{ "query": "prochlorperazine", "ingredient": "prochlorperazine", "slug": "prochlorperazine", "rxcui": "8704", "brands": [ "Compro", "Compazine" ], "names": [ "prochlorperazine", "prochlorperazine edisylate", "prochlorperazine maleate", "prochlorperazine mesylate" ], "classes": [ { "id": "N05AB", "name": "Phenothiazines with piperazine structure" } ], "alternatives": [ "acetophenazine", "fluphenazine", "perazine", "perphenazine", "thiopropazate", "thioproperazine", "trifluoperazine" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 40, "INTRAMUSCULAR": 14, "INTRAVENOUS": 14, "RECTAL": 3 }, "boxed_warning": "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. Prochlorperazine maleate is not approved f...", "indications_and_usage": "INDICATIONS & USAGE For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS) . The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). ...", "contraindications": "CONTRAINDICATIONS Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.). Do not use in pediatric surgery. Do not use in pediatric patients under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.", "warnings_and_cautions": "", "warnings": "WARNINGS 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. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye\u2019s syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye\u2019s syndrome. Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic drug treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug...", "adverse_reactions": "ADVERSE REACTIONS Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see WARNINGS). Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy. Neuromuscular (Extrapyramidal) Reactions These symptoms are seen in a significant number of hospitalized mental patients. They maybe characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower do...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "", "spl_medguide": "", "clinical_studies": "", "brand_name": "Prochlorperazine Maleate", "manufacturer": "Northstar Rx LLC", "application_number": "ANDA216202", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20250211", "set_id": "04bf8a16-218a-c648-e063-6294a90a1afb", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 46480, "serious": 33242, "death": 6364, "hospitalization": 18206, "primary_suspect": 46429, "top_reactions": [ [ "Nausea", 6142 ], [ "Fatigue", 5527 ], [ "Diarrhoea", 4298 ], [ "Death", 3299 ], [ "Vomiting", 3215 ], [ "Off Label Use", 2663 ], [ "Asthenia", 2383 ], [ "Febrile Neutropenia", 2279 ], [ "Decreased Appetite", 2095 ], [ "Dyspnoea", 1978 ], [ "Pneumonia", 1939 ], [ "Constipation", 1865 ], [ "Headache", 1861 ], [ "Pain", 1788 ], [ "Pyrexia", 1697 ] ], "by_year": { "2019": 4542, "2020": 4770, "2021": 4449, "2022": 3983, "2023": 3506, "2024": 3373, "2025": 3325, "2026": 1427 }, "by_year_primary": { "2019": 4541, "2020": 4770, "2021": 4445, "2022": 3965, "2023": 3495, "2024": 3367, "2025": 3320, "2026": 1425 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20221227", "reason": "Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.", "firm": "Jubilant Cadista Pharmaceuticals, Inc.", "status": "Terminated" }, { "class": "Class I", "date": "20190521", "reason": "Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .", "firm": "Heritage Pharmaceuticals, Inc.", "status": "Terminated" } ], "recall_total": 2, "drugsfda": { "applications": 59, "nda": 7, "anda": 40, "first_approval": "19561023", "rems": false, "rems_last": "", "labeling_supplements": 13, "labeling_recent": 0, "sponsors": [ "ABLE", "AJANTA PHARMA LTD", "ALPHARMA US PHARMS", "AMNEAL", "AUROBINDO PHARMA LTD", "AVET LIFESCIENCES", "BAXTER HLTHCARE", "BIONPHARMA" ], "unapproved": false, "first_approval_fmt": "10/23/1956" }, "trials": { "total": 50, "completed": 26, "terminated": 14, "with_results": 25, "industry": 9, "phase3": 12, "results_share": 0.9615384615384616, "terminated_share": 0.28 }, "pubmed": { "rct": 94, "meta": 2, "recent_rct": 3, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "prochlorperazine", "Compro", "Compazine" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 771125, "beneficiaries": 434704, "spend": 12852557.39, "by_brand": [ { "brand": "Prochlorperazine Maleate", "claims": 755746, "per_claim": 14.751427159, "is_generic": true }, { "brand": "Compro", "claims": 10507, "per_claim": 113.09576092, "is_generic": false }, { "brand": "Prochlorperazine", "claims": 3672, "per_claim": 110.94160131, "is_generic": true }, { "brand": "Prochlorperazine Edisylate", "claims": 1200, "per_claim": 90.458833333, "is_generic": true } ], "per_claim": 16.667281426487275 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 8112, "fills": 771125, "per_million": 10519.695250445779, "ratio": 3.7991643712729966, "median": 2768.949753790441 }, "scores": { "safety": { "score": 48, "letter": "F", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "10,520 FDA reports naming it as the suspect drug per million Medicare fills, 3.8x the median drug on this site (-12)", "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)", "1 Class I recall(s): reasonable probability of serious harm (-10)" ], "weight": 0.35 }, "evidence": { "score": 39, "letter": "F", "why": [ "94 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "28% of registered trials were terminated, withdrawn, or suspended (-8)" ], "weight": 0.25 }, "regulatory": { "score": 84, "letter": "B", "why": [ "Recalls since 2016: 1 Class I, 0 Class II, 1 Class III across 40 generic makers (-16)" ], "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 (40 applications)", "7 same-class alternatives exist" ], "weight": 0.1 } }, "total": 64, "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 nausea, fatigue, diarrhoea, 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 acetophenazine, fluphenazine, perazine? 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.)" ] }