What the label lists and what reports show
Ifosfamide side effects
Ifosfamide's FDA label: “The most common (≥ 10%) adverse reactions were alopecia, nausea/vomiting, hematuria, leukopenia, anemia, CNS toxicity, infection.” FAERS holds 21,359 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 febrile neutropenia (2,701 reports).
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the ifosfamide FDA label on DailyMed (effective December 2, 2024); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common (≥ 10%) adverse reactions were alopecia, nausea/vomiting, hematuria, leukopenia, anemia, CNS toxicity, infection.
Table 2: Adverse Reactions in Patients Treated with Single Agent Ifosfamide for Injection
This table is printed in the IFOSFAMIDE label published by Baxter Healthcare Company of December 2, 2024; the label quoted above does not print one.
| Adverse Reaction | Single Agent Ifosfamide for Injection % (number of patients) Skin and Subcutaneous Tissue Disorders |
|---|---|
| Alopecia | 90% |
| Dermatitis | 0.08% |
| Papular rash | 0.08% |
| Nausea/Vomiting | 47% |
| Diarrhea | 0.7% |
| Stomatitis | 0.3% |
| - without mesna | 44% |
| - with mesna | 21% |
| - without mesna | 11% |
| - with mesna | 5% |
| Leukopenia | 44% |
| Anemia Includes anemia and decrease in hemoglobin/hematocrit | 38% |
| - with mesna | 21.3% |
| Thrombocytopenia, 50 x 10 3 /µL | 4.8% |
| Central nervous system toxicity Includes coma and death Includes abnormal behavior,… | 15% |
| Peripheral neuropathy | 0.4% |
| Infection | 10% |
| Phlebitis Includes phlebitis and irritation of the venous walls | 2.8% |
| Neutropenic fever Includes granulocytopenic fever | 1% |
| Fatigue | 0.3% |
| Hepatotoxicity Includes increased serum alanine aminotransferase (ALT), serum aspartate… | 1.8% |
| Anorexia | 1.1% |
| Cardiotoxicity Includes severe or fatal congestive heart failure, tachycardia, pulmonary… | 0.5% |
| Hypotension Includes shock and death | 0.3% |
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 most common (≥ 10%) adverse reactions were alopecia, nausea/vomiting, hematuria, leukopenia, anemia, CNS toxicity, infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at phone: 1 866 888 2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted from 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 clinical practice. The adverse reactions in Table 2 below are based on 30 publications describing clinical experience with fractionated administration of ifosfamide as a single agent with a total dose of 4 to 12 g/m 2 per course.
Source: FDA drug label, Baxter Healthcare Corporation, effective December 2, 2024 (SPL set b7241707-7538-4d1a-91e7-3a25a91e0b9a), via openFDA; the full label on DailyMed
What do FAERS reports show?
21,359 reports list ifosfamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,405 are coded as a death and 6,605 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 20 reactions below, 16 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?
- Ifosfamide: 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