{
 "query": "diclofenac",
 "ingredient": "diclofenac",
 "slug": "diclofenac",
 "rxcui": "3355",
 "brands": [
  "Licart",
  "Lofena",
  "Flector",
  "Cambia",
  "Pennsaid",
  "Zipsor",
  "Aleve Arthritis Pain",
  "Cataflam",
  "Voltaren",
  "Xiclo",
  "Zorvolex"
 ],
 "names": [
  "diclofenac",
  "diclofenac diethylammonium",
  "diclofenac epolamine",
  "diclofenac potassium",
  "diclofenac sodium"
 ],
 "classes": [
  {
   "id": "M01AB",
   "name": "Acetic acid derivatives and related substances"
  },
  {
   "id": "M02AA",
   "name": "Antiinflammatory preparations, non-steroids for topical use"
  },
  {
   "id": "S01BC",
   "name": "Antiinflammatory agents, non-steroids"
  }
 ],
 "alternatives": [
  "aceclofenac",
  "acemetacin",
  "benzydamine",
  "bromfenac",
  "bufexamac",
  "bumadizone",
  "clofezone",
  "dexketoprofen",
  "etodolac",
  "etofenamate",
  "felbinac",
  "feprazone",
  "flurbiprofen",
  "ibuprofen",
  "indomethacin",
  "ketoprofen",
  "ketorolac",
  "lonazolac",
  "loxoprofen",
  "meclofenamic acid",
  "mofebutazone",
  "naproxen",
  "nepafenac",
  "niflumic acid",
  "nimesulide",
  "oxyphenbutazone",
  "phenylbutazone",
  "piketoprofen",
  "piroxicam",
  "proglumetacin",
  "salicylic acid",
  "sulindac",
  "tolmetin",
  "zomepirac"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "TOPICAL": 219,
   "ORAL": 188,
   "OPHTHALMIC": 6,
   "CUTANEOUS": 5,
   "TRANSDERMAL": 4
  },
  "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 ) ]. ZIPSOR 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-inflammato...",
  "indications_and_usage": "is indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ZIPSOR is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ( 1 )",
  "contraindications": "is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac 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 ) ] ZIPSOR contains gelatin and is contraindicated in patients with known hypersensitivity to bovine protein. Known hypersensitivity to diclofenac 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 ) ZIPSOR contains gelatin and should not be given to patients with known hypersensitivity to bovine protein. ( 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 ZIPSOR 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 ZIPSOR 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 : ZIPSOR is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) Serious Skin Reactions : Discontinue ZIPSOR at first appearance of skin rash or other signs of hyperse...",
  "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 ) ] Most common adverse reactions (incidence \u2265 1%) are gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, dizziness, headache, somnolence, pruritus, and increased sweating ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Assertio Therapeutics, Inc. at 1-866-458-6389 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 observ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "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 ZIPSOR 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 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 ) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tendernes...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued or Revised: April 2021 ZIP-001-C.7 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: \u2022 Increased risk of a heart attack or stroke that can lead to death . This risk may happen early in treatment and may increase: \u25cb with increasing doses of NSAIDs \u25cb with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a \u201ccoronary 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. \u2022 Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: \u25cb anytime during use \u25cb without warning symptoms \u25cb that may cause death The risk of getting an ulcer or bleeding increases with: \u25cb past history of stomach ulcers, or stomach or intestinal bleedi...",
  "clinical_studies": "The efficacy of ZIPSOR in adults was demonstrated in two multicenter, randomized, double-blind, placebo- controlled, parallel arm, multiple-dose clinical trials comparing ZIPSOR 25 mg and placebo in patients with pain following bunionectomy with osteotomy. Once patients met the criteria for randomization (pain intensity \u22654 on a 0-10 numerical pain rating scale) they received their initial dose of study medication followed by a remedication dose when requested by the patient, and were then dosed every six hours over four days. Pain intensity was recorded at 3 and 6 hours postdose during the fixed dosing period. In Study 1, mean baseline pain intensity scores were 6.9 in the ZIPSOR group (range: 4 \u2013 10) and 7.3 in the placebo group (range: 4 \u2013 10). In both studies, patients treated with ZIPSOR had a lower mean pain intensity score over the 48-hour inpatient period following the first remedication dose (see Figure 1 ). The median time to onset of pain relief was less than one hour for ZIPSOR 25 mg across the clinical trials. The results were similar in Study 2. Figure 1 Mean Pain Intensity Scores at the Midpoint and End of Each Dose Interval in Postbunionectomy Pain Study 1 Figure 1",
  "brand_name": "ZIPSOR",
  "manufacturer": "Assertio Therapeutics, Inc.",
  "application_number": "NDA022202",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250903",
  "set_id": "c982eca0-fc41-11e1-a9c8-0002a5d5c51b",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 141977,
  "serious": 78036,
  "death": 11456,
  "hospitalization": 34176,
  "primary_suspect": 141638,
  "top_reactions": [
   [
    "Drug Ineffective",
    30498
   ],
   [
    "Pain",
    14358
   ],
   [
    "Off Label Use",
    14212
   ],
   [
    "Product Use In Unapproved Indication",
    13842
   ],
   [
    "Fatigue",
    12916
   ],
   [
    "Rash",
    10349
   ],
   [
    "Arthralgia",
    10232
   ],
   [
    "Rheumatoid Arthritis",
    9813
   ],
   [
    "Product Use Issue",
    9430
   ],
   [
    "Abdominal Discomfort",
    9157
   ],
   [
    "Joint Swelling",
    8482
   ],
   [
    "Nausea",
    8413
   ],
   [
    "Alopecia",
    8392
   ],
   [
    "Systemic Lupus Erythematosus",
    8022
   ],
   [
    "Headache",
    8005
   ]
  ],
  "by_year": {
   "2019": 11049,
   "2020": 17795,
   "2021": 21318,
   "2022": 13326,
   "2023": 12785,
   "2024": 11237,
   "2025": 11066,
   "2026": 4197
  },
  "by_year_primary": {
   "2019": 11042,
   "2020": 17780,
   "2021": 21275,
   "2022": 13249,
   "2023": 12739,
   "2024": 11192,
   "2025": 11026,
   "2026": 4152
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260127",
   "reason": "Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20251222",
   "reason": "Failed PH Specifications",
   "firm": "Cipla USA, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230622",
   "reason": "Defective Delivery System",
   "firm": "ALEMBIC PHARMACEUTICALS, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20190702",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Altaire Pharmaceuticals, Inc.",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20190702",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Altaire Pharmaceuticals, Inc.",
   "status": "Completed"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 96,
  "nda": 16,
  "anda": 76,
  "first_approval": "19880728",
  "rems": false,
  "rems_last": "20110720",
  "labeling_supplements": 96,
  "labeling_recent": 27,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS UT INC",
   "ACTAVIS MID ATLANTIC",
   "ADVENTAPHARMA",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "ALTAIRE PHARMS INC",
   "AMNEAL"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/28/1988"
 },
 "trials": {
  "total": 602,
  "completed": 400,
  "terminated": 48,
  "with_results": 94,
  "industry": 198,
  "phase3": 124,
  "results_share": 0.235,
  "terminated_share": 0.07973421926910298
 },
 "pubmed": {
  "rct": 1070,
  "meta": 43,
  "recent_rct": 69,
  "cochrane": [
   {
    "pmid": "38078559",
    "title": "Diclofenac for acute postoperative pain in children",
    "year": "2023"
   },
   {
    "pmid": "30153336",
    "title": "Single-dose intravenous diclofenac for acute postoperative pain in adults",
    "year": "2018"
   },
   {
    "pmid": "26151766",
    "title": "Single dose oral diclofenac for acute postoperative pain in adults",
    "year": "2015"
   },
   {
    "pmid": "26134060",
    "title": "WITHDRAWN: Diclofenac for acute pain in children",
    "year": "2015"
   },
   {
    "pmid": "23633360",
    "title": "Diclofenac with or without an antiemetic for acute migraine headaches in adults",
    "year": "2013"
   },
   {
    "pmid": "22336852",
    "title": "Diclofenac with or without an antiemetic for acute migraine headaches in adults",
    "year": "2012"
   },
   {
    "pmid": "19821348",
    "title": "Diclofenac for acute pain in children",
    "year": "2009"
   },
   {
    "pmid": "19370609",
    "title": "Single dose oral diclofenac for acute postoperative pain in adults",
    "year": "2009"
   },
   {
    "pmid": "15106260",
    "title": "Single dose oral diclofenac for postoperative pain",
    "year": "2004"
   },
   {
    "pmid": "10796811",
    "title": "Single dose oral ibuprofen and diclofenac for postoperative pain",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 35099.68,
  "records": 166,
  "by_name": [
   [
    "Licart",
    35084.54
   ],
   [
    "Flector",
    15.14
   ]
  ],
  "names_checked": [
   "diclofenac",
   "Licart",
   "Lofena",
   "Flector",
   "Cambia",
   "Pennsaid",
   "Zipsor",
   "Aleve Arthritis Pain",
   "Cataflam",
   "Voltaren",
   "Xiclo",
   "Zorvolex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7443857,
  "beneficiaries": 2827132,
  "spend": 567230741.49,
  "by_brand": [
   {
    "brand": "Diclofenac Sodium",
    "claims": 6675521,
    "per_claim": 51.201972764,
    "is_generic": true
   },
   {
    "brand": "Diclofenac Potassium",
    "claims": 369447,
    "per_claim": 196.81860042,
    "is_generic": true
   },
   {
    "brand": "Diclofenac Sodium ER",
    "claims": 208582,
    "per_claim": 52.500532069,
    "is_generic": false
   },
   {
    "brand": "Diclofenac Epolamine",
    "claims": 170571,
    "per_claim": 659.11536768,
    "is_generic": true
   },
   {
    "brand": "Licart",
    "claims": 9198,
    "per_claim": 854.4047456,
    "is_generic": false
   },
   {
    "brand": "Lofena",
    "claims": 5482,
    "per_claim": 2714.1979715,
    "is_generic": false
   },
   {
    "brand": "Flector",
    "claims": 2533,
    "per_claim": 676.72143703,
    "is_generic": false
   },
   {
    "brand": "Cambia",
    "claims": 1103,
    "per_claim": 1221.2320308,
    "is_generic": false
   },
   {
    "brand": "Pennsaid",
    "claims": 1003,
    "per_claim": 2871.1561914,
    "is_generic": false
   },
   {
    "brand": "Zipsor",
    "claims": 417,
    "per_claim": 1585.7316787,
    "is_generic": false
   }
  ],
  "per_claim": 76.20118729980976
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "aceclofenac",
   "diclofenac"
  ],
  "reason": "Oral aceclofenac and oral diclofenac cause more cardiovascular adverse effects (including myocardial infarction and heart failure) and more cardiovascular deaths than other equally effective NSAIDs (Prescrire Int n\u00b0 167 , 210, 263; Rev Prescrire n\u00b0 362, 374). Downloaded from english.prescrire.org on 27/10/2026 Copyright(c)Prescrire. For personal use only. Prescrire International \u2022 February 2026 \u2022 Volume 35 - Issue 278 \u2022 Page 54-9 Drugs to avoid in 2026 \u2022 OUTLOOK",
  "edition": "2026",
  "qualifier": "oral diclofenac",
  "qualified": true,
  "matched": "diclofenac"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 26370,
  "fills": 7443857,
  "per_million": 3542.5183476791667,
  "ratio": 1.2793725645724632,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 63,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Prescrire lists one form only (oral diclofenac) as a drug to avoid; shown for context, no score effect",
    "3,543 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 67,
   "letter": "C",
   "why": [
    "1070 randomized trials and 43 systematic reviews/meta-analyses indexed in PubMed",
    "10 independent Cochrane review(s) exist",
    "Only 24% of completed registered trials posted results (-15)",
    "'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, 4 Class II, 1 Class III across 76 generic makers (-6)",
    "27 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 $35,100 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 (76 applications)",
    "34 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "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, product use in unapproved indication. 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, acemetacin, 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.)"
 ]
}