{
 "query": "lorazepam",
 "ingredient": "lorazepam",
 "slug": "lorazepam",
 "rxcui": "6470",
 "brands": [
  "Ativan",
  "Loreev"
 ],
 "names": [
  "lorazepam"
 ],
 "classes": [
  {
   "id": "N05BA",
   "name": "Benzodiazepine derivatives"
  }
 ],
 "alternatives": [
  "alprazolam",
  "bromazepam",
  "chlordiazepoxide",
  "clobazam",
  "clorazepate dipotassium",
  "clotiazepam",
  "cloxazolam",
  "diazepam",
  "ethyl loflazepate",
  "halazepam",
  "ketazolam",
  "medazepam",
  "nordazepam",
  "oxazepam",
  "prazepam",
  "tofisopam"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 90,
   "INTRAMUSCULAR": 9,
   "INTRAVENOUS": 9
  },
  "boxed_warning": "WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7 )]. The use of benzodiazepines, including LOREEV XR, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing LOREEV XR and throughout treatment, assess each patient\u2019s risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.2 )]. The continued use of benzodiazepines, including LOREEV XR, may lead to clinically significant physical dependence. The risks of dependence and with...",
  "indications_and_usage": "is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets. LOREEV XR is a benzodiazepine indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets ( 1 )",
  "contraindications": "is contraindicated in patients with: hypersensitivity to benzodiazepines or to any of the ingredients in LOREEV XR [see Warnings and Precautions ( 5.7 )] . acute narrow-angle glaucoma Hypersensitivity to benzodiazepines or any ingredients in LOREEV XR ( 4 ) Acute narrow-angle glaucoma ( 4 )",
  "warnings_and_cautions": "Depression: May cause CNS depression. Caution patients receiving LOREEV XR against operating machinery or driving a motor vehicle as well to avoid the concomitant use of alcohol and other CNS depressant drugs during treatment ( 5.4 , 7 ) Patients with Depression or Psychosis: Use with caution in patients with signs or symptoms of depression. Prescribe the least number of capsules feasible to avoid intentional overdosage ( 5.5 ) Allergic Reactions to FD&C Yellow No. 5 (Tartrazine): Contains FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons ( 5.7 ) Neonatal Sedation and Withdrawal Syndrome: LOREEV XR use during pregnancy can result in neonatal sedation and/or withdrawal ( 5.8 , 8.1 ) 5.1 Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including LOREEV XR, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines i...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] Central Nervous System (CNS) Depression [see Warnings and Precautions ( 5.4 )] Patients with Depression or Psychosis [see Warnings and Precautions ( 5.5 )] Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) [see Warnings and Precautions ( 5.7 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.8 )] Risk in Patients with Impaired Respiratory Function [see Warnings and Precautions ( 5.9 )] The safety of LOREEV XR in adults is based on studies with lorazepam tablets. The following adverse reactions associated with the use of lorazepam tablets were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In a sample of approximately 3,500 patients treat...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance LOREEV XR contains lorazepam, a Schedule IV controlled substance. 9.2 Abuse LOREEV XR is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications...",
  "controlled_substance": "9.1 Controlled Substance LOREEV XR contains lorazepam, a Schedule IV controlled substance.",
  "recent_major_changes": "Warnings and Precautions ( 5.8 ) 1/2023",
  "information_for_patients": "Advise the patient to read the FDA\u2010approved patient labeling ( Medication Guide ). Risks from Concomitant Use with Opioids Advise patients and caregivers about the risks of potentially fatal respiratory depression and sedation when LOREEV XR is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7 )] . Abuse, Misuse, and Addiction Inform patients that the use of LOREEV XR, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions ( 5.2 ), Drug Abuse and Dependence ( 9.2 )] . Withdrawal Reactions Inform patients that the continued use of...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. MEDICATION GUIDE LOREEV XR (lor-EEV ECKS-AR) (lorazepam) extended-release capsules, CIV What is the most important information I should know about LOREEV XR? LOREEV XR may cause serious side effects, including: LOREEV XR is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking LOREEV XR with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk for abuse, misuse, and addiction with benzodiazepines including LOREEV XR which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including LOREEV XR. These serious side effects...",
  "clinical_studies": "",
  "brand_name": "LOREEV XR",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "NDA214826",
  "pharm_class_epc": [
   "Benzodiazepine [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250703",
  "set_id": "c470fdee-8e18-4da9-b072-943d6b2518cf",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 142098,
  "serious": 109819,
  "death": 19706,
  "hospitalization": 59345,
  "primary_suspect": 141181,
  "top_reactions": [
   [
    "Fatigue",
    11462
   ],
   [
    "Drug Ineffective",
    10738
   ],
   [
    "Nausea",
    10402
   ],
   [
    "Off Label Use",
    10401
   ],
   [
    "Diarrhoea",
    8557
   ],
   [
    "Headache",
    7133
   ],
   [
    "Dyspnoea",
    7085
   ],
   [
    "Pain",
    6717
   ],
   [
    "Vomiting",
    6671
   ],
   [
    "Anxiety",
    6663
   ],
   [
    "Dizziness",
    6387
   ],
   [
    "Death",
    5719
   ],
   [
    "Asthenia",
    5551
   ],
   [
    "Malaise",
    5304
   ],
   [
    "Fall",
    5193
   ]
  ],
  "by_year": {
   "2019": 14493,
   "2020": 13868,
   "2021": 11767,
   "2022": 10547,
   "2023": 9689,
   "2024": 9662,
   "2025": 9065,
   "2026": 4041
  },
  "by_year_primary": {
   "2019": 14480,
   "2020": 13851,
   "2021": 11671,
   "2022": 10349,
   "2023": 9474,
   "2024": 9495,
   "2025": 8954,
   "2026": 3963
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250722",
   "reason": "Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230511",
   "reason": "Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220711",
   "reason": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220711",
   "reason": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220711",
   "reason": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170928",
   "reason": "Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam",
   "firm": "Leading Pharma, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20170803",
   "reason": "Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.",
   "firm": "Amneal Pharmaceuticals of New York, LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 73,
  "nda": 3,
  "anda": 53,
  "first_approval": "19770930",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 28,
  "labeling_recent": 6,
  "sponsors": [
   "ALMATICA",
   "AM THERAP",
   "AMNEAL PHARMS",
   "ANI PHARMS",
   "AUROBINDO PHARMA",
   "BAUSCH",
   "BEDFORD",
   "BEDFORD LABS"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/30/1977"
 },
 "trials": {
  "total": 183,
  "completed": 105,
  "terminated": 34,
  "with_results": 52,
  "industry": 50,
  "phase3": 27,
  "results_share": 0.49523809523809526,
  "terminated_share": 0.18579234972677597
 },
 "pubmed": {
  "rct": 368,
  "meta": 9,
  "recent_rct": 9,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "lorazepam",
   "Ativan",
   "Loreev"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 8140331,
  "beneficiaries": 1883727,
  "spend": 78389819.14,
  "by_brand": [
   {
    "brand": "Lorazepam",
    "claims": 8090182,
    "per_claim": 6.4794499654,
    "is_generic": true
   },
   {
    "brand": "Lorazepam Intensol",
    "claims": 38592,
    "per_claim": 29.907477716,
    "is_generic": false
   },
   {
    "brand": "Ativan",
    "claims": 6598,
    "per_claim": 3420.4915202,
    "is_generic": false
   },
   {
    "brand": "Loreev XR",
    "claims": 4959,
    "per_claim": 453.17548498,
    "is_generic": false
   }
  ],
  "per_claim": 9.6298073309304
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "lorazepam",
  "matched": "lorazepam",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 22412,
  "fills": 8140331,
  "per_million": 2753.204998666516,
  "ratio": 0.994313816961694,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 45,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,753 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 57,
   "letter": "D",
   "why": [
    "368 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 50% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 60,
   "letter": "D",
   "why": [
    "Recalls since 2016: 1 Class I, 6 Class II, 0 Class III across 53 generic makers (-27)",
    "6 label changes approved since 2021: the safety story is still moving (-8)",
    "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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (53 applications)",
    "16 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?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are fatigue, nausea. 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 alprazolam, bromazepam, chlordiazepoxide? 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.)"
 ]
}