Prescription medicine
Olutasidenib Brand names: Rezlidhia
Olutasidenib (Rezlidhia) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the olutasidenib FDA label on DailyMed (effective November 5, 2025, Rigel Pharmaceuticals, Inc.); the NDA 215814 record on Drugs@FDA; every olutasidenib label on DailyMed.
Highlights of the record
FDA label of November 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DIFFERENTIATION SYNDROME.
Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 )]. WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate corticosteroids and hemodynamic monitoring until symptom resolution.
Used for
From the label: indications and usageRelapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )].
Forms and strengths
- 150 mg
Capsule.
On the market
- Earliest approval on file
- December 1, 2022 Rezlidhia, Rigel Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 12, 2039 Rezlidhia capsules; 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
- 275 through July 30, 2026
What is olutasidenib used for?
From the label: indications and usageRelapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )]. REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
Conditions named in the indications of olutasidenib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (REZLIDHIA), Rigel Pharmaceuticals, Inc., effective November 5, 2025 (SPL set 4a0c7c8b-b95f-455d-9600-b7351e4397fe), via openFDA; the full label on DailyMed
What does the patient leaflet for olutasidenib 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 REZLIDHIA?REZLIDHIA may cause serious side effects including: Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life- threatening or lead to death. Differentiation syndrome in adults with acute myeloid leukemia (AML) has occurred as early as 1 day and up to 18 months after starting REZLIDHIA. 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 REZLIDHIA: fever cough trouble breathing decreased urination dizziness or lightheadedness weight gain swelling of your arms or legs If you develop signs and symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine or a medicine called hydroxyurea and may monitor you in the hospital. See "What are the possible side effects of REZLIDHIA?" for more information about side effects.
From the patient leaflet: How should I store REZLIDHIA?Store REZLIDHIA at room temperature from 68°F to 77°F (20°C to 25°C). Keep REZLIDHIA and all medicines out of the reach of children.
Source: FDA drug label (REZLIDHIA), Rigel Pharmaceuticals, Inc., effective November 5, 2025 (SPL set 4a0c7c8b-b95f-455d-9600-b7351e4397fe), via openFDA; the full label on DailyMed
Is there a generic for olutasidenib (Rezlidhia)?
No generic olutasidenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Rezlidhia capsules: the compound patent runs to May 16, 2039, and the last listed entry to November 12, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the olutasidenib label say about other medicines?
The olutasidenib label names 3 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Azacitidine | warnings and precautions | One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. |
| Dexamethasone | warnings and precautions | If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. |
| Hydroxyurea | warnings and precautions | Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. |
Source: FDA drug label (REZLIDHIA), Rigel Pharmaceuticals, Inc., effective November 5, 2025 (SPL set 4a0c7c8b-b95f-455d-9600-b7351e4397fe), via openFDA; the full label on DailyMed
What do FAERS reports show for olutasidenib?
The FDA Adverse Event Reporting System holds 275 reports that list olutasidenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 42 are coded as a death and 104 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.
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 olutasidenib?
37 other medicines are given the same way (oral) and in the same FDA class as olutasidenib 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?
- Olutasidenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other