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Retavase Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/4/2016

Retavase (reteplase) is a thrombolytic drug used to dissolve blood clots used to improve heart function and prevent congestive heart failure or death in people who have had a heart attack. Common side effects of Retavase include nausea, vomiting, fever, injection site bleeding, blood in the urine, bloody or tarry stools, stomach pain, or vomiting blood or vomit that looks like coffee grounds.

Retavase is for intravenous administration only. It is administered in a 10 +10 unit double-bolus injection dose. Two 10 unit bolus injections are required for a complete treatment. Retavase may interact with blood thinners, aspirin, or medications used to prevent blood clots. Tell your doctor all medications and supplements you use. During pregnancy, Retavase should be taken only if prescribed. It may be harmful to a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Retavase (reteplase) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Retavase in Detail - Patient Information: Side Effects

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

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

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing;
  • fast, slow, or uneven heart rate;
  • feeling like you might pass out;
  • weak pulse, fainting, slow breathing (breathing may stop);
  • darkening or purple discoloration of your fingers or toes;
  • blood in your urine;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • bleeding from needle punctures (such as from needles used in blood tests or in giving injection) injections; or
  • pale skin, easy bruising, or any bleeding that will not stop.

Less serious side effects may include:

  • nausea;
  • vomiting; or
  • fever.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Retavase (Reteplase)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Retavase FDA Prescribing Information: Side Effects
(Adverse Reactions)



The most frequent adverse reaction associated with Retavase® is bleeding (see WARNINGS). The types of bleeding events associated with thrombolytic therapy may be broadly categorized as either intracranial hemorrhage or other types of hemorrhage.

  • Intracranial hemorrhage (see CLINICAL PHARMACOLOGY)
    In the INJECT clinical trial the rate of in-hospital, intracranial hemorrhage among all patients treated with Retavase® was 0.8% (23 of 2,965 patients). As seen with Retavase® and other thrombolytic agents, the risk for intracranial hemorrhage is increased in patients with advanced age or with elevated blood pressure.
  • Other types of hemorrhage
    The incidence of other types of bleeding events in clinical studies of Retavase® varied depending upon the use of arterial catheterization or other invasive procedures and whether the study was performed in Europe or the USA. The overall incidence of any bleeding event in patients treated with Retavase® in clinical studies (n = 3,805) was 21.1%. The rates for bleeding events, regardless of severity, for the 10 + 10 unit Retavase® regimen from controlled clinical studies are summarized in Table 3.

Table 3 : Retavase Hemorrhage Rates

Bleeding Site INJECT Europe
n = 2,965
n = 210
n =113
Injection Site* 4.6% 48.6% 19.5%
Gastrointestinal 2.5% 9.0% 1.8%
Genitourinary 1.6% 9.5% 0.9%
Anemia, site unknown 2.6% 1.4% 0.9%
*includes the arterial catheterization site (all patients in the RAPID studies underwent arterial catheterization).

In these studies the severity and sites of bleeding events were comparable for Retavase® and the comparison thrombolytic agents.

Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, any concomitant heparin should be terminated immediately. In addition, the second bolus of Retavase® should not be given if the serious bleeding occurs before it is administered. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

Fibrin which is part of the hemostatic plug formed at needle puncture sites will be lysed during Retavase® therapy. Therefore, Retavase® therapy requires careful attention to potential bleeding sites (e.g., catheter insertion sites, arterial puncture sites).

Allergic Reactions

Among the 2,965 patients receiving Retavase® in the INJECT trial, serious allergic reactions were noted in 3 patients, with one patient experiencing dyspnea and hypotension. No anaphylactoid reactions were observed among the 3,856 patients treated with Retavase® in initial clinical trials. In an ongoing clinical trial two anaphylactoid reactions have been reported among approximately 2,500 patients receiving Retavase®.

Other Adverse Reactions

Patients administered Retavase® as treatment for myocardial infarction have experienced many events which are frequent sequelae of myocardial infarction and may or may not be attributable to Retavase® therapy. These events include cardiogenic shock, arrhythmias (e.g., sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation), AV block, pulmonary edema, heart failure, cardiac arrest, recurrent ischemia, reinfarction, myocardial rupture, mitral regurgitation, pericardial effusion, pericarditis, cardiac tamponade, venous thrombosis and embolism, and electromechanical dissociation. These events can be life-threatening and may lead to death. Other adverse events have been reported, including nausea and/or vomiting, hypotension, and fever.

Read the entire FDA prescribing information for Retavase (Reteplase)

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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