Drugs › Nonsteroidal anti-inflammatory drug
Generic name
Bayer aspirin extra strength: adverse event reports filed with FDA
1,567 reports list it as a suspect or interacting product, 2006–2026. Class: Nonsteroidal anti-inflammatory drug.
- 1,567
- reports as suspect product
- 0% of all reports · about 80 a year
- 3
- reports, 12 months to June 2026
- 4 in the 12 months before
- 78.2%
- marked serious by the reporter
- 71.8% across the class
- 13.7%
- record death among outcomes, as reported
- 214 reports · not verified by FDA
1,567 adverse event reports received by FDA list bayer aspirin extra strength, a generic name as a suspect or interacting product, from December 2006 to May 2026. A further 2,369 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 3 reports listed it, down 25% from 4 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 80 reports a year and 0% of the 20,646,523 reports in the database, and 0.3% of the reports for the nonsteroidal anti-inflammatory drug class. 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 gastrointestinal haemorrhage (13.3%), drug hypersensitivity (10.5%) and product use in unapproved indication (10.1%). A report can list several reactions, so shares add to more than 100%; 315 different terms appear across these reports. Gastrointestinal haemorrhage is recorded in 13.3% of these reports, a larger share than in the median nonsteroidal anti-inflammatory drug drug (0.9%).
78.2% of the reports are marked serious by the reporter (71.8% across the class); 13.7% record death among the outcomes and 41.9% record hospitalisation, as reported. 82.5% of the reports came from consumers, and the largest patient age group is 75 and over (23.8%). 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 Bayer aspirin extra strength reports recording the termmedian drug in nonsteroidal anti-inflammatory drug
- Gastrointestinal haemorrhagebleeding in the stomach or bowel13.3%209
- Drug hypersensitivityan allergic-type reaction to a medicine10.5%165
- Product use in unapproved indicationused for a purpose not on the label10.1%158
- Product use issuea problem in how the product was used7.4%116
- Off label useused for a purpose or in a way not on the label7.2%113
- Drug ineffectivethe medicine did not work as expected4.7%74
- Haemorrhagebleeding4.2%66
- Epistaxisnosebleed3.8%60
- Acute kidney injurysudden loss of kidney function3.6%57
- Rectal haemorrhage3.6%57
- Myocardial infarctionheart attack2.9%45
- Dyspnoeashortness of breath2.5%39
- Cerebrovascular accidentstroke2.4%37
- Nauseafeeling sick2.3%36
- Wrong technique in product usage processthe product was used in the wrong way2.1%33
- Abdominal discomfortstomach discomfort2%31
- Haematuriablood in the urine2%31
- Deaththe patient died; cause not stated by this term1.9%29
- Gastric haemorrhage1.8%28
- Incorrect dose administeredthe wrong dose was given1.8%28
- Internal haemorrhage1.8%28
- Dizzinesslight-headedness or unsteadiness1.7%26
- Gastric ulcera stomach ulcer1.7%26
- Diarrhoealoose or frequent stools1.6%25
- Falla fall1.5%24
Top 30 of 315 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
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. 97.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pain | 85 | 5.4% |
| Atrial fibrillation | 43 | 2.7% |
| Anticoagulant therapy | 41 | 2.6% |
| Cardiac disorder | 31 | 2% |
| Prophylaxis | 30 | 1.9% |
| Coronary artery disease | 22 | 1.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,567 reports.
In context
| Measure | Bayer aspirin extra strength | Nonsteroidal anti-inflammatory drug | All reports |
|---|---|---|---|
| Reports as suspect product | 1,567 | 548,672 | 20,646,523 |
| Share of that pool | — | 0.3% | 0% |
| Reports, latest 12 months | 3 | — | 1,332,454 |
| Marked serious | 78.2% | 71.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 137 | 162 | 91 |
| Hospitalisation recorded, per 1,000 reports | 419 | 356 | 213 |
| Consumer-filed share | 82.5% | 38.7% | 45.8% |
| Top term, share of reports | Gastrointestinal haemorrhage 13.3% | median 0.9% | 0.4% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Acetaminophen | generic | 86,936 | 11,554 | 94.8% |
| Ibuprofen | generic | 77,058 | 5,632 | 82.8% |
| Aspirin | generic | 72,158 | 3,575 | 93.2% |
| Diclofenac sodium | generic | 51,920 | 2,979 | 51.8% |
| Aleve | brand | 49,101 | 351 | 16.4% |
| Celebrex | brand | 45,731 | 735 | 72.2% |
| Diclofenac | generic | 27,760 | 2,842 | 91.6% |
| Naproxen | generic | 23,872 | 2,147 | 90.7% |
| Advil | brand | 19,649 | 522 | 27.6% |
| Celecoxib | generic | 15,201 | 1,925 | 82% |
| Naproxen sodium | generic | 9,874 | 1,220 | 79% |
| Meloxicam | generic | 7,860 | 459 | 73.1% |
| Diclofenac potassium | generic | 5,702 | 1,240 | 97.8% |
| Ketoprofen | generic | 5,639 | 661 | 98.3% |
| Advil pm | generic | 4,978 | 134 | 11.1% |
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.
Questions about Bayer aspirin extra strength reports
How many adverse event reports has FDA received for Bayer aspirin extra strength?
1,567 reports list Bayer aspirin extra strength as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 3 of them arrived in the latest 12 months. Another 2,369 list it only as a concomitant medication.
What reactions are recorded in Bayer aspirin extra strength reports?
gastrointestinal haemorrhage (13.3%), drug hypersensitivity (10.5%), product use in unapproved indication (10.1%), product use issue (7.4%) and off label use (7.2%). 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 Bayer aspirin extra strength was responsible.
How serious are the reports?
78.2% are marked serious by the reporter. Among the outcomes recorded, 13.7% of reports include death and 41.9% 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?
consumer or non-health professional (82.5%), other health professional (12.3%) and physician (3.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Bayer aspirin extra strength rising?
3 reports in the 12 months to June 2026, down 25% from 4 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 Bayer aspirin extra strength 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 Bayer aspirin extra strength?
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 Bayer aspirin extra strength as a suspect or interacting product; reports listing it only as a concomitant medication (2,369) 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.