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) Latest Known Outcomes for Reactions Reported for MELOXICAM Side Effect # of FDA Reports 1 DRUG INEFFECTIVE 6077 2 PAIN 4810 3 FATIGUE 4741 4 JOINT PAIN 4353 5 NAUSEA 3968 6 HEADACHE 3463 7 DIARRHEA 3350 8 SHORTNESS OF BREATH 2799 9 DIZZINESS 2756 10 PAIN IN EXTREMITY 2669 11 OFF LABEL USE 2661 12 MALAISE 2589 13 CHRONIC KIDNEY DISEASE 2341 14 VOMITING 2312 15 RHEUMATOID ARTHRITIS 2304 16 RASH 2291 17 CONDITION AGGRAVATED 2148 18 JOINT SWELLING 2139 19 ITCHING 2130 20 LACK OF STRENGTH AND ENERGY (ASTHENIA) 2118 Latest Known Outcome for Reported Reactions Number of Cases 1 Unknown Outcome 31795 2 Patient has not recovered/symtoms have not resolved 18276 3 Patient recovered 12328 4 Patient is recovering/symptoms resolving 5869 5 Patient died 3042 6 Patient has recovered but has consequent health issues 296
MELOXICAM Total Reports
| Male | Female | Unknown | Total |
|---|---|---|---|
| 15167 | 38385 | 4458 | 58,010 |
Top Countries Reporting
| Country | Number of Reports | |
|---|---|---|
| 1 | United States | 42698 |
| 2 | Canada | 5291 |
| 3 | United Kingdom | 701 |
| 4 | Brazil | 347 |
| 5 | Australia | 325 |
| 6 | Japan | 266 |
| 7 | Germany | 152 |
| 8 | Puerto Rico | 133 |
| 9 | 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 | |
FDA Approval Date: 2006-07-19 MOBIC (MELOXICAM) Rx Drug: VIVLODEX (MELOXICAM) Rx Drug: For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the
MedWatch voluntary reporting form.
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.
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.
Safety-Related FDA Updates
Safety-related Labeling Changes
Have experience (good or bad) with MOBIC? Rate MOBIC at Ask a Patient.
Safety-related Labeling Changes
Have experience (good or bad) with VIVLODEX? Rate VIVLODEX at Ask a Patient.
Notes
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.
