{ "query": "cilostazol", "ingredient": "cilostazol", "slug": "cilostazol", "rxcui": "21107", "brands": [], "names": [ "cilostazol" ], "classes": [ { "id": "B01AC", "name": "Platelet aggregation inhibitors excl. heparin" } ], "alternatives": [ "abciximab", "aloxiprin", "aspirin", "cangrelor", "clopidogrel", "dipyridamole", "epoprostenol", "eptifibatide", "iloprost", "indobufen", "prasugrel", "selexipag", "ticagrelor", "ticlopidine", "tirofiban", "treprostinil", "triflusal", "vorapaxar" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 11 }, "boxed_warning": "WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS Cilostazol is contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV heart failure [see Contraindications ( 4 )] . WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS See full prescribing information for complete boxed warning. Cilostazol is contraindicated in patients with heart failure of any severity. Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with the pharmacologic effect have caused decreased survival compared to placebo patients with class III-IV heart failure. ( 4 )", "indications_and_usage": "Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol tablets are a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ( 1 )", "contraindications": "Cilostazol tablets are contraindicated in patients with: Heart failure of any severity: Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV heart failure. Hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) Heart failure of any severity ( 4 ) Hypersensitivity to cilostazol or any components of cilostazol tablets ( 4 )", "warnings_and_cautions": "Risks of tachycardia, palpitation, tachyarrhythmia or hypotension. Risks of exacerbations of angina pectoris or myocardial infarction in patients with a history of ischemic heart disease ( 5.2 ) Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum ( 5.1 ) Risks of thrombocytopenia or leukopenia progressing to agranulocytosis-monitor platelets and white blood cell counts ( 5.3 ) Avoid use in patients with hemostatic disorders or active pathologic bleeding ( 5.4 ) 5.1 Tachycardia Cilostazol may induce tachycardia, palpitation, tachyarrhythmia or hypotension. The increase in heart rate associated with cilostazol is approximately 5 to 7 bpm. Patients with a history of ischemic heart disease may be at risk for exacerbations of angina pectoris or myocardial infarction. 5.2 Left Ventricular Outflow Tract Obstruction Left ventricular outflow tract obstruction has been reported in patients with sigmoid shaped interventricular septum. Monitor patients for the development of a new systolic murmur or cardiac symptoms after starting cilostazol. 5.3 Hematologic Adverse Reactions Cases of thrombocytopenia or leukopenia progressing to...", "warnings": "", "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the labeling: - Patients with Heart Failure [see Boxed Warning ] - Tachycardia [see Warnings and Precautions ( 5.1 )] - Left Ventricular Outflow Tract Obstruction [see Warnings and Precautions ( 5.2 )] - Hematologic Adverse Reactions [see Warnings and Precautions ( 5.3 )] - Hemostatic Disorders or Active Pathologic Bleeding [see Warnings and Precautions ( 5.4 )] Most common adverse reactions greater than or equal to 2% and at least twice that for placebo in patients on 100 mg twice daily are headache, diarrhea, abnormal stools, and palpitation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 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 clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions were assessed in eight placebo-controlled clinical trials involving patients exposed to either 50 or 100 mg twice daily cilo...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information) Advise the patient: to take cilostazol at least one-half hour before or two hours after food. to discuss with their doctor before taking any CYP3A4 or CYP2C19 inhibitors (e.g., omeprazole). that the beneficial effects of cilostazol on the symptoms of intermittent claudication may not be immediate. Although the patient may experience benefit in 2 to 4 weeks after initiation of therapy, treatment for up to 12 weeks may be required before a beneficial effect is experienced. Discontinue cilostazol if symptoms do not improve after 3 months. Manufactured In India By: Piramal Pharma Limited Pithampur 454775, Dist. Dhar, Madhya Pradesh, India Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. P 7/2022", "spl_medguide": "", "clinical_studies": "The ability of cilostazol to improve walking distance in patients with stable intermittent claudication was studied in eight, randomized, placebo-controlled, double-blind trials of 12 to 24 weeks\u2019 duration involving 2,274 patients using dosages of 50 mg twice daily (n = 303), 100 mg twice daily (n = 998), and placebo (n = 973). Efficacy was determined primarily by the change in maximal walking distance from baseline (compared to change on placebo) on one of several standardized exercise treadmill tests. Compared to patients treated with placebo, patients treated with cilostazol 50 or 100 mg twice daily experienced statistically significant improvements in walking distances both for the distance before the onset of claudication pain and the distance before exercise-limiting symptoms supervened (maximal walking distance). The effect of cilostazol on walking distance was seen as early as the first on-therapy observation point of two or four weeks. Figure 2 depicts the percent mean improvement in maximal walking distance, at study end for each of the eight studies. Figure 2: Percent Mean Improvement in Maximal Walking Distance at Study End for the Eight Randomized, Double-Blind, Placeb...", "brand_name": "Cilostazol", "manufacturer": "Bryant Ranch Prepack", "application_number": "ANDA077027", "pharm_class_epc": [ "Phosphodiesterase 3 Inhibitor [EPC]" ], "route": [ "ORAL" ], "effective_time": "20240111", "set_id": "53486382-eee0-4cbe-bc4a-a57484e0d5a7", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 6554, "serious": 5506, "death": 1060, "hospitalization": 3240, "primary_suspect": 6534, "top_reactions": [ [ "Diarrhoea", 340 ], [ "Off Label Use", 269 ], [ "Pneumonia", 260 ], [ "Death", 255 ], [ "Drug Ineffective", 234 ], [ "Fall", 220 ], [ "Nausea", 218 ], [ "Dyspnoea", 206 ], [ "Anaemia", 203 ], [ "Acute Kidney Injury", 201 ], [ "Vomiting", 192 ], [ "Fatigue", 190 ], [ "Chronic Kidney Disease", 176 ], [ "Asthenia", 173 ], [ "Decreased Appetite", 170 ] ], "by_year": { "2019": 546, "2020": 420, "2021": 368, "2022": 364, "2023": 360, "2024": 274, "2025": 317, "2026": 128 }, "by_year_primary": { "2019": 545, "2020": 419, "2021": 368, "2022": 362, "2023": 350, "2024": 272, "2025": 316, "2026": 125 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 16, "nda": 1, "anda": 15, "first_approval": "19990115", "rems": false, "rems_last": "", "labeling_supplements": 6, "labeling_recent": 0, "sponsors": [ "ACTAVIS ELIZABETH", "APOTEX", "AUROBINDO PHARMA USA", "CHARTWELL RX", "EPIC PHARMA LLC", "HIKMA", "IVAX SUB TEVA PHARMS", "OTSUKA" ], "unapproved": false, "first_approval_fmt": "01/15/1999" }, "trials": { "total": 186, "completed": 111, "terminated": 11, "with_results": 18, "industry": 69, "phase3": 36, "results_share": 0.16216216216216217, "terminated_share": 0.05913978494623656 }, "pubmed": { "rct": 235, "meta": 68, "recent_rct": 41, "cochrane": [ { "pmid": "34192807", "title": "Cilostazol for intermittent claudication", "year": "2021" }, { "pmid": "25358850", "title": "Cilostazol for intermittent claudication", "year": "2014" }, { "pmid": "21249700", "title": "Cilostazol versus aspirin for secondary prevention of vascular events after stroke of arterial origin", "year": "2011" }, { "pmid": "18254032", "title": "Cilostazol for peripheral arterial disease", "year": "2008" }, { "pmid": "17253494", "title": "Cilostazol for peripheral arterial disease", "year": "2007" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "cilostazol" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 795710, "beneficiaries": 200939, "spend": 17225761.16, "by_brand": [ { "brand": "Cilostazol", "claims": 795710, "per_claim": 21.648290407, "is_generic": true } ], "per_claim": 21.648290407309197 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 713, "fills": 795710, "per_million": 896.055095449347, "ratio": 0.32360829019115606, "median": 2768.949753790441 }, "scores": { "safety": { "score": 62, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "896 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site", "Death appears in 1.8x the share of reports seen across all of FAERS (-3)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 63, "letter": "C", "why": [ "235 randomized trials and 68 systematic reviews/meta-analyses indexed in PubMed", "5 independent Cochrane review(s) exist", "Only 16% of completed registered trials posted results (-15)" ], "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 $0 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 (15 applications)", "18 same-class alternatives exist" ], "weight": 0.1 } }, "total": 77, "grade": "B", "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 diarrhoea, pneumonia, death. 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 abciximab, aloxiprin, aspirin? 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.)" ] }