Fibrin sealant topical Side Effects

For the Consumer

Applies to fibrin sealant topical: solution

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

If any of the following side effects occur while taking fibrin sealant topical, check with your doctor or nurse immediately:

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

• 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

Minor Side Effects

Some of the side effects that can occur with fibrin sealant topical 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:

• 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]

Not all side effects for fibrin sealant topical 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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