What the label lists and what reports show
Pacritinib side effects
Pacritinib's FDA label: “The most common (≥20% of patients) adverse reactions are diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema ( 6.1 ).” FAERS holds 2,964 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 diarrhoea (622 reports).
- No generic listed
Check it at the source: the pacritinib FDA label on DailyMed (effective July 30, 2026, Sobi, 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 VONJO?VONJO can cause serious side effects including: Bleeding. VONJO can cause severe bleeding, which can be serious and, in some cases may lead to death. Stop taking VONJO and tell your healthcare provider right away if you develop any of these symptoms: unusual bleeding, bruising, and fever. Get medical help right away for any bleeding that you cannot stop. You will need to stop taking VONJO 7 days before any planned surgery or invasive procedure (such as a heart catheterization, stent placement in a coronary artery in your heart, or a procedure for varicose veins). Your healthcare provider should tell you when you can start taking VONJO again. Diarrhea. Diarrhea is common with VONJO, but can also be severe, and cause loss of too much body fluid (dehydration). Dehydration can lead to kidney problems. Tell your healthcare provider if you develop diarrhea during treatment with VONJO. […]
Source: FDA drug label, Sobi, Inc., effective July 30, 2026 (SPL set 4b5ab444-0e1a-4984-99db-76ad11a298ee), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥20% of patients) adverse reactions are diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema ( 6.1 ).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | All Grades a % | Grade ≥3 % | All Grades a % | Grade ≥3 % |
|---|---|---|---|---|
| Diarrhea | 48 | 4 | 15 | 0 |
| Thrombocytopenia | 34 | 32 | 23 | 18 |
| Nausea | 32 | 1 | 11 | 1 |
| Anemia | 24 | 22 | 15 | 14 |
| Peripheral edema | 20 | 1 | 15 | 0 |
| Vomiting | 19 | 0 | 5 | 1 |
| Dizziness | 15 | 1 | 5 | 0 |
| Pyrexia | 15 | 1 | 3 | 0 |
| Epistaxis | 12 | 5 | 13 | 1 |
| Dyspnea | 10 | 0 | 9 | 3 |
| Pruritus | 10 | 2 | 6 | 0 |
| Upper respiratory tract infection | 10 | 0 | 6 | 0 |
| Cough | 8 | 2 | 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 described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )] Diarrhea [see Warnings and Precautions ( 5.2 )] Thrombocytopenia [see Warnings and Precautions ( 5.3 )] Prolonged QT Interval [see Warnings and Precautions ( 5.4 )] Major Adverse Cardiac Events [see Warnings and Precautions ( 5.5 )] Thrombosis [see Warnings and Precautions ( 5.6 )] Secondary Malignancies [see Warnings and Precautions ( 5.7 )] Risk of Infection [see Warnings and Precautions ( 5.8 )] Symptom Exacerbation Following Interruption or Discontinuation of Treatment [see Warnings and Precautions ( 5.9 )] The most common (≥20% of patients) adverse reactions are diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sobi, Inc. at (866) 773-5274 and www.VONJO.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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. PERSIST-2 Trial The safety of VONJO was evaluated in the randomized, controlled PERSIST-2 trial [see Clinical Studies ( 14 )]. …
Source: FDA drug label, Sobi, Inc., effective July 30, 2026 (SPL set 4b5ab444-0e1a-4984-99db-76ad11a298ee), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,964 reports list pacritinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 339 are coded as a death and 546 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. Reports rose sharply in 2023 (1,102, against a median of 3 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 9 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?
- Pacritinib: 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