{
 "query": "lansoprazole",
 "ingredient": "lansoprazole",
 "slug": "lansoprazole",
 "rxcui": "17128",
 "brands": [
  "Prevacid"
 ],
 "names": [
  "lansoprazole"
 ],
 "classes": [
  {
   "id": "A02BC",
   "name": "Proton pump inhibitors"
  }
 ],
 "alternatives": [
  "dexlansoprazole",
  "esomeprazole",
  "omeprazole",
  "pantoprazole",
  "rabeprazole",
  "vonoprazan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 102
  },
  "boxed_warning": "",
  "indications_and_usage": "and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. ( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. ( 1.2 ) Maintenance of healed duodenal ulcers in adults. ( 1.3 ) Treatment of active benign gastric ulcer in adults. ( 1.4 ) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5 ) Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7 ) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8 ) Maintenance of healing of EE in adults. ( 1.9 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10 ) 1.1 Treatment of Active Duodenal Ulcer PREVACID and PREVACID SoluTab are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1) ] . 1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Th...",
  "contraindications": "and PREVACID SoluTab are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . Proton Pump Inhibitors (PPIs), including PREVACID and PREVACID SoluTab, are contraindicated with rilpivirine-containing products [see Drug Interactions (7) ] . For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Contraindications section of their prescribing information. Contraindicated in patients with known hypersensitivity to any component of the PREVACID or PREVACID SoluTab formulations. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 )",
  "warnings_and_cautions": "Gastric Malignancy : In adults, symptomatic response with PREVACID or PREVACID SoluTab 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 of Clostridium difficile -associated diarrhea. ( 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 exacerbation of existing disease; discontinue PREVACID and PREVACID SoluTab and refer to specialist for evaluation. ( 5.6 ) Cyanocobalamin (Vitamin B12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7 ) Hypomagnesemia and Mineral Meta...",
  "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 (5.12) ] Most commonly reported adverse reactions (\u22651%): diarrhea, abdominal pain, nausea and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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 not reflect th...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Advise patients to: Acute Tubulointerstitial Nephritis To call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions (5.2) ] . Clostridium difficile -Associated Diarrhea To immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3) ] . Bone Fracture To report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions To discontinue PREVACID or PREVACID SoluTab and immediately call their healthcare provider for further evaluation [see Warnings and Precautions (5.5) ]. Cutaneous and Systemic Lupus Erythematosus To immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.6) ] . Cyanocobalamin (Vitamin B12) Deficiency To report any clinical symptoms that may be associated with cyanocobalamin deficiency to their ...",
  "spl_medguide": "MEDICATION GUIDE PREVACID (prev-a-sid) (lansoprazole) delayed-release capsules, for oral use and PREVACID SoluTab (prev-a-sid sol-u-tab) (lansoprazole) delayed-release orally disintegrating tablets This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 3/2025 What is the most important information that I should know about PREVACID and PREVACID SoluTab? You should take PREVACID and PREVACID SoluTab exactly as prescribed, at the lowest dose possible and for the shortest time needed. PREVACID and PREVACID SoluTab may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. PREVACID and PREVACID SoluTab can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PREVACID and PREVACID SoluTab, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including PREVACID and PREVACID SoluTab. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrh...",
  "clinical_studies": "14.1 Duodenal Ulcer In a US multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of PREVACID once daily) study of 284 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after two and four weeks was significantly higher with all doses of PREVACID than with placebo. There was no evidence of a greater or earlier response with the two higher doses compared with PREVACID 15 mg. Based on this study and the second study described below, the recommended dose of PREVACID in duodenal ulcer is 15 mg per day (Table 9) . Table 9. Duodenal Ulcer Healing Rates Week PREVACID Placebo (N=72) 15 mg daily (N=68) 30 mg daily (N=74) 60 mg daily (N=70) 2 42.4% (p\u22640.001) vs placebo. 35.6% 39.1% 11.3% 4 89.4% 91.7% 89.9% 46.1% PREVACID 15 mg was significantly more effective than placebo in relieving day and nighttime abdominal pain and in decreasing the amount of antacid taken per day. In a second US multicenter study, also double-blind, placebo-controlled, dose-comparison (15 and 30 mg of PREVACID once daily), and including a comparison with ranitidine, in 280 patients with endoscopically documented duodenal ulcer, the percentage of patient...",
  "brand_name": "Prevacid",
  "manufacturer": "Takeda Pharmaceuticals America, Inc.",
  "application_number": "NDA020406",
  "pharm_class_epc": [
   "Proton Pump Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250708",
  "set_id": "71ba78cb-7e46-43eb-9425-fa130f537f84",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 145876,
  "serious": 131626,
  "death": 17190,
  "hospitalization": 52079,
  "primary_suspect": 145298,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    32852
   ],
   [
    "Acute Kidney Injury",
    19054
   ],
   [
    "Renal Failure",
    13195
   ],
   [
    "End Stage Renal Disease",
    9807
   ],
   [
    "Renal Injury",
    9440
   ],
   [
    "Diarrhoea",
    7336
   ],
   [
    "Off Label Use",
    6981
   ],
   [
    "Nausea",
    6641
   ],
   [
    "Dyspnoea",
    6364
   ],
   [
    "Fatigue",
    6275
   ],
   [
    "Vomiting",
    5525
   ],
   [
    "Headache",
    5502
   ],
   [
    "Pain",
    5145
   ],
   [
    "Drug Ineffective",
    4981
   ],
   [
    "Malaise",
    4934
   ]
  ],
  "by_year": {
   "2019": 26295,
   "2020": 12352,
   "2021": 10216,
   "2022": 8106,
   "2023": 8258,
   "2024": 8730,
   "2025": 7965,
   "2026": 3740
  },
  "by_year_primary": {
   "2019": 26289,
   "2020": 12342,
   "2021": 10193,
   "2022": 7950,
   "2023": 8172,
   "2024": 8621,
   "2025": 7836,
   "2026": 3696
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220323",
   "reason": "Failed Dissolution Specifications; during long term stability testing.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220323",
   "reason": "Failed Dissolution Specifications; during long term stability testing.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201203",
   "reason": "Failed Dissolution Specifications",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201203",
   "reason": "Failed Dissolution Specifications",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201027",
   "reason": "Failed Dissolution Specification",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201027",
   "reason": "Failed Dissolution Specification",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190311",
   "reason": "Subpotent Drug.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130130",
   "reason": "Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.",
   "firm": "Mylan Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 36,
  "nda": 6,
  "anda": 30,
  "first_approval": "19950510",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 100,
  "labeling_recent": 9,
  "sponsors": [
   "ADAPTIS",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL MOLECULAR",
   "DEXCEL"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/10/1995"
 },
 "trials": {
  "total": 318,
  "completed": 210,
  "terminated": 40,
  "with_results": 84,
  "industry": 163,
  "phase3": 84,
  "results_share": 0.4,
  "terminated_share": 0.12578616352201258
 },
 "pubmed": {
  "rct": 372,
  "meta": 13,
  "recent_rct": 17,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "lansoprazole",
   "Prevacid"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1240163,
  "beneficiaries": 326487,
  "spend": 56586076.260000005,
  "by_brand": [
   {
    "brand": "Lansoprazole",
    "claims": 1231347,
    "per_claim": 38.401056136,
    "is_generic": true
   },
   {
    "brand": "Prevacid",
    "claims": 8816,
    "per_claim": 1055.0193954,
    "is_generic": false
   }
  ],
  "per_claim": 45.62793460214505
 },
 "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": 20153,
  "fills": 1240163,
  "per_million": 16250.283228898137,
  "ratio": 5.868753380827144,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 77,
   "letter": "B",
   "why": [
    "FDA issued 2 Drug Safety Communication(s) about this drug's class since 2010 (-8)",
    "16,250 FDA reports naming it as the suspect drug per million Medicare fills, 5.9x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "372 randomized trials and 13 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": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 6 Class II, 1 Class III across 30 generic makers (-6)",
    "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 (30 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "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 dexlansoprazole, esomeprazole, 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.)"
 ]
}