{
 "query": "naproxen",
 "ingredient": "naproxen",
 "slug": "naproxen",
 "rxcui": "7258",
 "brands": [
  "Naprelan",
  "Aleve",
  "Anaprox",
  "Naprosyn",
  "Wal-Proxen"
 ],
 "names": [
  "naproxen",
  "naproxen sodium"
 ],
 "classes": [
  {
   "id": "M01AE",
   "name": "Propionic acid derivatives"
  },
  {
   "id": "G02CC",
   "name": "Antiinflammatory products for vaginal administration"
  },
  {
   "id": "M02AA",
   "name": "Antiinflammatory preparations, non-steroids for topical use"
  }
 ],
 "alternatives": [
  "aceclofenac",
  "alminoprofen",
  "benzydamine",
  "bufexamac",
  "clofezone",
  "dexketoprofen",
  "diclofenac",
  "etofenamate",
  "felbinac",
  "fenbufen",
  "fenoprofen",
  "feprazone",
  "flurbiprofen",
  "ibuprofen",
  "indomethacin",
  "ketoprofen",
  "loxoprofen",
  "meclofenamic acid",
  "mofebutazone",
  "niflumic acid",
  "nimesulide",
  "oxaprozin",
  "oxyphenbutazone",
  "phenylbutazone",
  "piketoprofen",
  "piroxicam",
  "suprofen",
  "tiaprofenic acid",
  "tolmetin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 163
  },
  "boxed_warning": "WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ( 5.1 )] . NAPRELAN 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 )] . WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal anti-inflammator...",
  "indications_and_usage": "NAPRELAN Tablets are indicated for the treatment of: \u2022 rheumatoid arthritis (RA) \u2022 osteoarthritis (OA) \u2022 ankylosing spondylitis (AS) \u2022 tendinitis, bursitis \u2022 acute gout \u2022 primary dysmenorrhea (PD) \u2022 the relief of mild to moderate pain [see Warnings and Precautions ( 5 )] . NAPRELAN is a nonsteroidal anti-inflammatory drug indicated for the treatment of: \u2022 rheumatoid arthritis (RA)( 1 ) \u2022 osteoarthritis (OA)(1) \u2022 ankylosing spondylitis (AS)(1) \u2022 tendinitis, bursitis (1) \u2022 acute gout (1) \u2022 primary dysmenorrhea (PD) (1) \u2022 the relief of mild to moderate pain (1)",
  "contraindications": "NAPRELAN is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ] Known hypersensitivity to naproxen 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 )",
  "warnings_and_cautions": "Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) Heart Failure and Edema: Avoid use of NAPRELAN in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of NAPRELAN in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity: NAPRELAN is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) Serious Skin Reactions: Discontinue NAPRELAN at first appearance of skin rash or other signs of hypers...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] The most frequent adverse events were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TWi Pharmaceuticals, Inc. at 1-844-518-2989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.9 ) 11/2024",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with NAPRELAN and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Bleeding, Ulceration, and Perforation NAPRELAN, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [ see Warnings and Precautions ( 5.2 ) ]. Hep...",
  "spl_medguide": "Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a \"coronary artery bypass graft (CABG).\" Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called \u201ccorticosteroids\u201d, \u201canticoagulants\u201d, \u201cSSRIs\u201d, or \u201cSNRIs\u201d increasing doses of NSAIDs longer use o...",
  "clinical_studies": "Rheumatoid Arthritis The use of NAPRELAN Tablets for the management of the signs and symptoms of rheumatoid arthritis was assessed in a 12 week double-blind, randomized, placebo, and active-controlled study in 348 patients. Two NAPRELAN 500 mg tablets (1,000 mg) once daily and naproxen 500 mg tablets twice daily (1,000 mg) were more effective than placebo. Clinical effectiveness was demonstrated at one week and continued for the duration of the study. Osteoarthritis The use of NAPRELAN Tablets for the management of the signs and symptoms of osteoarthritis of the knee was assessed in a 12 week double-blind, placebo, and active-controlled study in 347 patients. Two NAPRELAN 500 mg tablets (1,000 mg) once daily and naproxen 500 mg tablets twice daily (1,000 mg) were more effective than placebo. Clinical effectiveness was demonstrated at one week and continued for the duration of the study. Analgesia The onset of the analgesic effect of NAPRELAN Tablets was seen within 30 minutes in a pharmacokinetic/pharmacodynamic study of patients with pain following oral surgery. In controlled clinical trials, naproxen has been used in combination with gold, D-penicillamine, methotrexate, and corti...",
  "brand_name": "Naprelan",
  "manufacturer": "Upsher-Smith Laboratories, LLC",
  "application_number": "NDA020353",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260108",
  "set_id": "b8a51c9a-488e-4377-a041-436f6a2f8893",
  "has_boxed_warning": true,
  "boxed_labels": "36 of 36",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 123557,
  "serious": 76357,
  "death": 9655,
  "hospitalization": 31055,
  "primary_suspect": 123278,
  "top_reactions": [
   [
    "Drug Ineffective",
    20590
   ],
   [
    "Pain",
    11268
   ],
   [
    "Fatigue",
    10793
   ],
   [
    "Nausea",
    9922
   ],
   [
    "Arthralgia",
    9647
   ],
   [
    "Off Label Use",
    9033
   ],
   [
    "Headache",
    8341
   ],
   [
    "Diarrhoea",
    7922
   ],
   [
    "Dizziness",
    7253
   ],
   [
    "Vomiting",
    6954
   ],
   [
    "Rash",
    6683
   ],
   [
    "Malaise",
    6310
   ],
   [
    "Product Use Issue",
    6263
   ],
   [
    "Dyspnoea",
    6059
   ],
   [
    "Rheumatoid Arthritis",
    6054
   ]
  ],
  "by_year": {
   "2019": 13021,
   "2020": 11816,
   "2021": 9354,
   "2022": 7878,
   "2023": 7752,
   "2024": 7663,
   "2025": 7946,
   "2026": 3024
  },
  "by_year_primary": {
   "2019": 13017,
   "2020": 11810,
   "2021": 9315,
   "2022": 7836,
   "2023": 7703,
   "2024": 7616,
   "2025": 7885,
   "2026": 2997
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260420",
   "reason": "Chemical contamination; presence of lead and lithium above specification",
   "firm": "Acella Pharmaceuticals, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20231107",
   "reason": "Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210827",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210827",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20120706",
   "reason": "Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.",
   "firm": "Glenmark Generics Inc., USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 83,
  "nda": 7,
  "anda": 74,
  "first_approval": "19760311",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 151,
  "labeling_recent": 20,
  "sponsors": [
   "ABLE",
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "AMNEAL",
   "AMNEAL PHARMS NY",
   "ATNAHS PHARMA US",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/11/1976"
 },
 "trials": {
  "total": 383,
  "completed": 285,
  "terminated": 43,
  "with_results": 124,
  "industry": 220,
  "phase3": 89,
  "results_share": 0.43508771929824563,
  "terminated_share": 0.1122715404699739
 },
 "pubmed": {
  "rct": 533,
  "meta": 15,
  "recent_rct": 21,
  "cochrane": [
   {
    "pmid": "27096438",
    "title": "Sumatriptan plus naproxen for the treatment of acute migraine attacks in adults",
    "year": "2016"
   },
   {
    "pmid": "24142431",
    "title": "Sumatriptan plus naproxen for acute migraine attacks in adults",
    "year": "2013"
   },
   {
    "pmid": "24142263",
    "title": "Naproxen with or without an antiemetic for acute migraine headaches in adults",
    "year": "2013"
   },
   {
    "pmid": "25267911",
    "title": "Sumatriptan plus naproxen for acute migraine headaches in adults",
    "year": "2010"
   },
   {
    "pmid": "19160232",
    "title": "Single dose oral naproxen and naproxen sodium for acute postoperative pain in adults",
    "year": "2009"
   },
   {
    "pmid": "15495091",
    "title": "Single dose oral naproxen and naproxen sodium for acute postoperative pain",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "naproxen",
   "Naprelan",
   "Aleve",
   "Anaprox",
   "Naprosyn",
   "Wal-Proxen"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2968917,
  "beneficiaries": 1410820,
  "spend": 41514293.81,
  "by_brand": [
   {
    "brand": "Naproxen",
    "claims": 2872130,
    "per_claim": 11.752149307,
    "is_generic": true
   },
   {
    "brand": "Naproxen Sodium",
    "claims": 69827,
    "per_claim": 39.826170536,
    "is_generic": true
   },
   {
    "brand": "Ec-Naproxen",
    "claims": 22834,
    "per_claim": 83.122756854,
    "is_generic": false
   },
   {
    "brand": "Naproxen Sodium ER",
    "claims": 2266,
    "per_claim": 813.41223742,
    "is_generic": false
   },
   {
    "brand": "Naproxen Sodium Cr",
    "claims": 1814,
    "per_claim": 644.89026461,
    "is_generic": false
   },
   {
    "brand": "Naprelan",
    "claims": 46,
    "per_claim": 1491.3719565,
    "is_generic": false
   }
  ],
  "per_claim": 13.982975546301901
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "naproxen",
  "matched": "naproxen",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 18498,
  "fills": 2968917,
  "per_million": 6230.5547780554325,
  "ratio": 2.2501508991004147,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 63,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "6,231 FDA reports naming it as the suspect drug per million Medicare fills, 2.3x the median drug on this site (-7)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "A boxed warning caps the overall grade at C (score 75 shown as 74)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "533 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "6 independent Cochrane review(s) exist",
    "Only 44% 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": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 0 Class III across 74 generic makers (-6)",
    "20 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (74 applications)",
    "29 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "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, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over aceclofenac, alminoprofen, benzydamine? 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.)"
 ]
}