Eltrombopag olamine: adverse event reports filed with FDA

3,088

reports as suspect product

0% of all reports · about 184 a year

206

reports, 12 months to June 2026

276 in the 12 months before

98.9%

marked serious by the reporter

68.8% across the class

22.1%

record death among outcomes, as reported

681 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Eltrombopag olamine reports recording the termmedian drug in thrombopoietin receptor agonist

1. Platelet count decreasedlow platelet count41.9%1,295
2. Deaththe patient died; cause not stated by this term14.4%444
3. Drug ineffectivethe medicine did not work as expected11.4%352
4. Platelet count increased11.3%350
5. Fatiguetiredness8.7%268
6. Haemoglobin decreasedlow haemoglobin8.3%256
7. Off label useused for a purpose or in a way not on the label8.2%254
8. Headachehead pain8.1%250
9. Contusiona bruise7.2%221
10. Malaisegeneral feeling of being unwell6.8%209
11. Product use in unapproved indicationused for a purpose not on the label6.7%207
12. Haemorrhagebleeding6.6%203
13. Petechiaetiny bleeding spots in the skin5.7%177
14. Pyrexiafever5.7%175
15. Platelet count abnormal5.6%172
16. Astheniaweakness or lack of energy4.9%151
17. Incorrect dose administeredthe wrong dose was given4.8%148
18. Diarrhoealoose or frequent stools4.5%138
19. Thrombocytopenialow platelets4.4%136
20. Dizzinesslight-headedness or unsteadiness4.3%134
21. Nauseafeeling sick4.2%131
22. Epistaxisnosebleed4.2%129
23. Arthralgiajoint pain4%123
24. Painpain, site not specified4%123
25. Influenzaflu3.9%119
26. Immune thrombocytopenia3.8%118
27. Illness3.8%117
28. Disease recurrencethe disease came back3.6%112
29. Covid-19COVID-19 infection3.6%110
30. Inappropriate schedule of product administrationthe product was taken at the wrong times3.6%110

Top 30 of 780 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the thrombopoietin receptor agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 33,996 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 0.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,088 reports.

Drugs most often listed in the same reports

Other products listed in reports where Eltrombopag olamine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the thrombopoietin receptor agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Eltrombopag olamine as a suspect or interacting product; reports listing it only as a concomitant medication (469) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.