Applies to urokinase: intravenous powder for injection.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Urokinase increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop. Bleeding may occur from a surgical incision, or from the skin where a needle was inserted during a blood test or while receiving injectable medication. You may also have bleeding on the inside of your body, such as in your stomach or intestines, kidneys or bladder, brain, or within the muscles.

Call your doctor at once if you have signs of bleeding inside your body, such as:

• easy bruising or bleeding (nosebleeds, bleeding gums, bleeding from a wound, incision, catheter, or needle injection);

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• red or pink urine; or

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Some side effects may occur during or within 1 hour after the injection. Tell your caregiver right away if you feel chilled or feverish, nauseated, light-headed, or have chest tightness, back pain, trouble breathing, or fast heartbeats.

Also call your doctor at once if you have:

• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

• swelling, rapid weight gain, little or no urinating;

• severe stomach pain, nausea, and vomiting;

• darkening or purple discoloration of your fingers or toes;

• very slow heartbeats, shortness of breath, feeling light-headed;

• sudden severe back pain, muscle weakness, numbness or loss of feeling in your arms or legs;

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats; or

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

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 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]