{ "query": "ezetimibe", "ingredient": "ezetimibe", "slug": "ezetimibe", "rxcui": "341248", "brands": [ "Zetia" ], "names": [ "ezetimibe" ], "classes": [], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 50 }, "boxed_warning": "", "indications_and_usage": "\u00ae is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. When ZETIA is used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use. ZETIA is indicated ( 1 ): In combination with a stat...", "contraindications": "is contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ZETIA. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see Adverse Reactions (6.2) ] . When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ZETIA is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated. Refer to the Prescribing Information of these products for a list of their contraindications [see Warnings and Precautions (5.1) ] . Hypersensitivity to ezetimibe or any excipient of ZETIA. ( 4 ) When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ZETIA is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated. Refer to the Prescribing Information of these products for a list of their contraindications. ( 4 )", "warnings_and_cautions": "Risks Associated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies : Refer to the Prescribing Information of these products for a description of their risks including, but not limited to, the warnings and precautions. ( 5.1 ) Liver Enzyme Abnormalities and Monitoring : Increases in serum transaminases have been reported with use of ZETIA. Perform liver enzyme testing as clinically indicated and consider withdrawal of ZETIA if increases in ALT or AST \u22653 \u00d7 ULN persist. ( 5.2 ) Skeletal Muscle Effects (e.g., Myopathy and Rhabdomyolysis) : ZETIA may cause myopathy and rhabdomyolysis. In post-marketing reports, most patients who developed rhabdomyolysis were taking a statin or other agents known to be associated with an increased risk of rhabdomyolysis, such as fibrates. If myopathy is suspected, discontinue ZETIA and other concomitant medications, as appropriate. ( 5.3 ) 5.1 Risks Associated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies If ZETIA is administered with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for a description of their r...", "warnings": "", "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections of the label: Liver enzyme abnormalities [see Warnings and Precautions (5.2) ] Rhabdomyolysis and myopathy [see Warnings and Precautions (5.3) ] Common adverse reactions in clinical trials: ZETIA administered alone (incidence \u22652% and greater than placebo): upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. ( 6.1 ) ZETIA coadministered with a statin (incidence \u22652% and greater than statin alone): nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 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 clinical practice. Monotherapy In 10 double-blind, placebo-...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Indications and Usage ( 1 ) 7/2023 Dosage and Administration ( 2 ) 7/2023 Contraindications ( 4 ) 7/2023 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 7/2023", "information_for_patients": "Advise the patient to read the FDA-Approved Patient Labeling ( Patient Information ). Inform patients that ZETIA may cause liver enzyme elevations [see Warnings and Precautions (5.2) ] . Muscle Pain Advise patients that ZETIA may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.3) , and Drug Interactions (7) ] . Pregnancy Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if ZETIA should be discontinued [see Use in Specific Populations (8.1) ] . Breastfeeding Advise patients who have a lipid disorder and are breastfeeding to discuss the options with their healthcare provider [see Use in Specific Populations (8.2) ] . Missed Dose Instruct patients to take ZETIA only as prescribed. If a dose is missed, it should be taken as soon as possible. Advise patients not to double their next dose. O...", "spl_medguide": "", "clinical_studies": "Primary Hyperlipidemia in Adults ZETIA reduces total-C, LDL-C, Apo B, and non-HDL-C in patients with hyperlipidemia. Maximal to near maximal response is generally achieved within 2 weeks and maintained during chronic therapy. Monotherapy In two multicenter, double-blind, placebo-controlled, 12-week trials in 1719 patients (age range 18 to 86 years, 52% females; 91% White, 5% Black or African American, 1% Asian, 3% other races mostly identified as Hispanic or Latino ethnicity) with primary hyperlipidemia, ZETIA significantly lowered total-C, LDL-C, Apo B, and non-HDL-C compared to placebo (see Table 6 ). Reduction in LDL-C was consistent across age, sex, and baseline LDL-C. TABLE 6: Response to ZETIA in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline Baseline - on no lipid-lowering drug. ) Treatment Group N Total-C LDL-C Apo B Non-HDL-C Trial 1 ZETIA significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to placebo. Placebo 205 +1 +1 -1 +1 Ezetimibe 622 -12 -18 -15 -16 Trial 2 Placebo 226 +1 +1 -1 +2 Ezetimibe 666 -12 -18 -16 -16 Pooled Data (Trials 1 & 2) Placebo 431 0 +1 -2 +1 Ezetimibe 1288 -13 -18 -16 -16 Combination with Statins: ZETIA A...", "brand_name": "Zetia", "manufacturer": "Organon LLC", "application_number": "NDA021445", "pharm_class_epc": [ "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "route": [ "ORAL" ], "effective_time": "20251125", "set_id": "174e45e0-45bb-48b7-9e60-8f6cfc1d22bb", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 58671, "serious": 41448, "death": 3763, "hospitalization": 18369, "primary_suspect": 58216, "top_reactions": [ [ "Fatigue", 4206 ], [ "Myalgia", 3559 ], [ "Nausea", 3462 ], [ "Diarrhoea", 3400 ], [ "Drug Ineffective", 2981 ], [ "Dyspnoea", 2892 ], [ "Headache", 2809 ], [ "Dizziness", 2802 ], [ "Arthralgia", 2470 ], [ "Off Label Use", 2376 ], [ "Asthenia", 2370 ], [ "Pain", 2274 ], [ "Fall", 2056 ], [ "Malaise", 2027 ], [ "Vomiting", 1974 ] ], "by_year": { "2019": 4837, "2020": 4762, "2021": 4436, "2022": 4641, "2023": 5328, "2024": 6165, "2025": 7334, "2026": 4143 }, "by_year_primary": { "2019": 4833, "2020": 4750, "2021": 4414, "2022": 4522, "2023": 5239, "2024": 6104, "2025": 7236, "2026": 4098 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 17, "nda": 1, "anda": 16, "first_approval": "20021025", "rems": false, "rems_last": "", "labeling_supplements": 18, "labeling_recent": 2, "sponsors": [ "ACCORD HLTHCARE", "ALKEM LABS LTD", "AMNEAL PHARMS CO", "APOTEX", "AUROBINDO PHARMA", "GLENMARK PHARMS LTD", "HETERO LABS LTD III", "MACLEODS PHARMS" ], "unapproved": false, "first_approval_fmt": "10/25/2002" }, "trials": { "total": 491, "completed": 322, "terminated": 29, "with_results": 131, "industry": 316, "phase3": 153, "results_share": 0.40683229813664595, "terminated_share": 0.059063136456211814 }, "pubmed": { "rct": 441, "meta": 83, "recent_rct": 66, "cochrane": [ { "pmid": "30480766", "title": "Ezetimibe for the prevention of cardiovascular disease and all-cause mortality events", "year": "2018" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "ezetimibe", "Zetia" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 8755353, "beneficiaries": 2412870, "spend": 214566675.64999998, "by_brand": [ { "brand": "Ezetimibe", "claims": 8748229, "per_claim": 23.859818164, "is_generic": true }, { "brand": "Zetia", "claims": 7124, "per_claim": 819.13566115, "is_generic": false } ], "per_claim": 24.506913159298087 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 17438, "fills": 8755353, "per_million": 1991.695823115299, "ratio": 0.7192964843037863, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "1,992 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 (0.7x)" ], "weight": 0.35 }, "evidence": { "score": 77, "letter": "B", "why": [ "441 randomized trials and 83 systematic reviews/meta-analyses indexed in PubMed", "1 independent Cochrane review(s) exist", "Only 41% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 91, "letter": "A", "why": [ "No recalls on record since 2016", "2 label changes approved since 2021 (-4)", "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 (16 applications)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 90, "grade": "A", "questions": [ "The most-reported problems in FDA's adverse event data are fatigue, myalgia, nausea, diarrhoea. 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.)" ] }