{
 "query": "dexlansoprazole",
 "ingredient": "dexlansoprazole",
 "slug": "dexlansoprazole",
 "rxcui": "816346",
 "brands": [
  "Dexilant"
 ],
 "names": [
  "dexlansoprazole",
  "dexlansoprazole sesquihydrate"
 ],
 "classes": [
  {
   "id": "A02BC",
   "name": "Proton pump inhibitors"
  }
 ],
 "alternatives": [
  "esomeprazole",
  "lansoprazole",
  "omeprazole",
  "pantoprazole",
  "rabeprazole",
  "vonoprazan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 15
  },
  "boxed_warning": "",
  "indications_and_usage": "Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn. ( 1.2 ) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3 ) 1.1 Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. 1.3 Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.",
  "contraindications": "Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11) ] . Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . PPIs, including dexlansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products [see Drug Interactions (7) ]. Patients with known hypersensitivity to any component of the formulation. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 )",
  "warnings_and_cautions": "Dexlansoprazole Delayed-Release Capsules, 60 mg contain FD&C Yellow # 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow # 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Gastric Malignancy : In adults, symptomatic response with dexlansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. ( 5.2 ) Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.3 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 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 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exac...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3 )] Bone Fracture [see Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )] Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions ( 5.7 )] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.11 )] Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age [see Warnings and Precautions ( 5.12 )] The most common adverse reactions are: Adults (\u22652%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. ( 6.1 ) Patients 12 to 17 years of age (\u22655%): headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch....",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Severe Cutaneous Adverse Reactions ( 5.5 ) 03/2022 Hypomagnesemia and Mineral Metabolism ( 5.8 ) 03/2022",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: Hypersensitivity Reactions [see Contraindications (4) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions (5.7) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8) ] Drug Interactions Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications (4) ] or high-dose methotrexate [see Warnings and Precautions (5.10) ]. Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pre...",
  "spl_medguide": "MEDICATION GUIDE Dexlansoprazole (DEX lan SOE pra zol) Delayed-Release Capsules, for oral use Read this Medication Guide before you start taking dexlansoprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Dexlansoprazole delayed-release capsules, 60 mg contain FD&C Yellow # 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow # 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. What is the most important information that I should know about dexlansoprazole delayed-release capsules? Dexlansoprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Dexlansoprazole delayed-release capsules can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, inc...",
  "clinical_studies": "14.1 Healing of Erosive Esophagitis in Adults Two multicenter, double-blind, active-controlled, randomized, eight week studies were conducted in patients with endoscopically confirmed EE. Severity of the disease was classified based on the Los Angeles Classification Grading System (Grades A to D). Patients were randomized to one of the following three treatment groups: Dexlansoprazole 60 mg once daily, dexlansoprazole 90 mg once daily or lansoprazole 30 mg once daily. Patients who were H. pylori positive or who had Barrett\u2019s Esophagus and/or definite dysplastic changes at baseline were excluded from these studies. A total of 4,092 patients were enrolled and ranged in age from 18 to 90 years (median age 48 years) with 54% male. Race was distributed as follows: 87% Caucasian, 5% Black and 8% Other. Based on the Los Angeles Classification, 71% of patients had mild EE (Grades A and B) and 29% of patients had moderate to severe EE (Grades C and D) before treatment. The studies were designed to test noninferiority. If noninferiority was demonstrated then superiority would be tested. Although noninferiority was demonstrated in both studies, the finding of superiority in one study was not ...",
  "brand_name": "Dexlansoprazole",
  "manufacturer": "Bryant Ranch Prepack",
  "application_number": "ANDA202294",
  "pharm_class_epc": [
   "Proton Pump Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240105",
  "set_id": "3ed69e5a-aa78-4118-aa32-59a10f80c901",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 39313,
  "serious": 32399,
  "death": 3643,
  "hospitalization": 6700,
  "primary_suspect": 39299,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    16114
   ],
   [
    "Acute Kidney Injury",
    7816
   ],
   [
    "Renal Failure",
    6720
   ],
   [
    "End Stage Renal Disease",
    4875
   ],
   [
    "Renal Injury",
    4340
   ],
   [
    "Drug Ineffective",
    2428
   ],
   [
    "Fatigue",
    2269
   ],
   [
    "Off Label Use",
    2258
   ],
   [
    "Tubulointerstitial Nephritis",
    2194
   ],
   [
    "Nausea",
    2017
   ],
   [
    "Death",
    1838
   ],
   [
    "Headache",
    1813
   ],
   [
    "Diarrhoea",
    1808
   ],
   [
    "Pain",
    1789
   ],
   [
    "Dyspnoea",
    1508
   ]
  ],
  "by_year": {
   "2019": 7825,
   "2020": 2732,
   "2021": 2422,
   "2022": 1915,
   "2023": 1559,
   "2024": 1362,
   "2025": 1303,
   "2026": 616
  },
  "by_year_primary": {
   "2019": 7825,
   "2020": 2732,
   "2021": 2419,
   "2022": 1913,
   "2023": 1557,
   "2024": 1359,
   "2025": 1302,
   "2026": 616
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 6,
  "nda": 2,
  "anda": 4,
  "first_approval": "20090130",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 24,
  "labeling_recent": 3,
  "sponsors": [
   "ALEMBIC",
   "MYLAN",
   "PH HEALTH",
   "TAKEDA PHARMS USA",
   "TWI PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/30/2009"
 },
 "trials": {
  "total": 318,
  "completed": 210,
  "terminated": 40,
  "with_results": 84,
  "industry": 163,
  "phase3": 84,
  "results_share": 0.4,
  "terminated_share": 0.12578616352201258
 },
 "pubmed": {
  "rct": 22,
  "meta": 1,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 21203.26,
  "records": 9,
  "by_name": [
   [
    "Dexilant",
    21203.26
   ]
  ],
  "names_checked": [
   "dexlansoprazole",
   "Dexilant"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 882900,
  "beneficiaries": 196009,
  "spend": 261509728.11,
  "by_brand": [
   {
    "brand": "Dexlansoprazole Dr",
    "claims": 796724,
    "per_claim": 276.74824224,
    "is_generic": false
   },
   {
    "brand": "Dexilant",
    "claims": 86176,
    "per_claim": 475.97662412,
    "is_generic": false
   }
  ],
  "per_claim": 296.19405154604146
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20120208",
   "title": "Proton Pump Inhibitors - Clostridum difficile -associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm290510.htm",
   "kind": "class",
   "matched": "proton pump inhibitor"
  },
  {
   "date": "20110302",
   "title": "PPIs - Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm245011.htm",
   "kind": "class",
   "matched": "proton pump inhibitor"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3277,
  "fills": 882900,
  "per_million": 3711.6321214180543,
  "ratio": 1.340447625074152,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 89,
   "letter": "A",
   "why": [
    "FDA issued 2 Drug Safety Communication(s) about this drug's class since 2010 (-8)",
    "3,712 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 26,
   "letter": "F",
   "why": [
    "22 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 40% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "3 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $21,203 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 (4 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, acute kidney injury, renal failure, end stage renal disease. How would we recognize and handle those?",
  "Why this one over esomeprazole, lansoprazole, omeprazole? 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.)"
 ]
}