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Mobic (MELOXICAM)
Meloxicam works by inhibiting the enzyme prostaglandin G/H synthase 2, which is involved in the production of prostaglandins that cause pain and inflammation.
Mobic (Meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID) developed by Boehringer Ingelheim, targeting prostaglandin G/H synthase 2. It is a small molecule modality, FDA-approved in 2000 for treating juvenile rheumatoid arthritis, osteoarthritis, and rheumatoid arthritis. Mobic is now off-patent with 24 generic manufacturers. Its half-life is 18 hours with 97% bioavailability. Key safety considerations include gastrointestinal and renal side effects.
At a glance
| Generic name | MELOXICAM |
|---|---|
| Sponsor | Boehringer Ingelheim |
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Target | Prostaglandin G/H synthase 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Mechanism of Action. Meloxicam is nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition.
Approved indications
- Juvenile rheumatoid arthritis
- Osteoarthritis
- Rheumatoid arthritis
Boxed warnings
- WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning . 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 ( 5.1 ) Meloxicam tablet is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) 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 ( 5.2 ) 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 ) ]. Meloxicam tablet is 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 ) ].
Common side effects
- Gastrointestinal
- Abdominal pain
- Diarrhea
- Dyspepsia
- Flatulence
- Nausea
- Dyspeptic signs and symptoms+
- Influenza-like illness
- Upper Respiratory tract infections-pathogen class unspecified+
- Joint related signs and symptoms+
- Headaches NOS
- Rash NOS
Drug interactions
- fluconazole
- voriconazole
- warfarin
Key clinical trials
- Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis (NA)
- Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement (PHASE3)
- Comparison of Mesotherapy Treatment Doses in Patients With Chronic Non-Specific Neck Pain (NA)
- Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2) (PHASE3)
- Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia (PHASE2)
- Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery (PHASE2)
- Phase 2B Upper Extremity Nerve Block Study (PHASE2)
- Bunionectomy Study for Postoperative Analgesia (EPOCH 1) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9808468 | 2035-03-31 | Method of Use |
| 10709713 | 2030-05-26 | Method of Use |
| 11458145 | 2039-03-08 | Method of Use |
| 10881663 | 2039-03-08 | Method of Use |
| 11253478 | 2030-05-26 | Formulation |
| 8545879 | 2030-08-31 | Formulation |
| 9974746 | 2030-05-26 | Formulation |
| 9526734 | 2033-03-31 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |