What the label lists and what reports show
Idarubicin side effects
Idarubicin's FDA label lists its adverse reactions in its own words. FAERS holds 1,119 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 myelosuppression (180 reports).
- Generic listed
- Boxed warning
Check it at the source: the idarubicin FDA label on DailyMed (effective May 9, 2025, Meitheal Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsApproximately 550 patients with AML have received idarubicin in combination with cytarabine in controlled clinical trials worldwide. In addition, over 550 patients with acute leukemia have been treated in uncontrolled trials utilizing idarubicin as a single agent or in combination. The table below lists the adverse experiences reported in U.S. Study 2 (see CLINICAL STUDIES ) and is representative of the experiences in other studies. These adverse experiences constitute all reported or observed experiences, including those not considered to be drug related. Patients undergoing induction therapy for AML are seriously ill due to their disease, are receiving multiple transfusions, and concomitant medications including potentially toxic antibiotics and antifungal agents. The contribution of the study drug to the adverse experience profile is difficult to establish. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Experiences | Induction Phase IDR (N=110) | Percentage of Patients DNR (N=118) |
|---|---|---|
| Infection | 95% | 97% |
| Nausea & Vomiting | 82% | 80% |
| Hair Loss | 77% | 72% |
| Abdominal Cramps/Diarrhea | 73% | 68% |
| Hemorrhage | 63% | 65% |
| Mucositis | 50% | 55% |
| Dermatologic | 46% | 40% |
| Mental Status | 41% | 34% |
| Pulmonary-Clinical | 39% | 39% |
| Fever (not elsewhere classified) | 26% | 28% |
| Headache | 20% | 24% |
| Cardiac-Clinical | 16% | 24% |
| Neurologic-Peripheral Nerves | 7% | 9% |
| Pulmonary Allergy | 2% | 4% |
| Seizure | 4% | 5% |
| Cerebellar | 4% | 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.
Source: FDA drug label, Meitheal Pharmaceuticals Inc., effective May 9, 2025 (SPL set d31254be-6bd2-4ac1-acab-bc00e2209d28), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,119 reports list idarubicin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 249 are coded as a death and 458 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 22 reactions below, 4 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?
- Idarubicin: 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