What the label lists and what reports show
Enasidenib side effects
Enasidenib's FDA label: “The most common adverse reactions (≥20%) are nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite ( 6.1 ).” FAERS holds 3,296 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 fatigue (219 reports).
- No generic listed
- Boxed warning
Check it at the source: the enasidenib FDA label on DailyMed (effective January 16, 2025, Celgene Corporation); 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 IDHIFA?IDHIFA may cause serious side effects, including: See “What is the most important information I should know about IDHIFA?” The most common side effects of IDHIFA include: • nausea • vomiting • diarrhea • jaundice • decreased appetite Tell your healthcare provider if you have any changes to the color of your skin or the whites of your eyes. Your healthcare provider will monitor you for side effects during treatment and may tell you to stop taking IDHIFA if you develop certain side effects. These are not all the possible side effects of IDHIFA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA-1088.
Source: FDA drug label, NDA209606 (Bristol Myers Squibb), as published by Celgene Corporation, effective January 16, 2025 (SPL set a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite ( 6.1 ).
Table 2: Adverse Reactions Reported in ≥10% (Any Grade) or ≥3% (Grade 3-5) of Patients with Relapsed or Refractory AML
| Body System Adverse Reaction | All Grades N=214 n (%) | ≥Grade 3 N=214 n (%) |
|---|---|---|
| Nausea | 107 (50) | 11 (5) |
| Diarrhea | 91 (43) | 17 (8) |
| Vomiting | 73 (34) | 4 (2) |
| Decreased appetite | 73 (34) | 9 (4) |
| Tumor lysis syndrome b | 13 (6) | 12 (6) |
| Differentiation syndrome c | 29 (14) | 15 (7) |
| Noninfectious leukocytosis | 26 (12) | 12 (6) |
| Dysgeusia | 25 (12) | 0 (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: • Differentiation Syndrome [see Warnings and Precautions (5.1) ] The most common adverse reactions (≥20%) are nausea, vomiting, diarrhea, elevated bilirubin, and decreased appetite ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Bristol Myers Squibb at 1-800-721-5072 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. The safety evaluation of single-agent IDHIFA is based on 214 patients with relapsed or refractory AML who were assigned to receive 100 mg daily [see Clinical Studies (14.1) ]. The median duration of exposure to IDHIFA was 4.3 months (range 0.3 to 23.6). The 30-day and 60-day mortality rates observed with IDHIFA were 4.2% (9/214) and 11.7% (25/214), respectively. Serious adverse reactions were reported in 77.1% of patients. The most frequent serious adverse reactions (≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting (3%), decreased appetite (3%), tumor lysis syndrome (5%), and differentiation syndrome (8%). …
Source: FDA drug label, NDA209606 (Bristol Myers Squibb), as published by Celgene Corporation, effective January 16, 2025 (SPL set a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,296 reports list enasidenib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 822 are coded as a death and 843 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 21 reactions below, 8 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?
- Enasidenib: 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