Drugs › Nonsteroidal anti-inflammatory drug
Brand name · Naproxen sodium
Aleve: adverse event reports filed with FDA
49,101 reports list it as a suspect or interacting product, 2004–2026. Class: Nonsteroidal anti-inflammatory drug. Also reported as Aleve /00256202/, Aleve Tablet, Aleve Tablets.
- 49,101
- reports as suspect product
- 0.2% of all reports · about 2,183 a year
- 351
- reports, 12 months to June 2026
- 570 in the 12 months before
- 16.4%
- marked serious by the reporter
- 71.8% across the class
- 0.6%
- record death among outcomes, as reported
- 304 reports · not verified by FDA
49,101 adverse event reports received by FDA list the brand name Aleve (naproxen sodium) as a suspect or interacting product, from January 2004 to June 2026. A further 21,786 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, 351 reports listed it, down 38% from 570 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 2,183 reports a year and 0.2% of the 20,646,523 reports in the database, and 8.9% 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 drug ineffective (17.3%), no adverse event (9.2%) and product use issue (7.1%). A report can list several reactions, so shares add to more than 100%; 1,329 different terms appear across these reports. Drug ineffective is recorded in 17.3% of these reports, about the same share as in the median nonsteroidal anti-inflammatory drug drug (13.9%).
16.4% of the reports are marked serious by the reporter (71.8% across the class); 0.6% record death among the outcomes and 4.5% record hospitalisation, as reported. 93.5% of the reports came from consumers, and the largest patient age group is 75 and over (12%). 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 Aleve reports recording the termmedian drug in nonsteroidal anti-inflammatory drug
- Drug ineffectivethe medicine did not work as expected17.3%8,492
- No adverse eventno adverse event was reported9.2%4,513
- Product use issuea problem in how the product was used7.1%3,506
- Headachehead pain4.5%2,228
- Painpain, site not specified3.1%1,540
- Therapeutic response unexpected2.7%1,324
- Abdominal pain upperupper stomach pain2.7%1,319
- Drug hypersensitivityan allergic-type reaction to a medicine2.7%1,302
- Nauseafeeling sick2.5%1,237
- Dizzinesslight-headedness or unsteadiness2.4%1,198
- Expired product administeredthe product was used past its expiry date2.4%1,159
- Abdominal discomfortstomach discomfort2.3%1,110
- Hypersensitivityan allergic-type reaction2%983
- Pruritusitching2%961
- Urticariahives1.8%882
- Incorrect dose administeredthe wrong dose was given1.8%878
- Arthralgiajoint pain1.7%826
- Product use in unapproved indicationused for a purpose not on the label1.7%811
- Back painback pain1.6%784
- Vomitingbeing sick1.6%768
- Somnolencedrowsiness1.5%745
- Off label useused for a purpose or in a way not on the label1.5%744
- Feeling abnormalfeeling odd or not right1.5%735
- Dyspnoeashortness of breath1.5%713
- Rashskin rash1.4%696
- Dyspepsiaindigestion1.3%635
- Diarrhoealoose or frequent stools1.3%629
- Blood pressure increaseda raised blood pressure reading1.2%613
Top 30 of 1,329 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. 97.3% 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 | 6,562 | 13.4% |
| Headache | 3,012 | 6.1% |
| Back pain | 2,938 | 6% |
| Arthritis | 2,765 | 5.6% |
| Arthralgia | 2,579 | 5.3% |
| Analgesic therapy | 1,823 | 3.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 49,101 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Aleve reports |
|---|---|---|
| Aspirin | 1,727 | 3.5% |
| Ibuprofen | 1,296 | 2.6% |
| Tylenol | 877 | 1.8% |
| Lisinopril | 856 | 1.7% |
| Synthroid | 698 | 1.4% |
| Advil | 636 | 1.3% |
| Lipitor | 596 | 1.2% |
| Bayer Low Dose | 481 | 1% |
| Vitamin d | 456 | 0.9% |
| Simvastatin | 447 | 0.9% |
Other products listed in reports where Aleve 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
| Measure | Aleve | Nonsteroidal anti-inflammatory drug | All reports |
|---|---|---|---|
| Reports as suspect product | 49,101 | 548,672 | 20,646,523 |
| Share of that pool | — | 8.9% | 0.2% |
| Reports, latest 12 months | 351 | — | 1,332,454 |
| Marked serious | 16.4% | 71.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 6 | 162 | 91 |
| Hospitalisation recorded, per 1,000 reports | 45 | 356 | 213 |
| Consumer-filed share | 93.5% | 38.7% | 45.8% |
| Top term, share of reports | Drug ineffective 17.3% | median 13.9% | 6.3% |
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% |
| 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% |
| Motrin | brand | 4,658 | 91 | 50.2% |
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 Aleve reports
How many adverse event reports has FDA received for Aleve?
49,101 reports list Aleve as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 351 of them arrived in the latest 12 months. Another 21,786 list it only as a concomitant medication.
What reactions are recorded in Aleve reports?
drug ineffective (17.3%), no adverse event (9.2%), product use issue (7.1%), headache (4.5%) and pain (3.1%). 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 Aleve was responsible.
How serious are the reports?
16.4% are marked serious by the reporter. Among the outcomes recorded, 0.6% of reports include death and 4.5% 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 (93.5%), not given (2.4%) and other health professional (2.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Aleve rising?
351 reports in the 12 months to June 2026, down 38% from 570 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 Aleve 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 Aleve?
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 Aleve as a suspect or interacting product; reports listing it only as a concomitant medication (21,786) 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.