{
 "query": "alprazolam",
 "ingredient": "alprazolam",
 "slug": "alprazolam",
 "rxcui": "596",
 "brands": [
  "Xanax"
 ],
 "names": [
  "alprazolam"
 ],
 "classes": [
  {
   "id": "N05BA",
   "name": "Benzodiazepine derivatives"
  }
 ],
 "alternatives": [
  "bromazepam",
  "chlordiazepoxide",
  "clobazam",
  "clorazepate dipotassium",
  "clotiazepam",
  "cloxazolam",
  "diazepam",
  "ethyl loflazepate",
  "halazepam",
  "ketazolam",
  "lorazepam",
  "medazepam",
  "nordazepam",
  "oxazepam",
  "prazepam",
  "tofisopam"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 77
  },
  "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 ). The use of benzodiazepines, including Alprazolam, 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 Alprazolam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ) . The continued use of benzodiazepines, including Alprazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and ...",
  "indications_and_usage": "INDICATIONS AND USAGE Anxiety Disorders Alprazolam Tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in thro...",
  "contraindications": "CONTRAINDICATIONS Alprazolam Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alprazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see WARNINGS and PRECAUTIONS\u2013Drug Interactions ).",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including alprazolam, 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 increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe alprazolam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of alprazolam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking alprazolam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when alprazolam is ...",
  "adverse_reactions": "ADVERSE REACTIONS Side effects to Alprazolam Tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam, e.g., drowsiness or light-headedness. The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (i.e., four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of alprazolam (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of alprazolam in patients with panic disorder, with or without agoraphobia. These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics, and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving r...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Controlled Substance Alprazolam contains alprazolam , a Schedule IV controlled substance. Abuse Alprazolam 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 us...",
  "controlled_substance": "Controlled Substance Alprazolam contains alprazolam , a Schedule IV controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when alprazolam 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 PRECAUTIONS - Drug Interactions ). Abuse, Misuse, and Addiction Inform patients that the use of Alprazolam, 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 \u2013 Abuse, Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE ). Withdrawal Reactions Inform patients that the continued ...",
  "spl_medguide": "MEDICATION GUIDE ALPRAZOLAM Tablets, C-IV What is the most important information I should know about alprazolam? Alprazolam 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:Do not drive or operate heavy machinery until you know how taking Alprazolam with opioids affects you. shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Alprazolam, 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 Alprazolam. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency ro...",
  "clinical_studies": "CLINICAL STUDIES Anxiety Disorders Alprazolam Tablets were compared to placebo in double blind clinical studies (doses up to 4 mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. Alprazolam was significantly better than placebo at each of the evaluation periods of these 4-week studies as judged by the following psychometric instruments: Physician's Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient's Global Impressions and Self-Rating Symptom Scale. Panic Disorder Support for the effectiveness of Alprazolam in the treatment of panic disorder came from three short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder. The average dose of Alprazolam was 5\u20136 mg/day in two of the studies, and the doses of Alprazolam were fixed at 2 and 6 mg/day in the third study. In all three studies, Alprazolam was superior to placebo on a variable defined as \"the number of patients with zero panic attacks\" (range, 37\u201383% met this criterion), as well as on a global improvement score. In two of the three studies, Alprazolam was superior to pla...",
  "brand_name": "Alprazolam",
  "manufacturer": "Proficient Rx LP",
  "application_number": "NDA018276",
  "pharm_class_epc": [
   "Benzodiazepine [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230804",
  "set_id": "10de2b3b-3b3f-4a5a-a9e7-a8401f53b8cc",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 149291,
  "serious": 104577,
  "death": 22331,
  "hospitalization": 48147,
  "primary_suspect": 148548,
  "top_reactions": [
   [
    "Drug Ineffective",
    10258
   ],
   [
    "Fatigue",
    9122
   ],
   [
    "Nausea",
    8817
   ],
   [
    "Drug Abuse",
    8627
   ],
   [
    "Toxicity To Various Agents",
    7952
   ],
   [
    "Headache",
    7216
   ],
   [
    "Pain",
    6738
   ],
   [
    "Diarrhoea",
    6685
   ],
   [
    "Off Label Use",
    6573
   ],
   [
    "Anxiety",
    6562
   ],
   [
    "Dyspnoea",
    5533
   ],
   [
    "Dizziness",
    5224
   ],
   [
    "Death",
    5084
   ],
   [
    "Fall",
    5079
   ],
   [
    "Malaise",
    4845
   ]
  ],
  "by_year": {
   "2019": 16224,
   "2020": 15189,
   "2021": 10866,
   "2022": 9687,
   "2023": 8840,
   "2024": 8557,
   "2025": 8442,
   "2026": 3979
  },
  "by_year_primary": {
   "2019": 16211,
   "2020": 15176,
   "2021": 10829,
   "2022": 9516,
   "2023": 8668,
   "2024": 8435,
   "2025": 8332,
   "2026": 3899
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220428",
   "reason": "Failed Dissolution Specifications: low out-of-specification dissolution test results observed.",
   "firm": "Viatris Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20150924",
   "reason": "Subpotent Drug",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141217",
   "reason": "Subpotent Drug",
   "firm": "Neolpharma, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140725",
   "reason": "Presence of Foreign Substance; tablets may contain stainless steel metal particulates",
   "firm": "Sandoz Incorporated",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140210",
   "reason": "Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.",
   "firm": "Actavis Elizabeth LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20131009",
   "reason": "Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets",
   "firm": "Actavis Elizabeth LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 40,
  "nda": 3,
  "anda": 36,
  "first_approval": "19811016",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 31,
  "labeling_recent": 6,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "AMNEAL PHARMS NY",
   "ANI PHARMS",
   "APOTEX INC",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "HERITAGE PHARMS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/16/1981"
 },
 "trials": {
  "total": 109,
  "completed": 76,
  "terminated": 12,
  "with_results": 25,
  "industry": 61,
  "phase3": 8,
  "results_share": 0.32894736842105265,
  "terminated_share": 0.11009174311926606
 },
 "pubmed": {
  "rct": 280,
  "meta": 6,
  "recent_rct": 13,
  "cochrane": [
   {
    "pmid": "26638213",
    "title": "Alprazolam for essential tremor",
    "year": "2015"
   },
   {
    "pmid": "22786504",
    "title": "Alprazolam for depression",
    "year": "2012"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 6205.0,
  "records": 3,
  "by_name": [
   [
    "Xanax",
    6205.0
   ]
  ],
  "names_checked": [
   "alprazolam",
   "Xanax"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 11711922,
  "beneficiaries": 2317499,
  "spend": 77177339.31,
  "by_brand": [
   {
    "brand": "Alprazolam",
    "claims": 11609703,
    "per_claim": 5.2241345132,
    "is_generic": true
   },
   {
    "brand": "Alprazolam ER",
    "claims": 55629,
    "per_claim": 33.055867263,
    "is_generic": false
   },
   {
    "brand": "Xanax",
    "claims": 20242,
    "per_claim": 660.72297648,
    "is_generic": false
   },
   {
    "brand": "Alprazolam XR",
    "claims": 16776,
    "per_claim": 28.697970911,
    "is_generic": false
   },
   {
    "brand": "Alprazolam ODT",
    "claims": 8884,
    "per_claim": 63.428869878,
    "is_generic": false
   },
   {
    "brand": "Alprazolam Intensol",
    "claims": 389,
    "per_claim": 118.75107969,
    "is_generic": false
   },
   {
    "brand": "Xanax XR",
    "claims": 299,
    "per_claim": 743.60013378,
    "is_generic": false
   }
  ],
  "per_claim": 6.589639113887541
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 20666,
  "fills": 11711922,
  "per_million": 1764.5267787814844,
  "ratio": 0.6372548928943211,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 58,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "1,765 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death appears in 1.6x the share of reports seen across all of FAERS (-2)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "280 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed",
    "2 independent Cochrane review(s) exist",
    "Only 33% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 36 generic makers (-1)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $6,205 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 (36 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "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, drug abuse. How would we recognize and handle those?",
  "Why this one over bromazepam, chlordiazepoxide, clobazam? 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.)"
 ]
}