What the label lists and what reports show
Avatrombopag side effects
Avatrombopag's FDA label: “In adult patients with chronic liver disease, the most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.” FAERS holds 2,571 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is platelet count decreased (421 reports).
- No generic listed
Check it at the source: the avatrombopag FDA label on DailyMed (effective August 13, 2025, AkaRx, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DOPTELET or DOPTELET SPRINKLE?DOPTELET or DOPTELET SPRINKLE may cause serious side effects, including: Blood clots. People with chronic liver disease or persistent or chronic immune thrombocytopenia and people with certain blood clotting conditions may have an increased risk of developing blood clots. […]
Source: FDA drug label, AkaRx, Inc., effective August 13, 2025 (SPL set e2d5960d-6c18-46cc-86bd-089222b09852), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn adult patients with chronic liver disease, the most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions | DOPTELET (N=128) % | Placebo (N= 22) % |
|---|---|---|
| Headache | 31 | 14 |
| Fatigue | 28 | 9 |
| Contusion | 26 | 18 |
| Epistaxis | 19 | 18 |
| Upper Respiratory Tract Infection | 15 | 5 |
| Arthralgia | 13 | 0 |
| Gingival Bleeding | 13 | 0 |
| Petechiae | 11 | 9 |
| Nasopharyngitis | 10 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in detail in other sections of the labeling: Thrombotic/Thromboembolic Complications [ see Warnings and Precautions ( 5.1 ) ] In adult patients with chronic liver disease, the most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral. ( 6.1 ) In adult patients with chronic immune thrombocytopenia, the most common adverse reactions (≥10%) were headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis. ( 6.1 ) In pediatric patients with persistent or chronic immune thrombocytopenia, the most common adverse reactions (≥10%) were viral infection, nasopharyngitis, cough, pyrexia, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sobi, Inc. at 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, AkaRx, Inc., effective August 13, 2025 (SPL set e2d5960d-6c18-46cc-86bd-089222b09852), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,571 reports list avatrombopag among the medicines taken, each a report of something that happened, not proof the medicine caused it; 172 are coded as a death and 521 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Avatrombopag: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions