{ "query": "candesartan", "ingredient": "candesartan", "slug": "candesartan", "rxcui": "214354", "brands": [ "Atacand" ], "names": [ "candesartan", "candesartan cilexetil" ], "classes": [ { "id": "C09CA", "name": "Angiotensin II receptor blockers (ARBs), plain" } ], "alternatives": [ "azilsartan medoxomil", "eprosartan", "irbesartan", "losartan", "olmesartan medoxomil", "telmisartan", "valsartan" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 20 }, "boxed_warning": "WARNING: FETAL TOXICITY \u2022 When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible [see Warnings and Precautions (5.1)]. \u2022 Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. \u2022 When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible. (5.1) \u2022 Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)", "indications_and_usage": "Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: \u00b7 Treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). \u00b7 Treatment of heart failure (NYHA class II-IV); candesartan cilexetil tablets reduces cardiovascular death and heart failure hospitalization (1.2). 1.1 Hypertension Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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. 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. M...", "contraindications": "Candesartan cilexetil tablets are contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes [see Drug Interactions (7.4)]. Known hypersensitivity to product components (4). Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes (4).", "warnings_and_cautions": "\u00b7 Observe for signs and symptoms of hypotension (5.3). \u00b7 Monitor renal function (5.4) and potassium levels (5.5). 5.1 Fetal Toxicity Pregnancy Category D 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 candesartan cilexetil tablets as soon as possible [see Use in Specific Populations (8.1)]. Oral doses \u226510 mg of candesartan cilexetil/kg/day administered to pregnant rats during late gestation and continued through lactation were associated with reduced survival and an increased incidence of hydronephrosis in the offspring. The 10-mg/kg/day dose in rats is approximately 2.8 times the maximum recommended daily human dose (MRHD) of 32 mg on a mg/m 2 basis (comparison assumes human body weight of 50 kg). Candesartan cilexetil given to pregnant rabbits at an oral dose of 3 mg/kg/day (approximately 1.7 times t...", "warnings": "", "adverse_reactions": "\u00b7 Most common adverse reactions which caused adult patients to discontinue therapy for: o Hypertension were headache (0.6%) and dizziness (0.3%) (6.1). o Heart Failure were hypotension (4.1%) (5.3), abnormal renal function (6.3%) (5.4), and hyperkalemia (2.4%) (5.5). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies 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 Candesartan cilexetil has been evaluated for safety in more than 3600 patients/subjects, including more than 3200 patients treated for hypertension. About 600 of these patients were studied for at least 6 months and about 200 for at least 1 year. In general, treatment with candesartan cilexetil was well tolerated. The overall incidence of adverse events reported with candesartan cilexetil was similar to placebo. The rate of withdrawals due to adverse events in all trials in patients (7510 total) was 3.3% (i.e., 10...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Warnings and Precautions (5.5) 02/2016", "information_for_patients": "Advise patient to read FDA-approved patient labeling (Patient Information). Pregnancy Advise female patients of childbearing age should be told about the consequences of exposure to candesartan cilexetil tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village: Panelav, P.O. Tajpura Near Baska, Taluka Halol, Panch Mahal 389350, Gujarat, India. Revised: 11/2017", "spl_medguide": "", "clinical_studies": "14.1 Hypertension Adult The antihypertensive effects of candesartan cilexetil were examined in 14 placebo-controlled trials of 4- to 12-weeks duration, primarily at daily doses of 2 to 32 mg per day in patients with baseline diastolic blood pressures of 95 to 114 mm Hg. Most of the trials were of candesartan cilexetil as a single agent, but it was also studied as add-on to hydrochlorothiazide and amlodipine. These studies included a total of 2350 patients randomized to one of several doses of candesartan cilexetil and 1027 to placebo. Except for a study in diabetics, all studies showed significant effects, generally dose related, of 2 to 32 mg on trough (24 hour) systolic and diastolic pressures compared to placebo, with doses of 8 to 32 mg giving effects of about 8 to 12/4 to 8 mm Hg. There were no exaggerated first-dose effects in these patients. Most of the antihypertensive effect was seen within 2 weeks of initial dosing and the full effect in 4 weeks. With once-daily dosing, blood pressure effect was maintained over 24 hours, with trough to peak ratios of blood pressure effect generally over 80%. Candesartan cilexetil had an additional blood pressure lowering effect when added...", "brand_name": "CANDESARTAN CILEXETIL", "manufacturer": "Alembic Pharmaceuticals Limited", "application_number": "ANDA210302", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20230127", "set_id": "d5b43fa0-6678-4219-99f1-10d273d49baf", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 51174, "serious": 48766, "death": 6428, "hospitalization": 26726, "primary_suspect": 50802, "top_reactions": [ [ "Off Label Use", 4811 ], [ "Fatigue", 4522 ], [ "Dyspnoea", 4372 ], [ "Nausea", 4242 ], [ "Diarrhoea", 3952 ], [ "Dizziness", 3825 ], [ "Headache", 3798 ], [ "Drug Ineffective", 3470 ], [ "Pain", 3415 ], [ "Vomiting", 3167 ], [ "Arthralgia", 3043 ], [ "Malaise", 2909 ], [ "Asthenia", 2830 ], [ "Hypertension", 2795 ], [ "Fall", 2680 ] ], "by_year": { "2019": 4990, "2020": 5286, "2021": 4635, "2022": 4466, "2023": 4601, "2024": 5160, "2025": 5235, "2026": 2546 }, "by_year_primary": { "2019": 4979, "2020": 5280, "2021": 4597, "2022": 4391, "2023": 4554, "2024": 5039, "2025": 5185, "2026": 2524 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20210913", "reason": "Failed Impurities/Degradation Specifications; out of specification for Related Compound", "firm": "Viatris", "status": "Terminated" }, { "class": "Class III", "date": "20210322", "reason": "Failed Impurities/Degradation Specifications", "firm": "Macleods Pharma Usa Inc", "status": "Terminated" } ], "recall_total": 2, "drugsfda": { "applications": 8, "nda": 1, "anda": 7, "first_approval": "19980604", "rems": false, "rems_last": "", "labeling_supplements": 13, "labeling_recent": 0, "sponsors": [ "ALEMBIC", "ANI PHARMS", "APOTEX", "MACLEODS PHARMS", "MYLAN", "PRINSTON INC", "ZYDUS LIFESCIENCES" ], "unapproved": false, "first_approval_fmt": "06/04/1998" }, "trials": { "total": 207, "completed": 132, "terminated": 18, "with_results": 30, "industry": 113, "phase3": 53, "results_share": 0.22727272727272727, "terminated_share": 0.08695652173913043 }, "pubmed": { "rct": 289, "meta": 9, "recent_rct": 14, "cochrane": [] }, "payments": { "year": "2024", "usd": 1474.69, "records": 28, "by_name": [ [ "Atacand", 1474.69 ] ], "names_checked": [ "candesartan", "Atacand" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 496692, "beneficiaries": 120578, "spend": 41532423.8, "by_brand": [ { "brand": "Candesartan Cilexetil", "claims": 493798, "per_claim": 80.535716406, "is_generic": true }, { "brand": "Atacand", "claims": 2894, "per_claim": 609.5535971, "is_generic": false } ], "per_claim": 83.61806471616212 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 12748, "fills": 496692, "per_million": 25665.80496565276, "ratio": 9.269147961431441, "median": 2768.949753790441 }, "scores": { "safety": { "score": 50, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "25,666 FDA reports naming it as the suspect drug per million Medicare fills, 9.3x the median drug on this site (-15)", "Death share in reports is near or below the FAERS average (1.4x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 48, "letter": "F", "why": [ "289 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 23% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 93, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 0 Class II, 2 Class III (-2)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $1,475 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 (7 applications)", "7 same-class alternatives exist" ], "weight": 0.1 } }, "total": 68, "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, nausea. 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 azilsartan medoxomil, eprosartan, irbesartan? 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.)" ] }