Mitoxantrone: Side Effects, Uses & Monitoring
Mitoxantrone injection, USP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening re
- Data source
- FDA labeling via NIH DailyMed (label 1634528a…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
Mitoxantrone injection, USP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone injection, USP (concentrate) is not indicated in the treatment of patients with primary progressive multiple sclerosis. The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability. Mitoxantrone injection, USP (concentrate) in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. Mitoxantrone injection, USP (concentrate) in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymp…
Conditions associated with Mitoxantrone in labeling
Leukemia
Cancer of the blood-forming tissues, causing abnormal blood cells that can lead to anemia, infection, and blee...
Multiple Sclerosis
A chronic autoimmune disease that damages the myelin sheath of nerves, causing a wide range of neurological sy...
Prostate Cancer
Cancer of the prostate gland. Often slow-growing; treatment decisions depend on stage and risk....
Frequently Asked Questions
What is Mitoxantrone used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Mitoxantrone?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Mitoxantrone require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Mitoxantrone.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.