Prescription medicine
Ifosfamide Brand names: Ifex
Ifosfamide (Ifex) is a prescription medicine. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the ifosfamide FDA label on DailyMed (effective December 2, 2024); every ifosfamide label on DailyMed.
Highlights of the record
FDA label of December 2, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
MYELOSUPPRESSION, ENCEPHALOPATHY,.
NEPHROTOXICITY and UROTOXICITY
Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ].
Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ].
Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ]. WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY See full prescribing information for complete boxed warning.
Myelosuppression can be severe and lead to fatal infections ( 5.1 )
Encephalopathy can be severe and may result in death ( 5.2 )
Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe.
Used for
From the label: indications and usageIFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
Forms and strengths
- 1 g
- 1 g/20ml
- 3 g/60ml
- 50 mg/ml
Injection (powder) for solution; injection; injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- 5 first May 28, 2002; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 4 of 8 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest June 12, 2019; 2 more by firms not listed as its makers
- FAERS reports
- 21,359 through July 30, 2026
What is ifosfamide used for?
From the label: indications and usageIFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (IFEX), Baxter Healthcare Corporation, effective December 2, 2024 (SPL set b7241707-7538-4d1a-91e7-3a25a91e0b9a), via openFDA; the full label on DailyMed
Is there a generic for ifosfamide (Ifex)?
The FDA approved the first generic ifosfamide on May 28, 2002. 5 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ifosfamide from 2 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is ifosfamide in shortage?
The FDA Drug Shortage Database lists 4 of 8 ifosfamide presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on June 12, 2026. 4 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| IFEX, Injection, 1 g/20 mL (NDC 0338-3991-01) | Baxter Healthcare | Current | October 2, 2026 |
| IFEX, Injection, 3 g/60 mL (NDC 0338-3993-01) | Baxter Healthcare | Current | October 2, 2026 |
| Ifosfamide, Injection, 1 g/1 (NDC 21586-211-02) | SteriMax, Inc. | Current | September 8, 2026 |
| Ifosfamide, Injection, 1 g/1 (NDC 63323-142-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Ifosfamide, Injection, 1 g/20 mL (NDC 10019-925-01) | Baxter Healthcare | Current | October 2, 2026 |
| Ifosfamide, Injection, 3 g/60 mL (NDC 10019-926-02) | Baxter Healthcare | Current | October 2, 2026 |
| Ifosfamide, Injection, 50 mg/1 mL (NDC 0143-9530-01) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Ifosfamide, Injection, 50 mg/1 mL (NDC 0143-9531-01) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has ifosfamide been recalled?
The FDA's Enforcement Report lists 3 recalls naming ifosfamide since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of ifosfamide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| September 13, 2013 | Class II | AmeriSource Bergen not a listed maker | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ifosfamide label say about other medicines?
The ifosfamide label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name ifosfamide. 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 |
|---|---|---|
| Busulfan | warnings and precautions | Hemorrhagic cystitis is dose‑dependent and the risk is increased with past or concomitant radiation of the bladder or busulfan treatment. |
| Cisplatin | warnings and precautions | Risk factors include high ifosfamide dosage, hypoalbuminemia, impaired renal function, poor performance status, bulky abdominal-pelvic disease, nephrotoxic treatments including cisplatin, CNS active drugs, or alcohol use. |
| Mesna | boxed warning | Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ]. |
| Methylene blue | warnings and precautions | Dose interruption or permanent discontinuation may be required based on individual safety and tolerability. Consider methylene blue for treatment of encephalopathy. |
Other labels that name ifosfamide
Source: FDA drug label (IFEX), 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 for ifosfamide?
The FDA Adverse Event Reporting System holds 21,359 reports that list ifosfamide among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Ifosfamide side effects
- the label's list beside FAERS reports
- Ifosfamide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other