Factor XIII Side Effects

Some side effects of factor XIII may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to factor XIII: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking factor XIII: hives; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• new or worsening bleeding episodes;

• unusual bruising;

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

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

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• pain, swelling, warmth, or redness in one or both legs.

Less serious side effects of factor XIII may include:

• fever, chills, flu symptoms;

• stomach pain, vomiting, diarrhea,

• headache;

• joint pain;

• mild rash or itching; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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 factor XIII: intravenous powder for injection

Hypersensitivity

Hypersensitivity side effects have included allergy, rash, pruritus, and erythema, chills/rise in temperature, arthralgia, headache, elevated thrombin antithrombin levels, and an increase in hepatic enzymes.

Hematologic

Hematologic side effects have included factor XIII inhibitor formation.

Cardiovascular

Cardiovascular side effects have included thrombosis and embolism.

General

General side effects have included flu-like syndrome and pyrexia.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, diarrhea and vomiting.

Musculoskeletal

Musculoskeletal side effects have included contusion, joint injury, limb injury, road traffic accident, and arthralgia.

Respiratory

Respiratory side effects have included upper respiratory tract infection and epistaxis.

Nervous system

Nervous system side effects have included headache and head injury.

Immunologic

Immunologic side effects have included allergic/anaphylactic reaction (including cutaneous reactions, alteration in blood pressure, nausea, dyspnea, fever, and chills).

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