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Mitomycin Side Effects

For the Consumer

Applies to mitomycin: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by mitomycin. In the event that any of these side effects do occur, they may require 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.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Severity: Moderate

If any of the following side effects occur while taking mitomycin, check with your doctor or nurse as soon as possible:

Less common:
  • Cough
  • decreased urination
  • shortness of breath
  • sores in mouth and on lips
  • swelling of feet or lower legs
  • Bloody vomit

Minor Side Effects

Some of the side effects that can occur with mitomycin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Loss of appetite
  • nausea and vomiting
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.

Side Effects: Post Treatment

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

  • 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

Not all side effects for mitomycin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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