What the label lists and what reports show
Ivosidenib side effects
Ivosidenib's FDA label: “The most common adverse reactions including laboratory abnormalities (≥ 25%) […]” FAERS holds 2,057 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 (169 reports).
- No generic listed
- Boxed warning
Check it at the source: the ivosidenib FDA label on DailyMed (effective December 22, 2025, Servier Pharmaceutical LLC); 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 TIBSOVO?TIBSOVO may cause serious side effects, including: See " What is the most important information I should know about TIBSOVO? " Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before and during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint. Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. […]
Source: FDA drug label, Servier Pharmaceutical LLC, effective December 22, 2025 (SPL set 65d254c0-67ad-42c4-b972-ad463b755b2d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions including laboratory abnormalities (≥ 25%) […]
Table 6: Adverse Reactions Reported in ≥ 10% (Any Grade) or ≥ 5% (Grade ≥ 3) of Patients with Relapsed or Refractory AML
| Body System Adverse Reaction | All Grades n (%) | Grade ≥ 3 n (%) |
|---|---|---|
| Fatigue Grouped term includes asthenia and fatigue. | 69 (39) | 6 (3) |
| Edema Grouped term includes peripheral edema, edema, fluid overload, fluid retention, and… | 57 (32) | 2 (1) |
| Pyrexia | 41 (23) | 2 (1) |
| Chest pain Grouped term includes angina pectoris, chest pain, chest discomfort, and… | 29 (16) | 5 (3) |
| Leukocytosis Grouped term includes leukocytosis, hyperleukocytosis, and increased white… | 68 (38) | 15 (8) |
| Differentiation Syndrome Differentiation syndrome can be associated with other commonly… | 34 (19) | 23 (13) |
| Arthralgia Grouped term includes arthralgia, back pain, musculoskeletal stiffness, neck… | 64 (36) | 8 (4) |
| Myalgia Grouped term includes myalgia, muscular weakness, musculoskeletal pain,… | 33 (18) | 1 (1) |
| Diarrhea | 60 (34) | 4 (2) |
| Nausea | 56 (31) | 1 (1) |
| Mucositis Grouped term includes aphthous ulcer, esophageal pain, esophagitis, gingival… | 51 (28) | 6 (3) |
| Constipation | 35 (20) | 1 (1) |
| Vomiting Grouped term includes vomiting and retching. | 32 (18) | 2 (1) |
| Abdominal pain Grouped term includes abdominal pain, upper abdominal pain, abdominal… | 29 (16) | 2 (1) |
| Dyspnea Grouped term includes dyspnea, respiratory failure, hypoxia, and dyspnea… | 59 (33) | 16 (9) |
| Cough Grouped term includes cough, productive cough, and upper airway cough syndrome. | 40 (22) | 1 (<1) |
| Pleural effusion | 23 (13) | 5 (3) |
| Electrocardiogram QT prolonged | 46 (26) | 18 (10) |
| Rash Grouped term includes dermatitis acneiform, dermatitis, rash, rash maculo-papular,… | 46 (26) | 4 (2) |
| Decreased appetite | 33 (18) | 3 (2) |
| Tumor lysis syndrome | 14 (8) | 11 (6) |
| Headache | 28 (16) | 0 |
| Neuropathy Grouped term includes ataxia, burning sensation, gait disturbance,… | 21 (12) | 2 (1) |
| Hypotension Grouped term includes hypotension and orthostatic hypotension. | 22 (12) | 7 (4) |
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 in AML and MDS [see Warnings and Precautions (5.1) ] QTc Interval Prolongation [see Warnings and Precautions (5.2) ] Guillain-Barré Syndrome [see Warnings and Precautions (5.3) ] The most common adverse reactions including laboratory abnormalities (≥ 25%) in patients with AML are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia ( 6.1 ). The most common adverse reactions including laboratory abnormalities (≥25%) in patients with relapsed or refractory MDS are creatinine increased, hemoglobin decrease, arthralgia, albumin decreased, aspartate aminotransferase increased, fatigue, diarrhea, cough, sodium decreased, mucositis, decreased appetite, myalgia, phosphate decreased, pruritus, and rash ( 6.1 ). …
Source: FDA drug label, Servier Pharmaceutical LLC, effective December 22, 2025 (SPL set 65d254c0-67ad-42c4-b972-ad463b755b2d), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,057 reports list ivosidenib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 207 are coded as a death and 642 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 19 reactions below, 15 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?
- Ivosidenib: 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