Meloxicam (Mobic)
meloxicam
Indications
| Indication | Approved Population | Therapy Type | Status |
|---|---|---|---|
| Osteoarthritis | Adults | Monotherapy | FDA Approved |
| Rheumatoid arthritis | Adults | Monotherapy or adjunctive with DMARDs | FDA Approved |
| Juvenile rheumatoid arthritis (pauciarticular & polyarticular) | ≥2 years (suspension); ≥60 kg (tablets) | Monotherapy or adjunctive | FDA Approved |
Meloxicam is a preferential (but not fully selective) COX-2 inhibitor belonging to the oxicam class of NSAIDs. At therapeutic doses, it inhibits COX-2 to a greater extent than COX-1, positioning it between fully selective coxibs like celecoxib and non-selective agents like naproxen. Its long half-life of 15–20 hours enables convenient once-daily dosing. Meloxicam was the 27th most commonly prescribed medication in the United States in 2023, with over 20 million prescriptions. Unlike celecoxib, meloxicam is not a sulfonamide and has no sulfonamide allergy contraindication.
Acute gout flares — Meloxicam 15 mg daily has been used for acute gout, though it lacks the rapid-onset advantage of indomethacin or naproxen. Evidence quality: Low.
Perioperative analgesia (ERAS protocols) — Oral or IV meloxicam (Anjeso 30 mg IV) is used as part of multimodal opioid-sparing strategies in surgical settings. Evidence quality: Moderate.
Chronic low back pain — NSAIDs including meloxicam are recommended as first-line pharmacotherapy by ACP guidelines. Evidence quality: Moderate.
Dosing
Adult Dosing by Clinical Scenario
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| Osteoarthritis — chronic symptom management | 7.5 mg once daily | 7.5–15 mg once daily | 15 mg/day | Titrate to 15 mg/day if additional benefit required; may be taken without regard to meals Use lowest effective dose for shortest duration |
| Rheumatoid arthritis — active disease | 7.5 mg once daily | 7.5–15 mg once daily | 15 mg/day | Adjust dose based on clinical response; does not alter disease course — use alongside DMARDs Once-daily dosing supported by 15–20 h half-life |
| Haemodialysis patients | 7.5 mg once daily | 7.5 mg once daily | 7.5 mg/day | Maximum 7.5 mg/day; meloxicam is not dialysable Avoid in severe renal impairment not on dialysis |
Pediatric Dosing
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| JRA (≥2 years, oral suspension) | 0.125 mg/kg once daily | 0.125 mg/kg once daily | 7.5 mg/day | Weight-based dosing using oral suspension (7.5 mg/5 mL); no additional benefit at higher doses in paediatric trials Suspension contains sorbitol — do not co-administer with sodium polystyrene sulfonate (risk of intestinal necrosis) |
| JRA (≥60 kg, Mobic tablets) | 7.5 mg once daily | 7.5 mg once daily | 7.5 mg/day | Tablets should not be used in children <60 kg; no additional benefit from 15 mg in clinical trials Tablets are NOT interchangeable with other meloxicam formulations at same mg strength |
Mobic tablets have not demonstrated equivalent systemic exposure to other approved oral meloxicam formulations (including Vivlodex capsules 5/10 mg and generic capsules), even when the milligram strength is the same. Different formulations should not be substituted for one another. Vivlodex, a lower-dose formulation using SoluMatrix Fine Particle Technology, is approved only for OA pain at 5–10 mg/day — different from Mobic’s 7.5–15 mg/day range. Always verify which formulation the patient is receiving.
Special Population Adjustments
| Population | Adjustment | Rationale |
|---|---|---|
| Mild–moderate hepatic impairment | No dose adjustment required | PK not significantly altered in Child-Pugh I–II; protein binding unaffected |
| Severe hepatic impairment (Child-Pugh C) | Not adequately studied; use with caution | No controlled data available |
| Severe renal impairment | Not recommended | Metabolites excreted renally; may hasten renal dysfunction |
| Haemodialysis | Max 7.5 mg/day | Meloxicam is not dialysable; dose cap based on PK data |
| Elderly (≥65 years) | Start at 7.5 mg; elderly females have 47% higher AUC vs younger females | Increased GI, CV, and renal risk; elderly females show higher exposure (vs younger females) but similar adverse event profile to elderly males |
Pharmacology
Mechanism of Action
Meloxicam is an enolic acid (oxicam) derivative that preferentially inhibits cyclooxygenase-2 (COX-2) over COX-1 at therapeutic concentrations, though it is not as COX-2 selective as celecoxib. This preferential COX-2 inhibition reduces inflammatory prostaglandin synthesis at sites of pain and inflammation while producing somewhat less disruption of COX-1-mediated gastroprotective prostaglandins than fully non-selective agents. However, at higher doses, this selectivity diminishes. Meloxicam also demonstrates analgesic and antipyretic activity through peripheral and central prostaglandin synthesis inhibition. A notable pharmacokinetic feature is biliary recycling, which produces a secondary plasma concentration peak at 12–14 hours post-dose and contributes to its extended duration of action.
ADME Profile
| Parameter | Value | Clinical Implication |
|---|---|---|
| Absorption | Bioavailability 89% (absolute); Tmax 4–5 h (fasted), 5–6 h (with food); high-fat meal increases Cmax ~22% but does not affect AUC; linear PK across 7.5–30 mg | Almost complete absorption; may be taken with or without food; prolonged absorption due to low solubility contributes to extended half-life; antacids do not affect absorption |
| Distribution | Vss ~10 L; ~99.4% albumin-bound (decreases to ~99% in renal disease); synovial fluid penetration 40–50% of plasma; RBC penetration <10% | Low Vd indicates confinement primarily to plasma; high synovial fluid penetration supports efficacy for joint inflammation; free fraction increases in renal impairment |
| Metabolism | CYP2C9 (major) and CYP3A4 (minor) to 5’-hydroxymethyl metabolite, then to 5’-carboxymethyl metabolite; 4 inactive metabolites total; biliary recycling produces secondary plasma peak at 12–14 h | CYP2C9 polymorphisms may alter exposure (caution in poor metabolisers); CYP2C9 inhibitors (e.g., fluconazole, voriconazole) increase meloxicam AUC; cholestyramine accelerates elimination |
| Elimination | t½ 15–20 h; clearance 7–9 mL/min; excreted equally in urine and faeces (as metabolites); <0.25% unchanged in urine; steady state in 3–5 days; not dialysable | Long half-life supports once-daily dosing; steady state in <1 week; metabolite accumulation possible in renal impairment; gender variation: females t½ ~19.5 h vs males ~23.4 h (single dose); clinically insignificant |
Side Effects
Data from Phase 2/3 trials including 10,122 OA patients and 1,012 RA patients at 7.5 mg/day, and 3,505 OA and 1,351 RA patients at 15 mg/day. Most common adverse events (≥5% and greater than placebo) were diarrhoea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms (FDA PI, revised 11/2024). Note: headache was reported at 7.8–8.3% but was lower than placebo (10.2%) and is not considered drug-related.
| Adverse Effect | Incidence (7.5 mg / 15 mg) | Clinical Note |
|---|---|---|
| Diarrhoea | 7.8% / 3.2% (vs 3.8% placebo, OA trial) | More common at 7.5 mg in OA trial; evaluate for GI complications if persistent or bloody |
| Upper respiratory tract infection | 3.2% / 1.9% (OA); 7.0% / 6.5% (RA) (vs 1.9% OA; 4.1% RA placebo) | Consistently elevated across trials; usually self-limiting |
| Dyspepsia | 4.5% / 4.5% (OA); 5.8% / 4.0% (RA) (vs 4.5% OA; 3.8% RA placebo) | Lower than diclofenac (6.5%) in head-to-head OA comparisons; co-prescribe PPI if high-risk |
| Influenza-like symptoms | 4.5% / 5.8% (OA); 2.9% / 2.3% (RA) (vs 5.1% OA; 2.1% RA placebo) | Borderline difference from placebo; may overlap with underlying inflammatory disease symptoms |
| Peripheral edema | 1.9% / 4.5% (vs 2.5% placebo, OA trial) | Dose-related (4.5% at 15 mg); monitor weight and BP; use caution in heart failure |
| Nausea | 3.9% / 3.8% (OA); 3.3% / 3.8% (RA) (vs 3.2% OA; 2.6% RA placebo) | Marginally higher than placebo; take with food if troublesome |
| Abdominal pain | 1.9% / 2.6% (OA); 2.9% / 2.3% (RA) (vs 2.5% OA; 0.6% RA placebo) | Evaluate if persistent or worsening; may signal developing ulceration |
| Dizziness | 2.6% / 3.8% (vs 3.2% placebo, OA trial) | Similar to or less than placebo in OA; advise caution with driving at initiation |
| Flatulence | 3.2% / 3.2% (vs 4.5% placebo, OA trial) | Lower than placebo; NSAID class effect; generally mild |
| Rash | 2.6% / 0.6% (OA); 1.0% / 2.1% (RA) (vs 2.5% OA; 1.7% RA placebo) | Discontinue immediately if progressing; evaluate for SJS/TEN/DRESS |
| Adverse Effect | Estimated Frequency | Typical Onset | Required Action |
|---|---|---|---|
| Cardiovascular thrombotic events (MI, stroke) | NSAID class risk; may begin early in treatment | First weeks; increases with dose and duration | Use lowest effective dose for shortest duration; avoid post-CABG; monitor CV symptoms |
| GI bleeding, ulceration, perforation | ~1% at 3–6 months; 2–4% at 1 year (NSAID class) | Any time; without warning | Discontinue immediately; urgent endoscopy; haemodynamic support |
| Hepatotoxicity (severe) | Rare; ALT/AST ≥3× ULN in ~1%; <3× ULN in up to 15% | Weeks to months | Discontinue if symptomatic or ≥3× ULN; hepatic workup |
| Acute kidney injury / renal papillary necrosis | Uncommon; higher in dehydrated/elderly or with concurrent nephrotoxics | Days to weeks | Discontinue; IV hydration; monitor creatinine; correct volume status before initiating |
| Severe skin reactions (SJS, TEN, FDE/GBFDE, DRESS) | Very rare | 1–8 weeks; FDE may recur at same site | Discontinue immediately; dermatology referral; permanent discontinuation; FDE added to PI 11/2024 |
| Anaphylactoid reactions | Very rare | Minutes to hours | Emergency management; permanent discontinuation |
| Heart failure exacerbation | ~2-fold increased hospitalisation (NSAID class) | Days to weeks | Avoid in severe HF; monitor fluid balance; discontinue if decompensation |
| Agranulocytosis | Very rare (postmarketing) | Variable | Discontinue; CBC with differential; haematology referral |
The FDA updated the meloxicam label in November 2024 to include fixed drug eruption (FDE) and its severe variant, generalised bullous FDE (GBFDE), as a potential serious skin reaction. FDE typically presents as recurring well-demarcated erythematous or violaceous patches at the same anatomical site with each drug re-exposure. GBFDE can be life-threatening. Discontinue meloxicam immediately if FDE is suspected and do not rechallenge.
Drug Interactions
Meloxicam is a CYP2C9 substrate with minor CYP3A4 involvement. It undergoes biliary recycling which is accelerated by cholestyramine. Meloxicam does not significantly affect the pharmacokinetics of warfarin or methotrexate at standard doses, but pharmacodynamic interactions (bleeding, renal) remain clinically important.
Monitoring
- Blood PressureBaseline, 2–4 weeks, then periodically
RoutineNSAIDs including meloxicam can elevate BP. Monitor more frequently in patients on antihypertensives or with CV risk factors. - Renal FunctionBaseline, then q6–12 months
RoutineSerum creatinine, BUN, eGFR. Meloxicam metabolites are renally excreted. Check within 1–2 weeks in high-risk patients. - Hepatic FunctionBaseline; then if symptoms
Trigger-basedALT/AST elevation <3× ULN may occur in up to 15% of NSAID users; ≥3× ULN in ~1%. Discontinue if symptomatic or persistent elevation. - CBCBaseline; then if signs of anaemia or bleeding
Trigger-basedMonitor Hb/Hct for occult GI blood loss; agranulocytosis reported postmarketing (very rare). - GI SymptomsEvery visit
RoutineAsk about dyspepsia, abdominal pain, dark stools, haematemesis. Low threshold for endoscopy if new symptoms. - CV SymptomsEvery visit
RoutineScreen for chest pain, dyspnoea, fluid retention, oedema. Reassess risk-benefit periodically. - SkinEvery visit; urgently if rash
Trigger-basedScreen for fixed drug eruption (recurring patches at same site), SJS/TEN (blistering, mucosal erosion), and DRESS (fever, rash, eosinophilia).
Contraindications & Cautions
Absolute Contraindications
- Known hypersensitivity to meloxicam or any component, including history of anaphylaxis or serious skin reactions
- Aspirin-exacerbated respiratory disease (AERD) — history of asthma, urticaria, or allergic reactions after aspirin or other NSAIDs
- Peri-operative CABG surgery setting
- Pregnancy ≥30 weeks gestation — risk of premature ductus arteriosus closure and fetal renal dysfunction
- Previous serious skin reaction to any NSAID
Relative Contraindications (Specialist Input Recommended)
- Severe renal impairment — not recommended; metabolites excreted renally
- Active peptic ulcer or recent GI bleed — mandatory PPI if NSAID essential
- Severe heart failure (NYHA III–IV) — risk of decompensation
- Pregnancy 20–30 weeks — limit use; risk of oligohydramnios
- Concurrent pemetrexed (CrCl <45 mL/min) — contraindicated per PI
Use with Caution
- Elderly (≥65 years) — increased GI, CV, renal risk; start at 7.5 mg; elderly females have 47% higher AUC
- Known CV disease or risk factors — lowest dose, shortest duration
- Mild–moderate hepatic impairment — no dose change needed but monitor LFTs
- Concurrent anticoagulants, SSRIs, corticosteroids — additive bleeding risk
- Asthma (without aspirin sensitivity) — monitor for bronchospasm
- Dehydration or hypovolaemia — correct volume status before starting
Cardiovascular Thrombotic Events: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may begin early in treatment and increase with duration of use. Meloxicam is contraindicated in the setting of CABG surgery.
Gastrointestinal Bleeding, Ulceration, and Perforation: NSAIDs cause an increased risk of serious 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 without warning. Elderly patients and those with prior peptic ulcer disease or GI bleeding are at greater risk.
Patient Counselling
Purpose of Therapy
Meloxicam reduces pain, swelling, and stiffness caused by arthritis by blocking inflammatory chemicals in the body. It is taken once daily and is not a cure for arthritis but helps manage symptoms to improve daily functioning. Use at the lowest effective dose for the shortest time needed.
How to Take
Take once daily at the same time each day, with or without food. Swallow tablets whole with water. For children on oral suspension, measure carefully with the dosing syringe provided. Do not combine with other NSAID products (ibuprofen, naproxen, aspirin for pain). Different brands of meloxicam are not interchangeable even at the same dose.
Sources
- Mobic (meloxicam) tablets — Full Prescribing Information. Revised 11/2024. U.S. FDA Reference ID: 5482828. accessdata.fda.govPrimary source for all approved indications, dosing, adverse reactions (Tables 1a and 1b), contraindications, and boxed warning cited throughout this monograph.
- Meloxicam oral suspension — Full Prescribing Information. Revised 2024. accessdata.fda.govSource for suspension-specific data including JRA dosing (0.125 mg/kg/day) and sorbitol interaction with sodium polystyrene sulfonate.
- Vivlodex (meloxicam) capsules — Full Prescribing Information. dailymed.nlm.nih.govSource for low-dose SoluMatrix formulation data (5–10 mg); documents non-interchangeability with Mobic tablets.
- Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis. N Engl J Med. 2016;375(26):2519–2529. doi:10.1056/NEJMoa1611593PRECISION trial: key NSAID cardiovascular safety comparator; meloxicam not directly studied but provides context for NSAID-class CV risk assessment.
- Bhala N, Emberson J, Merhi A, et al. (CNT Collaboration). Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs. Lancet. 2013;382(9894):769–779. doi:10.1016/S0140-6736(13)60900-9Individual participant data meta-analysis providing NSAID-class CV and GI risk estimates, including heart failure hospitalisation data.
- Hawkey C, Kahan A, Steinbrück K, et al. Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients. Br J Rheumatol. 1998;37(9):937–945. doi:10.1093/rheumatology/37.9.937MELISSA trial: large-scale GI tolerability comparison (N=9,323) demonstrating favourable GI profile of meloxicam 7.5 mg vs diclofenac 100 mg.
- Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis. Arthritis Care Res. 2020;72(2):149–162. doi:10.1002/acr.24131Conditionally recommends oral NSAIDs including meloxicam for OA; advises lowest effective dose and shortest duration.
- Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive treatments for acute, subacute, and chronic low back pain. Ann Intern Med. 2017;166(7):514–530. doi:10.7326/M16-2367ACP guideline recommending NSAIDs as first-line pharmacotherapy for acute and chronic low back pain.
- Engelhardt G, Homma D, Schlegel K, et al. Anti-inflammatory, analgesic, antipyretic and related properties of meloxicam. Inflamm Res. 1995;44(10):423–433. doi:10.1007/BF01757699Foundational pharmacological characterisation of meloxicam’s preferential COX-2 inhibition and GI tolerability in preclinical models.
- Chesné C, Guyomard C, Guillouzo A, et al. Metabolism of meloxicam in human liver involves cytochromes P4502C9 and 3A4. Xenobiotica. 1998;28(1):1–13. doi:10.1080/004982598239704In vitro study establishing CYP2C9 as the major and CYP3A4 as the minor enzyme in meloxicam biotransformation.
- Turck D, Roth W, Busch U. A review of the clinical pharmacokinetics of meloxicam. Br J Rheumatol. 1996;35(Suppl 1):13–16. doi:10.1093/rheumatology/35.suppl_1.13Definitive PK review covering absolute bioavailability (89%), Vd (~10 L), half-life (15–20 h), protein binding (~99.4%), and biliary recycling.
- Boulton DW, Kollia GD, Haber EB, Mojaverian P. Population pharmacokinetic analysis of meloxicam in rheumatoid arthritis patients. Br J Clin Pharmacol. 2002;53(3):333. doi:10.1046/j.1365-2125.2002.01557.xPopulation PK analysis confirming clearance 7–8 mL/min, t½ ~20 h, and effects of sulphasalazine and glucocorticoids on meloxicam clearance in RA.
- Bae JW, Kim JH, Choi CI, et al. Effects of CYP2C9*1/*13 on the pharmacokinetics and pharmacodynamics of meloxicam. Br J Clin Pharmacol. 2011;71(4):550–555. doi:10.1111/j.1365-2125.2010.03853.xDemonstrates that CYP2C9*1/*13 genotype decreases meloxicam metabolism by 62%, supporting pharmacogenomic caution in variant carriers.
- Meloxicam. In: Drugs and Lactation Database (LactMed). Bethesda, MD: National Institute of Child Health and Human Development; Updated Jul 15, 2025. ncbi.nlm.nih.govConfirms no human breastfeeding data available for meloxicam; recommends other agents (ibuprofen, celecoxib) as preferred alternatives.