Skip to Content

Mitomycin Side Effects

For the Consumer

Applies to mitomycin: intravenous powder for solution


Intravenous route (Powder for Solution)

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin injection. Hemolytic Uremic Syndrome (HUS) has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during therapy with mitomycin, but most cases occur at doses greater than or equal to 60 mg. Blood product transfusion may exacerbate the symptoms associated with this syndrome.

Along with its needed effects, mitomycin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

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

Less Common

  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • unusual bleeding or bruising


  • Redness or pain, especially at place of injection

Check with your doctor as soon as possible if any of the following side effects occur while taking mitomycin:

Less Common

  • Cough
  • decreased urination
  • shortness of breath
  • sores in mouth and on lips
  • swelling of feet or lower legs


  • Bloody vomit

Some side effects of mitomycin 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

Less Common

  • Numbness or tingling in fingers and toes
  • purple-colored bands on nails
  • skin rash
  • unusual tiredness or weakness

Mitomycin sometimes causes a temporary loss of hair. After treatment has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Blood in urine

Also, check with your doctor if you notice any of the following:

  • Black, tarry stools
  • blood in stools
  • cough or hoarseness
  • decreased urination
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • red or painful skin
  • shortness of breath
  • swelling of feet or lower legs
  • unusual bleeding or bruising

For Healthcare Professionals

Applies to mitomycin: compounding powder, intravenous powder for injection


Recovery from thrombocytopenia has generally been reported to take place within ten weeks. Approximately 25% of leukopenic or thrombocytopenic episodes have been reported to have not recovered.[Ref]

Hematologic side effects including bone marrow toxicity (64.4%) have been the most common and most serious toxicity associated with the use of mitomycin. Thrombocytopenia and/or leukopenia have been reported to occur anytime within eight weeks of initiation of therapy. Mitomycin produces cumulative myelosuppression.[Ref]


HUS has been reported to occur most often at doses greater than or equal to 60 mg. HUS consists primarily of microangiopathic hemolytic anemia (hematocrit less than or equal to 25%), thrombocytopenia (platelet count less than or equal to 100,000/mm3), and irreversible renal failure (serum creatinine greater than or equal to 1.6 mg/dL). A 52% mortality rate has been associated with this syndrome.[Ref]

Other side effects have included hemolytic uremic syndrome (HUS).[Ref]


Extravasation has been reported even without an accompanying stinging or burning sensation and even if their is adequate blood return when the injection needle is aspirated.[Ref]

Dermatologic side effects have included the necrosis and consequent sloughing of tissue which results if the drug is extravasated during injection. Alopecia has been frequently reported. Cellulitis at the injection site has been reported and is occasionally severe. Rashes have rarely been reported. Delayed erythema and/or ulceration has been reported to occur either at or distant from the injection site, weeks to months after mitomycin. Allergic contact dermatitis has also been reported.[Ref]


Respiratory side effects have been reported infrequently. However, they may be severe and even life threatening. Adult respiratory distress syndrome has been reported.[Ref]

Dyspnea with a nonproductive cough and radiographic evidence of pulmonary infiltrates may be indicative of mitomycin-induced pulmonary toxicity.

Adult respiratory distress syndrome has been reported in a few patients receiving mitomycin in combination with other chemotherapy and maintained at fraction of inspired oxygen concentrations greater than 50% perioperatively. Because oxygen itself is toxic to the lungs, it is recommended to use only enough oxygen to provide adequate arterial saturation.[Ref]


No correlation between the total dose administered or duration of therapy and the degree of renal impairment has been reported.[Ref]

Renal side effects including a statistically significant rise in creatinine (2%) have been reported.[Ref]


Cardiovascular side effects including congestive heart failure have rarely been reported. Edema and thrombophlebitis have also been reported.[Ref]

Almost all of the patients who experience congestive heart failure had received prior doxorubicin therapy.[Ref]


General side effects including fever, headache, confusion, drowsiness, syncope, fatigue, and pain have been reported.[Ref]


Gastrointestinal side effects including anorexia, nausea, vomiting and diarrhea have been reported.[Ref]


Genitourinary side effects including two cases of urethral slough and one case of necrosis of the glans penis have been reported.[Ref]


1. "Product Information. Mutamycin (mitomycin)." Bristol-Myers Squibb, Princeton, NJ.

2. Fisher AA "Allergic contact dermatitis to mitomycin-C." Cutis 47 (1991): 225-7

3. Vidal C, de la Fuente R, Gonzalez Quintela A "Three cases of allergic dermatitis due to intravesical mitomycin C." Dermatology 184 (1992): 208-9

4. de Groot AC, Conemans JM "Systemic allergic contact dermatitis from intravesical instillation of the antitumor antibiotic mitomycin C." Contact Dermatitis 24 (1991): 201-9

5. Okuno SH, Frytak S "Mitomycin lung toxicity - Acute and chronic phases." Am J Clin Oncol 20 (1997): 282-4

6. Thompson CC, Bailey MK, Conroy JM, Bromley HR "Postoperative pulmonary toxicity associated with mitomycin-C therapy." South Med J 85 (1992): 1257-9

7. Neulander EZ, Lismer L, Kaneti J "Necrosis of the glans penis: A rare complication of intravesical therapy with mitomycin C." J Urol 164 (2000): 1306

8. Brady JD, Assimos DG, Jordan CH "Urethral slough: A rare and previously unreported complication of intravesical mitomycin." J Urol 164 (2000): 1305

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.