Reported Reactions

Drugs › Nonsteroidal anti-inflammatory drug

Generic name

Meloxicam: adverse event reports filed with FDA

7,860 reports list it as a suspect or interacting product, 2004–2026. Class: Nonsteroidal anti-inflammatory drug. Also reported as Meloxicam 7 5mg, Meloxicam 7 5, Meloxicam Tablets.

7,860
reports as suspect product
0% of all reports · about 349 a year
459
reports, 12 months to June 2026
501 in the 12 months before
73.1%
marked serious by the reporter
71.8% across the class
15.4%
record death among outcomes, as reported
1,211 reports · not verified by FDA

7,860 adverse event reports received by FDA list meloxicam, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 50,398 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, 459 reports listed it, close to the 501 of 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 349 reports a year and 0% of the 20,646,523 reports in the database, and 1.4% 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.

Reporters most often recorded drug ineffective (18.5%), arthralgia (9.1%) and pain (8.1%). A report can list several reactions, so shares add to more than 100%; 1,325 different terms appear across these reports. Drug ineffective is recorded in 18.5% of these reports, a larger share than in the median nonsteroidal anti-inflammatory drug drug (13.9%).

73.1% of the reports are marked serious by the reporter (71.8% across the class); 15.4% record death among the outcomes and 33% record hospitalisation, as reported. 32.6% of the reports came from consumers, and the largest patient age group is 45 to 64 (24%). 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

03875Jul 2021: 41Aug 2021: 33Sep 2021: 43Oct 2021: 19Nov 2021: 30Dec 2021: 322022Jan 2022: 52Feb 2022: 42Mar 2022: 56Apr 2022: 35May 2022: 45Jun 2022: 53Jul 2022: 35Aug 2022: 36Sep 2022: 36Oct 2022: 28Nov 2022: 38Dec 2022: 412023Jan 2023: 64Feb 2023: 61Mar 2023: 52Apr 2023: 56May 2023: 70Jun 2023: 55Jul 2023: 41Aug 2023: 75Sep 2023: 56Oct 2023: 44Nov 2023: 35Dec 2023: 462024Jan 2024: 50Feb 2024: 46Mar 2024: 30Apr 2024: 40May 2024: 51Jun 2024: 47Jul 2024: 60Aug 2024: 39Sep 2024: 37Oct 2024: 56Nov 2024: 31Dec 2024: 382025Jan 2025: 45Feb 2025: 29Mar 2025: 57Apr 2025: 32May 2025: 31Jun 2025: 46Jul 2025: 46Aug 2025: 27Sep 2025: 22Oct 2025: 27Nov 2025: 59Dec 2025: 402026Jan 2026: 37Feb 2026: 61Mar 2026: 40Apr 2026: 36May 2026: 27Jun 2026: 37

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

03446872004: 2720042005: 252006: 352007: 7920072008: 1242009: 1582010: 14320102011: 2412012: 2552013: 23320132014: 3252015: 4562016: 54020162017: 5782018: 5842019: 68720192020: 5312021: 4632022: 49720222023: 6552024: 5252025: 46120252026: 238

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

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

  1. Drug ineffectivethe medicine did not work as expected18.5%1,453
  2. Arthralgiajoint pain9.1%718
  3. Painpain, site not specified8.1%633
  4. Dizzinesslight-headedness or unsteadiness7.1%557
  5. Pain in extremitypain in an arm or leg6.8%534
  6. Fatiguetiredness6.5%511
  7. Drug hypersensitivityan allergic-type reaction to a medicine6.3%495
  8. Completed suicidedeath by suicide6.2%485
  9. Joint swellinga swollen joint6.1%483
  10. Nauseafeeling sick6.1%479
  11. Peripheral swellingswelling of the arms or legs6%470
  12. Diarrhoealoose or frequent stools5.9%461
  13. Dyspnoeashortness of breath5.7%450
  14. Musculoskeletal stiffnessstiffness in muscles or joints5.4%425
  15. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease5.1%403
  16. Malaisegeneral feeling of being unwell4.9%389
  17. Drug intolerancethe medicine was not tolerated4.8%375
  18. Headachehead pain4.6%365
  19. Toxicity to various agentspoisoning or toxic effect of one or more substances4.5%351
  20. Rashskin rash4.4%346
  21. Pneumonialung infection4.3%341
  22. Abdominal discomfortstomach discomfort4.3%339
  23. Pruritusitching4.2%333
  24. Condition aggravatedthe condition being treated got worse4.2%332
  25. Muscular weaknessmuscle weakness4.1%321
  26. Drug interactionan interaction between medicines4%318
  27. Hypertensionhigh blood pressure4%317
  28. Vomitingbeing sick3.9%308

Top 30 of 1,325 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

Death15.4%1,211
Life-threatening8.3%656
Hospitalisation (initial or prolonged)33%2,596
Disability5.3%419
Congenital anomaly1.3%104
Other serious48.6%3,818
Not serious26.9%2,118

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

Under 20%2
2 to 110.2%16
12 to 171.6%128
18 to 4414%1,098
45 to 6424%1,890
65 to 7414.5%1,138
75 and over10.5%823
Age not given35.2%2,765

Patient sex

Female57.4%4,509
Male25.6%2,011
Not given17%1,340

Who reported

Physician26.3%2,069
Pharmacist8%631
Other health professional27.5%2,158
Lawyer0.2%19
Consumer or non-health professional32.6%2,564
Not given5.3%419

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 64.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Pain4966.3%
Rheumatoid arthritis3484.4%
Arthritis3464.4%
Osteoarthritis2413.1%
Arthralgia2393%
Back pain1552%

The indication field is filled in by the reporter and is often blank; shares are of all 7,860 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Meloxicam reports
Methotrexate1,04813.3%
Prednisone82610.5%
Humira7169.1%
Ibuprofen6988.9%
Acetaminophen6948.8%
Sulfasalazine6187.9%
Lisinopril5827.4%
Gabapentin5707.3%
Celecoxib5266.7%
Folic acid5036.4%

Other products listed in reports where Meloxicam 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

MeasureMeloxicamNonsteroidal anti-inflammatory drugAll reports
Reports as suspect product7,860548,67220,646,523
Share of that pool—1.4%0%
Reports, latest 12 months459—1,332,454
Marked serious73.1%71.8%57.4%
Death recorded among outcomes, per 1,000 reports15416291
Hospitalisation recorded, per 1,000 reports330356213
Consumer-filed share32.6%38.7%45.8%
Top term, share of reportsDrug ineffective 18.5%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

DrugName typeReportsLatest 12 monthsMarked serious
Acetaminophengeneric86,93611,55494.8%
Ibuprofengeneric77,0585,63282.8%
Aspiringeneric72,1583,57593.2%
Diclofenac sodiumgeneric51,9202,97951.8%
Alevebrand49,10135116.4%
Celebrexbrand45,73173572.2%
Diclofenacgeneric27,7602,84291.6%
Naproxengeneric23,8722,14790.7%
Advilbrand19,64952227.6%
Celecoxibgeneric15,2011,92582%
Naproxen sodiumgeneric9,8741,22079%
Diclofenac potassiumgeneric5,7021,24097.8%
Ketoprofengeneric5,63966198.3%
Advil pmgeneric4,97813411.1%
Motrinbrand4,6589150.2%

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 Meloxicam reports

How many adverse event reports has FDA received for Meloxicam?

7,860 reports list Meloxicam as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 459 of them arrived in the latest 12 months. Another 50,398 list it only as a concomitant medication.

What reactions are recorded in Meloxicam reports?

drug ineffective (18.5%), arthralgia (9.1%), pain (8.1%), dizziness (7.1%) and pain in extremity (6.8%). 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 Meloxicam was responsible.

How serious are the reports?

73.1% are marked serious by the reporter. Among the outcomes recorded, 15.4% of reports include death and 33% 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 (32.6%), other health professional (27.5%) and physician (26.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Meloxicam rising?

459 reports in the 12 months to June 2026, close to the 501 of 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 Meloxicam 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 Meloxicam?

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 Meloxicam as a suspect or interacting product; reports listing it only as a concomitant medication (50,398) 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.