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Last reviewed on RxList: 8/20/2020
Mitosol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Mitosol?

Mitosol (mitomycin) is an antibiotic intended for topical application to the surgical site of glaucoma filtration surgery.

What Are Side Effects of Mitosol?

Common side effects of Mitosol include:

  • local reactions such as eye inflammation
  • hypotony
  • hypotony maculopathy
  • blebitis
  • endophthalmitis
  • vascular reactions
  • corneal reactions, and
  • cataract

Dosage for Mitosol

Each vial of Mitosol contains 0.2 mg of mitomycin and mannitol in a 1:2 concentration ratio. Mitosol is contraindicated in women who are or may become pregnant during therapy and in those who are hypersensitive to mitomycin. Serious side effects include cataract formation and corneal or scleral damage.

What Drugs, Substances, or Supplements Interact with Mitosol?

Mitosol may interact with other drugs. Tell your doctor all medications and supplements you use.

Mitosol During Pregnancy and Breastfeeding

Mitosol may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in breastfeeding infants from Mitosol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. It is recommended that women receiving Mitosol not breast feed because of the potential for serious adverse reactions in nursing infants. The safety and effectiveness of Mitosol in the pediatric population has not been studied.

Additional Information

Our Mitosol 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.


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Ophthalmic Adverse Reactions

The most frequent adverse reactions to Mitosol® occur locally, as an extension of the pharmacological activity of the drug. These reactions include:

Blebitis: bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctivial necrosis, thin-walled bleb

Cornea: corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet's detachment, induced astigmatism


Hypotony: choroidal reactions (choroidal detachment, choroidal effusion, serous choroidal detachment, suprachoroidal hemorrhage, hypotony maculopathy, presence of supraciliochoroidal fluid, hypoechogenic suprachoroidal effusion)

Inflammation: iritis, fibrin reaction

Lens: cataract development, cataract progression, capsule opacification, capsular constriction and/or capsulotomy rupture, posterior synechiae

Retina: retinal pigment epithelial tear, retinal detachment (serous and rhegatogenous)

Scleritis: wound dehiscence

Vascular: hyphema, central retinal vein occlusion, hemiretinal vein occlusion, retinal hemorrhage, vitreal hemorrhage and blood clot, subconjunctival hemorrhage, disk hemorrhage

Additional Reactions: macular edema, sclera thinning or ulceration, intraocular lens capture, disk swelling, malignant glaucoma, lacrimal drainage system obstruction, ciliary block, corneal vascularization, visual acuity decrease, cystic conjunctival degeneration, upper eyelid retraction, dislocated implants, severe loss of vision.

Read the entire FDA prescribing information for Mitosol (Mitomycin)


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© Mitosol Patient Information is supplied by Cerner Multum, Inc. and Mitosol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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