Brand name · Revumenib

Revuforj: adverse event reports filed with FDA

824 reports list it as a suspect or interacting product, 2024–2026.

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.

824
reports as suspect product: 0% of all reports · about 523 a year; 550
reports, 12 months to June 2026: 274 in the 12 months before; 57.8%
marked serious by the reporter: 57.4% across all reports; 13.5%
record death among outcomes, as reported: 111 reports · not verified by FDA

824 adverse event reports received by FDA list the brand name Revuforj (revumenib) as a suspect or interacting product, from December 2024 to June 2026. A further 44 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 550 reports listed it, up 101% from 274 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 523 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded off label use (27.7%), nausea (16%) and platelet count decreased (15.9%). A report can list several reactions, so shares add to more than 100%; 243 different terms appear across these reports. Off label use is recorded in 27.7% of these reports, against 4.1% of all reports in the database.

57.8% of the reports are marked serious by the reporter; 13.5% record death among the outcomes and 29% record hospitalisation, as reported. 68.9% of the reports came from consumers, and the largest patient age group is 18 to 44 (11.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Revuforj reports recording the termall reports in the database

Off label useused for a purpose or in a way not on the label27.7%228
Nauseafeeling sick16%132
Platelet count decreasedlow platelet count15.9%131
Product dose omission issuea dose was missed12.4%102
Deaththe patient died; cause not stated by this term10.2%84
Fatiguetiredness10.2%84
Vomitingbeing sick7.4%61
White blood cell count decreasedlow white cell count6.8%56
Pyrexiafever5.7%47
Diarrhoealoose or frequent stools5.1%42
Haemoglobin decreasedlow haemoglobin5%41
Electrocardiogram QT prolongeda QT prolongation on the ECG4.9%40
Full blood count decreased4.7%39
Differentiation syndrome4.6%38
Neutrophil count decreased4%33
Disease progressionthe disease advanced3.9%32
Thrombocytopenialow platelets3.9%32
Decreased appetitereduced appetite3.6%30
Drug ineffectivethe medicine did not work as expected3.6%30
Laboratory test abnormal3.6%30
Headachehead pain3.4%28
Arthralgiajoint pain3.3%27
Peripheral swellingswelling of the arms or legs3.2%26
Illness3%25
Taste disorder2.9%24
Abdominal discomfortstomach discomfort2.8%23
Dyspnoeashortness of breath2.8%23
Infectionan infection, type not specified2.8%23
Astheniaweakness or lack of energy2.7%22
Product use issuea problem in how the product was used2.7%22

Top 30 of 243 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. 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."

Outcomes recorded

Death13.5%111

Life-threatening0.7%6

Hospitalisation (initial or prolonged)29%239

Disability0.1%1

Congenital anomaly0%0

Other serious45%371

Not serious42.2%348

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 21.9%16

2 to 113.3%27

12 to 173%25

18 to 4411.4%94

45 to 648.9%73

65 to 749.2%76

75 and over5.5%45

Age not given56.8%468

Patient sex

Female43%354

Male42.5%350

Not given14.6%120

Who reported

Physician16.6%137

Pharmacist4.9%40

Other health professional9.6%79

Lawyer0%0

Consumer or non-health professional68.9%568

Not given0%0

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)	Reports	Share
Acute myeloid leukaemia	466	56.6%
Acute lymphocytic leukaemia	35	4.2%
Acute leukaemia	32	3.9%
Acute myeloid leukaemia refractory	16	1.9%
Leukaemia	10	1.2%
Acute myeloid leukaemia recurrent	6	0.7%

The indication field is filled in by the reporter and is often blank; shares are of all 824 reports.

In context

Measure	Revuforj	All reports
Reports as suspect product	824	20,646,523
Share of that pool	—	0%
Reports, latest 12 months	550	1,332,454
Marked serious	57.8%	57.4%
Death recorded among outcomes, per 1,000 reports	135	91
Hospitalisation recorded, per 1,000 reports	290	213
Consumer-filed share	68.9%	45.8%
Top term, share of reports	Off label use 27.7%	4.1%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Questions about Revuforj reports

How many adverse event reports has FDA received for Revuforj?

824 reports list Revuforj as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 550 of them arrived in the latest 12 months. Another 44 list it only as a concomitant medication.

What reactions are recorded in Revuforj reports?

off label use (27.7%), nausea (16%), platelet count decreased (15.9%), product dose omission issue (12.4%) and death (10.2%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Revuforj was responsible.

How serious are the reports?

57.8% are marked serious by the reporter. Among the outcomes recorded, 13.5% of reports include death and 29% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (68.9%), physician (16.6%) and other health professional (9.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Revuforj rising?

550 reports in the 12 months to June 2026, up 101% from 274 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Revuforj was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Revuforj?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Revuforj as a suspect or interacting product; reports listing it only as a concomitant medication (44) are excluded. 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.