Pharmacologic class (EPC) · 5 drug pages

Thrombopoietin receptor agonist: adverse event reports filed with FDA

33,996 reports list a drug in this class as a suspect or interacting product, 2008–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

33,996
reports across the class: 0.2% of all reports; 1,299
reports, 12 months to June 2026: 1,572 in the 12 months before; 68.8%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Thrombopoietin receptor agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 33,996 adverse event reports received by FDA, 0.2% of the database, from August 2008 to June 2026.

1,299 reports arrived in the 12 months to June 2026, down 17% from 1,572 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 68.8% of the class's reports are marked serious, 19.9% record death among the outcomes and 23.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are platelet count decreased (15.7%), death (12%) and drug ineffective (9.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
PromactaEltrombopag olamine	brand	14,561	161	50.1%	Death
NplateRomiplostim	brand	11,565	310	74.3%	Platelet count decreased
Eltrombopag olamine	generic	3,088	206	98.9%	Platelet count decreased
Eltrombopag	generic	2,704	359	94.2%	Drug ineffective
Romiplostim	generic	2,078	263	92.1%	Off label use

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Platelet count decreasedlow platelet count15.7%5,344
Deaththe patient died; cause not stated by this term12%4,084
Drug ineffectivethe medicine did not work as expected9.9%3,379
Off label useused for a purpose or in a way not on the label5%1,699
Platelet count increased4.3%1,465
Headachehead pain4.2%1,432
Fatiguetiredness4.1%1,379
Thrombocytopenialow platelets4%1,375
Platelet count abnormal4%1,372
Therapeutic response decreasedthe medicine worked less well3%1,032
Nauseafeeling sick2.9%972
Diarrhoealoose or frequent stools2.3%790
Haemorrhagebleeding2.3%785
Malaisegeneral feeling of being unwell2.3%765
Contusiona bruise2.1%726
Product use in unapproved indicationused for a purpose not on the label2.1%721
Arthralgiajoint pain2.1%710
Pneumonialung infection2%683
Astheniaweakness or lack of energy2%682
Pyrexiafever1.8%626
Dizzinesslight-headedness or unsteadiness1.8%614
Hospitalisationadmission to hospital1.8%607
Epistaxisnosebleed1.7%575
Therapy non-responderthe treatment did not work1.7%574
Painpain, site not specified1.6%538

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death19.9%6,769

Life-threatening3.2%1,079

Hospitalisation (initial or prolonged)23.4%7,940

Disability0.9%320

Congenital anomaly0%13

Other serious42%14,285

Not serious31.2%10,602

Patient age

Under 20.3%92

2 to 111.6%556

12 to 171.5%499

18 to 447.8%2,658

45 to 6414.4%4,890

65 to 749.8%3,321

75 and over11.9%4,039

Age not given52.8%17,941

Who reported

Physician30.9%10,503

Pharmacist6.4%2,177

Other health professional22.2%7,564

Lawyer0%0

Consumer or non-health professional38.5%13,100

Not given1.9%652

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Thrombopoietin receptor agonist reports

Which drugs are in the Thrombopoietin receptor agonist class on this site?

Promacta, Nplate, Eltrombopag olamine, Eltrombopag and Romiplostim. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

33,996 reports through June 2026, 1,299 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

platelet count decreased (15.7%), death (12%), drug ineffective (9.9%), off label use (5%) and platelet count increased (4.3%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.