Tenecteplase side effects: what 1,560 FDA adverse event reports show

Tenecteplase · Tnkase · 34 reaction terms · 1,708 drug–reaction co-reports · data 2026-09-14

Drug class

Tissue plasminogen activator (tpa)

FDA label, Indications wording

Brand names

Tnkase

openFDA label

Who reports

1,560 reports · 74% serious · 365 with death outcome · 46% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TNKase is a tissue plasminogen activator (tPA) indicated: for the treatment of acute ischemic stroke (AIS) in adults. ( 1.1 ) to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. ( 1.2 ) 1.1 Acute Ischemic Stroke TNKase is indicated for the treatment of acute ischemic stroke (AIS) in adults.

FDA label, Indications and Usage

What it is

Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycopro.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 24 strongest signals

Labeled adverse reaction 6Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 4Not in label — unassessed 8

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 10 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Haemorrhage intracranial	115	103.8 87.0–123.9ROR 112.0 · χ² 11,525 / p <1e-300	101.3 EB05 86.7 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 79.3 · 94% clinician	no trial data cached
Cerebral haemorrhage	158	59.6 51.4–69.2ROR 66.3 · χ² 9,027 / p <1e-300	59.0 EB05 51.7 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.9 · 91% clinician	no trial data cached
Subarachnoid haemorrhage	44	58.1 43.4–77.8ROR 59.8 · χ² 2,405 / p <1e-300	56.5 EB05 43.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 40.8 · 98% clinician	no trial data cached
Angioedema (deep swelling of face/throat)	121	36.9 31.1–43.9ROR 40.0 · χ² 4,193 / p <1e-300	36.7 EB05 31.5 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 29.9 · 97% clinician	no trial data cached
Cardiogenic shock	34	32.1 23.0–44.8ROR 32.8 · χ² 992 / p 5e-218	31.5 EB05 23.6 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.8 · 100% clinician	no trial data cached
No adverse event	311	23.6 21.4–26.1ROR 29.2 · χ² 6,756 / p <1e-300	23.5 EB05 21.4 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.6	no trial data cached
Hemiparesis	29	22.9 16.0–32.9ROR 23.3 · χ² 585 / p 1e-129	22.6 EB05 16.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.1 · 93% clinician	no trial data cached
Ventricular fibrillation	16	19.3 11.9–31.5ROR 19.5 · χ² 260 / p 9e-59	18.7 EB05 11.9 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.0	no trial data cached
Ischaemic stroke	25	18.8 12.8–27.8ROR 19.1 · χ² 404 / p 3e-90	18.5 EB05 13.1 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 14.6 · 96% clinician	no trial data cached
Brain oedema	17	18.1 11.3–29.1ROR 18.3 · χ² 258 / p 2e-58	17.6 EB05 11.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.1	no trial data cached
Cerebral infarction	28	15.4 10.7–22.2ROR 15.7 · χ² 363 / p 3e-81	15.1 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.9 · 100% clinician	no trial data cached
Pneumonia aspiration	25	13.5 9.1–19.9ROR 13.7 · χ² 277 / p 2e-62	13.0 EB05 8.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · 100% clinician	no trial data cached
Myocardial ischaemia	11	12.9 7.2–23.2ROR 13.0 · χ² 109 / p 8e-26	11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.0	no trial data cached
Haematoma	23	11.9 7.9–17.8ROR 12.1 · χ² 219 / p 8e-50	11.1 EB05 7.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.6 · 95% clinician	no trial data cached
Aphasia (loss of speech)	24	10.7 7.2–15.9ROR 10.8 · χ² 201 / p 7e-46	9.8 EB05 6.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 92% clinician	no trial data cached
Haemorrhage	79	10.2 8.2–12.6ROR 10.7 · χ² 646 / p 7e-143	9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9	no trial data cached
Product preparation error	15	9.7 5.9–16.1ROR 9.8 · χ² 109 / p 8e-26	8.3 EB05 5.1 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Medication error	40	9.7 7.1–13.2ROR 9.9 · χ² 304 / p 2e-68	9.2 EB05 6.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Haematemesis (vomiting blood)	17	9.0 5.6–14.4ROR 9.1 · χ² 113 / p 1e-26	7.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Acute myocardial infarction	18	8.2 5.2–12.9ROR 8.3 · χ² 106 / p 3e-25	7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.0	no trial data cached
Off label use (used outside approved label)	412	6.4 5.9–6.9ROR 8.3 · χ² 1,945 / p <1e-300	6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9	no trial data cached
Shock	10	5.9 3.2–10.9ROR 5.9 · χ² 36 / p 1e-9	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.6	no trial data cached
Cerebrovascular accident (stroke)	69	5.5 4.3–6.9ROR 5.7 · χ² 249 / p 3e-56	5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.1	no trial data cached
Circumstance or information capable of leading to medication error	12	4.8 2.7–8.5ROR 4.8 · χ² 33 / p 6e-9	4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Off label use (used outside approved label)	412	6.4 5.9–6.9ROR 8.3 · χ² 1,945 / p <1e-300	6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9	no trial data cached
No adverse event	311	23.6 21.4–26.1ROR 29.2 · χ² 6,756 / p <1e-300	23.5 EB05 21.4 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.6	no trial data cached
Cerebral haemorrhage	158	59.6 51.4–69.2ROR 66.3 · χ² 9,027 / p <1e-300	59.0 EB05 51.7 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.9 · 91% clinician	no trial data cached
Angioedema (deep swelling of face/throat)	121	36.9 31.1–43.9ROR 40.0 · χ² 4,193 / p <1e-300	36.7 EB05 31.5 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 29.9 · 97% clinician	no trial data cached
Haemorrhage intracranial	115	103.8 87.0–123.9ROR 112.0 · χ² 11,525 / p <1e-300	101.3 EB05 86.7 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 79.3 · 94% clinician	no trial data cached
Haemorrhage	79	10.2 8.2–12.6ROR 10.7 · χ² 646 / p 7e-143	9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9	no trial data cached
Cerebrovascular accident (stroke)	69	5.5 4.3–6.9ROR 5.7 · χ² 249 / p 3e-56	5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.1	no trial data cached
Subarachnoid haemorrhage	44	58.1 43.4–77.8ROR 59.8 · χ² 2,405 / p <1e-300	56.5 EB05 43.9 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 40.8 · 98% clinician	no trial data cached
Medication error	40	9.7 7.1–13.2ROR 9.9 · χ² 304 / p 2e-68	9.2 EB05 6.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Cardiogenic shock	34	32.1 23.0–44.8ROR 32.8 · χ² 992 / p 5e-218	31.5 EB05 23.6 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.8 · 100% clinician	no trial data cached
Hemiparesis	29	22.9 16.0–32.9ROR 23.3 · χ² 585 / p 1e-129	22.6 EB05 16.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.1 · 93% clinician	no trial data cached
Cerebral infarction	28	15.4 10.7–22.2ROR 15.7 · χ² 363 / p 3e-81	15.1 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.9 · 100% clinician	no trial data cached
Pneumonia aspiration	25	13.5 9.1–19.9ROR 13.7 · χ² 277 / p 2e-62	13.0 EB05 8.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.5 · 100% clinician	no trial data cached
Ischaemic stroke	25	18.8 12.8–27.8ROR 19.1 · χ² 404 / p 3e-90	18.5 EB05 13.1 · IC025 +3.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 14.6 · 96% clinician	no trial data cached
Aphasia (loss of speech)	24	10.7 7.2–15.9ROR 10.8 · χ² 201 / p 7e-46	9.8 EB05 6.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 92% clinician	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Subarachnoid haemorrhage — n=44, PRR 58.1
Hemiparesis — n=29, PRR 22.9
Pneumonia aspiration — n=25, PRR 13.5
Haematoma — n=23, PRR 11.9
Aphasia — n=24, PRR 10.7

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Tenecteplase?

In FDA FAERS, the most frequently co-reported reaction terms for Tenecteplase are cerebral haemorrhage, angioedema, haemorrhage intracranial, haemorrhage, cerebrovascular accident, subarachnoid haemorrhage. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Tenecteplase have an FDA boxed warning?

No. The FDA label retrieved for Tenecteplase has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Tenecteplase causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID e647640d-c395-4b4b-a0be-1162f9c21d84, effective 20251215; matched on openfda.generic_name.exact:"TENECTEPLASE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 34 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.