Product name as reported
Metalyse: adverse event reports filed with FDA
657 reports list it as a suspect or interacting product, 2004–2026.
- 657
- reports as suspect product
- 0% of all reports · about 29 a year
- 113
- reports, 12 months to June 2026
- 41 in the 12 months before
- 99.5%
- marked serious by the reporter
- 57.4% across all reports
- 47.5%
- record death among outcomes, as reported
- 312 reports · not verified by FDA
Between January 2004 and June 2026, 657 adverse event reports received by FDA list the product name "Metalyse" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (10) are left out of every figure here.
In the 12 months to June 2026, 113 reports listed it, up 176% from 41 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 29 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are death (17.8%), drug ineffective (13.2%) and cerebral haemorrhage (8.7%). A report can list several reactions, so shares add to more than 100%; 190 different terms appear across these reports. Death is recorded in 17.8% of these reports, against 4.1% of all reports in the database.
99.5% of the reports are marked serious by the reporter; 47.5% record death among the outcomes and 28.2% record hospitalisation, as reported. 62.9% of the reports came from physicians, and the largest patient age group is 45 to 64 (24.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Metalyse reports recording the termall reports in the database
- Deaththe patient died; cause not stated by this term17.8%117
- Drug ineffectivethe medicine did not work as expected13.2%87
- Cerebral haemorrhage8.7%57
- Off label useused for a purpose or in a way not on the label7%46
- No adverse eventno adverse event was reported6.5%43
- Angioedemadeep swelling of skin or mucous membranes4.9%32
- Haemorrhage intracranial3.8%25
- Drug interactionan interaction between medicines3.2%21
- Electrocardiogram ST segment elevation3.2%21
- Haemorrhagebleeding3%20
- Treatment failurethe treatment did not work2.9%19
- Cardiac arrestthe heart stopped2.7%18
- Chest painchest pain2.7%18
- Ischaemic stroke2.6%17
- Tongue oedemaa swollen tongue1.8%12
- Cardiogenic shockshock from the heart failing to pump1.7%11
- Gingival bleedingbleeding gums1.7%11
- Haemoptysiscoughing up blood1.7%11
- Product quality issuea problem with the product itself1.7%11
- Subarachnoid haemorrhage1.7%11
- Cerebral haematoma1.5%10
- Cerebral infarction1.5%10
- Coma1.5%10
- Haemorrhagic stroke1.2%8
- Infarction1.2%8
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers1.2%8
- Haematomaa collection of blood under the skin or in tissue1.1%7
- Hypotensionlow blood pressure1.1%7
- Intestinal infarction1.1%7
Top 30 of 190 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 5.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Acute myocardial infarction | 177 | 26.9% |
| Myocardial infarction | 80 | 12.2% |
| Ischaemic stroke | 71 | 10.8% |
| Cerebrovascular accident | 46 | 7% |
| Thrombolysis | 36 | 5.5% |
| Pulmonary embolism | 17 | 2.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 657 reports.
In context
| Measure | Metalyse | All reports |
|---|---|---|
| Reports as suspect product | 657 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 113 | 1,332,454 |
| Marked serious | 99.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 475 | 91 |
| Hospitalisation recorded, per 1,000 reports | 282 | 213 |
| Consumer-filed share | 4.4% | 45.8% |
| Top term, share of reports | Death 17.8% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Metalyse reports
How many adverse event reports has FDA received for Metalyse?
657 reports list Metalyse as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 113 of them arrived in the latest 12 months. Another 10 list it only as a concomitant medication.
What reactions are recorded in Metalyse reports?
death (17.8%), drug ineffective (13.2%), cerebral haemorrhage (8.7%), off label use (7%) and no adverse event (6.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Metalyse was responsible.
How serious are the reports?
99.5% are marked serious by the reporter. Among the outcomes recorded, 47.5% of reports include death and 28.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (62.9%), other health professional (25%) and pharmacist (5.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Metalyse rising?
113 reports in the 12 months to June 2026, up 176% from 41 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Metalyse was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Metalyse?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Metalyse as a suspect or interacting product; reports listing it only as a concomitant medication (10) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.