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Novantrone Side Effects

Generic Name: mitoxantrone

Note: This document contains side effect information about mitoxantrone. Some of the dosage forms listed on this page may not apply to the brand name Novantrone.

For the Consumer

Applies to mitoxantrone: intravenous solution

Along with its needed effects, mitoxantrone (the active ingredient contained in Novantrone) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking mitoxantrone:

More common
  • Black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • cough or shortness of breath
  • difficult, burning, or painful urination
  • dizziness
  • fainting
  • fast, slow, or irregular heartbeat
  • frequent urge to urinate
  • lower back or side pain
  • pale skin
  • stomach pain
  • swelling or inflammation of the mouth
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Blood in the urine or stools
  • decrease in urination
  • fever or chills
  • pinpoint red spots on the skin
  • seizures
  • sore, red eyes
  • swelling of the feet and lower legs
  • yellow eyes or skin
  • Blue skin at the place of injection
  • pain or redness at the place of injection
  • skin rash

Some side effects of mitoxantrone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Absent, missed, or irregular menstrual periods
  • back pain
  • body aches or pains
  • congestion
  • constipation
  • diarrhea
  • dryness or soreness of the throat
  • hair loss
  • headache
  • longer or heavier menstrual periods
  • nausea or vomiting
  • oral bleeding
  • pain or tenderness around the eyes and cheekbones
  • runny nose
  • sneezing
  • stopping of menstrual bleeding
  • stuffy nose
  • tender, swollen glands in the neck
  • thinning of the hair

For Healthcare Professionals

Applies to mitoxantrone: intravenous solution


Very common (10% or more): Platelets low (up to 33%), leukopenia (up to 19%), white blood cells low (up to 100%)
Common (1% to 10%): Myelosuppression (especially leucopenia)
Uncommon (0.1% to 1%): Thrombocytopenia, anemia
Frequency not reported: Bone marrow depression[Ref]


Frequency not reported: Acute myeloid leukemia (AML), acute myelodysplastic syndrome (AMS)[Ref]


Very common (10% or more): Nausea (up to 76%), stomatitis (up to 19%), diarrhea (up to 16%), gastralgia/stomach burn/epigastric pain (up to 14%), constipation (up to 10%), aphthosis (up to 10%)
Common (1% to 10%): Vomiting
Uncommon (0.1% to 1%): Anorexia, GI bleeding, abdominal pain, altered taste
Frequency not reported: Mucositis, vomiting[Ref]


Very common (10% or more): Arrhythmia (up to 18%), ECG abnormal (up to 11%)
Uncommon (0.1% to 1%): Hypotension
Frequency not reported: Acute arrhythmias, transient ECG alterations, reduced left ventricular output, cardiac insufficiency, congestive heart failure (CHF)[Ref]


Uncommon (0.1% to 1%): Phlebitis, erythema, swelling, pain, burning and/or blue discoloration of the skin
Rare (less than 0.1%): Tissue necrosis (following extravasation)[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Somnolence, mild paresthesia[Ref]


Uncommon (0.1% to 1%): Anaphylaxis[Ref]


Very common (10% or more): Reversible alopecia (up to 61%)
Uncommon (0.1% to 1%): Urticaria, rash, nail pigmentation, onycholysis[Ref]


Uncommon (0.1% to 1%): Elevated serum creatinine, elevated blood urea nitrogen
Frequency not reported: Renal failure[Ref]


Very common (10% or more): Gamma-glutamyl transpeptidase increased (up to 15%)
Common (1% to 10%): Alanine aminotransferase (ALT or SGPT) increased, aspartate aminotransferase (AST or SGOT) increased, granulocytopenia, anemia
Uncommon (0.1% to 1%): Increased liver enzyme levels, elevated bilirubin levels[Ref]


Very common (10% or more): Asthenia (up to 24%)
Uncommon (0.1% to 1%): Fever, fatigue, weakness[Ref]


Very common (10% or more): Menstrual disorder (including amenorrhea) (up to 61%), urinary tract infection (up to 32%), abnormal urine (up to 11%)
Common (1% to 10%): Menorrhagia
Frequency not reported: Blue-green coloration of the urine 1 to 2 days after administration[Ref]


Frequency not reported: Amenorrhea[Ref]


Very common (10% or more): Infection (e.g., tonsillitis, enteritis, urinary tract infection, viral infection, endometritis) (up to 85%), cutaneous mycosis (up to 10%)[Ref]


Very common (10% or more): Glucose high (up to 10%), potassium low (up to 10%)
Common (1% to 10%): Back pain
Rare (less than 0.1%): Tumor lysis syndrome (characterized by hyperuricemia, hypercalcemia, hyperphosphatasemia, hypocalcemia)[Ref]


Uncommon (0.1% to 1%): Reversible blue coloration of the sclera
Frequency not reported: Lethargy, fatigue, seizures[Ref]


Frequency not reported: Depression[Ref]


Very common (10% or more): Upper respiratory tract infection (up to 53%), pharyngitis/throat infection (up to 19%), rhinitis (up to 10%)
Common (1% to 10%): Sinusitis
Uncommon (0.1% to 1%): Dyspnea, pneumonitis[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

3. "Product Information. Novantrone (mitoxantrone)." Immunex Corporation, Seattle, WA.

Some side effects of Novantrone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.