{
 "query": "linagliptin",
 "ingredient": "linagliptin",
 "slug": "linagliptin",
 "rxcui": "1100699",
 "brands": [
  "Tradjenta"
 ],
 "names": [
  "linagliptin"
 ],
 "classes": [
  {
   "id": "A10BH",
   "name": "Dipeptidyl peptidase 4 (DPP-4) inhibitors"
  }
 ],
 "alternatives": [
  "alogliptin",
  "saxagliptin",
  "sitagliptin",
  "vildagliptin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 8
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Limitations of Use Not recommended in patients with type 1 diabetes mellitus as it would not be effective ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use TRADJENTA is not recommended in patients with type 1 diabetes mellitus as it would not be effective. TRADJENTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA [see Warnings and Precautions (5.1) ].",
  "contraindications": "is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in TRADJENTA, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see Warnings and Precautions (5.3) and Adverse Reactions (6) ]. Hypersensitivity to linagliptin or any of the excipients in TRADJENTA ( 4 , 5.3 )",
  "warnings_and_cautions": "Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue TRADJENTA. ( 5.1 ) Hypoglycemia: Consider lowering the dosage of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating TRADJENTA ( 5.2 ) Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with TRADJENTA. If hypersensitivity reactions occur, discontinue TRADJENTA, treat promptly, and monitor until signs and symptoms resolve. ( 5.3 ) Arthralgia: Severe and disabling arthralgia has been reported in patients taking TRADJENTA. Consider as a possible cause for severe joint pain and discontinue drug if appropriate. ( 5.4 ) Bullous pemphigoid: There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA. ( 5.5 ) Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of TRADJENTA in patients who have known risk factors for heart fail...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.4) ] Bullous Pemphigoid [see Warnings and Precautions (5.5) ] Heart Failure [see Warnings and Precautions (5.6) ] Most common adverse reaction (incidence \u22655% and more often than placebo) was nasopharyngitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, 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 the rates observed in practice. The safety evaluation of TRADJENTA 5 mg once daily in patients with type 2 diabetes mellitus is based on 14 placebo-controlled trials...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Pancreatitis Inform patients that acute pancreatitis has been reported during use of TRADJENTA. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue TRADJENTA promptly and contact their healthcare provider if persistent severe abdominal pain occurs [see Warnings and Precautions (5.1) ] . Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Inform patients that the incidence of hypoglycemia is increased when TRADJENTA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin [see Warnings and Precautions (5.2) ] . Hypersensitivity Reactions Inform patients that serious allergic reactions, such as anaphylaxis, angioedema, and exfoliative skin conditions, have been reported during postmarketing use of TRADJENTA. If symptoms of allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in brea...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: June 2023 MEDICATION GUIDE TRADJENTA \u00ae (TRAD gen ta) (linagliptin tablets) for oral use What is the most important information I should know about TRADJENTA? TRADJENTA can cause serious side effects, including: Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking TRADJENTA, tell your healthcare provider if you have ever had: inflammation of your pancreas (pancreatitis) a history of alcoholism stones in your gallbladder (gallstones) high blood triglyceride levels Stop taking TRADJENTA and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. What is TRADJENTA? TRADJENTA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus. TRADJENTA is not for people with type 1 diabetes mellitus. If you have ha...",
  "clinical_studies": "14.1 Glycemic Control Trials in Adults with Type 2 Diabetes Mellitus TRADJENTA has been studied as monotherapy and in combination with metformin, sulfonylurea, pioglitazone, and insulin. TRADJENTA has also been studied in patients with type 2 diabetes mellitus and severe chronic renal impairment. In patients with type 2 diabetes mellitus, treatment with TRADJENTA produced clinically significant improvements in hemoglobin A1c (A1C), fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG) compared with placebo. Monotherapy A total of 730 patients with type 2 diabetes mellitus participated in 2 double-blind, placebo-controlled studies, one of 18 weeks' and another of 24 weeks' duration, to evaluate the efficacy and safety of TRADJENTA monotherapy. In both monotherapy studies, patients currently on an antihyperglycemic agent discontinued the agent and underwent a diet, exercise, and drug washout period of about 6 weeks that included an open-label placebo run-in during the last 2 weeks. Patients with inadequate glycemic control (A1C 7% to 10%) after the washout period were randomized; patients not currently on antihyperglycemic agents (off therapy for at least 8 weeks) with...",
  "brand_name": "Tradjenta",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "NDA201280",
  "pharm_class_epc": [
   "Dipeptidyl Peptidase 4 Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240122",
  "set_id": "b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 21198,
  "serious": 16690,
  "death": 2294,
  "hospitalization": 9170,
  "primary_suspect": 21129,
  "top_reactions": [
   [
    "Blood Glucose Increased",
    1401
   ],
   [
    "Diarrhoea",
    1378
   ],
   [
    "Nausea",
    1236
   ],
   [
    "Dyspnoea",
    1182
   ],
   [
    "Fatigue",
    1128
   ],
   [
    "Off Label Use",
    1098
   ],
   [
    "Dizziness",
    1033
   ],
   [
    "Vomiting",
    1031
   ],
   [
    "Acute Kidney Injury",
    979
   ],
   [
    "Malaise",
    941
   ],
   [
    "Pruritus",
    840
   ],
   [
    "Pyrexia",
    835
   ],
   [
    "Arthralgia",
    785
   ],
   [
    "Headache",
    785
   ],
   [
    "Drug Ineffective",
    734
   ]
  ],
  "by_year": {
   "2019": 2204,
   "2020": 1825,
   "2021": 1704,
   "2022": 1633,
   "2023": 1897,
   "2024": 1455,
   "2025": 1268,
   "2026": 681
  },
  "by_year_primary": {
   "2019": 2202,
   "2020": 1824,
   "2021": 1699,
   "2022": 1611,
   "2023": 1889,
   "2024": 1447,
   "2025": 1258,
   "2026": 670
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 9,
  "nda": 1,
  "anda": 8,
  "first_approval": "20110502",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 9,
  "labeling_recent": 1,
  "sponsors": [
   "AUROBINDO PHARMA LTD",
   "BOEHRINGER INGELHEIM",
   "DR REDDYS",
   "INVAGEN PHARMS",
   "MSN",
   "MYLAN",
   "SUNSHINE",
   "TEVA PHARMS USA"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/02/2011"
 },
 "trials": {
  "total": 227,
  "completed": 163,
  "terminated": 17,
  "with_results": 81,
  "industry": 148,
  "phase3": 53,
  "results_share": 0.49693251533742333,
  "terminated_share": 0.07488986784140969
 },
 "pubmed": {
  "rct": 141,
  "meta": 11,
  "recent_rct": 25,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 130883.01,
  "records": 6948,
  "by_name": [
   [
    "Tradjenta",
    130883.01
   ]
  ],
  "names_checked": [
   "linagliptin",
   "Tradjenta"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1446832,
  "beneficiaries": 274523,
  "spend": 1127598446.4,
  "by_brand": [
   {
    "brand": "Tradjenta",
    "claims": 1446832,
    "per_claim": 779.35686134,
    "is_generic": false
   }
  ],
  "per_claim": 779.3568613356631
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Allergy",
  "names": [
   "alogliptin",
   "linagliptin",
   "saxagliptin",
   "sitagliptin",
   "vildagliptin"
  ],
  "reason": "Gliptins or DPP-4 inhibitors, i.e. alogliptin, linagliptin, saxagliptin, sitagliptin and vildagliptin, have a burdensome adverse effect profile that includes serious hypersensitivity reactions (anaphylaxis and cutaneous reactions such as Stevens-Johnson syndrome), infections (in particular urinary tract and upper respiratory tract infections), pancreatitis, bullous pemphigoid, and intestinal obstruction b- Finasteride 5 mg is sometimes an option in benign prostatic hyper- plasia, when alpha-1 blockers provide insufficient relief of urinary symptoms, are unsuitable or provoke unacceptable adver...",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "linagliptin"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3375,
  "fills": 1446832,
  "per_million": 2332.6827164453093,
  "ratio": 0.842443136879634,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "2,333 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 41,
   "letter": "F",
   "why": [
    "141 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "No Cochrane review found (-5)",
    "Only 50% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $130,883 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (8 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "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?",
  "The most-reported problems in FDA's adverse event data are blood glucose increased, diarrhoea, nausea, dyspnoea. 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 alogliptin, saxagliptin, sitagliptin? 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.)"
 ]
}