Medicine guide

Meloxicam

15 mg · Tablet

Prescription only
Nonsteroidal Anti-inflammatory Drug

Active substance: Meloxicam
Used in: Muscles, joints and bones
Made by: Direct_Rx
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-08-12

What it is

Nonsteroidal Anti-inflammatory Drug

Used for

1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)] .

The label’s usual adult dose

2 Osteoarthritis For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily.

adults, the maximum recommended daily oral dose of meloxicam is 15 mg regardless of formulation.

Full directions ↓

Serious warning

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke,…

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

87other products contain Meloxicam — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

1.1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)] .
1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are 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 are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4)and Clinical Studies (14.2)] .

From the official label · 2026-08-12 · DailyMed

How it works

From this product’s own US prescribing label.

Meloxicam has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of meloxicam, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Peak level after5–6 h

Half-life15 h

Mostly cleared after≈ 3 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

Meloxicam is extensively metabolized in the liver.

How it leaves the body

Only traces of the unchanged parent compound are excreted in the urine (0.2%) and feces (1.6%).

With food

In comparison, neither the AUC nor the C max values for meloxicam suspension were affected following a similar high fat meal, while mean T max values were increased to approximately 7 hours.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-12

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.
This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)] .
Meloxicamis contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4)and Warnings and Precautions (5.1)] .
Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)] .

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Meloxicam is contraindicated in the following patients:
Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions ( 5.7,5.9)] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7,5.8)] In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1)]

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

2.1 General Dosing Instructions Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam tablets.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] .
After observing the response to initial therapy with meloxicam, adjust the dose to suit an individual patient's needs.
In
adults, the maximum recommended daily oral dose of meloxicam is 15 mg regardless of formulation.
In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)] .
Meloxicam may be taken without regard to timing of meals.
2.2 Osteoarthritis For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily.
Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.3 Rheumatoid Arthritis For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam is 7.5 mg once daily.
Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.4 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of meloxicam is 7.5 mg once daily in children who weigh ≥60 kg.
There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials.
Meloxicam tablets should not be used in children who weigh <60 kg.
2.5 Renal Impairment The use of meloxicam tablets in subjects with severe renal impairment is not recommended.
In patients on hemodialysis, the maximum dosage of meloxicam tablets is 7.5 mg per day [see Clinical Pharmacology (12.3)].
2.6 Non-Interchangeability with Other Formulations of Meloxicam Meloxicam tablets have not shown equivalent systemic exposure to other approved formulations of oral meloxicam.
Therefore, meloxicam tablets are not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same.
Do not substitute similar dose strengths of meloxicam tablets with other formulations of oral meloxicam product.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs.
The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate.
Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms.
Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.
The concurrent use of aspirin and an NSAID, such as meloxicam, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2)] .
Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG [see Contraindications (4)] .
Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.
In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.
Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of meloxicam tablet in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events.
If meloxicam tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
5.2 Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including meloxicam, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.
Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year.
However, even short-term NSAID therapy is not without risk.
Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.
Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status.
Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients.
Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.
Strategies to Minimize the GI Risks in NSAID-treated patients:
Use the lowest effective dosage for the shortest possible duration.
Avoid administration of more than one NSAID at a time.
Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding.
For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs.
Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy.
If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue meloxicam tablets until a serious GI adverse event is ruled out.
In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding [see Drug Interactions (7)] .
5.3 Hepatotoxicity Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials.
In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.
Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including meloxicam.
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms).
If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue meloxicam immediately, and perform a clinical evaluation of the patient [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)] .
5.4 Hypertension NSAIDs, including meloxicam, can lead to new onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events.
Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs [see Drug Interactions (7)] .
Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.
5.5 Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients.
In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
Use of meloxicam may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [see Drug Interactions (7)] .
Avoid the use of meloxicam tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
If meloxicam tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
5.6 Renal Toxicity and Hyperkalemia Renal Toxicity Long-term administration of NSAIDs, including meloxicam, has resulted in renal papillary necrosis, renal insufficiency, acute renal failure, and other renal injury.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.
In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.
Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly.
Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
The renal effects of meloxicam tablets may hasten the progression of renal dysfunction in patients with preexisting renal disease.
Because some meloxicam tablets metabolites are excreted by the kidney, monitor patients for signs of worsening renal function.
Correct volume status in dehydrated or hypovolemic patients prior to initiating meloxicam tablets.
Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of meloxicam tablets [see Drug Interactions (7)] .
No information is available from controlled clinical studies regarding the use of meloxicam tablets in patients with advanced renal disease.
Avoid the use of meloxicam tablets in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function.
If meloxicam tabletareis used in patients with advanced renal disease, monitor patients for signs of worsening renal function [see Clinical Pharmacology (12.3)] .
Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.
In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.
5.7 Anaphylactic Reactions Meloxicam has been associated with anaphylactic reactions in patients with and without known hypersensitivity to meloxicam and in patients with aspirin-sensitive asthma [see Contraindications (4)and Warnings and Precautions (5.8)] .
Seek emergency help if an anaphylactic reaction occurs.
5.8 Exacerbation of Asthma Related to Aspirin Sensitivity A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs.
Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, meloxicam tablets are contraindicated in patients with this form of aspirin sensitivity [see Contraindications (4)] .
When meloxicam tablets are used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.
5.9 Serious Skin Reactions NSAIDs, including meloxicam, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE).
FDE may present as a more severe variant known asgeneralized bullous fixed drug eruption (GBFDE), which can be life-threatening.
These serious events may occur without warning.
Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of meloxicam tablets at the first appearance of skin rash or any other sign of hypersensitivity.
Meloxicam tablets are contraindicated in patients with previous serious skin reactions to NSAIDs [see Contraindications (4)] .
5.10 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as meloxicam tablets.
Some of these events have been fatal or life-threatening.
DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling.
Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis.
Sometimes symptoms of DRESS may resemble an acute viral infection.
Eosinophilia is often present.
Because this disorder is variable in its presentation, other organ systems not noted here may be involved.
It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If such signs or symptoms are present, discontinue meloxicam tablets and evaluate the patient immediately.
Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus
Avoid use of NSAIDs, including meloxicam tablets, in pregnant women at about 30 weeks gestation and later.
NSAIDs, including meloxicam tablets, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs, including meloxicam tablets, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation.
In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit meloxicam tablets use to the lowest effective dose and shortest duration possible.
Consider ultrasound monitoring of amniotic fluid if meloxicam tablets treatment extends beyond 48 hours.
Discontinue meloxicam tablets if oligohydramnios occurs and follow up according to clinical practice [seeUse in Specific Populations (8.1)].
5.12 Hematologic Toxicity Anemia has occurred in NSAID-treated patients.
This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.
If a patient treated with meloxicam has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including meloxicam tablets, may increase the risk of bleeding events.
Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.
Monitor these patients for signs of bleeding [see Drug Interactions (7)] .
5.13 Masking of Inflammation and Fever The pharmacological activity of meloxicam in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.
5.14 Laboratory Monitoring Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [see Warnings and Precautions (5.2, 5.3, 5.6)] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Use of NSAIDs, including meloxicam tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
Because of these risks,limit dose and duration of meloxicam use between about 20 and 30 weeks of gestation, and
avoid meloxicam use at about 30 weeks of gestation and later in pregnancy [ see Clinical Considerations, Data].
Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including meloxicam tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.
In animal reproduction studies, embryofetal death was observed in rats and rabbits treated during the period of organogenesis with meloxicam at oral doses equivalent to 0.65- and 6.5-times the maximum recommended human dose (MRHD) of meloxicam tablets.
Increased incidence of septal heart defects were observed in rabbits treated throughout embryogenesis with meloxicam at an oral dose equivalent to 78-times the MRHD.
In pre- and post-natal reproduction studies, there was an increased incidence of dystocia, delayed parturition, and decreased offspring survival at 0.08-times MRHD of meloxicam.
No teratogenic effects were observed in rats and rabbits treated with meloxicam during organogenesis at an oral dose equivalent to 2.6 and 26-times the MRHD [see Data].
Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.
In animal studies, administration of prostaglandin synthesis inhibitors such as meloxicam, resulted in increased pre- and post-implantation loss.
Prostaglandins also have been shown to have an important role in fetal kidney development.
In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus:
Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including meloxicam tablets, can cause premature closure of the fetal ductus arteriosus ( see Data).
Oligohydramnios/Neonatal Renal Impairment:
If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.
If meloxicam tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios.
If oligohydramnios occurs, discontinue meloxicam tablets and follow up according to clinical practice ( see Data).
Labor or Delivery There are no studies on the effects of meloxicam tablets during labor or delivery.
In animal studies, NSAIDs, including meloxicam, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.
Data Human Data Premature Closure of Fetal Ductus Arteriosus:
Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus.
Oligohydramnios/Neonatal Renal Impairment Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug.
There have been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible.
Some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis.
Methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications.
These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use.
Because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIDs through maternal use is uncertain.
Animal Data Meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the MRHD of 15 mg of meloxicam tablets based on BSA comparison).
Administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day (78-fold greater than the MRHD based on BSA comparison).
The no effect level was 20 mg/kg/day (26-fold greater than the MRHD based on BSA conversion).
In rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65 and 6.5-fold greater, respectively, than the MRHD based on BSA comparison) when administered throughout organogenesis.
Oral administration of meloxicam to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at meloxicam doses of 0.125 mg/kg/day or greater (0.08-times MRHD based on BSA comparison).
8.2 Lactation Risk Summary There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meloxicam tablets and any potential adverse effects on the breastfed infant from the meloxicam tablets or from the underlying maternal condition.
Data Animal Data Meloxicam was present in the milk of lactating rats at concentrations higher than those in plasma.
8.3 Females and Males of Reproductive Potential Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including meloxicam tablets, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.
Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation.
Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation.
Consider withdrawal of NSAIDs, including meloxicam tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility.
8.4 Pediatric Use The safety and effectiveness of meloxicam in pediatric JRA patients from 2 to 17 years of age has been evaluated in three clinical trials [see Dosage and Administration (2.3), Adverse Reactions (6.1)and Clinical Studies (14.2)] .
8.5 Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions.
If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.1, 5.2, 5.3, 5.6, 5.14)] .
8.6 Hepatic Impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Patients with severe hepatic impairment have not been adequately studied.
Since meloxicam is significantly metabolized in the liver and hepatotoxicity may occur, use meloxicam with caution in patients with hepatic impairment [see Warnings and Precautions (5.3)and Clinical Pharmacology (12.3)] .
8.7 Renal Impairment No dose adjustment is necessary in patients with mild to moderate renal impairment.
Patients with severe renal impairment have not been studied.
The use of meloxicam tablets in subjects with severe renal impairment is not recommended.
In patients on hemodialysis, meloxicam should not exceed 7.5 mg per day.
Meloxicam is not dialyzable [see Dosage and Administration (2.1)and Clinical Pharmacology (12.3)] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

See Table 3 for clinically significant drug interactions with meloxicam.
See also Warnings and Precautions ( 5.2, 5.6, 5.12)and Clinical Pharmacology (12.3).
Table 3 Clinically Significant Drug Interactions with Meloxicam Drugs that Interfere with Hemostasis Clinical Impact:
Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding.
The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
Serotonin release by platelets plays an important role in hemostasis.
Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention:
Monitor patients with concomitant use of meloxicam tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.12)] .
Aspirin Clinical Impact:
Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone.
In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions (5.2)] .
Intervention:
Concomitant use of meloxicam tablets and low dose aspirin or analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.12)] .
Meloxicam tablets are not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, or Beta-Blockers Clinical Impact:
NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.
These effects are usually reversible.
Intervention:
During concomitant use of meloxicam tablets and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
During concomitant use of meloxicam tablets and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions (5.6)].
When these drugs are administered concomitantly, patients should be adequately hydrated.
Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics Clinical Impact:
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.
This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
However, studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect.
Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam.
Intervention:
During concomitant use of meloxicam tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions (5.6)] .
Lithium Clinical Impact:
NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance.
The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%.
This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis [see Clinical Pharmacology (12.3)] .
Intervention:
During concomitant use of meloxicam and lithium, monitor patients for signs of lithium toxicity.
Methotrexate Clinical Impact:
Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention:
During concomitant use of meloxicam tablets and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine Clinical Impact:
Concomitant use of meloxicam tablets and cyclosporine may increase cyclosporine’s nephrotoxicity.
Intervention:
During concomitant use of meloxicam tablets and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates Clinical Impact:
Concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see Warnings and Precautions (5.2)].
Intervention:
The concomitant use of meloxicam with other NSAIDs or salicylates is not recommended.
Pemetrexed Clinical Impact:
Concomitant use of meloxicam tablets and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention:
During concomitant use of meloxicam tablets and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.
Patients taking meloxicam should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
In patients with creatinine clearance below 45 mL/min, the concomitant administration of meloxicam with pemetrexed is not recommended.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care.
Gastrointestinal bleeding has occurred.
Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1, 5.2, 5.4, 5.6)] .
Manage patients with symptomatic and supportive care following an NSAID overdosage.
There are no specific antidotes.
Consider emesis and/or activated charcoal (60 to 100 grams in
adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).
Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
There is limited experience with meloxicam overdosage.
Cholestyramine is known to accelerate the clearance of meloxicam.
Accelerated removal of meloxicam by 4 g oral doses of cholestyramine given three times a day was demonstrated in a clinical trial.
Administration of cholestyramine may be useful following an overdosage.
For additional information about overdosage treatment, call a poison control center (1-800-222-1222).

Quoted from the official label, section “Overdosage”.

Side effects

The following adverse reactions are discussed in greater detail in other sections of the labeling:
Cardiovascular Thrombotic Events [see Boxed Warningand Warnings and Precautions (5.1)] GI Bleeding, Ulceration, and Perforation [see Boxed Warningand 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) [seeWarnings and Precautions (5.10)] Fetal Toxicity [seeWarnings and Precautions (5.11)] Hematologic Toxicity [see Warnings and Precautions (5.12)]
6.1 Clinical Trials Experience 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.
Adults Osteoarthritis and Rheumatoid Arthritis The meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with meloxicam 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with meloxicam 15 mg/day.
Meloxicam at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year.
Approximately 10,500 of these patients were treated in ten placebo and/or active-controlled osteoarthritis trials and 2363 of these patients were treated in ten placebo and/or active-controlled rheumatoid arthritis trials.
Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across meloxicam trials.
A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of meloxicam with placebo and with an active control.
Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of meloxicam with placebo.
Table 1a depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.
Table 1b depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials. [table1a] [table1b] The adverse events that occurred with meloxicam in ≥2% of patients treated short-term (4 to 6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2. [table2] Higher doses of meloxicam (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of meloxicam should not exceed 15 mg.
Pediatrics Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA) Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to meloxicam with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials.
These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study.
The adverse events observed in these pediatric studies with meloxicam were similar in nature to the adult clinical trial experience, although there were differences in frequency.
In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials.
Rash was reported in seven (<2%) patients receiving meloxicam.
No unexpected adverse events were identified during the course of the trials.
The adverse events did not demonstrate an age or gender-specific subgroup effect.
The following is a list of adverse drug reactions occurring in <2% of patients receiving meloxicam in clinical trials involving approximately 16,200 patients. [bodywhole]
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of meloxicam.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors:
(1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug.
Adverse reactions reported in worldwide postmarketing experience or the literature include:
acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure;
Stevens-Johnson syndrome; fixed drug eruption (FDE); toxic epidermal necrolysis, and infertility female.

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

Meloxicam tablets, USP 7.5 mg:
light yellow, round, biconvex, uncoated tablets, debossed with “C74” on one side and plain on the other side. 15 mg:
light yellow, round, biconvex, uncoated tablets, debossed with “C75” on one side and plain on the other side.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Meloxicam Tablets, USP are supplied as follows:
Meloxicam Tablets, USP 7.5 mg are light yellow, round, biconvex, uncoated tablets, debossed with “C74” on one side and plain on the other side.
Bottles of 30 NDC 53225-3075-1 Bottles of 60 NDC 53225-3075-2 Bottles of 90 NDC 53225-3075-3 Bottles of 100 NDC 53225-3075-4 Bottles of 120 NDC 53225-3075-5 Bottles of 500 NDC 53225-3075-6 Bottles of 1000 NDC 53225-3075-7 Meloxicam Tablets, USP 15 mg are light yellow, round, biconvex, uncoated tablets, debossed with “C75” on one side and plain on the other side.
Bottles of 30 NDC 53225-3015-1 Bottles of 60 NDC 53225-3015-2 Bottles of 90 NDC 53225-3015-3 Bottles of 100 NDC 53225-3015-4 Bottles of 120 NDC 53225-3015-5 Bottles of 30 NDC 72189-684-30 Bottles of 1000 NDC 53225-3015-7

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Keep in a dry place.
Dispense in a tight, light resistant, child-resistant container as defined in the USP.
Keep this and all medications out of the reach of children.

Quoted from the official label, section “Storage and Handling”.

What is in it

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID).
Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration.
Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide.
The molecular weight is 351.4.
Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. [Chemical Structure] Meloxicam is a pale-yellow powder, practically insoluble in water, with higher solubility observed in strong acids and bases.
It is very slightly soluble in methanol.
Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4.
Meloxicam has pKa values of 1.1 and 4.2.
Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.
The inactive ingredients in Meloxicam tablets, USP include colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium bicarbonate.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (41)

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Netherlands2 matching products

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Details

Made by	Direct_Rx
Active substance	Meloxicam
Used in	Muscles, joints and bones
Strength	15 mg
Form	Tablet
Route	Oral
Packs	30 TABLET in 1 BOTTLE
NDC	72189-684

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

85 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet79 products
- 7.5 mg38
  7.5 mg · 38 companies
  +30 more
- 15 mg41
  15 mg · 41 companies
  +33 more
Capsule4 products
- 5 mg2
  5 mg · 2 companies
  - ANI Pharmaceuticals, Inc.
  - Lupin Pharmaceuticals, Inc.
- 10 mg2
  10 mg · 2 companies
  - ANI Pharmaceuticals, Inc.
  - Lupin Pharmaceuticals, Inc.
Suspension2 products
- 7.5 mg/5mL2
  7.5 mg/5mL · 2 companies
  - Avondale Pharmaceuticals, LLC
  - Emerald Therapeutics, LLC

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Meloxicam7.5 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · Meloxicam Meloxicam15 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · Meloxicam Meloxicam7.5 mgPrescription onlyTablet AiPing Pharmaceutical, Inc · Meloxicam Meloxicam15 mgPrescription onlyTablet AiPing Pharmaceutical, Inc · Meloxicam Meloxicam7.5 mgPrescription onlyTablet Unichem Pharmaceuticals (USA), Inc. · Meloxicam Meloxicam15 mgPrescription onlyTablet Unichem Pharmaceuticals (USA), Inc. · Meloxicam

See every product with Meloxicam