What the label lists and what reports show
Tenecteplase side effects
Tenecteplase's FDA label: “The most common adverse reaction is bleeding.” FAERS holds 1,560 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cerebral haemorrhage (158 reports).
- No generic listed
Check it at the source: the tenecteplase FDA label on DailyMed (effective December 15, 2025, Genentech, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reaction is bleeding.
Table 3 Incidence of Adverse Reactions in Trial 1 in Patients Treated for Acute Ischemic Stroke Within 0 to 3 Hours from Symptom Onset
| Adverse Reaction | TNKase N=592 % | Activase N= 555 % |
|---|---|---|
| Death | 15.0 | 15.0 |
| Symptomatic intracerebral hemorrhage intracerebral hemorrhage that, in the opinion of the… | 3.4 | 3.1 |
| Extracranial (peripheral) bleeding requiring blood transfusion | 1.0 | 0.7 |
| Orolingual angioedema | 1.0 | 1.4 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4), Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.2) ] Thromboembolism [see Warnings and Precautions (5.3) ] Cholesterol Embolization [see Warnings and Precautions (5.4) ] Arrhythmias [see Warnings and Precautions (5.5) ] Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI [see Warnings and Precautions (5.6) ] The most common adverse reaction is bleeding. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequent adverse reaction associated with TNKase in all approved indications is bleeding. …
Source: FDA drug label, Genentech, Inc., effective December 15, 2025 (SPL set e647640d-c395-4b4b-a0be-1162f9c21d84), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,560 reports list tenecteplase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 365 are coded as a death and 422 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tenecteplase: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions