{
 "query": "mesalamine",
 "ingredient": "mesalamine",
 "slug": "mesalamine",
 "rxcui": "52582",
 "brands": [
  "Pentasa",
  "Apriso",
  "Lialda",
  "Canasa",
  "Delzicol",
  "Rowasa"
 ],
 "names": [
  "mesalamine"
 ],
 "classes": [
  {
   "id": "A07EC",
   "name": "Aminosalicylic acid and similar agents"
  }
 ],
 "alternatives": [
  "balsalazide",
  "olsalazine",
  "sulfasalazine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 37,
   "RECTAL": 16
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae is indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. LIALDA is an aminosalicylate indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 ) treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. ( 1 )",
  "contraindications": "is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of LIALDA [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) , Description (11) ] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of LIALDA. ( 4 )",
  "warnings_and_cautions": "Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of LIALDA in patients with known renal impairment or taking nephrotoxic drugs. Discontinue LIALDA if renal function deteriorates while on therapy. ( 5.1 , 7.1 , 8.6 ) Mesalamine-Induced Acute Intolerance Syndrome : Symptoms may be difficult to distinguish from an ulcerative colitis exacerbation. Monitor for worsening symptoms while on treatment. Discontinue treatment if acute intolerance syndrome is suspected. ( 5.2 ) Hypersensitivity Reactions, including myocarditis and pericarditis : Evaluate patients immediately and discontinue LIALDA if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure : Evaluate the risks and benefits of using LIALDA in patients with known liver impairment. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Upper Gastrointestinal Tract Obstruction : Avoid in patients with pyloric stenosis or other organic or functional obstruction. ( 5.6 ) Photosensitivity : Ad...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in labeling: Renal impairment, including renal failure [see Warnings and Precautions (5.1) ] Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Hepatic failure [see Warnings and Precautions (5.4) ] Severe cutaneous adverse reactions [see Warnings and Precautions (5.5) ] Upper gastrointestinal tract obstruction [see Warnings and Precautions (5.6) ] Photosensitivity [see Warnings and Precautions (5.7) ] Nephrolithiasis [see Warnings and Precautions (5.8) ] Most common adverse reactions in: adults (\u22652%) are headache, flatulence, liver function test abnormal, abdominal pain, and diarrhea. ( 6.1 ) pediatric patients (\u22655%) are abdominal pain, upper respiratory tract infection, vomiting, anemia, headache, and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 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 clinica...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Renal Impairment ( 5.1 ) 11/2022",
  "information_for_patients": "Renal Impairment Inform patients that LIALDA may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Warnings and Precautions (5.1) ] . Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions Instruct patients to stop taking LIALDA and report to their healthcare provider if they experience new or worsening symptoms of acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see Warnings and Precautions (5.2 , 5.3) ] . Hepatic Failure Advise patients with known liver disease to contact their healthcare provider if they experience signs or symptoms of worsening liver function [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Instruct patients to stop taking LIALDA and report to their healthcare provider at first appea...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Adults with Mildly to Moderately Active Ulcerative Colitis Induction of Remission Two similarly designed, randomized, double-blind, placebo-controlled trials (Study 1, NCT00503243 and Study 2, NCT00548574 ) were conducted in 517 adult patients with mildly to moderately active ulcerative colitis. The study population was primarily Caucasian (80%), had a mean age of 42 years (6% age 65 years or older), and was approximately 50% male. Both studies used LIALDA dosages of 2.4 g and 4.8 g administered once daily for 8 weeks, except in Study 1 the 2.4 g dosage was administered as two divided doses (i.e., 1.2 g twice daily). The primary efficacy endpoint in both trials was to compare the percentage of patients in remission after 8 weeks of treatment for the LIALDA treatment groups versus placebo. Remission was defined as an Ulcerative Colitis Disease Activity Index (UC-DAI) of \u22641, with scores of zero for rectal bleeding and for stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline. In both studies, the LIALDA dosages of 2.4 g and 4.8 g once daily demonstrated superiority over placebo in the primary efficacy endpoint (Table 6). Both LIALDA dosages also p...",
  "brand_name": "Lialda",
  "manufacturer": "Takeda Pharmaceuticals America, Inc.",
  "application_number": "NDA022000",
  "pharm_class_epc": [
   "Aminosalicylate [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260324",
  "set_id": "3098a080-be86-4265-9818-7fc4beab77b7",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 63326,
  "serious": 51794,
  "death": 3792,
  "hospitalization": 21365,
  "primary_suspect": 63221,
  "top_reactions": [
   [
    "Off Label Use",
    11970
   ],
   [
    "Drug Ineffective",
    9314
   ],
   [
    "Colitis Ulcerative",
    8479
   ],
   [
    "Condition Aggravated",
    6168
   ],
   [
    "Diarrhoea",
    5758
   ],
   [
    "Fatigue",
    4783
   ],
   [
    "Haematochezia",
    4448
   ],
   [
    "Abdominal Pain",
    4271
   ],
   [
    "Nausea",
    3829
   ],
   [
    "Headache",
    3799
   ],
   [
    "Crohn^S Disease",
    3761
   ],
   [
    "Arthralgia",
    3687
   ],
   [
    "Weight Decreased",
    3456
   ],
   [
    "Pyrexia",
    3368
   ],
   [
    "Malaise",
    3302
   ]
  ],
  "by_year": {
   "2019": 5106,
   "2020": 5824,
   "2021": 6206,
   "2022": 6082,
   "2023": 5932,
   "2024": 5826,
   "2025": 5535,
   "2026": 2249
  },
  "by_year_primary": {
   "2019": 5105,
   "2020": 5823,
   "2021": 6200,
   "2022": 6052,
   "2023": 5916,
   "2024": 5800,
   "2025": 5519,
   "2026": 2245
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240205",
   "reason": "Failed Dissolution Specifications: Out of specification for dissolution.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240118",
   "reason": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20201028",
   "reason": "Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200220",
   "reason": "Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20161202",
   "reason": "Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules",
   "firm": "Shire PLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 45,
  "nda": 9,
  "anda": 36,
  "first_approval": "19871224",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 94,
  "labeling_recent": 30,
  "sponsors": [
   "ABBVIE",
   "ACTAVIS LABS FL",
   "ACTAVIS MID ATLANTIC",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL",
   "AMTA",
   "ANNORA PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/24/1987"
 },
 "trials": {
  "total": 229,
  "completed": 148,
  "terminated": 27,
  "with_results": 50,
  "industry": 123,
  "phase3": 77,
  "results_share": 0.33783783783783783,
  "terminated_share": 0.11790393013100436
 },
 "pubmed": {
  "rct": 88,
  "meta": 18,
  "recent_rct": 10,
  "cochrane": [
   {
    "pmid": "28973845",
    "title": "Mesalamine (5-ASA) for the prevention of recurrent diverticulitis",
    "year": "2017"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "mesalamine",
   "Pentasa",
   "Apriso",
   "Lialda",
   "Canasa",
   "Delzicol",
   "Rowasa"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 651247,
  "beneficiaries": 154730,
  "spend": 311773454.5,
  "by_brand": [
   {
    "brand": "Mesalamine",
    "claims": 426970,
    "per_claim": 478.8178614,
    "is_generic": true
   },
   {
    "brand": "Mesalamine ER",
    "claims": 142036,
    "per_claim": 289.77295819,
    "is_generic": false
   },
   {
    "brand": "Mesalamine Dr",
    "claims": 47962,
    "per_claim": 458.59195509,
    "is_generic": false
   },
   {
    "brand": "Pentasa",
    "claims": 22117,
    "per_claim": 1357.6919451,
    "is_generic": false
   },
   {
    "brand": "Apriso",
    "claims": 6392,
    "per_claim": 820.21317897,
    "is_generic": false
   },
   {
    "brand": "Lialda",
    "claims": 4327,
    "per_claim": 1624.4384215,
    "is_generic": false
   },
   {
    "brand": "Canasa",
    "claims": 842,
    "per_claim": 1429.5251188,
    "is_generic": false
   },
   {
    "brand": "Delzicol",
    "claims": 584,
    "per_claim": 1102.6599315,
    "is_generic": false
   },
   {
    "brand": "Sfrowasa",
    "claims": 17,
    "per_claim": 1881.1170588,
    "is_generic": false
   }
  ],
  "per_claim": 478.7330375418236
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 13564,
  "fills": 651247,
  "per_million": 20827.735098971665,
  "ratio": 7.521889868337404,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 80,
   "letter": "B",
   "why": [
    "20,828 FDA reports naming it as the suspect drug per million Medicare fills, 7.5x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.7x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 48,
   "letter": "F",
   "why": [
    "88 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 34% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 1 Class III across 36 generic makers (-6)",
    "30 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 (36 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are colitis ulcerative, condition aggravated. 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 balsalazide, olsalazine, sulfasalazine? 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.)"
 ]
}