{
 "query": "valsartan",
 "ingredient": "valsartan",
 "slug": "valsartan",
 "rxcui": "69749",
 "brands": [
  "Diovan"
 ],
 "names": [
  "valsartan"
 ],
 "classes": [
  {
   "id": "C09CA",
   "name": "Angiotensin II receptor blockers (ARBs), plain"
  }
 ],
 "alternatives": [
  "azilsartan medoxomil",
  "candesartan",
  "eprosartan",
  "irbesartan",
  "losartan",
  "olmesartan medoxomil",
  "telmisartan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 162
  },
  "boxed_warning": "WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Diovan as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Diovan as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )",
  "indications_and_usage": "Diovan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension , to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults ( 1.2 ) Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3 ) 1.1 Hypertension Diovan \u00ae is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan. Control of high blood pressure ...",
  "contraindications": "Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with Diovan in patients with diabetes [see Drug Interactions (7.3)] . Known hypersensitivity to any component. Do not coadminister aliskiren with Diovan in patients with diabetes ( 4 )",
  "warnings_and_cautions": "Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Diovan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Diovan as soon as possible [see Use in Specific Populations (8.1)] . 5.2 Hypotension Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with Diovan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of Diovan, or the treatment should start under close medical supervision. Patients with heart failure or post-myocardi...",
  "warnings": "",
  "adverse_reactions": "Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Diovan has been evaluated for safety in more than 4000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adv...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy: Advise female patients of childbearing age about the consequences of exposure to Diovan during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their healthcare provider as soon as possible [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)] . Lactation: Advise women not to breastfeed during treatment with Diovan [see Use in Specific Populations (8.2)] . Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider. Tell patients that if syncope occurs to discontinue Diovan until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions (5.2)] . Hyperkalemia: Advise patients not to use salt substitutes without consulting their healthcare provider [see Drug Interactions (7.1)]...",
  "spl_medguide": "",
  "clinical_studies": "Effects on Mortality Amongst Subgroups in VALIANT 14.1 Hypertension Adult Hypertension The antihypertensive effects of Diovan (valsartan) were demonstrated principally in 7 placebo-controlled, 4- to 12-week trials (1 in patients over 65 years) of dosages from 10 mg/day to 320 mg/day in patients with baseline diastolic blood pressures of 95-115 mmHg. The studies allowed comparison of once-daily and twice-daily regimens of 160 mg/day; comparison of peak and trough effects; comparison (in pooled data) of response by gender, age, and race; and evaluation of incremental effects of hydrochlorothiazide. Administration of valsartan to patients with essential hypertension results in a significant reduction of sitting, supine, and standing systolic and diastolic blood pressure, usually with little or no orthostatic change. In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs at approximately 2 hours, and maximum reduction of blood pressure is achieved within 6 hours. The antihypertensive effect persists for 24 hours after dosing, but there is a decrease from peak effect at lower doses (40 mg) presumably reflecting loss of inhibition of angio...",
  "brand_name": "Diovan",
  "manufacturer": "Novartis Pharmaceuticals Corporation",
  "application_number": "NDA021283",
  "pharm_class_epc": [
   "Angiotensin 2 Receptor Blocker [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260811",
  "set_id": "5ddba454-f3e6-43c2-a7a6-58365d297213",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 70511,
  "serious": 54093,
  "death": 5744,
  "hospitalization": 27235,
  "primary_suspect": 70075,
  "top_reactions": [
   [
    "Drug Ineffective",
    4888
   ],
   [
    "Fatigue",
    4148
   ],
   [
    "Dyspnoea",
    3670
   ],
   [
    "Diarrhoea",
    3491
   ],
   [
    "Nausea",
    3470
   ],
   [
    "Acute Kidney Injury",
    3446
   ],
   [
    "Dizziness",
    3445
   ],
   [
    "Headache",
    3275
   ],
   [
    "Blood Pressure Increased",
    2892
   ],
   [
    "Off Label Use",
    2857
   ],
   [
    "Hypertension",
    2808
   ],
   [
    "Pain",
    2598
   ],
   [
    "Malaise",
    2562
   ],
   [
    "Fall",
    2468
   ],
   [
    "Asthenia",
    2465
   ]
  ],
  "by_year": {
   "2019": 7653,
   "2020": 5850,
   "2021": 4947,
   "2022": 4395,
   "2023": 3911,
   "2024": 4222,
   "2025": 4192,
   "2026": 2030
  },
  "by_year_primary": {
   "2019": 7643,
   "2020": 5840,
   "2021": 4928,
   "2022": 4338,
   "2023": 3814,
   "2024": 4121,
   "2025": 4106,
   "2026": 1981
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260804",
   "reason": "Failed Dissolution Specifications",
   "firm": "Novartis Pharmaceuticals Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20181231",
   "reason": "CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20181231",
   "reason": "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20181231",
   "reason": "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20181231",
   "reason": "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20181231",
   "reason": "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20180814",
   "reason": "Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.",
   "firm": "Jubilant Cadista Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180814",
   "reason": "Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.",
   "firm": "Jubilant Cadista Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180814",
   "reason": "Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.",
   "firm": "Jubilant Cadista Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180808",
   "reason": "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.",
   "firm": "Hetero Labs Limited Unit V",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20180808",
   "reason": "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.",
   "firm": "Hetero Labs Limited Unit V",
   "status": "Completed"
  }
 ],
 "recall_total": 20,
 "drugsfda": {
  "applications": 27,
  "nda": 3,
  "anda": 24,
  "first_approval": "19961223",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 26,
  "labeling_recent": 1,
  "sponsors": [
   "ADAPTIS",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "AUROBINDO PHARMA LTD",
   "BOSTAL DRUG",
   "CARMEL BIOSCIENCES",
   "DR REDDYS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/23/1996"
 },
 "trials": {
  "total": 569,
  "completed": 377,
  "terminated": 48,
  "with_results": 117,
  "industry": 310,
  "phase3": 142,
  "results_share": 0.3103448275862069,
  "terminated_share": 0.0843585237258348
 },
 "pubmed": {
  "rct": 615,
  "meta": 100,
  "recent_rct": 121,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 74.0,
  "records": 4,
  "by_name": [
   [
    "valsartan",
    74.0
   ]
  ],
  "names_checked": [
   "valsartan",
   "Diovan"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4717517,
  "beneficiaries": 1205634,
  "spend": 148439850.3,
  "by_brand": [
   {
    "brand": "Valsartan",
    "claims": 4691604,
    "per_claim": 27.218392846,
    "is_generic": true
   },
   {
    "brand": "Diovan",
    "claims": 25913,
    "per_claim": 800.44493305,
    "is_generic": false
   }
  ],
  "per_claim": 31.46567363721212
 },
 "mdl": [
  {
   "number": "2930",
   "title": "Entresto (Sacubitril/Valsartan) Patent Litigation",
   "judge": "Andrews, Richard G.",
   "court": "DE",
   "docket": "1:20-md-2930",
   "actions": "",
   "matched": "valsartan"
  },
  {
   "number": "2875",
   "title": "Valsartan, Losartan, and Irbesartan Products Liability Litigation",
   "judge": "Bumb, Renee M.",
   "court": "NJ",
   "docket": "1:19-md-2875",
   "actions": "",
   "matched": "valsartan"
  }
 ],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "valsartan + amlodipine + hydrochlorothiazide",
  "matched": "valsartan",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10208,
  "fills": 4717517,
  "per_million": 2163.8501779643825,
  "ratio": 0.7814696438612756,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,164 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 (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "615 randomized trials and 100 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 31% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 17 Class II, 3 Class III across 24 generic makers (-7)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $74 tied to this drug last year: negligible",
    "Named in 2 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (24 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, dyspnoea, diarrhoea. How would we recognize and handle those?",
  "Why this one over azilsartan medoxomil, candesartan, eprosartan? What would make you pick one of those instead?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "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.)"
 ]
}