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Urokinase Side Effects

For the Consumer

Applies to urokinase: intravenous powder for solution

Along with its needed effects, urokinase 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 urokinase:

More common
  • Bleeding gums
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • headache
  • increased menstrual flow or vaginal bleeding
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • shortness of breath
Rare
  • Cough
  • fast heartbeat
  • hives or welts
  • itching skin
  • noisy breathing
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
Incidence not known
  • Blue lips and fingernails
  • blurred vision
  • chest pain or discomfort
  • confusion
  • convulsions
  • coughing that sometimes produces a pink frothy sputum
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • inability to speak
  • increased sweating
  • low blood pressure or pulse
  • numbness or tingling in the face, arms, or legs
  • pale skin
  • severe or sudden headache
  • severe or sudden weakness in the arm or leg on one side of the body
  • slurred speech
  • swelling in the legs and ankles
  • trouble with walking or speaking
  • unconsciousness

For Healthcare Professionals

Applies to urokinase: intravenous powder for injection

General

The most common and severe adverse reaction was hemorrhage, with puncture site being the most frequent location.[Ref]

Hematologic

Very common (10% or more): Bleeding resulting in at least 5% decrease in hematocrit (36.9%)
Common (1% to 10%): Significant bleeding events requiring transfusion of greater than 2 units of blood
Frequency not reported: Hemorrhage, hematocrit decreased without clinically detectable hemorrhage, fatal hemorrhage, hematocrit decreased, thrombocytopenia[Ref]

Cardiovascular

Common (1% to 10%): Hematoma, artery dissection, embolism, cholesterol embolism
Rare (less than 0.1%): Vascular pseudoaneurysm
Frequency not reported: Thromboembolism, wound hemorrhage, hypotension, flushing, cyanosis, tachycardia, hypertension, myocardial infarction
Postmarketing reports: Cardiac arrest, reperfusion ventricular arrhythmias[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal hemorrhage, retroperitoneal hemorrhage
Frequency not reported: Gingival hemorrhage, retroperitoneal hematoma, nausea, vomiting, orolingual edema[Ref]

Nervous system

Common (1% to 10%): Stroke, intracranial hemorrhage
Frequency not reported: Fatal intracranial hemorrhage, intracranial hematoma, hemiplegia
Postmarketing reports: Cerebral embolism, cerebral vascular accident[Ref]

Other

Common (1% to 10%): Fever, chills
Frequency not reported: Substernal pain
Postmarketing reports: Chest pain[Ref]

Genitourinary

Common (1% to 10%): Urogenital hemorrhage
Rare (less than 0.1%): Macroscopic hematuria
Frequency not reported: Microscopic hematuria[Ref]

Musculoskeletal

Common (1% to 10%): Muscle hemorrhage
Frequency not reported: Back pain[Ref]

Immunologic

Uncommon (0.1% to 1%): Allergic reaction
Rare (less than 0.1%): Hypersensitivity reactions, anaphylaxis
Very rare (less than 0.01%): Fatal anaphylaxis[Ref]

Hepatic

Uncommon (0.1% to 1%): Intrahepatic hemorrhage
Frequency not reported: Transient increase in transaminases[Ref]

Renal

Uncommon (0.1% to 1%): Renal failure[Ref]

Respiratory

Frequency not reported: Epistaxis, pulmonary embolism, dyspnea, hypoxemia, bronchospasm, recurrent pulmonary embolism
Postmarketing reports: Pulmonary edema[Ref]

Dermatologic

Frequency not reported: Urticaria, rash, pruritus, diaphoresis[Ref]

Local

Frequency not reported: Puncture site hemorrhage, puncture site hematoma, infusion reactions[Ref]

Metabolic

Frequency not reported: Acidosis[Ref]

References

1. "Product Information. Kinlytic (urokinase)." ImaRx Therapeutics, Inc, Tucson,, AR.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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