{
 "query": "meloxicam",
 "ingredient": "meloxicam",
 "slug": "meloxicam",
 "rxcui": "41493",
 "brands": [
  "Anjeso",
  "Mobic",
  "Qamzova",
  "Qmiiz",
  "Vivlodex",
  "Xifyrm",
  "Zybic"
 ],
 "names": [
  "meloxicam"
 ],
 "classes": [
  {
   "id": "M01AC",
   "name": "Oxicams"
  }
 ],
 "alternatives": [
  "droxicam",
  "lornoxicam",
  "piroxicam",
  "tenoxicam"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 117,
   "INTRAVENOUS": 2,
   "INFILTRATION": 1
  },
  "boxed_warning": "WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions ( 5.1 )]. Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4.2 ) and Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [ see Warnings and Precautions ( 5.2 ) ]. WARNING: CARDIOVASCULAR and GASTROINTESTINAL RISKS See full prescribing information for complete boxed warning . Cardiovascular Risk NSAIDs may caus...",
  "indications_and_usage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3 ) 1.1 Osteoarthritis (OA) Meloxicam tablets, USP is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ( 14.1 ) ]. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ( 14.1 ) ]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets, USP is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [ see Clinical Studies ( 14.2 ) ].",
  "contraindications": "Known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam ( 4.1 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4.1 ) Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery ( 4.2 ) 4.1 Allergic Reactions Meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. Meloxicam should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.13 ) ]. 4.2 Coronary Surgery Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ].",
  "warnings_and_cautions": "Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk. ( 5.1 ) Serious gastrointestinal (GI) adverse events which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at higher risk for GI events, especially the elderly. ( 5.2 ) Elevated liver enzymes, and rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen. ( 5.3 ) New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment. ( 5.4 ) Fluid retention and edema. Should be used with caution in patients with fluid retention or heart failure. ( 5.5 ) Renal papillary necrosis and other renal injury with long-term use. Use with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists. The use of meloxicam in patients with severe renal impairment is not recommended. ( 5.6 ) Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS...",
  "warnings": "",
  "adverse_reactions": "Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular thrombotic events [ see Boxed Warning and Warnings and Precautions ( 5.1 )] Gastrointestinal effects \u2013 risk of GI ulceration, bleeding, and perforation [ see Boxed Warning and Warnings and Precautions ( 5.2 ) ] Hepatic effects [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Congestive heart failure and edema [see Warnings and Precautions ( 5.5 )] Renal effects [see Warnings and Precautions ( 5.6 )] Anaphylactoid reactions [ see Warnings and Precautions ( 5.7 )] Adverse skin reactions [see Warnings and Precautions ( 5.8 )] Most common (\u22655% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms ( 6.1 ) Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experien...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-approved Medication Guide Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. 17.1 Medication Guide Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using meloxicam. 17.2 Cardiovascular Effects NSAIDs including meloxicam may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [ see Warnings and Precautions ( 5.1 ) ]. 17.3 Gastrointestinal Effects NSAIDs including meloxicam, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without w...",
  "spl_medguide": "MEDICATION GUIDE MELOXICAM Tablets, USP Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: with longer use of NSAID medicines in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a \"coronary artery bypass graft (CABG).\" NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: can happen without warning symptoms may cause death The chance of a person getting an ulcer or bleeding increases with: taking medicines called \"corticosteroids\" and \"anticoagulants\" longer use smoking drinking alcohol older age having poor health NSAID medicines should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medic...",
  "clinical_studies": "14.1 Osteoarthritis and Rheumatoid Arthritis The use of meloxicam for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. Meloxicam (3.75 mg, 7.5 mg, and 15 mg daily) was compared to placebo. 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). Patients on meloxicam 7.5 mg daily and meloxicam 15 mg daily showed significant improvement in each of these endpoints compared with placebo. The use of meloxicam for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks' to 6 months' duration. In these trials, the efficacy of meloxicam, in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial. The use of meloxicam for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinationa...",
  "brand_name": "Meloxicam",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA077918",
  "pharm_class_epc": [
   "Nonsteroidal Anti-inflammatory Drug [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20200720",
  "set_id": "2a29daa9-74e5-4ed6-b5f1-ce04dc411b26",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 60108,
  "serious": 34448,
  "death": 3663,
  "hospitalization": 13972,
  "primary_suspect": 60045,
  "top_reactions": [
   [
    "Drug Ineffective",
    6727
   ],
   [
    "Pain",
    5014
   ],
   [
    "Fatigue",
    5006
   ],
   [
    "Arthralgia",
    4548
   ],
   [
    "Nausea",
    4198
   ],
   [
    "Headache",
    3612
   ],
   [
    "Diarrhoea",
    3544
   ],
   [
    "Off Label Use",
    3055
   ],
   [
    "Dyspnoea",
    2815
   ],
   [
    "Dizziness",
    2805
   ],
   [
    "Malaise",
    2743
   ],
   [
    "Pain In Extremity",
    2735
   ],
   [
    "Chronic Kidney Disease",
    2563
   ],
   [
    "Rheumatoid Arthritis",
    2443
   ],
   [
    "Vomiting",
    2375
   ]
  ],
  "by_year": {
   "2019": 6579,
   "2020": 6160,
   "2021": 4615,
   "2022": 4144,
   "2023": 3812,
   "2024": 3793,
   "2025": 3851,
   "2026": 1829
  },
  "by_year_primary": {
   "2019": 6575,
   "2020": 6158,
   "2021": 4611,
   "2022": 4135,
   "2023": 3806,
   "2024": 3782,
   "2025": 3836,
   "2026": 1822
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 33,
  "nda": 7,
  "anda": 26,
  "first_approval": "20000413",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 30,
  "labeling_recent": 9,
  "sponsors": [
   "AIPING PHARM INC",
   "ASCENT PHARMS INC",
   "AUROBINDO PHARMA",
   "AVONDALE PHARMS",
   "AZURITY",
   "BAUDAX",
   "BOEHRINGER INGELHEIM",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/13/2000"
 },
 "trials": {
  "total": 163,
  "completed": 116,
  "terminated": 12,
  "with_results": 48,
  "industry": 96,
  "phase3": 49,
  "results_share": 0.41379310344827586,
  "terminated_share": 0.0736196319018405
 },
 "pubmed": {
  "rct": 220,
  "meta": 7,
  "recent_rct": 17,
  "cochrane": [
   {
    "pmid": "19821429",
    "title": "Single dose oral meloxicam for acute postoperative pain in adults",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "meloxicam",
   "Anjeso",
   "Mobic",
   "Qamzova",
   "Qmiiz",
   "Vivlodex",
   "Xifyrm",
   "Zybic"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 12080589,
  "beneficiaries": 4115676,
  "spend": 51524956.86,
  "by_brand": [
   {
    "brand": "Meloxicam",
    "claims": 12080589,
    "per_claim": 4.2651030393,
    "is_generic": true
   }
  ],
  "per_claim": 4.265103039264062
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "meloxicam",
   "piroxicam",
   "tenoxicam"
  ],
  "reason": "Meloxicam, piroxicam and tenoxicam, when used systemically, expose patients to an increased risk of gastrointestinal disorders and cutaneous disorders (including Stevens-Johnson syndrome and toxic epidermal necrolysis), but are no more effective than other NSAIDs ( Prescrire Int n\u00b0 212; Rev Prescrire n\u00b0 321). \u201cMuscle relaxants\u201d. V arious drugs used as muscle relaxants have no demonstrated efficacy beyond that of a placebo, but expose patients to the risk of sometimes severe adverse effects. An effective analgesic is a better option, with paracetamol as the first choice, keeping exposure to a m...",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "meloxicam"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 9440,
  "fills": 12080589,
  "per_million": 781.418853004601,
  "ratio": 0.28220766806436615,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 60,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "781 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 42,
   "letter": "F",
   "why": [
    "220 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "1 independent Cochrane review(s) exist",
    "Only 41% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 26 generic makers (-3)",
    "9 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (26 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are pain, fatigue, arthralgia. How would we recognize and handle those?",
  "Why this one over droxicam, lornoxicam, piroxicam? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}