Drug · FAERS side-effect profile with label screen

Avatrombopag Maleate side effects: what 2,215 FDA adverse event reports show

Avatrombopag Maleate · Doptelet, Doptelet Sprinkle · 32 reaction terms · 1,109 drug–reaction co-reports · data 2026-09-14

Drug class

Thrombopoietin receptor agonist

FDA label, Indications wording

Brand names

Doptelet, Doptelet Sprinkle

openFDA label

Who reports

2,215 reports · 35% serious · 128 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. ( 1.1 ) Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

FDA label, Indications and Usage

What it is

The active ingredient in DOPTELET is avatrombopag maleate, a thrombopoietin receptor agonist.

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 15 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Reporting / coding artifact 8Lab value / disease marker 1Not in label — unassessed 1

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. 17 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
Platelet count increased	201	147.8 129.4–168.8ROR 162.4 · χ² 28,721 / p <1e-300	143.5 EB05 127.6 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious PRR 69.2 · 74% consumer	no trial data cached
Platelet count decreased	390	34.8 31.8–38.0ROR 42.0 · χ² 12,769 / p <1e-300	34.6 EB05 31.8 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 29.9 · 70% consumer	no trial data cached
Petechiae	16	14.6 8.9–23.7ROR 14.7 · χ² 189 / p 3e-43	13.7 EB05 8.3 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.7	no trial data cached
Drug effect less than expected	18	12.1 7.6–19.2ROR 12.2 · χ² 172 / p 1e-39	11.1 EB05 6.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious n=5	no trial data cached
Gingival bleeding	15	10.4 6.3–17.2ROR 10.4 · χ² 118 / p 9e-28	9.0 EB05 5.4 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3	no trial data cached
Product prescribing issue	11	5.1 2.8–9.2ROR 5.1 · χ² 32 / p 6e-9	4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.0	no trial data cached
Laboratory test abnormal	15	4.8 2.9–8.0ROR 4.8 · χ² 42 / p 6e-11	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5	no trial data cached
Intentional dose omission	13	4.5 2.6–7.7ROR 4.5 · χ² 32 / p 8e-9	3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7	no trial data cached
Deep vein thrombosis (leg blood clot)	30	4.3 3.0–6.2ROR 4.4 · χ² 74 / p 4e-18	4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.8	no trial data cached
Inappropriate schedule of product administration	81	4.3 3.5–5.4ROR 4.5 · χ² 206 / p 5e-47	4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Adverse drug reaction	39	4.1 3.0–5.6ROR 4.2 · χ² 90 / p 1e-21	3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0 · 90% consumer	no trial data cached
Intentional product misuse	36	3.9 2.8–5.4ROR 4.0 · χ² 76 / p 2e-18	3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 86% consumer	no trial data cached
Product dose omission issue	111	3.7 3.1–4.4ROR 3.8 · χ² 218 / p 1e-49	3.6 EB05 3.1 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1 · 76% consumer	no trial data cached
Emotional disorder	10	3.0 1.6–5.7ROR 3.1 · χ² 12 / p 3e-4	2.8 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 4.6	no trial data cached
Haemorrhage	30	2.7 1.9–3.9ROR 2.7 · χ² 31 / p 1e-8	2.6 EB05 1.9 · IC025 +0.8	Labeled (related wording) related wording	serious PRR 4.6	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
Platelet count decreased	390	34.8 31.8–38.0ROR 42.0 · χ² 12,769 / p <1e-300	34.6 EB05 31.8 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 29.9 · 70% consumer	no trial data cached
Platelet count increased	201	147.8 129.4–168.8ROR 162.4 · χ² 28,721 / p <1e-300	143.5 EB05 127.6 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious PRR 69.2 · 74% consumer	no trial data cached
Product dose omission issue	111	3.7 3.1–4.4ROR 3.8 · χ² 218 / p 1e-49	3.6 EB05 3.1 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1 · 76% consumer	no trial data cached
Inappropriate schedule of product administration	81	4.3 3.5–5.4ROR 4.5 · χ² 206 / p 5e-47	4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Adverse drug reaction	39	4.1 3.0–5.6ROR 4.2 · χ² 90 / p 1e-21	3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0 · 90% consumer	no trial data cached
Intentional product misuse	36	3.9 2.8–5.4ROR 4.0 · χ² 76 / p 2e-18	3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 86% consumer	no trial data cached
Haemorrhage	30	2.7 1.9–3.9ROR 2.7 · χ² 31 / p 1e-8	2.6 EB05 1.9 · IC025 +0.8	Labeled (related wording) related wording	serious PRR 4.6	no trial data cached
Deep vein thrombosis (leg blood clot)	30	4.3 3.0–6.2ROR 4.4 · χ² 74 / p 4e-18	4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.8	no trial data cached
Drug effect less than expected	18	12.1 7.6–19.2ROR 12.2 · χ² 172 / p 1e-39	11.1 EB05 6.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious n=5	no trial data cached
Petechiae	16	14.6 8.9–23.7ROR 14.7 · χ² 189 / p 3e-43	13.7 EB05 8.3 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.7	no trial data cached
Laboratory test abnormal	15	4.8 2.9–8.0ROR 4.8 · χ² 42 / p 6e-11	4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5	no trial data cached
Gingival bleeding	15	10.4 6.3–17.2ROR 10.4 · χ² 118 / p 9e-28	9.0 EB05 5.4 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3	no trial data cached
Intentional dose omission	13	4.5 2.6–7.7ROR 4.5 · χ² 32 / p 8e-9	3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7	no trial data cached
Product prescribing issue	11	5.1 2.8–9.2ROR 5.1 · χ² 32 / p 6e-9	4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.0	no trial data cached
Emotional disorder	10	3.0 1.6–5.7ROR 3.1 · χ² 12 / p 3e-4	2.8 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 4.6	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 Avatrombopag?

In FDA FAERS, the most frequently co-reported reaction terms for Avatrombopag are platelet count decreased, platelet count increased, haemorrhage, deep vein thrombosis, petechiae, gingival bleeding. 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 Avatrombopag have an FDA boxed warning?

No. The FDA label retrieved for Avatrombopag has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Avatrombopag 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 e2d5960d-6c18-46cc-86bd-089222b09852, effective 20250813; matched on openfda.generic_name.exact:"AVATROMBOPAG")
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, 32 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.