What the label lists and what reports show
Meloxicam side effects
Meloxicam's FDA label: “Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms (6.1) Adverse events observed in pediatric studies were similar in nature to the adult clinical trial …” FAERS holds 57,757 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (4,757 reports).
- Generic listed
- Boxed warning
Check it at the source: the meloxicam FDA label on DailyMed (effective January 29, 2026, PD-Rx Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NSAIDs?NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. Get emergency help right away if you get any of the following symptoms: Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: If you take too much of your NSAID, call your healthcare provider or get medical help right away. These are not all the possible side effects of NSAIDs. […]
Source: FDA drug label, PD-Rx Pharmaceuticals, Inc., effective January 29, 2026 (SPL set 19c13159-71f1-2427-e063-6394a90ad44e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms (6.1) Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AiPing Pharmaceutical, Inc., at 1-888-339-6420 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 2 Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials
This table is printed in the Meloxicam label published by Aurobindo Pharma Limited of March 15, 2025; the label quoted above does not print one.
| Reaction | Meloxicam 7.5 mg daily | Meloxicam 15 mg daily | Meloxicam 7.5 mg daily | Meloxicam 15 mg daily |
|---|---|---|---|---|
| No. of Patients | 8955 | 256 | 169 | 306 |
| Gastrointestinal | 11.8 | 18 | 26.6 | 24.2 |
| Abdominal pain | 2.7 | 2.3 | 4.7 | 2.9 |
| Constipation | 0.8 | 1.2 | 1.8 | 2.6 |
| Diarrhea | 1.9 | 2.7 | 5.9 | 2.6 |
| Dyspepsia | 3.8 | 7.4 | 8.9 | 9.5 |
| Flatulence | 0.5 | 0.4 | 3 | 2.6 |
| Nausea | 2.4 | 4.7 | 4.7 | 7.2 |
| Vomiting | 0.6 | 0.8 | 1.8 | 2.6 |
| Accident household | 0 | 0 | 0.6 | 2.9 |
| Edema 1 | 0.6 | 2 | 2.4 | 1.6 |
| Pain | 0.9 | 2 | 3.6 | 5.2 |
| Dizziness | 1.1 | 1.6 | 2.4 | 2.6 |
| Headache | 2.4 | 2.7 | 3.6 | 2.6 |
| Anemia | 0.1 | 0 | 4.1 | 2.9 |
| Arthralgia | 0.5 | 0 | 5.3 | 1.3 |
| Back pain | 0.5 | 0.4 | 3 | 0.7 |
| Insomnia | 0.4 | 0 | 3.6 | 1.6 |
| Coughing | 0.2 | 0.8 | 2.4 | 1 |
| Upper respiratory tract infection | 0.2 | 0 | 8.3 | 7.5 |
| Pruritus | 0.4 | 1.2 | 2.4 | 0 |
| Rash 2 | 0.3 | 1.2 | 3 | 1.3 |
| Micturition frequency | 0.1 | 0.4 | 2.4 | 1.3 |
| Urinary tract infection | 0.3 | 0.4 | 4.7 | 6.9 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Boxed Warning and Warnings and Precautions (5.1)] GI Bleeding, Ulceration, and Perforation [see Boxed Warning and Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Heart Failure and Edema [see Warnings and Precautions (5.5)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)] Anaphylactic Reactions [see Warnings and Precautions (5.7)] Serious Skin Reactions [see Warnings and Precautions (5.9)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.10)] Fetal Toxicity [see Warnings and Precautions (5.11)] Hematologic Toxicity [see Warnings and Precautions (5.12)] Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms (6.1) Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AiPing Pharmaceutical, Inc., at 1-888-339-6420 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, PD-Rx Pharmaceuticals, Inc., effective January 29, 2026 (SPL set 19c13159-71f1-2427-e063-6394a90ad44e), via openFDA; the full label on DailyMed
What do FAERS reports show?
57,757 reports list meloxicam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,732 are coded as a death and 13,857 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Meloxicam: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions