Nplateromiplostim
According to the FDA label: Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
14,659 adverse event reports submitted to the FDA (2008–2026)
Top Reported Adverse Events
The most frequently reported events in association with Nplate in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Ineffective 1,726 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Platelet Count Decreased 1,706 reports
A blood test result showing a low level of platelets, the cells that help blood clot. This is the lab-measurement version of thrombocytopenia.
Full definition in the glossary →Off Label Use 1,199 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Death 993 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →- Platelet Count Abnormal 945 reports
Therapeutic Response Decreased 941 reports
A report that a treatment seemed to work less well than before. Similar to drug ineffective and therapeutic product effect decreased.
Full definition in the glossary →Thrombocytopenia 934 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Headache 591 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Fatigue 462 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Hospitalisation 381 reports
A report that the person was admitted to a hospital. This records that a hospital stay occurred, which is one way the seriousness of an event is tracked. Also spelled hospitalization in American English.
Full definition in the glossary →Haemorrhage 379 reports
Bleeding, particularly heavy or uncontrolled bleeding. Also spelled hemorrhage in American English.
Full definition in the glossary →- Platelet Count Increased 378 reports
Arthralgia 355 reports
Product Storage Error 345 reports
A report that a medication was stored incorrectly, for example at the wrong temperature. This is a handling category, not a sign of a problem with the drug.
Full definition in the glossary →Nausea 340 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 6,359 |
| Male | 5,547 |
| Unknown | 105 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 594 |
| 18-34 | 895 |
| 35-49 | 973 |
| 50-64 | 1,960 |
| 65-74 | 1,604 |
| 75+ | 1,747 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Nplate. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 8,361 |
| Hospitalization | 3,713 |
| Non-Serious | 3,406 |
| Death | 2,600 |
| Life-Threatening | 443 |
| Disability | 152 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Nplate. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2008 | 47 |
| 2009 | 410 |
| 2010 | 1,850 |
| 2011 | 2,054 |
| 2012 | 891 |
| 2013 | 527 |
| 2014 | 630 |
| 2015 | 799 |
| 2016 | 616 |
| 2017 | 982 |
| 2018 | 1,124 |
| 2019 | 612 |
| 2020 | 522 |
| 2021 | 535 |
| 2022 | 605 |
| 2023 | 826 |
| 2024 | 790 |
| 2025 | 683 |
| 2026 (partial) | 156 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Nplate
In FDA adverse event reports that mention Nplate, these medications appeared most often in the same report.
- Rituximab (1,416 reports)
- Prednisone (1,109 reports)
- Eltrombopag Olamine (845 reports)
- Eltrombopag (602 reports)
- Dexamethasone (529 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026