{
 "query": "varenicline",
 "ingredient": "varenicline",
 "slug": "varenicline",
 "rxcui": "591622",
 "brands": [
  "Tyrvaya",
  "Chantix"
 ],
 "names": [
  "varenicline",
  "varenicline tartrate"
 ],
 "classes": [
  {
   "id": "N07BA",
   "name": "Drugs used in nicotine dependence"
  }
 ],
 "alternatives": [
  "cytisine",
  "nicotine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 35
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated for use as an aid to smoking cessation treatment. CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )",
  "contraindications": "is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to CHANTIX. History of serious hypersensitivity or skin reactions to CHANTIX. ( 4 )",
  "warnings_and_cautions": "Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with CHANTIX for the occurrence of such symptoms and instruct them to discontinue CHANTIX and contact a healthcare provider if they experience such adverse events. ( 5.1 ) Seizures : New or worsening seizures have been observed in patients taking CHANTIX. CHANTIX should be used cautiously in patients with a history of seizures or other factors that can lower the seizure threshold. ( 5.2 ) Interaction with Alcohol : Increased effects of alcohol have been reported. Instruct patients to reduce the amount of alcohol they consume until they know whether CHANTIX affects them. ( 5.3 ) Accidental Injury : Accidental injuries (e.g., traffic accidents) have been reported. Instruct patients to use caution driving or operating machinery until they know how CHANTIX may affect th...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling: Neuropsychiatric Adverse Events including Suicidality [see Warnings and Precautions (5.1) ] Seizures [see Warnings and Precautions (5.2) ] Interaction with alcohol [see Warnings and Precautions (5.3) ] Accidental injury [see Warnings and Precautions (5.4) ] Cardiovascular events [see Warnings and Precautions (5.5) ] Somnambulism [see Warnings and Precautions (5.6) ] Angioedema and hypersensitivity reactions [see Warnings and Precautions (5.7) ] Serious skin reactions [see Warnings and Precautions (5.8) ] In the placebo-controlled premarketing studies, the most common adverse events associated with CHANTIX (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. The treatment discontinuation rate due to adverse events in patients dosed with 1 mg twice daily was 12% for CHANTIX, compared to 10% for placebo in studies of three months' treatment. In this group, the discontinuation rates that are higher than placebo for the most common ad...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Varenicline is not a controlled substance. 9.3 Dependence Humans Fewer than 1 out of 1,000 patients reported euphoria in clinical trials with CHANTIX. At higher doses (greater than 2 mg), CHANTIX produced more frequent reports of gastrointestinal disturbances such as nausea and vomiting. There is no evidence of dose-escalation to maintain therapeutic effects in clinical studies, which suggests that tolerance does not develop. Abrupt discontinuation of CHANTIX was associated with an increase in irritability and sleep disturbances in up to 3% of patients. This suggests that, in some patients, varenicline may produce mild physical dependence which is not associated with addiction. In a human laboratory abuse liability study, a single oral dose of 1 mg varenicline did not produce any significant positive or negative subjective responses in smokers. In non-smokers, 1 mg varenicline produced an increase in some positive subjective effects, but this was accompanied by an increase in negative adverse effects, especially nausea. A single oral dose of 3 mg varenicline uniformly produced unpleasant subjective responses in both smokers and non-smokers. Animals Studies ...",
  "controlled_substance": "9.1 Controlled Substance Varenicline is not a controlled substance.",
  "recent_major_changes": "Boxed Warning-Removed 12/2016 Dosage and Administration, Usual Dosage for Adults ( 2.1 ) 8/2016 Warnings and Precautions, Neuropsychiatric Adverse Events including Suicidality ( 5.1 ) 12/2016 Warnings and Precautions, Somnambulism ( 5.6 ) 8/2016",
  "information_for_patients": "See FDA-approved patient labeling (Medication Guide) Initiate Treatment and Continue to Attempt to Quit if Lapse Instruct patients to set a date to quit smoking and to initiate CHANTIX treatment one week before the quit date. Alternatively, the patient can begin CHANTIX dosing and then set a date to quit smoking between days 8 and 35 of treatment. Encourage patients to continue to attempt to quit if they have early lapses after quit day [see Dosage and Administration (2.1) ]. For patients who are sure that they are not able or willing to quit abruptly, a gradual approach to quitting smoking with CHANTIX may be considered. Patients should begin CHANTIX dosing and reduce smoking during the first 12 weeks of treatment, then quit by the end of that period and continue treatment for an additional 12 weeks for a total of 24 weeks [see Dosage and Administration (2.1) ] . Encourage patients who are motivated to quit and who did not succeed in stopping smoking during prior CHANTIX therapy for reasons other than intolerability due to adverse events, or who relapsed after treatment to make another attempt with CHANTIX once factors contributing to the failed attempt have been identified and ad...",
  "spl_medguide": "MEDICATION GUIDE CHANTIX \u00ae (CHANT-iks) (varenicline) Tablets What is the most important information I should know about CHANTIX? When you try to quit smoking, with or without CHANTIX, you may have symptoms that may be due to nicotine withdrawal, including: urge to smoke depressed mood trouble sleeping irritability frustration anger feeling anxious difficulty concentrating restlessness decreased heart rate increased appetite weight gain Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Some people have had serious side effects while taking CHANTIX to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions . Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX. These symptoms happened more often in people who had a history of mental health problems before taking CHANTIX, than in people wi...",
  "clinical_studies": "The efficacy of CHANTIX in smoking cessation was demonstrated in six clinical trials in which a total of 3659 chronic cigarette smokers (\u226510 cigarettes per day) were treated with CHANTIX. In all clinical studies, abstinence from smoking was determined by patient self-report and verified by measurement of exhaled carbon monoxide (CO\u226410 ppm) at weekly visits. Among the CHANTIX-treated patients enrolled in these studies, the completion rate was 65%. Except for the dose-ranging study (Study 1) and the maintenance of abstinence study (Study 6), patients were treated for 12 weeks and then were followed for 40 weeks post-treatment. Most patients enrolled in these trials were white (79\u201396%). All studies enrolled almost equal numbers of men and women. The average age of patients in these studies was 43 years. Patients on average had smoked about 21 cigarettes per day for an average of approximately 25 years. Patients set a date to stop smoking (target quit date) with dosing starting 1 week before this date. Seven additional studies evaluated the efficacy of CHANTIX in patients with cardiovascular disease, in patients with chronic obstructive pulmonary disease [see Clinical Studies (14.7) ],...",
  "brand_name": "CHANTIX",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "NDA021928",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20171218",
  "set_id": "b4403cea-6300-4d89-8fde-5149a80b08b9",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 25551,
  "serious": 9690,
  "death": 683,
  "hospitalization": 2977,
  "primary_suspect": 25531,
  "top_reactions": [
   [
    "Drug Ineffective",
    2948
   ],
   [
    "Nausea",
    2591
   ],
   [
    "Abnormal Dreams",
    1682
   ],
   [
    "Depression",
    1169
   ],
   [
    "Malaise",
    1120
   ],
   [
    "Anxiety",
    1010
   ],
   [
    "Nightmare",
    1001
   ],
   [
    "Insomnia",
    972
   ],
   [
    "Feeling Abnormal",
    969
   ],
   [
    "Vomiting",
    964
   ],
   [
    "Headache",
    948
   ],
   [
    "Fatigue",
    798
   ],
   [
    "Drug Hypersensitivity",
    781
   ],
   [
    "Sneezing",
    754
   ],
   [
    "Suicidal Ideation",
    719
   ]
  ],
  "by_year": {
   "2019": 2867,
   "2020": 2024,
   "2021": 1324,
   "2022": 1683,
   "2023": 1114,
   "2024": 1771,
   "2025": 894,
   "2026": 412
  },
  "by_year_primary": {
   "2019": 2867,
   "2020": 2024,
   "2021": 1324,
   "2022": 1679,
   "2023": 1111,
   "2024": 1766,
   "2025": 890,
   "2026": 409
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20251111",
   "reason": "Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was  below specification limit.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210813",
   "reason": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit",
   "firm": "Pfizer Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210813",
   "reason": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit",
   "firm": "Pfizer Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210609",
   "reason": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit",
   "firm": "Pfizer Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210609",
   "reason": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit",
   "firm": "Pfizer Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210609",
   "reason": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit",
   "firm": "Pfizer Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 26,
  "nda": 2,
  "anda": 22,
  "first_approval": "20060510",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 1,
  "sponsors": [
   "ADAPTIS",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "APOTEX",
   "AUROBINDO PHARMA",
   "DR REDDYS",
   "HETERO LABS LTD III",
   "LUPIN"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/10/2006"
 },
 "trials": {
  "total": 405,
  "completed": 292,
  "terminated": 44,
  "with_results": 197,
  "industry": 124,
  "phase3": 73,
  "results_share": 0.6746575342465754,
  "terminated_share": 0.10864197530864197
 },
 "pubmed": {
  "rct": 274,
  "meta": 43,
  "recent_rct": 65,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 1075226.56,
  "records": 19190,
  "by_name": [
   [
    "Tyrvaya",
    1075193.24
   ],
   [
    "Chantix",
    33.32
   ]
  ],
  "names_checked": [
   "varenicline",
   "Tyrvaya",
   "Chantix"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 660035,
  "beneficiaries": 256259,
  "spend": 204242459.02,
  "by_brand": [
   {
    "brand": "Varenicline Tartrate",
    "claims": 569550,
    "per_claim": 232.64145759,
    "is_generic": true
   },
   {
    "brand": "Tyrvaya",
    "claims": 90460,
    "per_claim": 792.9651992,
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   },
   {
    "brand": "Chantix",
    "claims": 25,
    "per_claim": 395.3972,
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   }
  ],
  "per_claim": 309.4418614467415
 },
 "mdl": [
  {
   "number": "3050",
   "title": "Chantix (Varenicline) Marketing, Sales Practices and Products Liability Litigation (No. II)",
   "judge": "Failla, Katherine Polk",
   "court": "NYS",
   "docket": "1:22-md-3050",
   "actions": "",
   "matched": "chantix"
  }
 ],
 "dsc": [
  {
   "date": "20161216",
   "title": "FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm532221.htm",
   "kind": "drug",
   "matched": "chantix"
  },
  {
   "date": "20150309",
   "title": "FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm436494.htm",
   "kind": "drug",
   "matched": "chantix"
  },
  {
   "date": "20121212",
   "title": "Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm330367.htm",
   "kind": "drug",
   "matched": "chantix"
  },
  {
   "date": "20111024",
   "title": "Chantix (varenicline) - Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm276737.htm",
   "kind": "drug",
   "matched": "chantix"
  },
  {
   "date": "20110722",
   "title": "Chantix (varenicline) drug label now contains updated efficacy and safety information",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm264436.htm",
   "kind": "drug",
   "matched": "chantix"
  },
  {
   "date": "20110616",
   "title": "Chantix - Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm259161.htm",
   "kind": "drug",
   "matched": "chantix"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "varenicline",
  "matched": "varenicline",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3065,
  "fills": 660035,
  "per_million": 4643.693137485134,
  "ratio": 1.6770593728283945,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 76,
   "letter": "B",
   "why": [
    "FDA issued 6 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-20)",
    "4,644 FDA reports naming it as the suspect drug per million Medicare fills, 1.7x the median drug on this site (-4)",
    "Death share in reports is near or below the FAERS average (0.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 67,
   "letter": "C",
   "why": [
    "274 randomized trials and 43 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)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 1 Class III across 22 generic makers (-6)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 30,
   "letter": "F",
   "why": [
    "Pharma paid doctors $1,075,227 tied to this drug last year (-30)",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (22 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and ). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, abnormal dreams, depression. How would we recognize and handle those?",
  "Why this one over cytisine, nicotine? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "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.)"
 ]
}