{
 "query": "diazepam",
 "ingredient": "diazepam",
 "slug": "diazepam",
 "rxcui": "3322",
 "brands": [
  "Valtoco",
  "Valium",
  "Diastat",
  "Libervant"
 ],
 "names": [
  "diazepam"
 ],
 "classes": [
  {
   "id": "N05BA",
   "name": "Benzodiazepine derivatives"
  }
 ],
 "alternatives": [
  "alprazolam",
  "bromazepam",
  "chlordiazepoxide",
  "clobazam",
  "clorazepate dipotassium",
  "clotiazepam",
  "cloxazolam",
  "ethyl loflazepate",
  "halazepam",
  "ketazolam",
  "lorazepam",
  "medazepam",
  "nordazepam",
  "oxazepam",
  "prazepam",
  "tofisopam"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 60,
   "INTRAMUSCULAR": 22,
   "INTRAVENOUS": 21,
   "RECTAL": 4,
   "NASAL": 1
  },
  "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 in 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 diazepam, 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 diazepam and throughout treatment, assess each patient\u2019s risk for abuse, misuse, and addiction (see WARNINGS ) . The continued use of benzodiazepines, including diazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher ...",
  "indications_and_usage": "INDICATIONS AND USAGE Diazepam tablets are indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
  "contraindications": "CONTRAINDICATIONS Diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. Diazepam tablets are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. It may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including diazepam, 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 diazepam 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 diazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking diazepam, 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 diazepam is used with ...",
  "adverse_reactions": "ADVERSE REACTIONS Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The following have also been reported: Central Nervous System : confusion, depression, dysarthria, headache, slurred speech, tremor, vertigo Gastrointestinal System : constipation, nausea, gastrointestinal disturbances Special Senses : blurred vision, diplopia, dizziness Cardiovascular System : hypotension Psychiatric and Paradoxical Reactions : stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, increased muscle spasticity, insomnia, sleep disturbances, and nightmares. Inappropriate behavior and other adverse behavioral effects have been reported when using benzodiazepines. Should these occur, use of the drug should be discontinued. They are more likely to occur in children and in the elderly. Urogenital System : incontinence, changes in libido, urinary retention Skin and Appendages : skin reactions Laboratories : elevated transaminases and alkaline phosphatase Other : changes in salivation, including dry mouth, hypersalivation Antegrade amnesia may occur using therapeutic dosage...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Controlled Substance Diazepam tablets contain diazepam, a Schedule IV controlled substance. Abuse Diazepam 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 Diazepam tablets contain diazepam, 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 ).",
  "spl_medguide": "MEDICATION GUIDE Diazepam Tablets, USP (dye AZ e pam) What is the most important information I should know about diazepam tablets? Diazepam tablets are 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 diazepam tablets with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including diazepam tablets, 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 diazepam tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare prov...",
  "clinical_studies": "",
  "brand_name": "DIAZEPAM",
  "manufacturer": "NuCare Pharmaceuticals, Inc.",
  "application_number": "ANDA217843",
  "pharm_class_epc": [
   "Benzodiazepine [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241226",
  "set_id": "21785bb2-cc96-7973-e063-6294a90ab1b8",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 92609,
  "serious": 74586,
  "death": 15723,
  "hospitalization": 32782,
  "primary_suspect": 91807,
  "top_reactions": [
   [
    "Toxicity To Various Agents",
    8457
   ],
   [
    "Drug Abuse",
    5878
   ],
   [
    "Drug Ineffective",
    5813
   ],
   [
    "Off Label Use",
    4662
   ],
   [
    "Fatigue",
    4533
   ],
   [
    "Nausea",
    4369
   ],
   [
    "Somnolence",
    4242
   ],
   [
    "Pain",
    3642
   ],
   [
    "Headache",
    3623
   ],
   [
    "Anxiety",
    3433
   ],
   [
    "Vomiting",
    3307
   ],
   [
    "Drug Interaction",
    3283
   ],
   [
    "Overdose",
    3148
   ],
   [
    "Diarrhoea",
    3127
   ],
   [
    "Fall",
    3104
   ]
  ],
  "by_year": {
   "2019": 9914,
   "2020": 9218,
   "2021": 7361,
   "2022": 6359,
   "2023": 6082,
   "2024": 6332,
   "2025": 6440,
   "2026": 2962
  },
  "by_year_primary": {
   "2019": 9903,
   "2020": 9204,
   "2021": 7283,
   "2022": 6224,
   "2023": 5926,
   "2024": 6167,
   "2025": 6299,
   "2026": 2885
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20180710",
   "reason": "Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.",
   "firm": "Valeant Pharmaceuticals North America LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20160623",
   "reason": "Crystallization: Product contains particulate identified to be crystallized active ingredient.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130816",
   "reason": "Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130516",
   "reason": "Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130226",
   "reason": "Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20120828",
   "reason": "Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20120606",
   "reason": "Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.",
   "firm": "Meridian Medical Technologies a Pfizer Company",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 100,
  "nda": 9,
  "anda": 64,
  "first_approval": "19631115",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 54,
  "labeling_recent": 14,
  "sponsors": [
   "ABRAXIS PHARM",
   "ACTAVIS ELIZABETH",
   "ALEMBIC",
   "AQUESTIVE",
   "AUROBINDO PHARMA LTD",
   "BARR",
   "BAUSCH",
   "BAXTER HLTHCARE CORP"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/15/1963"
 },
 "trials": {
  "total": 151,
  "completed": 97,
  "terminated": 17,
  "with_results": 34,
  "industry": 24,
  "phase3": 16,
  "results_share": 0.35051546391752575,
  "terminated_share": 0.11258278145695365
 },
 "pubmed": {
  "rct": 816,
  "meta": 17,
  "recent_rct": 17,
  "cochrane": [
   {
    "pmid": "21154341",
    "title": "Magnesium sulphate versus diazepam for eclampsia",
    "year": "2010"
   },
   {
    "pmid": "14974046",
    "title": "Diazepam for treating tetanus",
    "year": "2004"
   },
   {
    "pmid": "14583910",
    "title": "Magnesium sulphate versus diazepam for eclampsia",
    "year": "2003"
   },
   {
    "pmid": "10796145",
    "title": "Magnesium sulphate versus diazepam for eclampsia",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 1735985.91,
  "records": 17924,
  "by_name": [
   [
    "Valtoco",
    1731776.75
   ],
   [
    "Libervant",
    4209.16
   ]
  ],
  "names_checked": [
   "diazepam",
   "Valtoco",
   "Valium",
   "Diastat",
   "Libervant"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3013050,
  "beneficiaries": 939769,
  "spend": 48946203.06,
  "by_brand": [
   {
    "brand": "Diazepam",
    "claims": 2984541,
    "per_claim": 6.3454533545,
    "is_generic": true
   },
   {
    "brand": "Valtoco",
    "claims": 20987,
    "per_claim": 1161.9588288,
    "is_generic": false
   },
   {
    "brand": "Valium",
    "claims": 7522,
    "per_claim": 747.39529646,
    "is_generic": false
   }
  ],
  "per_claim": 16.244736416587845
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "diazepam",
  "matched": "diazepam",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15351,
  "fills": 3013050,
  "per_million": 5094.837457061782,
  "ratio": 1.8399891330954676,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 46,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "5,095 FDA reports naming it as the suspect drug per million Medicare fills, 1.8x the median drug on this site (-5)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death appears in 1.9x the share of reports seen across all of FAERS (-4)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 72,
   "letter": "C",
   "why": [
    "816 randomized trials and 17 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 35% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 64 generic makers (-2)",
    "14 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,735,986 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (64 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 68,
 "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 toxicity to various agents, drug abuse. 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?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}