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Prothrombin complex Side Effects

For the Consumer

Applies to prothrombin complex: intravenous powder for solution

Along with its needed effects, prothrombin complex 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 prothrombin complex:

Less common
  • Blurred vision
  • chest pain
  • confusion
  • convulsions
  • decrease in the amount of urine
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • headache, sudden, severe
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • noisy, rattling breathing
  • numbness or tingling in the hands, feet, or lips
  • pounding in the ears
  • slow or fast heartbeat
  • sweating
  • swelling of the fingers, hands, feet, or lower legs
  • tightness in the chest
  • troubled breathing
  • troubled breathing at rest
  • unusual tiredness or weakness
  • weakness
  • weight gain
Incidence not known
  • Anxiety
  • blood in the stools or urine
  • blue lips and fingernails
  • bruising
  • chest discomfort
  • coughing or vomiting blood
  • coughing that sometimes produces a pink frothy sputum
  • difficult or labored breathing
  • difficult, fast, noisy breathing, sometimes with wheezing
  • difficulty with speaking
  • double vision
  • fainting
  • feeling of warmth
  • headache
  • hives or welts
  • inability to move the arms, legs, or facial muscles
  • increased sweating
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, redness, or swelling in the arm or leg
  • pale skin
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • rash
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • slow speech
  • sudden shortness of breath or troubled breathing
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

Some side effects of prothrombin complex 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
  • muscle pain or stiffness
  • pain in the joints
Less common
  • Diarrhea
  • difficulty having a bowel movement (stool)
  • tearing of skin
  • trouble sleeping
Incidence not known
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to prothrombin complex: intravenous powder for injection

General

The most common adverse reactions were headache, nausea/vomiting, arthralgia, and hypotension.

The most serious adverse reactions were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.[Ref]

Cardiovascular

Common (1% to 10%): Hypotension (4.9%), tachycardia (2.9%), increased blood pressure/hypertension (2.9%)
Uncommon (0.1% to 1%): Venous thrombosis, calf (1.0%), deep vein thrombosis (1.0%), fistula clot (1.0%)
Postmarketing reports: Arterial thromboembolic events (including acute myocardial infarction and arterial thrombosis), venous thromboembolic events (including pulmonary embolism and venous thrombosis), and disseminated intravascular coagulation[Ref]

Gastrointestinal

Common (1% to 10%): Nausea/vomiting (3.9%), constipation (1.9%)[Ref]

Hypersensitivity

Postmarketing reports: Flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, and bronchospasm[Ref]

Metabolic

Common (1% to 10%): International normalized ratio increased (2.9%), hypokalemia (1.9%)
Uncommon (0.1% to 1%): Fluid overload (1.0%)[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia (3.9%)
Uncommon (0.1% to 1%): Chest pain (1.0%)[Ref]

Nervous system

Common (1% to 10%): Headache (7.8%), hemorrhage intracranial (2.9%), ischemic cerebrovascular accident (1.9%)[Ref]

Other

Common (1% to 10%): Skin laceration/contusion/subcutaneous hematoma (2.9%)
Uncommon (0.1% to 1%): Sudden death, unknown cause (1.0%)[Ref]

Psychiatric

Common (1% to 10%): Mental status changes (1.9%)
Uncommon (0.1% to 1%): Insomnia (1.0%)[Ref]

Respiratory

Common (1% to 10%): Respiratory distress/dyspnea/hypoxia (1.9%)
Uncommon (0.1% to 1%): Abnormal breath sounds/rales (1.0%)[Ref]

References

1. "Product Information. Kcentra (prothrombin complex)." CSL Behring, King of Prussia, PA.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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