Meloxicam is an active pharmaceutical ingredient in the Oxicams group (M01AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised February 20, 2026[1]
Short-term symptomatic treatment of exacerbations of osteoarthrosis. Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.
How to take
GB
CACanada· Health Canada
10 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS .........................................................................................
5 ADVERSE REACTIONS ......................................................................................................... 16 DRUG INTERACTIONS .........................................................................................................
22 DOSAGE AND ADMINISTRATION ..................................................................................... 28 OVERDOSAGE .......................................................................................................................
29 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 29 STORAGE AND STABILITY ................................................................................................. 34 DOSAGE FORMS, COMPOSITION AND PACKAGING .....................................................
USUnited States· FDA
7 products
Uses
USOfficial regulatory label· revised August 8, 2024[3]
1 )] . 1 )] . 2 )] .
How to take
USOfficial regulatory label· revised August 8, 2024
Drug interactions
Known interactions involving Meloxicam. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 556. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL492550022 · revised February 20, 2026
[2]Health Canada (DPD) · 02258315 · revised March 22, 2025
[3]FDA DailyMed · 06a401f0-4380-40… · revised August 8, 2024 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
4). The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis. 5mg per day. If necessary, in the absence of improvement, the dose may be increased to 15 mg/day.
Rheumatoid arthritis, ankylosing spondylitis: 15mg per day (see also “Special populations”). 5mg per day. DO NOT EXCEED THE DOSE OF 15mg per day. 5mg per day. 4). 5mg per day. e. patients with a creatinine clearance of greater than 25ml/min).
3). 3). 3). Method of administration For oral use. The total daily amount should be taken as a single dose, with water or another liquid, during a meal.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]
4). Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. The most commonly-observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration. Less frequently, gastritis has been observed.
4). The frequencies of adverse drug reactions given below are based on corresponding occurrences of reported adverse events in 27 clinical trials with a treatment duration of at least 14 days. 5 or 15mg meloxicam tablets or capsules over a period of up to one year.
Adverse drug reactions that have come to light as a result of reports received in relation to administration of the marketed product are included.
The frequency grouping is defined using the following convention:
Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4), flushing Respiratory, thoracic and mediastinal disorders Rare Asthma in individuals allergic to aspirin or other NSAIDs Very Common Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea Uncommon Occult or macroscopic gastrointestinal haemorrhage2, stomatitis, gastritis, eructation Rare Colitis, gastroduodenal ulcer2, oesophagitis Very rare Gastrointestinal perforation2 Gastrointestinal disorders Not known Pancreatitis MeDRA System Organ Class Frequency Adverse Reaction Uncommon Liver function disorders (eg raised transaminases or bilirubin)Hepatobiliary disorders Very Rare Hepatitis.
5). 4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]
2 and GI and cardiovascular risks below). The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect, nor should an additional NSAID be added to the therapy because this may increase the toxicity while therapeutic advantage has not been proven.
5). Meloxicam is not appropriate for the treatment of patients requiring relief from acute pain. In the absence of improvement after several days, the clinical benefit of the treatment should be reassessed. Any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their total cure before starting treatment with meloxicam.
Attention should routinely be paid to the possible onset of a recurrence in patients treated with meloxicam and with a past history of this type. Gastrointestinal effects Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
5). When gastrointestinal bleeding or ulceration occurs in patients receiving Meloxicam, the treatment should be withdrawn. 8). Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical monitoring of blood pressure for patients at risk is recommended at baseline and especially during treatment initiation with Meloxicam. Clinical trial and epidemiological data suggest that use of some NSAIDs including meloxicam (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk for meloxicam. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with meloxicam after careful consideration.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised February 20, 2026[1]
g. 6); − Children and adolescents aged under 16 years; − Meloxicam should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other NSAID’s; − Severely impaired liver function; − Non-dialysed severe renal failure; − Gastrointestinal bleeding, history of cerebrovascular bleeding or other bleeding disorders; − History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; − Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); − Severe heart failure
This is not medical advice. Consult a qualified healthcare professional.
34 PART II: SCIENTIFIC INFORMATION ............................................................................... 35 PHARMACEUTICAL INFORMATION ................................................................................. 35 CLINICAL TRIALS .................................................................................................................
39 REFERENCES ......................................................................................................................... 40 PART III: CONSUMER INFORMATION..............................................................................
5 mg & 15 mg Crospovidone, colloidal silica dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dehydrate. INDICATIONS AND CLINICAL USE TEVA-MELOXICAM (meloxicam) is indicated for the symptomatic treatment of: • Rheumatoid arthritis in adults, and • Painful osteoarthritis (arthrosis, degenerative joint disease) in adults Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2 inhibitor NSAIDs, unless otherwise indicated.
For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). Use of TEVA-MELOXICAM should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
TEVA-MELOXICAM, as a NSAID, does NOT treat clinical disease or prevent its progression. TEVA-MELOXICAM, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.
Geriatrics (> 65 years of age):
Evidence from clinical studies and post-market experience suggests that use in the geriatric population is associated with differences in safety (see WARNINGS AND PRECAUTIONS - Special Populations – Geriatrics and DOSAGE AND ADMINISTRATION – Recommended Dose and Dosage Adjustment – Geriatrics (> 65 years of age)).
TEVA-MELOXICAM – Product Monograph Page 4 of 47 Pediatrics (< 18 years of age):
Safety and efficacy have not been established in the pediatric population. TEVA-MELOXICAM is CONTRAINDICATED in this population. CONTRAINDICATIONS TEVA-MELOXICAM is contraindicated in: • the peri-operative setting of coronary artery bypasses graft surgery (CABG).
Although meloxicam has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/ thromboembolic events, deep surgical infections and sternal wound complications.
• during the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus, and prolonged parturition. • women who are breastfeeding because of the potential for serious adverse reactions in nursing infants.
NSAIDs are known to pass into mother’s milk. • individuals with severe uncontrolled heart failure; • individuals with known or suspected hypersensitivity to meloxicam or to any of the components/excipients. • individuals with a history of acute asthmatic attacks or symptoms of asthma, urticaria, nasal polyps, anaphylaxis, rhinitis, angioedema or other allergic manifestations that are precipitated by ASA or other NSAIDs, because of a potential for cross-sensitivity.
Fatal anaphylactoid reactions may occur in such individuals. Individuals with the above medical problem are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction. (See WARNINGS AND PRECAUTIONS – Hypersensitivity Reactions – Anaphylactoid Reactions, ASA-Intolerance).
• individuals with active or recent gastro-intestinal/gastric/duodenal/peptic ulceration/perforation, active GI bleeding; • individuals with cerebrovascular bleeding or other bleeding disorders; • inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis); • individuals with severe liver impairment or active liver disease.
5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of […]
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
g. 5 mg once daily (see WARNINGS AND PRECAUTIONS). The maximum recommended daily dose of TEVA-MELOXICAM tablets is 15 mg. Recommended Dose and Dosage Adjustment Use of TEVA-MELOXICAM is restricted to adults 18 years of age and older and should be limited to the lowest effective dose for the shortest possible duration of treatment (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
5 mg once daily. If necessary, the dose may be increased to 15 mg once daily. Rheumatoid arthritis: 15 mg once daily. 5 mg once daily. TEVA-MELOXICAM may be taken without regard to timing of meals.
Hepatic Impairment:
No dose adjustment is necessary in patients with mild to moderate hepatic insufficiency. TEVA-MELOXICAM is contraindicated in patients with severe liver impairment or active liver disease. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS - Hepatic/Biliary/Pancreatic and ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions – Hepatic Insufficiency.
50 mL/s). 5 mL/sec) or deteriorating renal disease (see CONTRAINDICATIONS). 5 mg/day. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS – Renal and ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions – Renal Insufficiency.
TEVA-MELOXICAM – Product Monograph Page 29 of 47 Geriatrics (> 65 years of age):
For elderly, frail or debilitated patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS – General and Special Populations - Geriatrics and ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions – Geriatrics.
Missed Dose If a dose is missed, the usual schedule must be resumed the following day. An extra dose must not be taken. OVERDOSAGE There is limited experience with meloxicam overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered.
Cholestyramine is known to accelerate the clearance of meloxicam. Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care.
Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed with symptomatic and supportive care following an NSAID overdose. In cases of acute overdose, gastric lavage followed by activated charcoal is recommended. Gastric lavage performed more than one hour after overdose has little benefit in the treatment of overdose.
Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. Accelerated removal of meloxicam by 4 gm oral doses of cholestyramine given three times a day was demonstrated in a clinical trial.
Administration of cholestyramine may be useful following an overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For management of a suspected drug overdose, contact your regional poison control centre.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action TEVA-MELOXICAM – Product Monograph Page 30 of 47 Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in animals.
Meloxicam showed potent anti-inflammatory activity in all standard models of inflammation. NSAIDs are believed to exert their pharmacologic effects primarily through inhibition of the enzyme cyclooxygenase (COX). In turn, inhibition of this enzyme leads to an inhibition of biosynthesis of prostaglandins and other autacoids, substances which are potent biological mediators involved in diverse physiologic functions as well as pathologic conditions.
To date, two isozymes of COX have been identified and characterized, namely, COX- 1 and COX-2 which have different intrinsic properties, expression controls and localization. COX-1, the constitutive form, has been described as a constitutive enzyme occurring in many tissues including the gastrointestinal tract, kidney, lungs, brain and platelets.
COX-1 is found in blood vessels, platelets, stomach and kidney. In contrast, COX-2, the inducible form, is mostly an inducible enzyme, limited in distribution and expressed in high levels in inflamed tissues. COX- 2 is thought to be involved in inflammatory responses.
Recent studies have shown that differential inhibition of these two isozymes is associated with a different biological profile. Meloxicam has shown a selective inhibition of COX-2 in several in vitro test systems, as demonstrated by a greater dose dependent inhibition of COX-2 over COX-1 at levels similar to those seen in plasma at therapeutic steady state concentrations.
The prostaglandins produced by the cyclooxygenases are not the only factors involved in the protection of the gastric mucosa. A human pharmacology […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
Risk of Cardiovascular (CV) Adverse Events:
Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (see WARNINGS AND PRECAUTIONS – Cardiovascular). TEVA-MELOXICAM is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal.
The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Caution should be exercised in prescribing TEVA-MELOXICAM to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV).
Use of NSAIDs, such as TEVA-MELOXICAM, can promote sodium retention in a dose- dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure (see WARNINGS AND PRECAUTIONS – Renal – Fluid and Electrolyte Balance).
Randomized clinical trials with meloxicam have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing TEVA-MELOXICAM. Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS – Gastrointestinal) Use of NSAIDs, such as TEVA-MELOXICAM, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).
Risk in Pregnancy:
Caution should be exercised in prescribing TEVA-MELOXICAM during the first and second trimesters of pregnancy. Use of NSAIDS at approximately 20 weeks of gestation or later may cause fetal renal dysfunction leading to oligohydramnios and neonatal renal impairment or failure (see WARNINGS AND PRECAUTIONS).
TEVA-MELOXICAM is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see CONTRAINDICATIONS). General For relevant drug interactions that require particular attention, see DRUG INTERACTIONS section.
TEVA-MELOXICAM – Product Monograph Page 6 of 47 Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration.
As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
TEVA-MELOXICAM is NOT recommended for use with other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (see DRUG INTERACTIONS – Drug/Drug Interactions - Acetylsalicylic Acid (ASA) or other NSAIDs).
4 mg lactose per maximum recommended daily dose. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine. 7 mg lactose per maximum recommended daily dose.
Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine. Carcinogenesis and Mutagenesis See TOXICOLOGY section. Cardiovascular TEVA-MELOXICAM is a non-steroidal anti-inflammatory drug (NSAID).
Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Caution should be exercised in prescribing TEVA-MELOXICAM to patients with risk factors for cardiovascular disease, cerebrovascular disease or renal disease, such as any of the following (NOT an exhaustive list): • Hypertension • Dyslipidemia/Hyperlipidemia • Diabetes Mellitus • Congestive Heart Failure (NYHA I) • Coronary Artery Disease (Atherosclerosis) • Peripheral Arterial Disease • Smoking • Creatinine Clearance (<60 mL/min or 1 mL/sec) TEVA-MELOXICAM – Product Monograph Page 7 of 47 Use of NSAIDs, such as TEVA-MELOXICAM, can lead to new hypertension or can worsen pre-existing hypertension, either of which may increase the risk of cardiovascular events as described above.
Thus blood pressure should be monitored regularly. Consideration should be given to discontinuing TEVA-MELOXICAM should hypertension either develop or worsen with its use. Use of NSAIDs, such as TEVA-MELOXICAM, can induce fluid retention and edema, and may exacerbate congestive heart failure, through a renally-mediated mechanism (see WARNINGS AND PRECAUTIONS – Renal – Fluid and Electrolyte Balance).
For patients with a high risk of developing an adverse CV event, other management strategies that do NOT include the use of NSAIDs should be considered first. To minimize the potential risk for an adverse CV event, the lowest effective dose should be used for the shortest possible duration.
Endocrine and Metabolism Corticosteroids:
TEVA-MELOXICAM is NOT a substitute for corticosteroids. It does NOT treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
, WARNINGS AND PRECAUTIONS - Advanced Renal Disease, DOSAGE AND ADMINISTRATION – Renal Impairment). In terminal renal failure, the increase in the volume of distribution may result in higher free meloxicam concentrations. 3% free fraction).
Hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. Meloxicam is not dialyzable. STORAGE AND STABILITY Store at controlled room temperature (15 - 30°C), safely out of the reach of children.
Store in a dry place. 5 mg meloxicam. 15 mg Tablets: Each pastel yellow, round, scored tablet, engraved with N on one side and 1│5 on the other side, contains 15 mg meloxicam. Each of the above strengths is available in unit dose, (2 x 5) cartons of 30 and HDPE bottles of 100.
Non-medicinal Ingredients: crospovidone, colloidal silica dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium citrate dehydrate. 4 g/mol Structural formula: Physicochemical properties: Meloxicam is a yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases.
It is very slightly soluble in methanol. 2. CLINICAL TRIALS Bioequivalence Study A single-dose, randomized, two-way, comparative bioavailability study was performed on Teva- Meloxicam 15 mg Tablets, and MobicoxTM 15 mg Tablets, in healthy adult male subjects, 19 to 54 years of age (inclusive), under fasting conditions.
66 (45) * Expressed as the arithmetic mean (CV%) only. ); purchased in Canada. Clinical Trials Randomized clinical trials with meloxicam have NOT been designed to detect differences in cardiovascular adverse events in a chronic setting.
Prospective, long-term studies required to compare the incidence of serious clinically significant upper gastrointestinal adverse events among patients taking meloxicam versus other NSAID products have not been performed. 181 The use of meloxicam for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a double-blind controlled trial involving a total of 774 patients randomized and treated with meloxicam (N=464), placebo (N=157) or diclofenac (N=153) for 12 weeks.
5 mg and 15 mg daily) was compared to placebo and diclofenac (100 mg) (refer to Table 5). The four primary endpoints were investigator’s global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function and stiffness) (refer to Table 6).
5 mg daily and meloxicam 15 mg daily showed significant improvement in each of these endpoints compared with placebo (refer to Table 6). 5 mg in the treatment of rheumatoid arthritis was also performed to investigate the full dose range of meloxicam in one trial (refer to Table 5).
5 mg, 15 mg, 22 mg) (N=536) or diclofenac (2 x 75 mg) (N=181) (refer to Table 5). Diclofenac 2 x 75 mg was included as active control to assess trial sensitivity. 5 mg were statistically superior to placebo in all primary endpoints, whereas 15 mg was statistically superior in three out of five primary endpoints (refer to Table 6).
Diclofenac was superior to placebo in four of the five primary endpoints. All active treatments were significantly superior to placebo in secondary endpoints such as withdrawal due to lack of efficacy, patient’s and investigator’s final global assessment of efficacy, the patient’s assessment of status with regard to a change in the arthritic condition and after adjustment for baseline also for the modified health assessment questionnaire.
5 mg may be a valuable dose for the treatment of RA but that acute flares might require a higher starting dose.
Study demographics and trial design Table 5:
Summary of Patient Demographics for Clinical Trials in Osteoarthritis and Rheumatoid Arthritis Study # […]
This is not medical advice. Consult a qualified healthcare professional.
1 General Dosing Instructions Carefully consider the potential benefits and risks of meloxicam tablets 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 tablets, adjust the dose to suit an individual patient's needs. In adults, the maximum recommended daily oral dose of meloxicam tablets is 15 mg regardless of formulation.
3 )] . Meloxicam tablets may be taken without regard to timing of meals. 5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. 5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
5 mg once daily in children who weigh ≥60 kg. 5 mg in clinical trials. Meloxicam tablets should not be used in children who weigh <60 kg. 5 Renal Impairment The use of meloxicam in subjects with severe renal impairment is not recommended.
3 )]. 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.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 2,932 reports total. [4]
Nausea 267
Drug Ineffective 261
Fatigue 251
Off Label Use 228
Arthralgia 227
Diarrhoea 209
Headache 200
Pruritus 199
Pain 191
Dyspnoea 171
Rash 165
Malaise 158
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised August 8, 2024[3]
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. gov/medwatch. 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.
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. Table 1a Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial Placebo Meloxicam 7 .
5 mg daily Meloxicam 15 mg daily Diclofenac 100 mg daily No . 0 Table 1b Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials Placebo Meloxicam 7 . 5 mg daily Meloxicam 15 mg daily No .
1 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. Table 2 Adverse Events (%) Occurring in ≥2% of Meloxicam Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials 4 to 6 Weeks Controlled Trials 6 Month Controlled Trials Meloxicam 7 .
5 mg daily Meloxicam 15 mg daily Meloxicam 7 . 5 mg daily Meloxicam 15 mg daily No . 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. 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.
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.
USOfficial regulatory label· Warnings and precautions· revised August 8, 2024[3]
5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. 3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. 7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Meloxicam is contraindicated in patients with aspirin-sensitive asthma.
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. 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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised August 8, 2024[3]
9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. 1 ) ] Known hypersensitivity to meloxicam or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). 8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Meloxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. • Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with the use of meloxicam.
• Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. progressive skin rash often with blisters or mucosal lesions) are present, meloxicam treatment should be discontinued.
• The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. • If the patient has developed SJS or TEN with the use of meloxicam, meloxicam must not be restarted in this patient at any time.
Parameters of liver and renal function As with most NSAIDs, occasional increases in serum transaminase levels, increases in serum bilirubin or other liver function parameters, as well as increases in serum creatinine and blood urea nitrogen and other laboratory disturbances, have been reported.
The majority of these instances involved transitory and slight abnormalities. Should any such abnormality prove significant or persistent, the administration of Meloxicam should be stopped and appropriate investigations undertaken. Functional renal failure NSAIDs, by […]
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 in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If meloxicam is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
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 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 ) ]. 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.
, nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). 3 ) ]. 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 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.
, diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [see Drug Interactions ( 7 )]. Avoid the use of meloxicam in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
If meloxicam is used in patients with severe heart failure, monitor patients for signs of worsening heart failure. 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 may hasten the progression of renal dysfunction in patients with preexisting renal disease. Because some meloxicam 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. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of meloxicam [see Drug Interactions ( 7 )].
No information is available from controlled clinical studies regarding the use of meloxicam in patients with advanced renal disease. Avoid the use of meloxicam in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function.
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.
8 )]. Seek emergency help if an anaphylactic reaction occurs. 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 is contraindicated in patients with this form of aspirin sensitivity [see Contraindications ( 4 )] . When meloxicam is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.
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 as generalized 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 tablet at the first appearance of skin rash or any other sign of hypersensitivity.
Meloxicam tablet is contraindicated in patients with previous serious skin reactions to NSAIDs [see Contraindications ( 4 )]. 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.
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 and evaluate the patient immediately. 11 Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus Avoid use of NSAIDs, including meloxicam, in pregnant women at about 30 weeks gestation and later.
NSAIDs, including meloxicam, 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, at about 20 weeks gestation or later in pregnancy may cause 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. 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 use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if meloxicam treatment extends beyond 48 hours.
1 )]. 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, may increase the risk of bleeding events. , 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 )].
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. 6 ) ].