Fibrin sealant topical Side Effects

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.

For the Consumer

Applies to fibrin sealant topical: topical kit, topical solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking fibrin sealant topical: hives, itching, warmth, redness, numbness, tingly feeling; nausea, vomiting, feeling light-headed, fast or slow heartbeats; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Fibrin sealant is sometimes applied with a spray device that uses gas pressure. High pressure may cause the release of air or gas under the skin tissues, where it can then travel throughout the body. This may be more likely when high pressure settings are improperly used by a healthcare provider during the spray application of fibrin sealant. Air or gas trapped within the body can cause serious or life-threatening effects. Talk with your doctor about this risk.

Tell your caregivers at once if you have:

  • chest pain, cough, trouble breathing, gasping for breath;

  • confusion, agitation, panic, extreme fear;

  • sudden numbness or weakness (especially on one side of the body);

  • sudden severe headache, slurred speech, problems with vision or balance;

  • blue-colored appearance under of your skin or lips;

  • nausea, dizziness or spinning sensation;

  • a light-headed feeling, like you might pass out; or

  • redness, itching, irritation, or slow healing of the skin wound or treated area;

Common side effects may include:

  • itching; or

  • swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

Hypersensitivity

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

Cardiovascular

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

Respiratory

Respiratory side effects including severe dyspnea have been reported rarely.

Dermatologic

Dermatologic side effects including flush, urticaria, and pruritus have been reported rarely.

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.

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.

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