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Reteplase Side Effects

The most commonly reported side effects of reteplase include coronary artery stenosis, coronary artery disease, and ventricular fibrillation, based on 578 FDA adverse event reports from 2004 to 2025.

Reteplase side effects

Percentages show how often each reaction appears relative to total reports for reteplase.

1
Coronary Artery Stenosis18.5%107
2
Coronary Artery Disease14.5%84
3
Ventricular Fibrillation7.4%43
4
Cardiac Failure7.4%43
5
Gastrointestinal Haemorrhage5.5%32
6
Haemoglobin Decreased5.0%29
7
Myocardial Infarction5.0%29
8
Cardiac Arrest4.7%27
9
Cardiogenic Shock4.7%27
10
Ejection Fraction Decreased4.7%27
11
Myocardial Ischaemia4.5%26
12
Coronary Artery Occlusion4.3%25
13
Atrial Fibrillation4.2%24
14
Hypotension3.8%22
15
Chest Pain3.6%21

These are voluntary reports and do not establish that reteplase caused these reactions.

Report severity

99.5%Serious575 reports
64.7%Hospitalizations374 reports
23.0%Fatal133 reports

Seriousness is determined by the reporter, not by OpenClaim.

Reteplase drug interactions

Other drugs that appear in adverse event reports alongside reteplase. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Abciximab76.3%441
2
Heparin6.7%39
3
Aspirin3.8%22
4
Enoxaparin-sodium2.1%12
5
Gemfibrozil1.9%11
6
Ticagrelor1.2%7
7
Tirofiban-hydrochloride1.0%6
8
Metoprolol1.0%6
9
Clopidogrel-bisulfate1.0%6
10
Ethinyl-estradiol1.0%6
11
Sterile1.0%6
12
Eptifibatide0.9%5
13
Drospirenone0.9%5
14
Alteplase0.9%5
15
Aprotinin0.7%4

Taken alongside

1
Aspirin36.7%212
2
Heparin29.6%171
3
Gemfibrozil20.2%117
4
Simvastatin16.8%97
5
Metoprolol13.8%80
6
Furosemide10.7%62
7
Atorvastatin-calcium10.6%61
8
Ramipril7.4%43
9
Omeprazole7.3%42
10
Bisoprolol-fumarate7.1%41
11
Nitroglycerin6.9%40
12
Perindopril6.7%39
13
Clopidogrel-bisulfate6.4%37
14
Ticlopidine-hydrochloride5.9%34
15
Isosorbide5.0%29

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports reteplase side effects

21.1% of reteplase adverse event reports involve female patients and 59.2% involve male patients. The largest age group is adult at 51%. These figures reflect who reports side effects, not underlying risk.

Sex

Female21.1%
Male59.2%
Unknown19.7%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6451.1%
65+48.9%

What is reteplase used for

Conditions and purposes for which patients were taking reteplase when the adverse event was reported.

Acute Myocardial InfarctionAnticoagulant TherapyAortic Bifurcation GraftArterial Occlusive DiseaseAcute Myocardial InfarctionCerebrovascular AccidentCoronary Artery OcclusionDeep Vein ThrombosisDrug Use For Unknown IndicationDevice MalfunctionFemoral Artery OcclusionFibrinolysisHypertensionIschaemic StrokeMyocardial Infarction

Showing 15 of 26 indications

Reteplase brand names and reporting trend

Reteplase is sold under the brand name Retavase.

Brand names

Retavase579

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking reteplase with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.