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meloxicam

Sold as Anjeso, Mobic, Qamzova, Qmiiz, Vivlodex and 2 more. Class: Oxicams. First FDA approval 04/13/2000: 26 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (70/100)

Safety ×35%
D
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
A

Safety: 60

Evidence: 42

Regulatory history: 89

Money & lawsuits: 100

Options: 100

FDA boxed warning

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions ( 5.1 )]. Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4.2 ) and Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [ see Warnings and Precautions ( 5.2 ) ]. WARNING: CARDIOVASCULAR and GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning . Cardiovascular Risk NSAIDs may caus...

Independent reviews and post-approval warnings

Prescrire: drug to avoid

Meloxicam, piroxicam and tenoxicam, when used systemically, expose patients to an increased risk of gastrointestinal disorders and cutaneous disorders (including Stevens-Johnson syndrome and toxic epidermal necrolysis), but are no more effective than other NSAIDs ( Prescrire Int n° 212; Rev Prescrire n° 321). “Muscle relaxants”. V arious drugs used as muscle relaxants have no demonstrated efficacy beyond that of a placebo, but expose patients to the risk of sometimes severe adverse effects. An effective analgesic is a better option, with paracetamol as the first choice, keeping exposure to a m...

Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Haematology) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.

What the FDA label says

Approved uses

Meloxicam is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3 ) 1.1 Osteoarthritis (OA) Meloxicam tablets, USP is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ( 14.1 ) ]. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ( 14.1 ) ]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets, USP is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [ see Clinical Studies ( 14.2 ) ].

Contraindications

Known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam ( 4.1 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4.1 ) Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery ( 4.2 ) 4.1 Allergic Reactions Meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.13 ) ]. 4.2 Coronary Surgery Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ].

Warnings and precautions

Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk. ( 5.1 ) Serious gastrointestinal (GI) adverse events which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at higher risk for GI events, especially the elderly. ( 5.2 ) Elevated liver enzymes, and rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen. ( 5.3 ) New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment. ( 5.4 ) Fluid retention and edema. Should be used with caution in patients with fluid retention or heart failure. ( 5.5 ) Renal papillary necrosis and other renal injury with long-term use. Use with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists. The use of meloxicam in patients with severe renal impairment is not recommended. ( 5.6 ) Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS...

Adverse reactions (label)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular thrombotic events [ see Boxed Warning and Warnings and Precautions ( 5.1 )] Gastrointestinal effects – risk of GI ulceration, bleeding, and perforation [ see Boxed Warning and Warnings and Precautions ( 5.2 ) ] Hepatic effects [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Congestive heart failure and edema [see Warnings and Precautions ( 5.5 )] Renal effects [see Warnings and Precautions ( 5.6 )] Anaphylactoid reactions [ see Warnings and Precautions ( 5.7 )] Adverse skin reactions [see Warnings and Precautions ( 5.8 )] 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 experien...

Source: FDA SPL label for Meloxicam (Aphena Pharma Solutions - Tennessee, LLC), effective 20200720. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

60,108reports that mention this drug
60,045of those blame this drug, not another one the person was taking
57%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
6.1%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Drug Ineffective · 6,727Pain · 5,014Fatigue · 5,006Arthralgia · 4,548Nausea · 4,198Headache · 3,612Diarrhoea · 3,544Off Label Use · 3,055Dyspnoea · 2,815Dizziness · 2,805Malaise · 2,743Pain In Extremity · 2,735Chronic Kidney Disease · 2,563Rheumatoid Arthritis · 2,443Vomiting · 2,375

Reports per year

20192020202120222023202420252026
6,5796,1604,6154,1443,8123,7933,8511,829

781 reports blaming this drug for every million Medicare prescriptions filled, which is 0.3× the typical drug on this site. (9,440 reports in 2024–2026, against 12,080,589 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

2recall actions on file
7 / 26brand / generic applications
9label changes since 2021
NoREMS program
DateClassFirmReason
01/2022Class IICARDINAL HEALTHCARECGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
03/2021Class IICardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

220randomized trials (PubMed)
7systematic reviews
163registered trials
41%of completed trials posted results
7%terminated or withdrawn
59%industry-funded

Independent Cochrane reviews

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

4,115,676Medicare Part D patients (2024)
12,080,589prescriptions filled
$4average cost per fill
$52Mtotal Medicare spend

Same-class alternatives

droxicamlornoxicampiroxicamtenoxicam

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?
  2. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
  3. The most-reported problems in FDA's adverse event data are pain, fatigue, arthralgia. How would we recognize and handle those?
  4. Why this one over droxicam, lornoxicam, piroxicam? What would make you pick one of those instead?
  5. What result are we expecting, by when, and what is the plan if it does not happen?
  6. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)