Note: This document contains side effect information about fibrin sealant topical. Some dosage forms listed on this page may not apply to the brand name Tisseel.

Applies to fibrin sealant topical: solution. Other dosage forms:

• topical application sheet, topical application solution

Serious side effects of Tisseel

Along with its needed effects, fibrin sealant topical (the active ingredient contained in Tisseel) 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 fibrin sealant topical:

Less common

• Collection of blood or fluids under the skin
• deep, dark purple bruise
• itching, pain, redness, or swelling of the skin, wound, or treated area

Incidence not known

• Blurred vision
• chest pain, discomfort, or tightness
• confusion
• cough
• difficulty breathing
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, slow, pounding, or irregular heartbeat or pulse
• flushing, redness of the skin
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness, dizziness, or fainting
• numbness or tingling in the face, arms, or legs
• pain in the chest, groin, or legs, especially the calves
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe, sudden headache
• shortness of breath
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sweating
• trouble healing
• trouble speaking or walking
• unusual tiredness or weakness
• unusually warm skin

Other side effects of Tisseel

Some side effects of fibrin sealant topical 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:

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• nausea

For Healthcare Professionals

Applies to fibrin sealant topical: topical kit, topical solution.

General

General side effects have been reported including rare reports of serious adverse events such as paralysis and other compressive complications possibly related to the use of fibrin sealant in combination with resorbable hemostatic agents. There have also been rare reports of fatalities following the misadministration of topical thrombin.^[Ref]

Hypersensitivity

Hypersensitivity side effects such as anaphylactic and anaphylactoid reactions including shock have been reported rarely.^[Ref]

Cardiovascular

Cardiovascular side effects including tachycardia, bradycardia, hypotension, and thromboembolic complications have been reported rarely.^[Ref]

Respiratory

Respiratory side effects including severe dyspnea have been reported rarely.^[Ref]

Dermatologic

Dermatologic side effects including flush, urticaria, and pruritus have been reported rarely.^[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea have been reported rarely.

Other

A D-dimer is a fragment produced during the degradation of a clot. Postoperatively increased D-dimers may result at least partly from the degradation of fibrin sealant.^[Ref]

Other side effects including increased D-dimer levels have been reported in a clinical study on cardiovascular surgery, but did not exceed values reported in the literature occurring after this type of surgery.^[Ref]