{ "query": "ziprasidone", "ingredient": "ziprasidone", "slug": "ziprasidone", "rxcui": "115698", "brands": [ "Geodon" ], "names": [ "ziprasidone", "ziprasidone hydrochloride", "ziprasidone hydrochloride anhydrous", "ziprasidone hydrochloride, monohydrate", "ziprasidone mesylate" ], "classes": [ { "id": "N05AE", "name": "Indole derivatives" } ], "alternatives": [ "lurasidone", "molindone", "oxypertine", "sertindole" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 30, "INTRAMUSCULAR": 8 }, "boxed_warning": "WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Ziprasidone hydrochloride capsules are not approved for...", "indications_and_usage": "Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone\u2019 s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [ see Warnings and Precautions (5.2) ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [ see Warnings and Precautions (5.2) ] Ziprasidone hydrochloride capsules are an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride capsules to prolong the QT interval and may consider the use of other drugs first ( 5.2 ) Ziprasidone hydrochloride capsules are indicated as an oral formulation for the: Treatment of schizophrenia. ( 1.1 ) \u2022 Adults: Effic...", "contraindications": "\u2022 Do not use in patients with a known history of QT prolongation ( 4.1 ) \u2022 Do not use in patients with recent acute myocardial infarction ( 4.1 ) \u2022 Do not use in patients with uncompensated heart failure ( 4.1 ) \u2022 Do not use in combination with other drugs that have demonstrated QT prolongation ( 4.1 ) \u2022 Do not use in patients with known hypersensitivity to ziprasidone ( 4.2 ) 4.1 QT Prolongation Because of ziprasidone\u2019s dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs, ziprasidone is contraindicated: \u2022 in patients with a known history of QT prolongation (including congenital long QT syndrome) \u2022 in patients with recent acute myocardial infarction \u2022 in patients with uncompensated heart failure Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with: \u2022 dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimoz...", "warnings_and_cautions": "\u2022 QT Interval Prolongation : Ziprasidone hydrochloride capsules use should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation. ( 5.2 ) \u2022 Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex has been reported with antipsychotic drugs. Manage with immediate discontinuation of drug and close monitoring. ( 5.3 ) \u2022 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with ziprasidone exposure. DRESS is sometimes fatal. Discontinue ziprasidone hydrochloride capsules if DRESS is suspected.( 5.4 ) \u2022 Tardive Dyskinesia : May develop acutely or chronically. ( 5.5 ) \u2022 Metabolic Changes : Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. ( 5.6 ) \u2022 Hyperglycemia and Diabetes Mellitus (DM): Monitor all patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients with DM risk factors should undergo blood glucose test...", "warnings": "", "adverse_reactions": "Commonly observed adverse reactions (incidence \u22655% and at least twice the incidence for placebo) were : \u2022 Schizophrenia : Somnolence, respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 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. Clinical trials for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years. These patients include: (1) 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000. The conditions and duration of treatment with ziprasidone included open-label and double-blind studi...", "drug_abuse_and_dependence": "9.3 Dependence Ziprasidone has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which ziprasidone will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of ziprasidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior).", "controlled_substance": "", "recent_major_changes": "Warnings and Precautions: ( 5.4 ) 12/2014", "information_for_patients": "See FDA-Approved Patient Labeling (17.4) . Please refer to the patient package insert. To assure safe and effective use of ziprasidone hydrochloride capsules, the information and instructions provided in the patient information should be discussed with patients. 17.1 Administration with Food Patients should be instructed to take ziprasidone hydrochloride capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food [see Drug Interactions (7.8) and Clinical Pharmacology (12.3) ]. 17.2 QTc Prolongation Patients should be advised to inform their health care providers of the following: History of QT prolongation; recent acute myocardial infarction; uncompensated heart failure; prescription of other drugs that have demonstrated QT prolongation; risk for significant electrolyte abnormalities; and history of cardiac arrhythmia [see Contraindications (4.1) and Warnings and Precautions (5.2) ]. Patients should be instructed to report the onset of any conditions that put them at risk for significant electrolyte disturbances, hypokalemia in particular, including but not limited to the initiation of diuretic therapy or prolonged di...", "spl_medguide": "", "clinical_studies": "14.1 Schizophrenia The efficacy of oral ziprasidone in the treatment of schizophrenia was evaluated in 5 placebo-controlled studies, 4 short-term (4- and 6-week) trials and one maintenance trial. All trials were in adult inpatients, most of whom met DSM III-R criteria for schizophrenia. Each study included 2 to 3 fixed doses of ziprasidone as well as placebo. Four of the 5 trials were able to distinguish ziprasidone from placebo; one short-term study did not. Although a single fixed-dose haloperidol arm was included as a comparative treatment in one of the three short-term trials, this single study was inadequate to provide a reliable and valid comparison of ziprasidone and haloperidol. Several instruments were used for assessing psychiatric signs and symptoms in these studies. The Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) are both multi-item inventories of general psychopathology usually used to evaluate the effects of drug treatment in schizophrenia. The BPRS psychosis cluster (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) is considered a particularly useful subset for assessing ac...", "brand_name": "ziprasidone hydrochloride", "manufacturer": "Proficient Rx LP", "application_number": "ANDA077561", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20210101", "set_id": "80c13492-3873-48ba-882f-58e02dc7237d", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 5247, "serious": 4214, "death": 549, "hospitalization": 1782, "primary_suspect": 5185, "top_reactions": [ [ "Drug Ineffective", 1100 ], [ "Suicide Attempt", 685 ], [ "Sedation", 564 ], [ "Dyskinesia", 558 ], [ "Sexual Dysfunction", 509 ], [ "Dystonia", 498 ], [ "Blood Prolactin Abnormal", 482 ], [ "Condition Aggravated", 456 ], [ "Weight Increased", 440 ], [ "Blood Glucose Increased", 430 ], [ "Anosognosia", 426 ], [ "Metabolic Disorder", 424 ], [ "Disturbance In Social Behaviour", 413 ], [ "Personality Change", 386 ], [ "Toxicity To Various Agents", 370 ] ], "by_year": { "2019": 668, "2020": 592, "2021": 539, "2022": 510, "2023": 354, "2024": 263, "2025": 272, "2026": 155 }, "by_year_primary": { "2019": 668, "2020": 584, "2021": 536, "2022": 495, "2023": 346, "2024": 253, "2025": 266, "2026": 144 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class I", "date": "20230531", "reason": "Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.", "firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories", "status": "Terminated" } ], "recall_total": 1, "drugsfda": { "applications": 15, "nda": 3, "anda": 12, "first_approval": "20010205", "rems": false, "rems_last": "", "labeling_supplements": 56, "labeling_recent": 4, "sponsors": [ "APOTEX", "AUROBINDO PHARMA", "CHARTWELL RX", "DR REDDYS LABS INC", "GLAND", "LUPIN PHARMS", "MACLEODS PHARMS", "MSN" ], "unapproved": false, "first_approval_fmt": "02/05/2001" }, "trials": { "total": 159, "completed": 114, "terminated": 28, "with_results": 61, "industry": 96, "phase3": 38, "results_share": 0.5350877192982456, "terminated_share": 0.1761006289308176 }, "pubmed": { "rct": 147, "meta": 11, "recent_rct": 5, "cochrane": [ { "pmid": "19821380", "title": "Ziprasidone versus other atypical antipsychotics for schizophrenia", "year": "2009" }, { "pmid": "11034737", "title": "Ziprasidone for schizophrenia and severe mental illness", "year": "2000" }, { "pmid": "10796670", "title": "Ziprasidone for schizophrenia and severe mental illness", "year": "2000" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "ziprasidone", "Geodon" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 639925, "beneficiaries": 79737, "spend": 46681237.260000005, "by_brand": [ { "brand": "Ziprasidone HCl", "claims": 634457, "per_claim": 64.319312909, "is_generic": true }, { "brand": "Ziprasidone Mesylate", "claims": 2734, "per_claim": 179.02285662, "is_generic": true }, { "brand": "Geodon", "claims": 2605, "per_claim": 2057.3527678, "is_generic": false }, { "brand": "Geodon", "claims": 129, "per_claim": 190.28294574, "is_generic": false } ], "per_claim": 72.9479818103684 }, "mdl": [], "dsc": [ { "date": "20141211", "title": "FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm426391.htm", "kind": "drug", "matched": "ziprasidone" } ], "settlements": [ { "year": 2009, "company": "Pfizer", "amount_usd": 2300000000.0, "amount_text": "$2.3 billion", "violations": "Off-label promotion, kickbacks", "products": "Bextra, Geodon, Zyvox, Lyrica", "laws": "False Claims Act, FDCA", "urls": [ "https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history" ], "matched": "geodon" } ], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 663, "fills": 639925, "per_million": 1036.0589131538852, "ratio": 0.3741703552892625, "median": 2768.949753790441 }, "scores": { "safety": { "score": 52, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-8)", "1,036 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site", "Death share in reports is near or below the FAERS average (1.1x)", "1 Class I recall(s): reasonable probability of serious harm (-10)" ], "weight": 0.35 }, "evidence": { "score": 59, "letter": "D", "why": [ "147 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed", "3 independent Cochrane review(s) exist", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 76, "letter": "B", "why": [ "Recalls since 2016: 1 Class I, 0 Class II, 0 Class III across 12 generic makers (-15)", "4 label changes approved since 2021 (-4)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 75, "letter": "B", "why": [ "Maker paid $2.3 billion in 2009 to settle federal allegations naming this drug (Off-label promotion, kickbacks) (-25)", "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 (12 applications)", "4 same-class alternatives exist" ], "weight": 0.1 } }, "total": 66, "grade": "C", "questions": [ "In 2014 the FDA issued a safety communication about this drug (FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reaction). Does that risk apply to me?", "The maker paid $2.3 billion in 2009 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?", "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 suicide attempt, sedation, dyskinesia. How would we recognize and handle those?", "Why this one over lurasidone, molindone, oxypertine? 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.)" ] }