"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Ifex Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ifex (ifosfamide) is used to treat testicular cancer. It is a cancer (antineoplastic) medication. This medication is available in generic form. Common side effects include nausea or vomiting (may be severe), diarrhea, stomach/abdominal pain, loss of appetite, or redness/pain/swelling at the injection site.
Ifex is administered intravenously at a dose of 1.2 g/mē per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity. Ifex may interact with "live" vaccines. Tell your doctor all medications and supplements you use. Ifex is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Both males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor to discuss birth control. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.
Our Ifex (ifosfamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ifex in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
- blood in the urine;
- lower back or side pain;
- frequent, painful or difficult urination;
- black or tarry stools;
- signs of infection such as fever; chills, or sore throat;
- extreme sleepiness, confusion, hallucination or coma; or
- unusual bleeding or bruising.
Other less serious side effects may be more likely to occur. Talk to your doctor if you experience
- nausea, vomiting, or decreased appetite;
- mouth sores;
- diarrhea; or
- temporary hair loss.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ifex (Ifosfamide)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Ifex Overview - Patient Information: Side Effects
Nausea, vomiting, diarrhea, stomach/abdominal pain, loss of appetite, or redness/pain/swelling at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Severe nausea, vomiting, and diarrhea may infrequently result in a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.
Temporary hair loss frequently occurs in patients using this drug. Normal hair growth should return after treatment has ended.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including: unusual weakness, seizure.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Ifex (Ifosfamide)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ifex FDA Prescribing Information: Side Effects
In patients receiving IFEX (ifosfamide) as a single agent, the dose-limiting toxicities are myelosuppression and urotoxicity. Dose fractionation, vigorous hydration, and a protector such as mesna can significantly reduce the incidence of hematuria, especially gross hematuria, associated with hemorrhagic cystitis. At a dose of 1.2 g/m² daily for 5 consecutive days, leukopenia, when it occurs, is usually mild to moderate. Other significant side effects include alopecia, nausea, vomiting, and central nervous system toxicities.
|Adverse Reaction||*Incidence (%)|
|Allergic Reaction||< 1|
|Pulmonary Symptoms||< 1|
|*Based upon 2,070 patients from the published literature in 30 single agent studies.|
Myelosuppression was dose related and dose limiting. It consisted mainly of leukopenia and, to a lesser extent, thrombocytopenia. A WBC count < 3000/μL is expected in 50% of the patients treated with IFEX (ifosfamide) single agent at doses of 1.2 g/m² per day for 5 consecutive days. At this dose level, thrombocytopenia (platelets < 100,000/μL) occurred in about 20% of the patients. At higher dosages, leukopenia was almost universal, and at total dosages of 10 to 12 g/m²/cycle, one half of the patients had a WBC count below 1000/μL and 8% of patients had platelet counts less than 50,000/μL. Myelosuppression was usually reversible and treatment can be given every 3 to 4 weeks. When IFEX (ifosfamide) is used in combination with other myelosuppressive agents, adjustments in dosing may be necessary. Patients who experience severe myelosuppression are potentially at increased risk for infection. Anemia has been reported as part of postmarketing surveillance.
Nausea and vomiting occurred in 58% of the patients who received IFEX (ifosfamide) . They were usually controlled by standard antiemetic therapy. Other gastrointestinal side effects include anorexia, diarrhea, and in some cases, constipation.
Urotoxicity consisted of hemorrhagic cystitis, dysuria, urinary frequency and other symptoms of bladder irritation. Hematuria occurred in 6% to 92% of patients treated with IFEX (ifosfamide) . The incidence and severity of hematuria can be significantly reduced by using vigorous hydration, a fractionated dose schedule and a protector such as mesna. At daily doses of 1.2 g/m² for 5 consecutive days without a protector, microscopic hematuria is expected in about one half of the patients and gross hematuria in about 8% of patients.
Renal toxicity occurred in 6% of the patients treated with ifosfamide as a single agent. Clinical signs, such as elevation in BUN or serum creatinine or decrease in creatinine clearance, were usually transient. They were most likely to be related to tubular damage. One episode of renal tubular acidosis which progressed into chronic renal failure was reported. Proteinuria and acidosis also occurred in rare instances. Metabolic acidosis was reported in 31% of patients in one study when IFEX (ifosfamide) was administered at doses of 2.0 to 2.5 g/m²/day for 4 days. Renal tubular acidosis, Fanconi syndrome, renal rickets and acute renal failure have been reported.
Close clinical monitoring of serum and urine chemistries including phosphorus, potassium, alkaline phosphatase and other appropriate laboratory studies is recommended. Appropriate replacement therapy should be administered as indicated.
Central Nervous System
CNS side effects were observed in 12% of patients treated with IFEX (ifosfamide) . Those most commonly seen were somnolence, confusion, depressive psychosis, and hallucinations. Other less frequent symptoms include dizziness, disorientation, and cranial nerve dysfunction. Seizures and coma with death were occasionally reported. The incidence of CNS toxicity may be higher in patients with altered renal function.
Alopecia occurred in approximately 83% of the patients treated with IFEX (ifosfamide) as a single agent. In combination, this incidence may be as high as 100%, depending on the other agents included in the chemotherapy regimen. Increases in liver enzymes and/or bilirubin were noted in 3% of the patients. Other less frequent side effects included phlebitis, pulmonary symptoms, fever of unknown origin, allergic reactions, stomatitis, cardiotoxicity, and polyneuropathy.
Read the entire FDA prescribing information for Ifex (Ifosfamide)
Additional Ifex Information
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