{ "query": "sitagliptin", "ingredient": "sitagliptin", "slug": "sitagliptin", "rxcui": "593411", "brands": [ "Januvia", "Brynovin", "Zituvio" ], "names": [ "sitagliptin", "sitagliptin hydrochloride", "sitagliptin phosphate" ], "classes": [ { "id": "A10BH", "name": "Dipeptidyl peptidase 4 (DPP-4) inhibitors" } ], "alternatives": [ "alogliptin", "linagliptin", "saxagliptin", "vildagliptin" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 32 }, "boxed_warning": "", "indications_and_usage": "\u00ae is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA 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: \u2022 JANUVIA should not be used in patients with type 1 diabetes ( 1 ) \u2022 JANUVIA has not been studied in patients with a history of pancreatitis. ( 1 , 5.1 ) Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. [See Warnings and Precautions (5.1) .]", "contraindications": "History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.5) ; Adverse Reactions (6.2) .] History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema ( 5.5 , 6.2 )", "warnings_and_cautions": "\u2022 Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA. ( 5.1 ) \u2022 Heart failure : Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of JANUVIA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.2 ) \u2022 Acute Renal Failure: Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. ( 5.3 ) \u2022 Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required. ( 5.4 , 7.1 ) \u2022 Hypersensitivity Reactions: There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with JANUVIA such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop JANUVIA, assess for...", "warnings": "", "adverse_reactions": "The following adverse reactions are also discussed elsewhere in the labeling: \u2022 Pancreatitis [see Warnings and Precautions (5.1) ] \u2022 Heart Failure [see Warnings and Precautions (5.2) ] \u2022 Acute Renal Failure [see Warnings and Precautions (5.3) ] \u2022 Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.4) ] \u2022 Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] \u2022 Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] \u2022 Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Adverse reactions reported in \u22655% of patients treated with JANUVIA and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with JANUVIA compared to placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 clin...", "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 postmarketing use of JANUVIA. 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 promptly discontinue JANUVIA and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.1) ]. Heart Failure Inform patients of the signs and symptoms of heart failure. Before initiating JANUVIA, ask patients about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Instruct patients to contact their health care provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.2) ]. Hypoglycemia Inform patients that the incidence of hypoglycemia is increased when JANUVIA is added to a sulfonylurea or insulin. Explain to patients receiving JANUVIA in combinati...", "spl_medguide": "Medication Guide JANUVIA \u00ae (jah-NEW-vee-ah) (sitagliptin) tablets, for oral use Read this Medication Guide carefully before you start taking JANUVIA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about JANUVIA, ask your doctor or pharmacist. What is the most important information I should know about JANUVIA? JANUVIA can cause serious side effects, including: \u2022 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 JANUVIA, tell your doctor if you have ever had: o pancreatitis o high blood triglyceride levels o stones in your gallbladder (gallstones) o kidney problems o a history of alcoholism Stop taking JANUVIA and call your doctor 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 through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. \u2022 Heart failure . Heart failure m...", "clinical_studies": "There were approximately 5200 patients with type 2 diabetes randomized in nine double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of sitagliptin on glycemic control. In a pooled analysis of seven of these studies, the ethnic/racial distribution was approximately 59% white, 20% Hispanic, 10% Asian, 6% black, and 6% other groups. Patients had an overall mean age of approximately 55 years (range 18 to 87 years). In addition, an active (glipizide)-controlled study of 52-weeks duration was conducted in 1172 patients with type 2 diabetes who had inadequate glycemic control on metformin. In patients with type 2 diabetes, treatment with JANUVIA produced clinically significant improvements in hemoglobin A1C, fasting plasma glucose (FPG) and 2-hour post-prandial glucose (PPG) compared to placebo. 14.1 Monotherapy A total of 1262 patients with type 2 diabetes participated in two double-blind, placebo-controlled studies, one of 18-week and another of 24-week duration, to evaluate the efficacy and safety of JANUVIA monotherapy. In both monotherapy studies, patients currently on an antihyperglycemic agent discontinued the agent, and underwent ...", "brand_name": "JANUVIA", "manufacturer": "Cardinal Health 107, LLC", "application_number": "NDA021995", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20251105", "set_id": "39253ddd-0245-43b1-ad28-d5923983afb4", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 56316, "serious": 40522, "death": 5950, "hospitalization": 22362, "primary_suspect": 56083, "top_reactions": [ [ "Blood Glucose Increased", 3149 ], [ "Nausea", 3081 ], [ "Diarrhoea", 3027 ], [ "Drug Ineffective", 2569 ], [ "Fatigue", 2566 ], [ "Acute Kidney Injury", 2513 ], [ "Vomiting", 2057 ], [ "Dyspnoea", 1992 ], [ "Death", 1967 ], [ "Dizziness", 1909 ], [ "Headache", 1822 ], [ "Asthenia", 1774 ], [ "Fall", 1725 ], [ "Product Dose Omission Issue", 1659 ], [ "Malaise", 1641 ] ], "by_year": { "2019": 5661, "2020": 5065, "2021": 4168, "2022": 3804, "2023": 3094, "2024": 3020, "2025": 2986, "2026": 1363 }, "by_year_primary": { "2019": 5658, "2020": 5063, "2021": 4147, "2022": 3760, "2023": 3028, "2024": 2959, "2025": 2965, "2026": 1348 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 22, "nda": 3, "anda": 3, "first_approval": "20061016", "rems": false, "rems_last": "", "labeling_supplements": 20, "labeling_recent": 1, "sponsors": [ "AJANTA PHARMA LTD", "ALKEM LABS LTD", "APOTEX", "AZURITY", "BIOCON PHARMA LTD", "DR REDDYS LABS LTD", "FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,", "LAURUS LABS LTD" ], "unapproved": false, "first_approval_fmt": "10/16/2006" }, "trials": { "total": 574, "completed": 443, "terminated": 49, "with_results": 235, "industry": 322, "phase3": 155, "results_share": 0.5304740406320542, "terminated_share": 0.08536585365853659 }, "pubmed": { "rct": 386, "meta": 26, "recent_rct": 60, "cochrane": [] }, "payments": { "year": "2024", "usd": 2264.93, "records": 63, "by_name": [ [ "Januvia", 2264.93 ] ], "names_checked": [ "sitagliptin", "Januvia", "Brynovin", "Zituvio" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 4037564, "beneficiaries": 834464, "spend": 3811180975.6000004, "by_brand": [ { "brand": "Januvia", "claims": 4027317, "per_claim": 945.50656474, "is_generic": false }, { "brand": "Sitagliptin", "claims": 10247, "per_claim": 324.61342832, "is_generic": true } ], "per_claim": 943.9307898524953 }, "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": "sitagliptin" }, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 7272, "fills": 4037564, "per_million": 1801.0860013612169, "ratio": 0.6504581742213609, "median": 2768.949753790441 }, "scores": { "safety": { "score": 90, "letter": "A", "why": [ "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)", "1,801 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site", "Death share in reports is near or below the FAERS average (1.2x)" ], "weight": 0.35 }, "evidence": { "score": 62, "letter": "D", "why": [ "386 randomized trials and 26 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)" ], "weight": 0.25 }, "regulatory": { "score": 100, "letter": "A", "why": [ "No recalls on record since 2016" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $2,265 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 (3 applications)", "4 same-class alternatives exist" ], "weight": 0.1 } }, "total": 87, "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, nausea, diarrhoea. How would we recognize and handle those?", "Why this one over alogliptin, linagliptin, saxagliptin? 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.)" ] }