Avapritinib side effects: what 578 FDA adverse event reports show

Avapritinib · 1,001 reaction terms · 42,548 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

578 reports · 45% serious · 65 with death outcome · 43% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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

Reporting / coding artifact 3Lab value / disease marker 5No label text to screen 32

What the badges mean

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.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 961 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Tryptase	52	5,582.9 3,188.8–9,774.3ROR 5,607.1 · χ² 66,976 / p <1e-300	883.5 EB05 699.7 · IC025 +6.1 3/3 methods agree	No label text to screen	–	no trial data cached
Indolent systemic mastocytosis	20	4,294.5 1,891.9–9,748.1ROR 4,301.7 · χ² 23,317 / p <1e-300	562.8 EB05 384.7 · IC025 +4.6 3/3 methods agree	No label text to screen	–	no trial data cached
Tryptase decreased	29	2,372.2 1,353.2–4,158.5ROR 2,377.9 · χ² 27,881 / p <1e-300	599.9 EB05 438.0 · IC025 +5.2 3/3 methods agree	No label text to screen	–	no trial data cached
Tryptase increased	285	1,194.1 1,027.7–1,387.5ROR 1,223.0 · χ² 199,728 / p <1e-300	672.8 EB05 609.7 · IC025 +8.1 3/3 methods agree	No label text to screen	–	no trial data cached
Systemic mastocytosis	40	282.8 202.5–394.9ROR 283.7 · χ² 9,403 / p <1e-300	217.8 EB05 166.8 · IC025 +5.4 3/3 methods agree	No label text to screen	–	no trial data cached
Periorbital swelling	410	140.7 127.4–155.4ROR 145.6 · χ² 52,456 / p <1e-300	129.4 EB05 119.2 · IC025 +6.7 3/3 methods agree	No label text to screen	–	no trial data cached
Mastocytosis	28	111.9 76.4–163.9ROR 112.1 · χ² 2,785 / p <1e-300	98.2 EB05 71.3 · IC025 +4.6 3/3 methods agree	No label text to screen	–	no trial data cached
Orbital oedema	26	93.6 63.1–138.9ROR 93.8 · χ² 2,173 / p <1e-300	83.6 EB05 59.9 · IC025 +4.4 3/3 methods agree	No label text to screen	–	no trial data cached
Periorbital oedema	178	61.9 53.3–71.8ROR 62.8 · χ² 10,233 / p <1e-300	59.4 EB05 52.4 · IC025 +5.4 3/3 methods agree	No label text to screen	–	no trial data cached
Hair colour changes	377	53.8 48.6–59.5ROR 55.5 · χ² 18,903 / p <1e-300	52.1 EB05 47.8 · IC025 +5.4 3/3 methods agree	No label text to screen	–	no trial data cached
Biopsy bone marrow	14	53.8 31.6–91.6ROR 53.9 · χ² 653 / p 2e-144	48.9 EB05 31.0 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Hernia pain	11	43.1 23.7–78.5ROR 43.2 · χ² 402 / p 1e-89	39.5 EB05 23.5 · IC025 +2.9 3/3 methods agree	No label text to screen	–	no trial data cached
Chronic myelomonocytic leukaemia	15	40.1 24.1–66.9ROR 40.2 · χ² 522 / p 9e-116	37.5 EB05 24.1 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Brain fog	320	39.0 35.0–43.6ROR 40.1 · χ² 11,570 / p <1e-300	38.1 EB05 34.7 · IC025 +5.0 3/3 methods agree	No label text to screen	–	no trial data cached
Eye oedema	42	30.3 22.3–41.1ROR 30.4 · χ² 1,140 / p 3e-250	29.4 EB05 22.7 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Immunisation reaction	11	27.2 15.0–49.3ROR 27.2 · χ² 248 / p 4e-56	25.6 EB05 15.1 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Tumour excision	12	26.4 14.9–46.7ROR 26.5 · χ² 265 / p 8e-60	25.0 EB05 15.1 · IC025 +2.7 3/3 methods agree	No label text to screen	–	no trial data cached
Lacrimation increased	438	25.9 23.6–28.4ROR 26.8 · χ² 10,320 / p <1e-300	25.5 EB05 23.6 · IC025 +4.5 3/3 methods agree	No label text to screen	–	no trial data cached
Swelling of eyelid	81	23.4 18.8–29.1ROR 23.6 · χ² 1,694 / p <1e-300	23.0 EB05 19.1 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Mast cell activation syndrome	17	22.6 14.0–36.5ROR 22.7 · χ² 326 / p 4e-73	21.8 EB05 14.3 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Symptom recurrence	74	22.2 17.7–28.0ROR 22.4 · χ² 1,461 / p <1e-300	21.9 EB05 18.0 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Medical procedure	19	20.4 13.0–32.1ROR 20.5 · χ² 328 / p 1e-73	19.8 EB05 13.2 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Red blood cell count abnormal	16	19.2 11.8–31.5ROR 19.3 · χ² 256 / p 6e-58	18.5 EB05 11.7 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Eye swelling	396	18.8 17.1–20.8ROR 19.5 · χ² 6,614 / p <1e-300	18.6 EB05 17.1 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Pigmentation disorder	64	18.3 14.3–23.4ROR 18.4 · χ² 1,017 / p 2e-223	18.0 EB05 14.6 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Platelet count abnormal	58	16.9 13.1–21.9ROR 17.0 · χ² 844 / p 7e-186	16.6 EB05 13.3 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Face oedema	159	16.5 14.1–19.3ROR 16.7 · χ² 2,278 / p <1e-300	16.3 EB05 14.3 · IC025 +3.7 3/3 methods agree	No label text to screen	–	no trial data cached
Skin depigmentation	12	15.5 8.8–27.4ROR 15.5 · χ² 147 / p 3e-34	14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Taste disorder	171	15.0 12.9–17.4ROR 15.2 · χ² 2,200 / p <1e-300	14.8 EB05 13.0 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Food intolerance	30	14.4 10.1–20.6ROR 14.4 · χ² 358 / p 4e-80	14.0 EB05 10.0 · IC025 +2.9 3/3 methods agree	No label text to screen	–	no trial data cached
Swelling face	528	14.3 13.1–15.5ROR 14.9 · χ² 6,459 / p <1e-300	14.1 EB05 13.1 · IC025 +3.7 3/3 methods agree	No label text to screen	–	no trial data cached
Ocular icterus	35	14.2 10.2–19.8ROR 14.2 · χ² 412 / p 5e-92	13.8 EB05 10.2 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Blood bilirubin abnormal	10	13.8 7.4–25.8ROR 13.8 · χ² 106 / p 4e-25	11.9 EB05 5.9 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Colonoscopy	17	13.5 8.4–21.8ROR 13.6 · χ² 184 / p 4e-42	12.5 EB05 7.7 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Hypogeusia	15	13.4 8.1–22.3ROR 13.4 · χ² 159 / p 9e-37	12.2 EB05 7.2 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Postural orthostatic tachycardia syndrome	10	13.4 7.2–24.9ROR 13.4 · χ² 102 / p 3e-24	11.4 EB05 5.7 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Intentional dose omission	190	12.2 10.6–14.0ROR 12.4 · χ² 1,927 / p <1e-300	12.0 EB05 10.7 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Photosensitivity reaction (sun sensitivity)	112	11.9 9.9–14.4ROR 12.0 · χ² 1,104 / p 3e-242	11.7 EB05 10.0 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Red blood cell count decreased	174	10.6 9.2–12.3ROR 10.8 · χ² 1,504 / p <1e-300	10.5 EB05 9.2 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Product dose omission in error	160	10.4 8.9–12.2ROR 10.6 · χ² 1,349 / p 1e-295	10.3 EB05 9.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	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)	1,735	3.9 3.7–4.1ROR 4.4 · χ² 3,868 / p <1e-300	3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Off label use (used outside approved label)	1,371	2.8 2.6–2.9ROR 3.0 · χ² 1,594 / p <1e-300	2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Nausea	1,218	2.7 2.6–2.8ROR 2.9 · χ² 1,342 / p 5e-294	2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Diarrhoea (diarrhea)	1,007	2.7 2.6–2.9ROR 2.9 · χ² 1,135 / p 4e-249	2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Headache	568	1.6 1.5–1.7ROR 1.6 · χ² 124 / p 4e-29	1.6 EB05 1.5 · IC025 +0.5	No label text to screen	–	no trial data cached
Dizziness	537	1.9 1.7–2.0ROR 1.9 · χ² 225 / p 3e-51	1.9 EB05 1.7 · IC025 +0.8	No label text to screen	–	no trial data cached
Swelling face	528	14.3 13.1–15.5ROR 14.9 · χ² 6,459 / p <1e-300	14.1 EB05 13.1 · IC025 +3.7 3/3 methods agree	No label text to screen	–	no trial data cached
Vomiting	518	1.9 1.8–2.1ROR 2.0 · χ² 234 / p 3e-53	1.9 EB05 1.8 · IC025 +0.8	No label text to screen	–	no trial data cached
Memory impairment	517	6.6 6.0–7.1ROR 6.8 · χ² 2,441 / p <1e-300	6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Asthenia (weakness)	476	2.2 2.0–2.4ROR 2.3 · χ² 318 / p 2e-71	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Rash	463	1.9 1.7–2.0ROR 1.9 · χ² 187 / p 7e-43	1.9 EB05 1.7 · IC025 +0.7	No label text to screen	–	no trial data cached
Product dose omission issue	460	2.8 2.6–3.1ROR 2.9 · χ² 544 / p 1e-120	2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Peripheral swelling	460	5.2 4.8–5.7ROR 5.4 · χ² 1,578 / p <1e-300	5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Platelet count decreased	459	7.5 6.9–8.2ROR 7.8 · χ² 2,596 / p <1e-300	7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Lacrimation increased	438	25.9 23.6–28.4ROR 26.8 · χ² 10,320 / p <1e-300	25.5 EB05 23.6 · IC025 +4.5 3/3 methods agree	No label text to screen	–	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 Avapritinib?

In FDA FAERS, the most frequently co-reported reaction terms for Avapritinib are fatigue, nausea, diarrhoea, headache, dizziness, swelling face. 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 Avapritinib 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 Avapritinib 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, field patient.drug.openfda.generic_name.exact, 1,001 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.