Prescription medicine
Enasidenib Brand names: Idhifa
Enasidenib (Idhifa) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the enasidenib FDA label on DailyMed (effective January 16, 2025, Celgene Corporation); the NDA 209606 record on Drugs@FDA; every enasidenib label on DailyMed.
Highlights of the record
FDA label of January 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DIFFERENTIATION SYNDROME.
Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 5.1 , 6.1 ).
Used for
From the label: indications and usageIDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ).
Forms and strengths
- 50 mg
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 1, 2017 Idhifa, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 16, 2034 Idhifa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,296 through July 30, 2026
What is enasidenib used for?
From the label: indications and usageIDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Conditions named in the indications of enasidenib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Isocitrate Dehydrogenase 2 Inhibitor.
Source: FDA drug label (Idhifa), 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 patient leaflet for enasidenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about IDHIFA?IDHIFA may cause serious side effects, including: • Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells which may be life-threatening or lead to death if not treated. Differentiation syndrome has happened within 1 day and up to 5 months after starting IDHIFA. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment with IDHIFA: o fever o cough o shortness of breath o swelling of arms and legs o swelling around neck, groin, or underarm area o fast weight gain (greater than 10 pounds within a week) o bone pain If you develop any of these symptoms of differentiation syndrome, your healthcare provider may start you on a medicine taken by mouth or given through a vein (intravenous) called corticosteroids and may monitor you in the hospital.
From the patient leaflet: How should I store IDHIFA?Store IDHIFA at room temperature between 68°F to 77°F (20°C to 25°C). • Keep IDHIFA in the original container. • Keep the container tightly closed with desiccant canister inside to protect the tablets from moisture. Keep IDHIFA and all medicines out of the reach of children.
Source: FDA drug label (Idhifa), 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
Is there a generic for enasidenib (Idhifa)?
No generic enasidenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Idhifa tablets: the compound patent runs to September 16, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the enasidenib label say about other medicines?
The enasidenib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name enasidenib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Caffeine | drug interactions | Consider reducing the frequency of caffeine intake from various food and beverages in a 24 hour period while taking IDHIFA because IDHIFA may increase the effect of caffeine in patients who are sensitive to it. |
| Dexamethasone | warnings and precautions | If differentiation syndrome is suspected, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) and hemodynamic monitoring until improvement. |
Other labels that name enasidenib
Source: FDA drug label (Idhifa), 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 for enasidenib?
The FDA Adverse Event Reporting System holds 3,296 reports that list enasidenib among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as enasidenib?
37 other medicines are given the same way (oral) and in the same FDA class as enasidenib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other isocitrate dehydrogenase 2 inhibitors
- the pharmacologic class, with prices and generics
- Enasidenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other