Bayer Low Dose: adverse event reports filed with FDA

3,806

reports as suspect product

0% of all reports · about 286 a year

40

reports, 12 months to June 2026

28 in the 12 months before

86.2%

marked serious by the reporter

71.8% across the class

20.4%

record death among outcomes, as reported

775 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

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Bayer Low Dose reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Gastrointestinal haemorrhagebleeding in the stomach or bowel22.8%867
2. Product use issuea problem in how the product was used11.5%438
3. Off label useused for a purpose or in a way not on the label9.9%377
4. Product use in unapproved indicationused for a purpose not on the label6.8%258
5. Upper gastrointestinal haemorrhage6.8%257
6. Epistaxisnosebleed5.4%205
7. Acute kidney injurysudden loss of kidney function5.1%193
8. Haematuriablood in the urine4.5%173
9. Rectal haemorrhage4.5%171
10. Haemorrhagebleeding3.7%142
11. Lower gastrointestinal haemorrhage3.5%135
12. Drug ineffectivethe medicine did not work as expected3.3%127
13. Internal haemorrhage2.9%109
14. Cerebrovascular accidentstroke2.6%100
15. Haemoptysiscoughing up blood2.4%91
16. Myocardial infarctionheart attack2.4%91
17. Falla fall2.1%80
18. Labelled drug-drug interaction medication error2%78
19. Contusiona bruise1.9%71
20. Anaemialow red blood cells1.6%61
21. Incorrect dose administeredthe wrong dose was given1.6%60
22. Gastric ulcer haemorrhage1.5%58
23. Cerebral haemorrhage1.5%57
24. Expired product administeredthe product was used past its expiry date1.5%56
25. Haematocheziablood in the stool1.4%55
26. Gastrointestinal vascular malformation haemorrhagic1.4%54
27. Incorrect drug administration duration1.4%53
28. Diverticulum intestinal haemorrhagic1.3%50
29. Drug hypersensitivityan allergic-type reaction to a medicine1.3%49
30. Wrong technique in product usage processthe product was used in the wrong way1.3%49

Top 30 of 409 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. 100% 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 3,806 reports.

Drugs most often listed in the same reports

Other products listed in reports where Bayer Low Dose is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 Bayer Low Dose as a suspect or interacting product; reports listing it only as a concomitant medication (868) 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.