{ "query": "memantine", "ingredient": "memantine", "slug": "memantine", "rxcui": "6719", "brands": [ "Namenda" ], "names": [ "memantine", "memantine hydrochloride" ], "classes": [], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 73 }, "boxed_warning": "", "indications_and_usage": "Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine HCl is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( 1 )", "contraindications": "Memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Memantine HCl is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. ( 4 )", "warnings_and_cautions": "Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. ( 5.1 , 7.1 ) 5.1 Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions ( 7.1 )] .", "warnings": "", "adverse_reactions": "Most common adverse reactions (\u2265 5 % and greater than placebo) are dizziness, headache, confusion and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Memantine HCl was evaluated in eight double-blind placebo-controlled trials involving a total of 1862 dementia (Alzheimer's disease, vascular dementia) patients (940 patients treated with Memantine HCl and 922 patients treated with placebo) for a treatment period up to 28 weeks. 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 clinical practice. Adverse Events Leading to Discontinuation In placebo-controlled trials in which dementia patients received doses of Memantine HCl up to 20 mg/day, the likelihood of discontinuation because of an adverse reaction was the same in the Memantine HCl group (10.1%) as in the placebo group (11.5%). No individual adverse reaction was associated with the discontinuation of t...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "See FDA-approved patient labeling ( Patient Information and Instructions for Use ). To assure safe and effective use of Memantine HCl, the following information and instructions provided in the patient information section should be discussed with patients and caregivers. Patients/caregivers should be instructed to follow the dose titration schedule provided by their physician or healthcare professional for Memantine HCl. They should be warned not to use any tablets of Memantine HCl that are damaged or show signs of tampering. If a patient misses a single dose of Memantine HCl, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take Memantine HCl for several days, dosing should not be resumed without consulting that patient's healthcare professional. Patients/caregivers should be instructed on how to use the Memantine HCl Oral Solution dosing device. They should be made aware of the patient instruction sheet that is enclosed with the product. Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist. Distributed by: Actavis Pharma, Inc. Parsippany,...", "spl_medguide": "", "clinical_studies": "The effectiveness of Memantine HCl as a treatment for patients with moderate to severe Alzheimer's disease was demonstrated in 2 randomized, double-blind, placebo-controlled clinical studies (Studies 1 and 2) conducted in the United States that assessed both cognitive function and day to day function. The mean age of patients participating in these two trials was 76 with a range of 50-93 years. Approximately 66% of patients were female and 91% of patients were Caucasian. A third study (Study 3), carried out in Latvia, enrolled patients with severe dementia, but did not assess cognitive function as a planned endpoint. Study Outcome Measures: In each U.S. study, the effectiveness of Memantine HCl was determined using both an instrument designed to evaluate overall function through caregiver-related assessment, and an instrument that measures cognition. Both studies showed that patients on Memantine HCl experienced significant improvement on both measures compared to placebo. Day-to-day function was assessed in both studies using the modified Alzheimer's disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL). The ADCS-ADL consists of a comprehensive battery of ADL...", "brand_name": "memantine hydrochloride", "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC", "application_number": "NDA021487", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20171130", "set_id": "c8f5c20b-4573-44c5-89fc-4da11b2e1fe1", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 20595, "serious": 15268, "death": 3242, "hospitalization": 7710, "primary_suspect": 20520, "top_reactions": [ [ "Fall", 1565 ], [ "Death", 1475 ], [ "Drug Ineffective", 1306 ], [ "Off Label Use", 1238 ], [ "Confusional State", 1082 ], [ "Fatigue", 997 ], [ "Hallucination", 936 ], [ "Dizziness", 804 ], [ "Asthenia", 788 ], [ "Condition Aggravated", 708 ], [ "Diarrhoea", 689 ], [ "Somnolence", 673 ], [ "Urinary Tract Infection", 654 ], [ "Nausea", 641 ], [ "Pneumonia", 593 ] ], "by_year": { "2019": 1806, "2020": 1812, "2021": 1542, "2022": 1543, "2023": 1476, "2024": 1650, "2025": 1666, "2026": 803 }, "by_year_primary": { "2019": 1804, "2020": 1812, "2021": 1536, "2022": 1530, "2023": 1454, "2024": 1636, "2025": 1660, "2026": 797 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20200212", "reason": "Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.", "firm": "Lupin Pharmaceuticals Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20191210", "reason": "Failed Dissolution Specifications: High out of specification result observed at stability studies.", "firm": "Lupin Pharmaceuticals Inc.", "status": "Terminated" } ], "recall_total": 2, "drugsfda": { "applications": 47, "nda": 3, "anda": 43, "first_approval": "20031016", "rems": false, "rems_last": "", "labeling_supplements": 13, "labeling_recent": 0, "sponsors": [ "ABBVIE", "AJANTA PHARMA LTD", "ALEMBIC", "ALLERGAN", "AMNEAL PHARMS", "ANI PHARMS", "APOTEX", "AUROBINDO PHARMA LTD" ], "unapproved": false, "first_approval_fmt": "10/16/2003" }, "trials": { "total": 271, "completed": 168, "terminated": 32, "with_results": 89, "industry": 98, "phase3": 64, "results_share": 0.5297619047619048, "terminated_share": 0.11808118081180811 }, "pubmed": { "rct": 255, "meta": 77, "recent_rct": 35, "cochrane": [ { "pmid": "36006807", "title": "Memantine for autism spectrum disorder", "year": "2022" }, { "pmid": "35608903", "title": "Withdrawal or continuation of cholinesterase inhibitors or memantine or both, in people with dementia", "year": "2021" }, { "pmid": "30891742", "title": "Memantine for dementia", "year": "2019" }, { "pmid": "19160343", "title": "Memantine for dementia in people with Down syndrome", "year": "2009" }, { "pmid": "16625572", "title": "Memantine for dementia", "year": "2006" }, { "pmid": "16034889", "title": "Memantine for dementia", "year": "2005" }, { "pmid": "15846650", "title": "Memantine for dementia", "year": "2005" }, { "pmid": "15495043", "title": "Memantine for dementia", "year": "2004" }, { "pmid": "12917950", "title": "Memantine for dementia", "year": "2003" }, { "pmid": "12535459", "title": "Memantine for dementia", "year": "2003" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "memantine", "Namenda" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 6282503, "beneficiaries": 1100889, "spend": 231336082.23, "by_brand": [ { "brand": "Memantine HCl", "claims": 5630610, "per_claim": 29.654066927, "is_generic": true }, { "brand": "Memantine HCl ER", "claims": 650504, "per_claim": 97.754444569, "is_generic": false }, { "brand": "Namenda XR", "claims": 1148, "per_claim": 608.48582753, "is_generic": false }, { "brand": "Namenda", "claims": 241, "per_claim": 321.15149378, "is_generic": false } ], "per_claim": 36.82227962803997 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": { "section": "Infectious diseases", "names": [ "memantine" ], "reason": "Memantine, an NMDA glutamate receptor antagonist, can cause neuropsychiatric disorders (hallucinations, confusion, dizziness or headache), sometimes leading to violent behaviour, seizures, psychotic disorders, as well as heart failure or bradyarrhythmia (Prescrire Int n\u00b0 204, 225, 227; Rev Prescrire n\u00b0 359, 398). Multiple sclerosis. The standard \u201cdisease-modifying\u201d treatment for multiple sclerosis is interferon beta , despite its limitations and many adverse effects. The harm-benefit balance of the other \u201cdisease-modifying\u201d treatments is no better and sometimes clearly unfavourable. This appli...", "edition": "2026", "qualifier": null, "qualified": false, "matched": "memantine" }, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 4093, "fills": 6282503, "per_million": 651.4919292517648, "ratio": 0.23528485064054755, "median": 2768.949753790441 }, "scores": { "safety": { "score": 82, "letter": "B", "why": [ "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)", "651 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site", "Death appears in 1.7x 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": 70, "letter": "C", "why": [ "255 randomized trials and 77 systematic reviews/meta-analyses indexed in PubMed", "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)", "10 independent Cochrane review(s) exist" ], "weight": 0.25 }, "regulatory": { "score": 98, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 43 generic makers (-2)" ], "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 (43 applications)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 83, "grade": "B", "questions": [ "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?", "The most-reported problems in FDA's adverse event data are fall, 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?", "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.)" ] }