{
 "query": "olmesartan",
 "ingredient": "olmesartan",
 "slug": "olmesartan",
 "rxcui": "321064",
 "brands": [
  "Benicar"
 ],
 "names": [
  "olmesartan",
  "olmesartan medoxomil"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 132
  },
  "boxed_warning": "WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Benicar as soon as possible (5.1, 8.1). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1, 8.1). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Benicar as soon as possible ( 5.1 , 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).",
  "indications_and_usage": "Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. 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 this drug principally belongs. There are no controlled trials demonstrating risk reduction with Benicar. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, ha...",
  "contraindications": "Do not co-administer aliskiren with Benicar in patients with diabetes [see Drug Interactions (7.3) ]. Do not co-administer aliskiren with Benicar in patients with diabetes ( 4 ).",
  "warnings_and_cautions": "Avoid fetal ( in utero ) exposure ( 5.1 ). Use of Benicar in children <1 year of age is not recommended ( 5.2 ). Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation ( 5.3 ). Monitor for worsening renal function in patients with renal impairment ( 5.4 ). Sprue-like enteropathy has been reported. Consider alternative antihypertensive therapy in cases where no other etiology is found ( 5.5 ). 5.1 Fetal Toxicity Benicar can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system (RAS) 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 Benicar as soon as possible [see Use in Specific Populations (8.1) ]. 5.2 Morbidity in Infants Use of Benicar in children <1 year of age is not recommended. Drugs that act directly on the renin-angiotensin-aldosterone syst...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reaction in adults was dizziness (3%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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 Benicar has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. Events generally were mild, transient and had no relationship to the dose of Benicar. Analysis of gender, age and race groups demonstrated no differences between Benicar and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with Benicar and 2.7% (i.e., 32/1179) of control patients. In pla...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.3 , 5.6 ) 10/2019",
  "information_for_patients": "Pregnancy: Advise female patients of childbearing age about the consequences of exposure to Benicar during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Lactation : Advise nursing women not to breastfeed during treatment with BENICAR [see Use in Specific Populations (8.2) ] . Hyperkalemia: Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting their healthcare provider [see Drug Interactions (7.1) ] .",
  "spl_medguide": "",
  "clinical_studies": "14.1 Adult Hypertension The antihypertensive effects of Benicar have been demonstrated in seven placebo-controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically significant reductions in peak and trough blood pressure. A total of 2693 patients (2145 Benicar; 548 placebo) with essential hypertension were studied. Benicar once daily lowered diastolic and systolic blood pressure. The response was dose related, as shown in the following graph. A Benicar dose of 20 mg daily produces a trough sitting blood pressure (BP) reduction over placebo of about 10/6 mmHg and a dose of 40 mg daily produces a trough sitting BP reduction over placebo of about 12/7 mmHg. Benicar doses greater than 40 mg had little additional effect. The onset of the antihypertensive effect occurred within 1 week and was largely manifest after 2 weeks. Data above are from seven placebo-controlled studies (2145 Benicar patients, 548 placebo patients). The blood pressure lowering effect was maintained throughout the 24-hour period with Benicar once daily, with trough-to-peak ratios for systolic and diastolic response between 60 and 80%. The blood pressure lowering effect of B...",
  "brand_name": "Benicar",
  "manufacturer": "Cosette Pharmaceuticals, Inc.",
  "application_number": "NDA021286",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230712",
  "set_id": "5b6f8a18-8f8a-4521-81c3-3a39c73c6646",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 38563,
  "serious": 28540,
  "death": 2224,
  "hospitalization": 16429,
  "primary_suspect": 38470,
  "top_reactions": [
   [
    "Sprue-Like Enteropathy",
    3929
   ],
   [
    "Diarrhoea",
    3138
   ],
   [
    "Acute Kidney Injury",
    2664
   ],
   [
    "Weight Decreased",
    2397
   ],
   [
    "Gastrooesophageal Reflux Disease",
    2102
   ],
   [
    "Dizziness",
    1960
   ],
   [
    "Drug Ineffective",
    1951
   ],
   [
    "Nausea",
    1942
   ],
   [
    "Fatigue",
    1843
   ],
   [
    "Hypotension",
    1409
   ],
   [
    "Off Label Use",
    1398
   ],
   [
    "Dyspnoea",
    1373
   ],
   [
    "Constipation",
    1358
   ],
   [
    "Haemorrhoids",
    1350
   ],
   [
    "Headache",
    1311
   ]
  ],
  "by_year": {
   "2019": 3852,
   "2020": 2718,
   "2021": 2480,
   "2022": 2566,
   "2023": 2468,
   "2024": 2300,
   "2025": 2330,
   "2026": 1330
  },
  "by_year_primary": {
   "2019": 3847,
   "2020": 2717,
   "2021": 2471,
   "2022": 2540,
   "2023": 2450,
   "2024": 2285,
   "2025": 2318,
   "2026": 1324
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20210429",
   "reason": "Presence of Foreign Tablet/Capsule",
   "firm": "Ascend Laboratories LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200124",
   "reason": "cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.",
   "firm": "Ascend Laboratories LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 26,
  "nda": 1,
  "anda": 25,
  "first_approval": "20020425",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 17,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ADAPTIS",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL",
   "AUROBINDO PHARMA",
   "CADILA PHARMS LTD",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/25/2002"
 },
 "trials": {
  "total": 164,
  "completed": 120,
  "terminated": 10,
  "with_results": 39,
  "industry": 111,
  "phase3": 57,
  "results_share": 0.325,
  "terminated_share": 0.06097560975609756
 },
 "pubmed": {
  "rct": 203,
  "meta": 15,
  "recent_rct": 9,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "olmesartan",
   "Benicar"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3518783,
  "beneficiaries": 916441,
  "spend": 83161839.24,
  "by_brand": [
   {
    "brand": "Olmesartan Medoxomil",
    "claims": 3499458,
    "per_claim": 19.762803346,
    "is_generic": true
   },
   {
    "brand": "Benicar",
    "claims": 19325,
    "per_claim": 724.591926,
    "is_generic": false
   }
  ],
  "per_claim": 23.633693592358494
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20140624",
   "title": "FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm402323.htm",
   "kind": "drug",
   "matched": "olmesartan"
  },
  {
   "date": "20130703",
   "title": "FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm359477.htm",
   "kind": "drug",
   "matched": "olmesartan medoxomil"
  },
  {
   "date": "20110414",
   "title": "Olmesartan - Safety Review Update of Benicar (olmesartan) and cardiovascular events",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm251268.htm",
   "kind": "drug",
   "matched": "benicar"
  }
 ],
 "settlements": [],
 "prescrire": {
  "section": "Cardiology",
  "names": [
   "olmesartan"
  ],
  "reason": "Olmesartan, an angiotensin II receptor blocker (ARB or sartan) marketed alone or in combination with hydrochlorothiazide or amlodipine, is no more effective than other ARBs against the cardiovascular complications of hypertension. However, it can cause sprue-like enteropathy leading to chronic diarrhoea (potentially severe) and weight loss, autoimmune hepatitis, and possibly an increase in cardiovascular mortality (Prescrire Int n\u00b0 148, 171, 242; Rev Prescrire n\u00b0 324, 374). Among the many other ARBs available, it is better to choose losartan or valsartan, which do not appear to have these adve...",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "olmesartan"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5927,
  "fills": 3518783,
  "per_million": 1684.3891765988412,
  "ratio": 0.6083133774071073,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 40,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 3 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-20)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "1,684 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 38,
   "letter": "F",
   "why": [
    "203 randomized trials and 15 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 32% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 25 generic makers (-2)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (25 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 59,
 "grade": "D",
 "questions": [
  "In 2014 the FDA issued a safety communication about this drug (FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label upd). Does that risk apply to me?",
  "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?",
  "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 sprue-like enteropathy, diarrhoea, acute kidney injury, weight decreased. How would we recognize and handle those?",
  "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.)"
 ]
}