Eltrombopag side effects: what 7,224 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,224 reports · 96% serious · 1,432 with death outcome · 53% female
Used for
Eltrombopag tablets are thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
What it is
Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone.
Boxed warning
RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, Eltrombopag tablets in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions ( 5.1 )] .
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. 295 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 |
|---|---|---|---|---|---|---|
| Platelet count increased | 409 | 93.8 85.2–103.2ROR 99.4 · χ² 36,294 / p <1e-300 | 90.5 EB05 83.4 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious PRR 71.1 | no trial data cached |
| Petechiae | 262 | 75.0 66.5–84.6ROR 77.8 · χ² 18,576 / p <1e-300 | 72.7 EB05 65.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 52.8 | no trial data cached |
| Platelet count decreased | 1,697 | 47.0 45.1–49.0ROR 61.1 · χ² 75,483 / p <1e-300 | 46.2 EB05 44.4 · IC025 +5.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 33.7 | no trial data cached |
| Gingival bleeding | 167 | 35.9 30.9–41.7ROR 36.7 · χ² 5,561 / p <1e-300 | 35.3 EB05 31.0 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 31.6 | no trial data cached |
| Therapy non-responder | 296 | 19.4 17.3–21.7ROR 20.2 · χ² 5,123 / p <1e-300 | 19.3 EB05 17.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.8 | no trial data cached |
| Myelodysplastic syndrome | 75 | 15.1 12.1–18.9ROR 15.3 · χ² 970 / p 3e-213 | 14.9 EB05 12.3 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.1 | no trial data cached |
| Decreased immune responsiveness | 47 | 14.0 10.5–18.7ROR 14.1 · χ² 553 / p 1e-122 | 13.8 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 85% consumer | no trial data cached |
| Therapy partial responder | 72 | 13.9 11.1–17.5ROR 14.1 · χ² 848 / p 9e-187 | 13.8 EB05 11.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · 100% clinician | no trial data cached |
| Acute myeloid leukaemia | 74 | 13.9 11.0–17.4ROR 14.0 · χ² 866 / p 1e-190 | 13.7 EB05 11.2 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.3 · 93% clinician | no trial data cached |
| Cytopenia | 47 | 11.5 8.6–15.2ROR 11.5 · χ² 437 / p 3e-97 | 11.1 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.9 · 91% clinician | no trial data cached |
| Product availability issue | 83 | 10.8 8.7–13.4ROR 10.9 · χ² 725 / p 6e-160 | 10.5 EB05 8.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 12.9 · 84% consumer | no trial data cached |
| Bone marrow failure | 75 | 10.7 8.5–13.4ROR 10.8 · χ² 646 / p 7e-143 | 10.4 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Thrombocytopenia (low platelets) | 399 | 10.4 9.5–11.5ROR 11.0 · χ² 3,394 / p <1e-300 | 10.3 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.4 | no trial data cached |
| Hyperbilirubinaemia | 36 | 10.2 7.3–14.1ROR 10.2 · χ² 288 / p 7e-65 | 9.6 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 100% clinician | no trial data cached |
| Haemoglobin decreased | 337 | 9.5 8.6–10.6ROR 10.0 · χ² 2,570 / p <1e-300 | 9.4 EB05 8.6 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.4 | no trial data cached |
| Disease recurrence | 153 | 9.3 8.0–10.9ROR 9.5 · χ² 1,129 / p 8e-248 | 9.2 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 | no trial data cached |
| Cytomegalovirus infection | 53 | 9.3 7.1–12.1ROR 9.3 · χ² 382 / p 2e-85 | 8.9 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 91% clinician | no trial data cached |
| Splenomegaly | 37 | 9.2 6.7–12.7ROR 9.2 · χ² 262 / p 4e-59 | 8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Thrombotic microangiopathy | 30 | 9.0 6.3–12.9ROR 9.0 · χ² 205 / p 7e-47 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · 100% clinician | no trial data cached |
| Haemorrhage intracranial | 46 | 8.9 6.7–11.9ROR 9.0 · χ² 315 / p 9e-71 | 8.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 77% (drug 53%) · 100% clinician | no trial data cached |
| Contusion | 293 | 8.9 7.9–9.9ROR 9.2 · χ² 2,041 / p <1e-300 | 8.8 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Haematoma | 79 | 8.8 7.1–11.0ROR 8.9 · χ² 540 / p 8e-120 | 8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Epistaxis (nosebleed) | 215 | 8.3 7.3–9.5ROR 8.6 · χ² 1,384 / p <1e-300 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Haemorrhage | 295 | 8.2 7.3–9.2ROR 8.5 · χ² 1,865 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 142 | 7.4 6.3–8.7ROR 7.5 · χ² 781 / p 3e-172 | 7.3 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.5 | no trial data cached |
| Sars-cov-2 test positive | 34 | 7.4 5.3–10.4ROR 7.4 · χ² 182 / p 1e-41 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=34 · ♀ 87% (drug 53%) | no trial data cached |
| Neutrophil count decreased | 97 | 7.0 5.7–8.5ROR 7.0 · χ² 489 / p 1e-108 | 6.8 EB05 5.7 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 | no trial data cached |
| Cerebral infarction | 58 | 6.9 5.3–8.9ROR 6.9 · χ² 286 / p 2e-64 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hepatomegaly | 23 | 6.8 4.5–10.2ROR 6.8 · χ² 107 / p 2e-25 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Blood bilirubin increased | 62 | 6.7 5.2–8.5ROR 6.7 · χ² 292 / p 9e-66 | 6.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Transaminases increased | 50 | 6.5 5.0–8.6ROR 6.6 · χ² 229 / p 5e-52 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Nephropathy toxic | 25 | 6.5 4.4–9.7ROR 6.5 · χ² 111 / p 2e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 25% (drug 53%) | no trial data cached |
| Bacteraemia | 26 | 6.4 4.4–9.4ROR 6.4 · χ² 114 / p 8e-27 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Drug ineffective for unapproved indication | 117 | 6.1 5.1–7.3ROR 6.2 · χ² 494 / p 8e-110 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 · 91% clinician | no trial data cached |
| Ischaemic stroke | 37 | 6.0 4.4–8.3ROR 6.0 · χ² 150 / p 1e-34 | 5.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 30% (drug 53%) | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 119 | 5.3 4.4–6.3ROR 5.4 · χ² 411 / p 1e-91 | 5.2 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.2 | no trial data cached |
| Red blood cell count decreased | 52 | 5.3 4.0–6.9ROR 5.3 · χ² 176 / p 2e-40 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.0 | no trial data cached |
| Product use in unapproved indication | 442 | 5.3 4.8–5.8ROR 5.5 · χ² 1,536 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Acute myocardial infarction | 53 | 5.2 4.0–6.8ROR 5.2 · χ² 176 / p 2e-40 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · ♀ 23% (drug 53%) · 96% clinician | no trial data cached |
| Cerebral haemorrhage | 63 | 5.1 4.0–6.5ROR 5.2 · χ² 205 / p 9e-47 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | 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 |
|---|---|---|---|---|---|---|
| Platelet count decreased | 1,697 | 47.0 45.1–49.0ROR 61.1 · χ² 75,483 / p <1e-300 | 46.2 EB05 44.4 · IC025 +5.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 33.7 | no trial data cached |
| Drug ineffective (drug did not work) | 875 | 1.9 1.8–2.1ROR 2.1 · χ² 417 / p 6e-93 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Off label use (used outside approved label) | 735 | 2.5 2.3–2.6ROR 2.6 · χ² 662 / p 3e-146 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Death | 597 | 2.0 1.9–2.2ROR 2.1 · χ² 316 / p 5e-71 | 2.0 EB05 1.9 · IC025 +0.9 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.2 · 73% consumer | no trial data cached |
| Product use in unapproved indication | 442 | 5.3 4.8–5.8ROR 5.5 · χ² 1,536 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Platelet count increased | 409 | 93.8 85.2–103.2ROR 99.4 · χ² 36,294 / p <1e-300 | 90.5 EB05 83.4 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious PRR 71.1 | no trial data cached |
| Thrombocytopenia (low platelets) | 399 | 10.4 9.5–11.5ROR 11.0 · χ² 3,394 / p <1e-300 | 10.3 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.4 | no trial data cached |
| Headache | 386 | 1.8 1.6–2.0ROR 1.8 · χ² 138 / p 4e-32 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.1 · ♀ 76% (drug 53%) | no trial data cached |
| Haemoglobin decreased | 337 | 9.5 8.6–10.6ROR 10.0 · χ² 2,570 / p <1e-300 | 9.4 EB05 8.6 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.4 | no trial data cached |
| Pyrexia (fever) | 328 | 2.8 2.5–3.1ROR 2.8 · χ² 370 / p 1e-82 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Therapy non-responder | 296 | 19.4 17.3–21.7ROR 20.2 · χ² 5,123 / p <1e-300 | 19.3 EB05 17.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.8 | no trial data cached |
| Haemorrhage | 295 | 8.2 7.3–9.2ROR 8.5 · χ² 1,865 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Contusion | 293 | 8.9 7.9–9.9ROR 9.2 · χ² 2,041 / p <1e-300 | 8.8 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Petechiae | 262 | 75.0 66.5–84.6ROR 77.8 · χ² 18,576 / p <1e-300 | 72.7 EB05 65.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 52.8 | no trial data cached |
| Malaise (feeling unwell) | 257 | 1.7 1.5–1.9ROR 1.7 · χ² 74 / p 3e-18 | 1.7 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.7 · 78% 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.
- Petechiae — n=262, PRR 75.0
- Decreased immune responsiveness — n=47, PRR 14.0
- Hyperbilirubinaemia — n=36, PRR 10.2
- Cytomegalovirus infection — n=53, PRR 9.3
- Splenomegaly — n=37, PRR 9.2
- Haemorrhage intracranial — n=46, PRR 8.9
- Contusion — n=293, PRR 8.9
- Haematoma — n=79, PRR 8.8
- Epistaxis — n=215, PRR 8.3
- Cerebral infarction — n=58, PRR 6.9
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 Eltrombopag?
In FDA FAERS, the most frequently co-reported reaction terms for Eltrombopag are platelet count decreased, platelet count increased, thrombocytopenia, headache, haemoglobin decreased, pyrexia. 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 Eltrombopag have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, Eltrombopag tablets in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions ( 5.1 )] .
Do FAERS signals prove that Eltrombopag 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 074dbfa7-eadb-e722-0a7a-86a97882f031, effective 20250610; matched on
openfda.generic_name.exact:"ELTROMBOPAG") - 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, 335 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.