Ecotrin: adverse event reports filed with FDA

828

reports as suspect product

0% of all reports · about 37 a year

4

reports, 12 months to June 2026

17 in the 12 months before

96.5%

marked serious by the reporter

71.8% across the class

20.9%

record death among outcomes, as reported

173 reports · not verified by FDA

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

Reactions recorded in the reports

share of Ecotrin reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Gastrointestinal haemorrhagebleeding in the stomach or bowel14.3%118
2. Deaththe patient died; cause not stated by this term8.6%71
3. Cerebrovascular accidentstroke5.6%46
4. Hallucination, auditory5.3%44
5. Paranoiaparanoia5.3%44
6. Psychotic disordera loss of contact with reality5.3%44
7. Myocardial infarctionheart attack3.6%30
8. Rectal haemorrhage3.1%26
9. Upper gastrointestinal haemorrhage3.1%26
10. Falla fall2.9%24
11. Cardiac disorder2.7%22
12. Epistaxisnosebleed2.7%22
13. Haemorrhagic anaemia2.5%21
14. Acute kidney injurysudden loss of kidney function2.4%20
15. Haematuriablood in the urine1.7%14
16. Lower gastrointestinal haemorrhage1.7%14
17. Renal failurekidney failure1.7%14
18. Dizzinesslight-headedness or unsteadiness1.6%13
19. International normalised ratio increasedblood clotting slower than intended (raised INR)1.6%13
20. Anaemialow red blood cells1.3%11
21. Hypertensionhigh blood pressure1.3%11
22. Astheniaweakness or lack of energy1.2%10
23. Cardiac failureheart failure1.2%10
24. Cerebral haemorrhage1.2%10
25. Dyspnoeashortness of breath1.2%10
26. Hospitalisationadmission to hospital1.2%10
27. Blood pressure increaseda raised blood pressure reading1.1%9
28. Contusiona bruise1.1%9
29. Pneumonialung infection1.1%9
30. Respiratory failurethe lungs could not supply enough oxygen1.1%9

Top 30 of 182 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 median share across the 47 drugs in the nonsteroidal anti-inflammatory drug class; 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 548,672 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 45.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 828 reports.

In context

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."

Other drugs in the nonsteroidal anti-inflammatory drug class

Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.

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 Ecotrin as a suspect or interacting product; reports listing it only as a concomitant medication (7,315) 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.