FDA Adverse Events Reports (FAERS) Summary for MELOXICAM

These tables and charts are based on 58,010 total reports for MELOXICAM (MELOXICAM) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 54,426 pharmaceutical company-submitted and non-U.S. FAERS reports and 3,584 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 3,584 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch MELOXICAM summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with MELOXICAM (reported in FAERS Database)

 Side Effect# of FDA Reports
1DRUG INEFFECTIVE6077
2PAIN4810
3FATIGUE4741
4JOINT PAIN4353
5NAUSEA3968
6HEADACHE3463
7DIARRHEA3350
8SHORTNESS OF BREATH2799
9DIZZINESS2756
10PAIN IN EXTREMITY2669
11OFF LABEL USE2661
12MALAISE2589
13CHRONIC KIDNEY DISEASE2341
14VOMITING2312
15RHEUMATOID ARTHRITIS2304
16RASH2291
17CONDITION AGGRAVATED2148
18JOINT SWELLING2139
19ITCHING2130
20LACK OF STRENGTH AND ENERGY (ASTHENIA)2118

Latest Known Outcomes for Reactions Reported for MELOXICAM

Latest Known Outcome for Reported ReactionsNumber of Cases
1Unknown Outcome31795
2Patient has not recovered/symtoms have not resolved18276
3Patient recovered12328
4Patient is recovering/symptoms resolving5869
5Patient died3042
6Patient has recovered but has consequent health issues296
Search all MedWatch and FAERS by keyword:

MELOXICAM Total Reports

 Male    Female    Unknown    Total  
 15167    38385    4458    58,010  

Top Countries Reporting

 Country  Number of Reports
United States  42698
Canada  5291
United Kingdom  701
Brazil  347
Australia  325
Japan  266
Germany  152
Puerto Rico  133
Czech Republic  124
10 Netherlands  124

Outcomes for Reports

Serious: 33790
Not Serious: 24188
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications      
Product used for unknown indication
JOINT PAIN
Pain
Inflammation
Headache

Top Companies Reporting

   BOEHRINGER INGELHEIM

Safety-Related FDA Updates

FDA Approval Date: 2006-07-19

MOBIC (MELOXICAM) Rx Drug:
Safety-related Labeling Changes


Have experience (good or bad) with MOBIC? Rate MOBIC at Ask a Patient.

VIVLODEX (MELOXICAM) Rx Drug:
Safety-related Labeling Changes


Have experience (good or bad) with VIVLODEX? Rate VIVLODEX at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for MELOXICAM reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.