 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 78% consumer | no trial data cached |
| Asthenia (weakness) | 246 | 2.6 2.3–3.0ROR 2.7 · χ² 251 / p 7e-57 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 72% consumer | no trial data cached |
| Product dose omission issue | 234 | 3.3 2.9–3.7ROR 3.4 · χ² 379 / p 1e-84 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 74% consumer | 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.
- Extra dose administered — n=357, PRR 36.3
- Palmar-plantar erythrodysaesthesia syndrome — n=186, PRR 32.2
- Neoplasm progression — n=265, PRR 30.6
- Hair texture abnormal — n=57, PRR 17.0
- Metastases to liver — n=62, PRR 14.3
- Gingival bleeding — n=42, PRR 12.4
- Neoplasm — n=25, PRR 8.7
- Blister — n=78, PRR 5.6
- Prescribed underdose — n=27, PRR 5.4
- Loss of personal independence in daily activities — n=58, PRR 4.9
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 Ripretinib?
In FDA FAERS, the most frequently co-reported reaction terms for Ripretinib are fatigue, alopecia, extra dose administered, pain, constipation, neoplasm progression. 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 Ripretinib have an FDA boxed warning?
No. The FDA label retrieved for Ripretinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ripretinib 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 9f18e462-03dd-4296-a02a-a0577e3ee78d, effective 20250512; matched on
openfda.generic_name.exact:"RIPRETINIB") - 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, 139 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.