Nplate: adverse event reports filed with FDA

11,565

reports as suspect product

0.1% of all reports · about 652 a year

310

reports, 12 months to June 2026

274 in the 12 months before

74.3%

marked serious by the reporter

68.8% across the class

16.8%

record death among outcomes, as reported

1,939 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 Nplate reports recording the termmedian drug in thrombopoietin receptor agonist

1. Platelet count decreasedlow platelet count12.4%1,438
2. Drug ineffectivethe medicine did not work as expected11.9%1,377
3. Therapeutic response decreasedthe medicine worked less well7.9%913
4. Platelet count abnormal7.8%905
5. Deaththe patient died; cause not stated by this term7.1%824
6. Thrombocytopenialow platelets6.6%765
7. Off label useused for a purpose or in a way not on the label5.5%638
8. Headachehead pain4.2%485
9. Fatiguetiredness3.3%376
10. Product storage errorthe product was stored wrongly3%344
11. Platelet count increased2.9%335
12. Hospitalisationadmission to hospital2.9%331
13. Arthralgiajoint pain2.8%321
14. Haemorrhagebleeding2.3%268
15. Thrombocytosis2.3%268
16. Nauseafeeling sick2.2%251
17. Contusiona bruise2.1%248
18. Circumstance or information capable of leading to medication errora situation that could lead to a medication error2%236
19. Astheniaweakness or lack of energy2%233
20. Pneumonialung infection1.9%222
21. Malaisegeneral feeling of being unwell1.8%207
22. Deep vein thrombosisa blood clot in a deep vein1.7%202
23. Myelodysplastic syndrome1.7%202
24. Epistaxisnosebleed1.7%201
25. Petechiaetiny bleeding spots in the skin1.7%194
26. Pulmonary embolisma blood clot in the lung1.7%193
27. Dizzinesslight-headedness or unsteadiness1.6%184
28. Pain in extremitypain in an arm or leg1.6%183
29. Cerebrovascular accidentstroke1.5%171
30. Anaemialow red blood cells1.4%165

Top 30 of 1,001 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. 71.6% 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 11,565 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nplate 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 Nplate as a suspect or interacting product; reports listing it only as a concomitant medication (672) 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.