{ "query": "montelukast", "ingredient": "montelukast", "slug": "montelukast", "rxcui": "88249", "brands": [ "Singulair" ], "names": [ "montelukast", "montelukast sodium" ], "classes": [ { "id": "R03DC", "name": "Leukotriene receptor antagonists" } ], "alternatives": [ "zafirlukast" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 64 }, "boxed_warning": "WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood [see Warnings and Precautions (5.1) ] . Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of SINGULAIR for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3) ] . In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR. Discuss the benefits and risks of SINGULAIR with patients and caregivers when prescribing SINGULAIR. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking SINGULAIR. If changes in behav...", "indications_and_usage": "is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma SINGULAIR \u00ae is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 Allergic Rhinitis SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. Because the benefits of SINGULAIR may not ou...", "contraindications": "is contraindicated in patients with hypersensitivity to any of its components. Hypersensitivity to any component of SINGULAIR ( 4 ).", "warnings_and_cautions": "Do not prescribe SINGULAIR to treat an acute asthma attack ( 5.2 ). Advise patients to have appropriate rescue medication available ( 5.2 ). Inhaled corticosteroid may be reduced gradually. Do not abruptly substitute SINGULAIR for inhaled or oral corticosteroids ( 5.3 ). Patients with known aspirin sensitivity should continue to avoid aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR ( 5.4 ). Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. These events have been sometimes associated with the reduction of oral corticosteroid therapy ( 5.5 and 6.2 ). Inform patients with phenylketonuria that the 4-mg and 5-mg chewable tablets contain phenylalanine ( 5.6 ). 5.1 Neuropsychiatric Events Serious neuropsychiatric (NP) events have been reported with use of SINGULAIR. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsess...", "warnings": "", "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Neuropsychiatric Events [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence \u22655% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., Inc., at 1-844-674-3200 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 clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence \u22655% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection,...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Indications and Usage ( 1.3 , 1.4 ) 02/2021 Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 ) 02/2021 Warnings and Precautions ( 5.1 , 5.6 ) 02/2021", "information_for_patients": "For the tablets and chewable tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling ( Medication Guide ). For the oral granules, advise the patient and/or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Advise patients about the potential risk for serious neuropsychiatric symptoms and behavioral changes with SINGULAIR use [see Warnings and Precautions (5.1) ] . Discuss the benefits and risks of SINGULAIR with patients when prescribing or continuing treatment with SINGULAIR [see Warnings and Precautions (5.1) ] . Advise patients to monitor for changes in behavior or neuropsychiatric symptoms in patients taking SINGULAIR [see Warnings and Precautions (5.1) ] . Instruct patients to discontinue SINGULAIR and contact a healthcare provider immediately if changes in behavior or thinking that are not typical for the patient occur, or if the patient develops suicidal ideation or suicidal behavior [see Warnings and Precautions (5.1) ] . Advise patients to take SINGULAIR daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physicians if their ...", "spl_medguide": "MEDICATION GUIDE SINGULAIR \u00ae (SING-u-lair) (montelukast sodium) tablets chewable tablets oral granules This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 6/2021 What is the most important information I should know about SINGULAIR? Serious mental health problems have happened in people taking SINGULAIR or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking SINGULAIR and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms: agitation, including aggressive behavior or hostility attention problems bad or vivid dreams depression disorientation (confusion) feeling anxious irritability hallucinations (seeing or hearing things that are not really there) memory problems obsessive-compulsive symptoms restlessness sleep walking stuttering suicidal thoughts and actions (including suicide) tremor trouble sleeping uncontrolled muscle movements What is SINGULAIR? SINGULAIR is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma...", "clinical_studies": "14.1 Asthma Adults and Adolescents 15 Years of Age and Older with Asthma Clinical trials in adults and adolescents 15 years of age and older demonstrated there is no additional clinical benefit to montelukast doses above 10 mg once daily. The efficacy of SINGULAIR for the chronic treatment of asthma in adults and adolescents 15 years of age and older was demonstrated in two (U.S. and Multinational) similarly designed, randomized, 12-week, double-blind, placebo-controlled trials in 1576 patients (795 treated with SINGULAIR, 530 treated with placebo, and 251 treated with active control). The median age was 33 years (range 15 to 85); 56.8% were females and 43.2% were males. The ethnic/racial distribution in these studies was 71.6% Caucasian, 17.7% Hispanic, 7.2% other origins and 3.5% Black. Patients had mild or moderate asthma and were non-smokers who required approximately 5 puffs of inhaled \u03b2-agonist per day on an \"as-needed\" basis. The patients had a mean baseline percent of predicted forced expiratory volume in 1 second (FEV 1 ) of 66% (approximate range, 40 to 90%). The co-primary endpoints in these trials were FEV 1 and daytime asthma symptoms. In both studies after 12 weeks, a...", "brand_name": "SINGULAIR", "manufacturer": "Organon LLC", "application_number": "NDA020830", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20250430", "set_id": "482dcc92-b47f-4ea6-854a-f5ac2aea7842", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 142271, "serious": 87600, "death": 5963, "hospitalization": 37985, "primary_suspect": 142054, "top_reactions": [ [ "Asthma", 16725 ], [ "Dyspnoea", 16723 ], [ "Drug Ineffective", 11044 ], [ "Fatigue", 10598 ], [ "Cough", 10286 ], [ "Headache", 9251 ], [ "Wheezing", 8474 ], [ "Pneumonia", 8296 ], [ "Nausea", 7797 ], [ "Pain", 7183 ], [ "Off Label Use", 7031 ], [ "Malaise", 6181 ], [ "Diarrhoea", 6134 ], [ "Anxiety", 5707 ], [ "Pruritus", 5587 ] ], "by_year": { "2019": 14187, "2020": 14759, "2021": 13286, "2022": 12196, "2023": 11601, "2024": 12753, "2025": 12510, "2026": 6508 }, "by_year_primary": { "2019": 14178, "2020": 14758, "2021": 13265, "2022": 12157, "2023": 11548, "2024": 12708, "2025": 12485, "2026": 6491 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20231013", "reason": "Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.", "firm": "Dr. Reddy's Laboratories, Inc.", "status": "Terminated" }, { "class": "Class II", "date": "20230207", "reason": "CGMP Deviations: recalling drug products following an FDA inspection.", "firm": "Accord Healthcare, Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20200120", "reason": "Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product", "firm": "Macleods Pharma Usa Inc", "status": "Terminated" }, { "class": "Class II", "date": "20180820", "reason": "Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.", "firm": "Hetero Labs Limited Unit V", "status": "Terminated" }, { "class": "Class I", "date": "20180815", "reason": "Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.", "firm": "Hetero Labs Limited Unit V", "status": "Ongoing" }, { "class": "Class III", "date": "20170107", "reason": "Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.", "firm": "Hetero USA Inc", "status": "Terminated" } ], "recall_total": 6, "drugsfda": { "applications": 52, "nda": 3, "anda": 49, "first_approval": "19980220", "rems": false, "rems_last": "", "labeling_supplements": 111, "labeling_recent": 3, "sponsors": [ "ACCORD HLTHCARE", "AIPING PHARM INC", "AJANTA PHARMA LTD", "AMNEAL PHARMS", "ANBISON LAB", "APOTEX CORP", "APOTEX INC", "AUROBINDO PHARMA LTD" ], "unapproved": false, "first_approval_fmt": "02/20/1998" }, "trials": { "total": 369, "completed": 269, "terminated": 28, "with_results": 92, "industry": 200, "phase3": 88, "results_share": 0.3420074349442379, "terminated_share": 0.07588075880758807 }, "pubmed": { "rct": 425, "meta": 39, "recent_rct": 41, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "montelukast", "Singulair" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 12473122, "beneficiaries": 3179795, "spend": 141975419.27, "by_brand": [ { "brand": "Montelukast Sodium", "claims": 12462037, "per_claim": 10.933637728, "is_generic": true }, { "brand": "Singulair", "claims": 11085, "per_claim": 516.01455661, "is_generic": false } ], "per_claim": 11.382508667036209 }, "mdl": [], "dsc": [ { "date": "20200304", "title": "FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug", "kind": "drug", "matched": "singulair" } ], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 31684, "fills": 12473122, "per_million": 2540.1820009457133, "ratio": 0.9173810385935804, "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 2020 (-8)", "2,540 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site", "Death share in reports is near or below the FAERS average (0.5x)", "1 Class I recall(s): reasonable probability of serious harm (-10)" ], "weight": 0.35 }, "evidence": { "score": 60, "letter": "D", "why": [ "425 randomized trials and 39 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 34% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 65, "letter": "C", "why": [ "Recalls since 2016: 1 Class I, 3 Class II, 2 Class III across 49 generic makers (-26)", "3 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": 90, "letter": "A", "why": [ "Generic versions approved (49 applications)", "1 same-class alternative(s) (-10)" ], "weight": 0.1 } }, "total": 67, "grade": "C", "questions": [ "In 2020 the FDA issued a safety communication about this drug (FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (S). Does that risk apply to me?", "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 asthma, dyspnoea, fatigue. How would we recognize and handle those?", "Why this one over zafirlukast? 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.)" ] }