Applies to factor XIII: intravenous powder for solution.

Serious side effects of Factor XIII

Along with its needed effects, factor XIII 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 factor XIII:

More common

• Bloody nose
• bruise
• collection of blood under the skin
• deep, dark purple bruise
• fever
• itching, pain, redness, or swelling

Incidence not known

• Chest pain
• cough
• dizziness or fainting
• hives
• pain in the chest, groin, or legs, especially the calves
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, scaly, swollen, or peeling areas of the skin
• severe, sudden headache
• shortness of breath
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• unusual tiredness or weakness

Other side effects of Factor XIII

Some side effects of factor XIII 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:

More common

• Difficulty with moving
• general feeling of discomfort or illness
• headache
• joint pain
• muscle aches and pains

For Healthcare Professionals

Applies to factor XIII: intravenous powder for injection.

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Uncommon (0.1% to 1%): Serious hypersensitivity^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Acute ischemia^[Ref]

Immunologic

Common (1% to 10%): Elevated thrombin-antithrombin levels

Uncommon (0.1% to 1%): Neutralizing antibodies against factor XIII^[Ref]

Musculoskeletal

Common (1% to 10%): Joint inflammation, arthralgia^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, erythema, hematoma^[Ref]

Nervous system

Common (1% to 10%): Headache^[Ref]

Metabolic

Common (1% to 10%): Increased blood lactate dehydrogenase^[Ref]