What the label lists and what reports show
Olutasidenib side effects
Olutasidenib's FDA label: “The most common (≥20%) adverse reactions, including laboratory abnormalities, are aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased …” FAERS holds 275 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 (27 reports).
- No generic listed
- Boxed warning
Check it at the source: the olutasidenib FDA label on DailyMed (effective November 5, 2025, Rigel 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 REZLIDHIA?REZLIDHIA may cause serious side effects, including: See “What is the most important information I should know about REZLIDHIA?” Liver problems. Changes in liver function tests are common during treatment with REZLIDHIA and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with REZLIDHIA. […]
Source: FDA drug label, Rigel Pharmaceuticals, Inc., effective November 5, 2025 (SPL set 4a0c7c8b-b95f-455d-9600-b7351e4397fe), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥20%) adverse reactions, including laboratory abnormalities, are aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.
Table 2: Adverse Reactions (≥10%) in Patients with Relapsed or Refractory AML in the Clinical Trial
| Body System Adverse Reaction | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|
| Nausea | 38 | 0 |
| Constipation | 26 | 0 |
| Mucositis Mucositis includes gingival hypertrophy, gingivitis, gingivitis ulcerative,… | 23 | 3 |
| Diarrhea | 20 | 1 |
| Abdominal pain Includes multiple similar adverse reaction terms. | 18 | 1 |
| Vomiting | 17 | 1 |
| Fatigue/malaise | 36 | 3 |
| Pyrexia | 24 | 1 |
| Edema | 18 | 3 |
| Arthralgia Arthralgia grouped term includes arthralgia, bone pain, back pain, neck pain,… | 28 | 3 |
| Leukocytosis | 25 | 9 |
| Differentiation syndrome Includes fatal adverse reaction. ' Symptoms of differentiation… | 16 | 8 |
| Dyspnea ' Dyspnea grouped term includes acute respiratory distress syndrome, dyspnea,… | 24 | 5 |
| Cough | 17 | 1 |
| Rash | 24 | 1 |
| Transaminitis Transaminitis grouped term includes alanine aminotransferase increased,… | 20 | 12 |
| Decreased appetite | 16 | 2 |
| Headache | 13 | 0 |
| Hypertension | 10 | 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 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] 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 most common (≥20%) adverse reactions, including laboratory abnormalities, are aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rigel Pharmaceuticals, Inc. at 1-800-983-1329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Relapsed or Refractory AML The safety of REZLIDHIA 150 mg administered twice daily was evaluated in 153 adults with relapsed or refractory AML with an IDH1 mutation [see Clinical Studies ( 14.1 )]. …
Source: FDA drug label, 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?
275 reports list olutasidenib among the medicines taken, 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. Of the 17 reactions below, 12 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.
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?
- Olutasidenib: 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