Drug · FAERS side-effect profile with label screen
Alteplase side effects: what 14,926 FDA adverse event reports show
Drug class
Tissue plasminogen activator (tpa)
FDA label, Indications wording
Brand names
Activase
openFDA label
Who reports
14,926 reports · 69% serious · 3,224 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Activase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS). ( 1.1 ) Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure. ( 1.2 ) Limitation of Use in AMI: the risk of stroke may be greater than the benefit in patients at low risk of death from cardiac causes. ( 1.2 ) Acute Massive Pulmonary Embolism (PE) for lysis.
FDA label, Indications and Usage
What it is
Alteplase is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator obtained from a human melanoma cell line.
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 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 8Likely indication confounding 7Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 21
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 992 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Reperfusion arrhythmia | 29 | 1,255.4 759.7–2,074.5ROR 1,257.8 · χ² 18,415 / p <1e-300 | 458.7 EB05 335.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Reocclusion | 26 | 720.3 448.6–1,156.7ROR 721.6 · χ² 11,818 / p <1e-300 | 351.4 EB05 252.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Nih stroke scale score increased | 27 | 667.9 422.1–1,056.9ROR 669.1 · χ² 11,684 / p <1e-300 | 341.6 EB05 246.6 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=27 · 100% clinician | no trial data cached |
| Nih stroke scale abnormal | 10 | 659.6 310.7–1,400.5ROR 660.1 · χ² 4,020 / p <1e-300 | 241.4 EB05 140.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Haemorrhagic transformation stroke | 433 | 571.3 511.3–638.2ROR 588.3 · χ² 174,128 / p <1e-300 | 397.6 EB05 367.2 · IC025 +8.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=432 · 95% clinician | no trial data cached |
| Postinfarction angina | 12 | 386.6 203.9–732.9ROR 386.9 · χ² 3,313 / p <1e-300 | 204.5 EB05 124.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Cerebral hyperperfusion syndrome | 17 | 318.2 187.9–539.0ROR 318.6 · χ² 4,117 / p <1e-300 | 200.8 EB05 132.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Stroke in evolution | 37 | 281.6 197.8–400.9ROR 282.3 · χ² 8,366 / p <1e-300 | 209.0 EB05 158.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | no trial data cached |
| Haemorrhagic infarction | 76 | 225.0 176.6–286.5ROR 226.1 · χ² 14,386 / p <1e-300 | 184.7 EB05 152.4 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=76 · ♀ 17% (drug 45%) · 91% clinician | no trial data cached |
| Product closure issue | 63 | 183.7 141.3–238.8ROR 184.5 · χ² 9,948 / p <1e-300 | 154.8 EB05 125.3 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=46 | no trial data cached |
| Reperfusion injury | 16 | 183.2 108.8–308.5ROR 183.4 · χ² 2,402 / p <1e-300 | 136.0 EB05 88.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Thrombolysis | 25 | 176.7 116.6–267.8ROR 177.0 · χ² 3,719 / p <1e-300 | 140.2 EB05 99.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Neurological decompensation | 196 | 132.6 114.7–153.4ROR 134.4 · χ² 23,251 / p <1e-300 | 119.7 EB05 106.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=134 · 100% clinician | no trial data cached |
| Haemorrhagic cerebral infarction | 57 | 123.6 94.3–161.9ROR 124.0 · χ² 6,250 / p <1e-300 | 109.5 EB05 87.6 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=56 · 98% clinician | no trial data cached |
| Intercepted product storage error | 259 | 115.4 101.7–130.8ROR 117.4 · χ² 27,005 / p <1e-300 | 105.8 EB05 95.4 · IC025 +6.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | 92% clinician | no trial data cached |
| Gingival bleeding | 1,029 | 114.3 107.5–121.6ROR 122.7 · χ² 106,754 / p <1e-300 | 105.5 EB05 100.2 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.7 · 98% clinician | no trial data cached |
| Tongue haemorrhage | 87 | 112.1 90.2–139.4ROR 112.8 · χ² 8,761 / p <1e-300 | 101.5 EB05 84.9 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 · 98% clinician | no trial data cached |
| Blood fibrinogen decreased | 78 | 105.1 83.5–132.2ROR 105.7 · χ² 7,380 / p <1e-300 | 95.5 EB05 79.0 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=58 | no trial data cached |
| Cns ventriculitis | 21 | 96.3 61.9–149.9ROR 96.5 · χ² 1,764 / p <1e-300 | 83.5 EB05 57.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Brain midline shift | 28 | 77.4 52.9–113.2ROR 77.6 · χ² 1,929 / p <1e-300 | 70.0 EB05 50.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Intercepted medication error | 244 | 77.3 68.0–87.8ROR 78.6 · χ² 17,335 / p <1e-300 | 72.9 EB05 65.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Brain stem haemorrhage | 49 | 76.1 57.1–101.4ROR 76.3 · χ² 3,372 / p <1e-300 | 70.3 EB05 55.3 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=49 | no trial data cached |
| Haemorrhage intracranial | 737 | 72.6 67.5–78.0ROR 76.3 · χ² 49,389 / p <1e-300 | 68.9 EB05 64.8 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 57.3 · 93% clinician | no trial data cached |
| Myocardial rupture | 15 | 71.7 42.7–120.4ROR 71.7 · χ² 928 / p 5e-204 | 63.0 EB05 40.5 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=15 | no trial data cached |
| Cerebral mass effect | 17 | 70.3 43.2–114.4ROR 70.4 · χ² 1,040 / p 2e-228 | 62.5 EB05 41.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Extravasation blood | 10 | 62.4 33.1–117.6ROR 62.4 · χ² 521 / p 1e-115 | 54.0 EB05 31.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Rhythm idioventricular | 13 | 58.5 33.6–101.8ROR 58.5 · χ² 650 / p 9e-144 | 52.1 EB05 32.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Cerebral haematoma | 124 | 53.9 45.1–64.4ROR 54.3 · χ² 6,147 / p <1e-300 | 51.5 EB05 44.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=123 · 99% clinician | no trial data cached |
| Puncture site haemorrhage | 25 | 51.5 34.6–76.8ROR 51.6 · χ² 1,146 / p 2e-251 | 48.0 EB05 34.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 100% clinician | no trial data cached |
| Brain herniation | 104 | 50.6 41.7–61.5ROR 51.0 · χ² 4,835 / p <1e-300 | 48.5 EB05 41.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=104 · 92% clinician | no trial data cached |
| Basal ganglia haemorrhage | 26 | 46.2 31.3–68.2ROR 46.3 · χ² 1,069 / p 1e-234 | 43.4 EB05 31.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 | no trial data cached |
| Lividity | 11 | 43.7 24.0–79.6ROR 43.7 · χ² 404 / p 4e-90 | 39.7 EB05 23.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Aplastic anaemia | 150 | 41.4 35.2–48.6ROR 41.8 · χ² 5,697 / p <1e-300 | 40.0 EB05 34.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=150 · 97% clinician | no trial data cached |
| Intraventricular haemorrhage | 69 | 39.9 31.4–50.7ROR 40.1 · χ² 2,508 / p <1e-300 | 38.5 EB05 31.4 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=68 · 100% clinician | no trial data cached |
| Cerebral artery occlusion | 27 | 36.4 24.9–53.3ROR 36.5 · χ² 872 / p 6e-192 | 34.7 EB05 25.1 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=27 · 92% clinician | no trial data cached |
| Artery dissection | 10 | 34.8 18.6–65.2ROR 34.8 · χ² 288 / p 6e-65 | 32.1 EB05 18.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Cerebral haemorrhage | 819 | 32.9 30.8–35.2ROR 34.8 · χ² 24,764 / p <1e-300 | 32.1 EB05 30.3 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.9 · 94% clinician | no trial data cached |
| Retinal pigment epithelial tear | 15 | 31.6 19.0–52.8ROR 31.7 · χ² 406 / p 2e-90 | 29.9 EB05 19.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Subcutaneous haematoma | 26 | 29.0 19.7–42.8ROR 29.1 · χ² 662 / p 2e-146 | 28.0 EB05 20.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 · ♀ 65% (drug 45%) · 100% clinician | no trial data cached |
| Hypofibrinogenaemia | 19 | 28.1 17.8–44.2ROR 28.1 · χ² 460 / p 3e-102 | 26.9 EB05 18.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=17 | 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 |
|---|---|---|---|---|---|---|
| No adverse event | 2,519 | 20.2 19.5–21.0ROR 24.1 · χ² 45,746 / p <1e-300 | 19.9 EB05 19.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 27.5 · 91% clinician | no trial data cached |
| Off label use (used outside approved label) | 1,868 | 3.0 2.9–3.2ROR 3.3 · χ² 2,639 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 94% clinician | no trial data cached |
| Death | 1,192 | 1.9 1.8–2.1ROR 2.0 · χ² 570 / p 4e-126 | 1.9 EB05 1.9 · IC025 +0.9 | Outcome field, not a reaction | serious PRR 1.6 | no trial data cached |
| Gingival bleeding | 1,029 | 114.3 107.5–121.6ROR 122.7 · χ² 106,754 / p <1e-300 | 105.5 EB05 100.2 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.7 · 98% clinician | no trial data cached |
| Cerebral haemorrhage | 819 | 32.9 30.8–35.2ROR 34.8 · χ² 24,764 / p <1e-300 | 32.1 EB05 30.3 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.9 · 94% clinician | no trial data cached |
| Haemorrhage intracranial | 737 | 72.6 67.5–78.0ROR 76.3 · χ² 49,389 / p <1e-300 | 68.9 EB05 64.8 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 57.3 · 93% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 635 | 0.7 0.6–0.7ROR 0.7 · χ² 104 / p 1e-24 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 · 94% clinician | no trial data cached |
| Angioedema (deep swelling of face/throat) | 626 | 20.2 18.7–21.8ROR 21.0 · χ² 11,263 / p <1e-300 | 19.9 EB05 18.6 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 · 95% clinician | no trial data cached |
| Haemorrhage | 574 | 7.8 7.2–8.4ROR 8.0 · χ² 3,366 / p <1e-300 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.6 · 91% clinician | no trial data cached |
| Haemorrhagic transformation stroke | 433 | 571.3 511.3–638.2ROR 588.3 · χ² 174,128 / p <1e-300 | 397.6 EB05 367.2 · IC025 +8.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=432 · 95% clinician | no trial data cached |
| Product storage error | 386 | 6.3 5.7–6.9ROR 6.4 · χ² 1,711 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 0.7 · ♀ 86% (drug 45%) | no trial data cached |
| Nausea | 369 | 0.7 0.6–0.7ROR 0.6 · χ² 68 / p 7e-17 | 0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | no trial data cached |
| Hypotension (low blood pressure) | 346 | 2.4 2.2–2.7ROR 2.5 · χ² 292 / p 1e-65 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 · 95% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 345 | 0.9 0.8–1.0ROR 0.9 · χ² 8 / p 0.002 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 | no trial data cached |
| Vomiting | 342 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.334 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | 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.
- Reperfusion arrhythmia — n=29, PRR 1,255.4
- Reocclusion — n=26, PRR 720.3
- Stroke in evolution — n=37, PRR 281.6
- Thrombolysis — n=25, PRR 176.7
- Neurological decompensation — n=196, PRR 132.6
- Cns ventriculitis — n=21, PRR 96.3
- Brain midline shift — n=28, PRR 77.4
- Intercepted medication error — n=244, PRR 77.3
- Cerebral haematoma — n=124, PRR 53.9
- Brain herniation — n=104, PRR 50.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Alteplase ↔ Cerebral haemorrhage.
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 Alteplase?
In FDA FAERS, the most frequently co-reported reaction terms for Alteplase are gingival bleeding, cerebral haemorrhage, haemorrhage intracranial, angioedema, haemorrhage, haemorrhagic transformation stroke. 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 Alteplase have an FDA boxed warning?
No. The FDA label retrieved for Alteplase has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Alteplase 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 c669f77c-fa48-478b-a14b-80b20a0139c2, effective 20260120; matched on
openfda.generic_name.exact:"ALTEPLASE") - 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, fieldpatient.drug.openfda.generic_name.exact, 1,032 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.