Eltrombopag Olamine side effects: what 22,929 FDA adverse event reports show
Drug class
Not stated in label
Who reports
22,929 reports · 65% serious · 4,879 with death outcome · 55% 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. THESE HIHGLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning.
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. 1,033 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 |
|---|---|---|---|---|---|---|
| Bone marrow reticulin fibrosis | 54 | 236.3 175.2–318.8ROR 236.9 · χ² 9,841 / p <1e-300 | 175.9 EB05 139.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=48 | not reported in cached trials |
| Paroxysmal nocturnal haemoglobinuria | 49 | 109.1 81.1–146.7ROR 109.3 · χ² 4,585 / p <1e-300 | 93.9 EB05 73.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=49 | not reported in cached trials |
| Mucocutaneous haemorrhage | 13 | 92.3 52.2–163.3ROR 92.3 · χ² 984 / p 3e-216 | 74.9 EB05 46.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Platelet count increased | 1,112 | 85.1 80.1–90.4ROR 89.4 · χ² 84,418 / p <1e-300 | 77.7 EB05 74.0 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious PRR 51.7 · 74% consumer | NCT00351468: 3/302 (1.0%) on Eltrombopag Olamine (serious AE) |
| Platelet count abnormal | 485 | 80.0 73.0–87.7ROR 81.7 · χ² 34,689 / p <1e-300 | 73.4 EB05 68.0 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=332 | NCT00351468: 3/302 (1.0%) on Eltrombopag Olamine (serious AE) |
| Immune thrombocytopenia | 296 | 64.8 57.6–72.8ROR 65.6 · χ² 17,284 / p <1e-300 | 60.3 EB05 54.7 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=295 | not reported in cached trials |
| Oral blood blister | 13 | 64.8 36.9–113.7ROR 64.8 · χ² 703 / p 3e-155 | 55.8 EB05 34.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Evans syndrome | 29 | 58.6 40.3–85.3ROR 58.7 · χ² 1,489 / p <1e-300 | 53.3 EB05 38.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 88% (drug 55%) | not reported in cached trials |
| Platelet disorder | 146 | 55.9 47.4–66.1ROR 56.3 · χ² 7,367 / p <1e-300 | 52.4 EB05 45.6 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=100 | NCT00351468: 3/302 (1.0%) on Eltrombopag Olamine (serious AE) |
| Aplastic anaemia | 216 | 39.3 34.3–45.0ROR 39.6 · χ² 7,685 / p <1e-300 | 37.6 EB05 33.5 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious n=215 | not reported in cached trials |
| Platelet count decreased | 4,025 | 35.9 34.9–36.9ROR 43.3 · χ² 131,957 / p <1e-300 | 34.6 EB05 33.7 · IC025 +5.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 25.0 | NCT00351468: 3/302 (1.0%) on Eltrombopag Olamine (serious AE) |
| Labelled drug-food interaction medication error | 19 | 35.8 22.7–56.7ROR 35.9 · χ² 586 / p 1e-129 | 33.5 EB05 22.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=7 | not reported in cached trials |
| Cerebral venous sinus thrombosis | 29 | 33.5 23.1–48.6ROR 33.6 · χ² 851 / p 2e-187 | 31.8 EB05 23.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 82% (drug 55%) | not reported in cached trials |
| Myelofibrosis | 107 | 33.5 27.6–40.6ROR 33.6 · χ² 3,219 / p <1e-300 | 32.1 EB05 27.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=105 | not reported in cached trials |
| Splenectomy | 40 | 32.6 23.8–44.6ROR 32.6 · χ² 1,151 / p 1e-252 | 31.1 EB05 23.8 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious n=36 | not reported in cached trials |
| Transplant dysfunction | 54 | 28.9 22.1–37.9ROR 29.0 · χ² 1,383 / p <1e-300 | 27.8 EB05 22.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=54 · ♀ 76% (drug 55%) · 100% clinician | not reported in cached trials |
| Petechiae | 315 | 28.5 25.5–31.9ROR 28.9 · χ² 8,092 / p <1e-300 | 27.7 EB05 25.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 | not reported in cached trials |
| Cystitis viral | 11 | 27.2 14.9–49.5ROR 27.2 · χ² 244 / p 2e-55 | 25.3 EB05 14.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | not reported in cached trials |
| Thrombocytosis | 100 | 25.7 21.1–31.4ROR 25.8 · χ² 2,287 / p <1e-300 | 24.9 EB05 21.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=79 | not reported in cached trials |
| Antiphospholipid syndrome | 42 | 24.6 18.1–33.5ROR 24.7 · χ² 904 / p 6e-199 | 23.8 EB05 18.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=42 | not reported in cached trials |
| Idiopathic thrombocytopenic purpura | 41 | 24.0 17.6–32.7ROR 24.0 · χ² 858 / p 8e-189 | 23.2 EB05 17.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=40 | not reported in cached trials |
| Mean platelet volume increased | 15 | 23.6 14.1–39.4ROR 23.6 · χ² 295 / p 2e-66 | 22.4 EB05 14.2 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Marrow hyperplasia | 17 | 23.2 14.3–37.5ROR 23.2 · χ² 330 / p 5e-74 | 22.0 EB05 14.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Chronic myelomonocytic leukaemia | 16 | 22.5 13.7–37.0ROR 22.5 · χ² 300 / p 2e-67 | 21.4 EB05 13.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Biopsy bone marrow abnormal | 11 | 22.4 12.3–40.8ROR 22.4 · χ² 199 / p 1e-45 | 20.9 EB05 12.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Oesophageal adenocarcinoma | 10 | 19.6 10.5–36.7ROR 19.7 · χ² 155 / p 6e-36 | 18.0 EB05 9.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Immune thrombocytopenic purpura | 60 | 19.5 15.1–25.2ROR 19.6 · χ² 1,014 / p 9e-223 | 19.0 EB05 15.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=58 · ♀ 30% (drug 55%) | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Platelet count | 12 | 19.3 10.9–34.2ROR 19.3 · χ² 186 / p 1e-42 | 18.0 EB05 10.3 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | – | NCT00351468: 3/302 (1.0%) on Eltrombopag Olamine (serious AE) |
| Iron overload | 22 | 19.0 12.5–29.0ROR 19.0 · χ² 350 / p 2e-78 | 18.3 EB05 12.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Eye colour change | 20 | 18.4 11.8–28.7ROR 18.5 · χ² 306 / p 7e-69 | 17.7 EB05 11.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=8 · ♀ 80% (drug 55%) | not reported in cached trials |
| Haemorrhagic disorder | 21 | 17.8 11.6–27.5ROR 17.8 · χ² 311 / p 7e-70 | 17.1 EB05 11.6 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Product supply issue | 135 | 17.8 15.0–21.1ROR 17.9 · χ² 2,086 / p <1e-300 | 17.5 EB05 15.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=106 · 93% consumer | not reported in cached trials |
| Mucosal haemorrhage | 22 | 17.8 11.7–27.1ROR 17.8 · χ² 325 / p 5e-73 | 17.1 EB05 11.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | not reported in cached trials |
| Discouragement | 44 | 17.7 13.2–23.9ROR 17.7 · χ² 664 / p 8e-147 | 17.2 EB05 13.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 82% (drug 55%) · 100% consumer | not reported in cached trials |
| Cerebral venous thrombosis | 33 | 16.8 11.9–23.8ROR 16.9 · χ² 467 / p 7e-104 | 16.3 EB05 12.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 76% (drug 55%) · 100% clinician | not reported in cached trials |
| Head banging | 10 | 16.2 8.6–30.2ROR 16.2 · χ² 125 / p 2e-29 | 14.3 EB05 7.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Platelet transfusion | 22 | 16.0 10.5–24.4ROR 16.0 · χ² 290 / p 3e-65 | 15.3 EB05 10.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Portal vein thrombosis | 53 | 15.3 11.7–20.1ROR 15.3 · χ² 682 / p 1e-150 | 14.9 EB05 11.8 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious n=53 | not reported in cached trials |
| Gingival bleeding | 207 | 14.0 12.2–16.1ROR 14.2 · χ² 2,458 / p <1e-300 | 13.8 EB05 12.3 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 17.0 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Superior sagittal sinus thrombosis | 12 | 13.8 7.8–24.3ROR 13.8 · χ² 128 / p 7e-30 | 12.1 EB05 6.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Eltrombopag Olamine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (8 of 40 signal terms matched).
- NCT00351468 — EXTEND (Eltrombopag Extended Dosing Study) (N=302, PHASE3; 180 AE terms posted; arms: Eltrombopag, Treatment + 1 Day; Eltrombopag, >1 to 30 Days Post-Therapy)
- NCT00370331 — RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag (N=197, PHASE3; 62 AE terms posted; arms: Placebo; Eltrombopag 50 mg QD)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 4,025 | 35.9 34.9–36.9ROR 43.3 · χ² 131,957 / p <1e-300 | 34.6 EB05 33.7 · IC025 +5.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 25.0 | NCT00351468: 3/302 (1.0%) on Eltrombopag Olamine (serious AE) |
| Death | 3,340 | 3.6 3.4–3.7ROR 4.0 · χ² 6,375 / p <1e-300 | 3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 3.1 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Drug ineffective (drug did not work) | 1,968 | 1.4 1.3–1.4ROR 1.4 · χ² 207 / p 3e-47 | 1.4 EB05 1.3 · IC025 +0.4 | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Fatigue (tiredness) | 1,130 | 1.3 1.3–1.4ROR 1.3 · χ² 96 / p 5e-23 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.1 | NCT00351468: 4/302 (1.3%) on Eltrombopag Olamine |
| Platelet count increased | 1,112 | 85.1 80.1–90.4ROR 89.4 · χ² 84,418 / p <1e-300 | 77.7 EB05 74.0 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious PRR 51.7 · 74% consumer | NCT00351468: 3/302 (1.0%) on Eltrombopag Olamine (serious AE) |
| Headache | 992 | 1.4 1.4–1.5ROR 1.5 · χ² 142 / p 5e-33 | 1.4 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Off label use (used outside approved label) | 940 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.391 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Nausea | 825 | 1.0 0.9–1.0ROR 1.0 · χ² 2 / p 0.099 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine |
| Diarrhoea (diarrhea) | 812 | 1.2 1.1–1.2ROR 1.2 · χ² 17 / p 2e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 0.9 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Product use in unapproved indication | 743 | 2.8 2.6–3.0ROR 2.8 · χ² 857 / p 1e-188 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | not reported in cached trials |
| Malaise (feeling unwell) | 599 | 1.2 1.2–1.3ROR 1.3 · χ² 30 / p 3e-8 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.2 · 78% consumer | not reported in cached trials |
| Thrombocytopenia (low platelets) | 598 | 4.9 4.6–5.3ROR 5.0 · χ² 1,867 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.3 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Pyrexia (fever) | 565 | 1.5 1.4–1.6ROR 1.5 · χ² 93 / p 3e-22 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
| Asthenia (weakness) | 542 | 1.3 1.2–1.4ROR 1.3 · χ² 42 / p 4e-11 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.2 | not reported in cached trials |
| Contusion | 511 | 4.9 4.5–5.3ROR 5.0 · χ² 1,572 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | NCT00351468: 1/302 (0.3%) on Eltrombopag Olamine (serious AE) |
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.
- Bone marrow reticulin fibrosis — n=54, PRR 236.3
- Paroxysmal nocturnal haemoglobinuria — n=49, PRR 109.1
- Evans syndrome — n=29, PRR 58.6
- Cerebral venous sinus thrombosis — n=29, PRR 33.5
- Myelofibrosis — n=107, PRR 33.5
- Transplant dysfunction — n=54, PRR 28.9
- Petechiae — n=315, PRR 28.5
- Thrombocytosis — n=100, PRR 25.7
- Idiopathic thrombocytopenic purpura — n=41, PRR 24.0
- Immune thrombocytopenic purpura — n=60, PRR 19.5 (also seen in trial arm)
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 Olamine?
In FDA FAERS, the most frequently co-reported reaction terms for Eltrombopag Olamine are platelet count decreased, fatigue, platelet count increased, headache, nausea, diarrhoea. 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 Olamine 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. THESE HIHGLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning.
Do FAERS signals prove that Eltrombopag Olamine 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 52ba8e06-aa7d-caa6-e063-6294a90a5ce5, effective 20260630; matched on
openfda.generic_name.exact:"ELTROMBOPAG OLAMINE") - 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, 1,073 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 - ClinicalTrials.gov API v2 (query
ELTROMBOPAG OLAMINE, results-bearing studies sorted by enrollment)
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.