What the label lists and what reports show
Revumenib side effects
Revumenib's FDA label: “The most common adverse reactions (≥ 20%) […]” FAERS holds 878 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 nausea (139 reports).
- No generic listed
- Boxed warning
Check it at the source: the revumenib FDA label on DailyMed (effective February 4, 2026, Syndax Pharmaceuticals, 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 REVUFORJ?REVUFORJ may cause serious side effects including: see “ What is the most important information I should know about REVUFORJ? ” The most common side effects of REVUFORJ include: infections, including bacterial and viral infections changes in liver function tests bleeding (hemorrhage) nausea and vomiting muscle pain low white blood cell counts with fever diarrhea tiredness swelling in the arms and legs decreased appetite constipation Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with REVUFORJ if you develop certain side effects. REVUFORJ may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you. These are not all possible side effects of REVUFORJ. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Syndax Pharmaceuticals, Inc., effective February 4, 2026 (SPL set 6eb3cdbc-0e74-477d-82d6-3bb172d3f63f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 20%) […]
Table 7. Adverse Reactions Reported in ≥ 20% (Any Grade) or ≥ 5% (Grade 3 or 4) in Patients with R/R Acute Leukemia
| TEAE | All Grades % | Grade 3 or 4 % |
|---|---|---|
| Nausea a | 48 | 5 |
| Diarrhea b | 29 | 5 |
| Constipation | 20 | 0 |
| Hemorrhage #,c | 48 | 10 |
| Thrombosis d | 11 | 6 |
| Infection without identified pathogen e | 46 | 30 |
| Bacterial infection f | 27 | 18 |
| Viral Infection g | 23 | 6 |
| Febrile neutropenia | 37 | 35 |
| Musculoskeletal pain h | 37 | 6 |
| Electrocardiogram QT prolonged | 36 | 17 |
| Differentiation syndrome | 25 | 12 |
| Fatigue i | 24 | 5 |
| Edema j | 24 | 0 |
| Decreased appetite | 20 | 5 |
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: Differentiation Syndrome [see Warnings and Precautions (5.1) ] QTc Interval Prolongation and Torsades de Pointes [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥ 20%) including laboratory abnormalities, are phosphate increased, hemorrhage, nausea, infection without identified pathogen, aspartate aminotransferase increased, alanine aminotransferase increased, creatinine increased, musculoskeletal pain, febrile neutropenia, electrocardiogram QT prolonged, potassium decreased, parathyroid hormone intact increased, alkaline phosphatase increased, diarrhea, bacterial infection, triglycerides increased, differentiation syndrome, fatigue, edema, viral infection, phosphate decreased, decreased appetite, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals, Inc., at 1-888-539-3REV 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.
Source: FDA drug label, Syndax Pharmaceuticals, Inc., effective February 4, 2026 (SPL set 6eb3cdbc-0e74-477d-82d6-3bb172d3f63f), via openFDA; the full label on DailyMed
What do FAERS reports show?
878 reports list revumenib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 266 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 20 reactions below, 11 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?
- Revumenib: 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