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Varenicline

Varenicline is a prescription medicine used as a stop-smoking aid in tablet form, and as a nasal spray (Tyrvaya) for the signs and symptoms of dry eye disease.

Brand names ChantixTyrvaya
Drug classes Cholinergic Receptor Agonist
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 41 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 2
Other forms & routes:
Nasal
Varenicline at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Varenicline (Chantix) is a stop-smoking medicine, on the market since about 2006 and available as a generic, that weakly stimulates nicotine receptors in the brain while blocking nicotine from them, so smoking feels less rewarding; it is widely considered one of the most effective quit aids, and a nasal spray form (Tyrvaya) treats dry eye disease. Most people tolerate it fairly well; nausea is the side effect people notice most, usually mild and fading, along with vivid dreams and trouble sleeping. Stop the tablets and call your prescriber right away for depression, agitation, unusual behavior or suicidal thoughts, or for a seizure or serious allergic or skin reaction.

Clinical pearls

  • Food does not change how varenicline is absorbed, so taking it after a meal is a fair way to soften nausea.
  • Start about a week before your quit date, or start first and pick a quit day between days 8 and 35.
  • Go easy on alcohol at first, since varenicline can make it hit harder, sometimes with aggressive behavior or memory loss.
  • If you take warfarin, insulin or theophylline, tell that prescriber you are quitting, since stopping smoking can change your dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Nasal spray
Earliest FDA record2006
Companies listing it with the FDA31
FDA label last updatedApr 15, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Varenicline, written from its FDA label.

What Varenicline is used for

▾

Varenicline is used differently depending on the product.

  • Varenicline tablets, including Chantix: an aid to smoking cessation treatment.
  • Tyrvaya nasal spray: treatment of the signs and symptoms of dry eye disease.

How Varenicline works

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In the tablets, varenicline binds to the α4β2 nicotinic receptor in the brain. It stimulates the receptor, but at a much lower level than nicotine. It also blocks nicotine from activating the receptor. This is believed to lessen the reward and reinforcement felt from smoking.

It is highly selective for this receptor and also binds moderately to the 5-HT3 receptor. Tyrvaya is described as a cholinergic agonist.

Varenicline dosage

▾

Varenicline tablets are taken by mouth. They are started at a lower dose for the first week and then taken twice daily, for a total of 12 weeks. You can take them with or without food.

  • Start about a week before your quit date, or start and quit between days 8 and 35.
  • An extra 12 weeks is recommended if you quit successfully.
  • A gradual approach may be considered if you cannot quit abruptly.
  • Tyrvaya nasal spray is used once in each nostril twice daily, about 12 hours apart. If you miss a dose, take the next one at the regular time.

Dosing details from the FDA-approved label

From the Varenicline prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Smoking cessation, usual dosage for adults (standard approach)
    • Begin dosing one week before the date set to stop smoking (or begin dosing and quit between days 8 and 35 of treatment)
    • Days 1 to 3: 0.5 mg once daily
    • Days 4 to 7: 0.5 mg twice daily
    • Day 8 to end of treatment: 1 mg twice daily
    • Treat for 12 weeks
    • An additional 12 weeks is recommended for patients who have successfully stopped smoking
    • Taken orally after eating and with a full glass of water
  • Smoking cessation, gradual approach for patients not able or willing to quit abruptly
    • Begin dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of complete abstinence by 12 weeks
    • Continue treatment for an additional 12 weeks, for a total of 24 weeks
    • Encourage patients to attempt quitting sooner if they feel ready
  • Severe renal impairment (estimated creatinine clearance less than 30 mL per min)
    • Starting dose 0.5 mg once daily
    • May then be titrated as needed to a maximum of 0.5 mg twice daily
    • Maximum: 0.5 mg twice daily
    • No dosage adjustment for mild to moderate renal impairment
  • End-stage renal disease undergoing hemodialysis
    • A maximum dose of 0.5 mg once daily may be administered if tolerated
    • Maximum: 0.5 mg once daily
    • Give only if tolerated
  • Elderly and patients with impaired hepatic function
    • No dosage adjustment is necessary for patients with hepatic impairment
    • Elderly more likely to have decreased renal function; take care in dose selection and it may be useful to monitor renal function
  • Patients who cannot tolerate adverse effects
    • Consider a temporary or permanent dose reduction
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Begin varenicline tablets dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. ( 2.1 ) • Starting Week: 0.5 mg once daily on days 1 to 3 and 0.5 mg twice daily on days 4 to 7. ( 2.1 ) • Continuing Weeks: 1 mg twice daily for a total of 12 weeks. ( 2.1 ) • An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. ( 2.1 ) • Consider a gradual approach to quitting smoking with varenicline tablets for patients who are sure that they are not able or willing to quit abruptly. Patients should begin varenicline tablets dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue treatment for an additional 12 weeks, for a total of 24 weeks. ( 2.1 ) • Severe Renal Impairment (estimated creatinine clearance less than 30 mL/min): Begin with 0.5 mg once daily and titrate to 0.5 mg twice daily. For patients with end-stage renal disease undergoing hemodialysis, a maximum of 0.5 mg daily may be given if tolerated. ( 2.2 ) • Consider dose reduction for patients who cannot tolerate adverse effects. ( 2.1 ) • Another attempt at treatment is recommended for those who fail to stop smoking or relapse when factors contributing to the failed attempt have been addressed. ( 2.1 ) • Provide patients with appropriate educational materials and counseling to support the quit attempt. ( 2.1 ) 2.1 Usual Dosage for Adults Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt. The patient should set a date to stop smoking. Begin varenicline tablets dosing one week before this date. Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. Varenicline tablets should be taken orally after eating and with a full glass of water.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Varenicline side effects

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Common side effects of the tablets include:

Common side effects

  • Nausea (the most common, and often mild or temporary)
  • Vivid, unusual or strange dreams
  • Trouble sleeping (insomnia)
  • Constipation
  • Gas (flatulence)
  • Vomiting
  • Headache

When to get medical help

  • Stop the tablets and call your healthcare provider right away if you notice agitation, depressed mood, unusual changes in behavior or thinking, or thoughts of suicide.
  • Stop the tablets and get help if you have a seizure.
  • Stop the tablets and seek immediate care for swelling of the face, mouth, tongue, lips, gums, neck or throat.
  • Stop the tablets and contact a provider right away at the first sign of a skin rash with sores in the mouth or other mucous membranes.
  • Stop the tablets and tell your provider if you walk in your sleep (somnambulism).
  • Get immediate medical attention for signs of a heart attack or stroke, and report new or worsening heart symptoms.

Serious reactions include mood or behavior changes, seizures, allergic swelling, serious skin reactions and sleepwalking. Stop the tablets and get help if these occur.

Varenicline warnings and precautions

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  • Mood and behavior changes: depression, agitation, aggression, hallucinations and suicidal thoughts have been reported with the tablets.
  • Seizures: use cautiously if you have a seizure history.
  • Alcohol: its effects may be increased.
  • Accidental injury: use caution driving or operating machinery.
  • Heart events: people with heart disease may be at higher risk.
  • Sleepwalking, angioedema (swelling) and serious skin reactions have been reported.

Varenicline interactions

▾

Varenicline tablets have no clinically meaningful pharmacokinetic drug interactions, but some points matter.

  • Alcohol: can feel stronger and may lead to unusual behavior.
  • Nicotine patches: more side effects and more stopping of treatment when combined.
  • Other stop-smoking drugs, such as bupropion: safety of combining has not been established.
  • Theophylline, warfarin, insulin: quitting smoking can change how these work, so doses may need adjusting.

Interactions listed in the FDA-approved label

From the Varenicline prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Bupropion: Varenicline (1 mg twice daily) did not alter the steady-state pharmacokinetics of bupropion (150 mg twice daily) in 46 smokers. The safety of the combination of bupropion and varenicline has not been established.
  • Nicotine replacement therapy (transdermal nicotine): Co-administration did not affect nicotine pharmacokinetics, but nausea, headache, vomiting, dizziness, dyspepsia, and fatigue were more frequent than with NRT alone; 8 of 22 (36%) on the combination discontinued due to adverse events versus 1 of 17 (6%) on NRT and placebo. Safety and efficacy in combination with other smoking cessation therapies have not been established.
  • Theophylline, warfarin, insulin (effect of smoking cessation): Physiological changes from smoking cessation, with or without varenicline, may alter the pharmacokinetics or pharmacodynamics of certain drugs such as these. Dosage adjustment may be necessary.
Read the label’s full interactions text

7 DRUG INTERACTIONS Based on varenicline characteristics and clinical experience to date, varenicline tablets have no clinically meaningful pharmacokinetic drug interactions [see Clinical Pharmacology (12.3) ] . • Other Smoking Cessation Therapies: Safety and efficacy in combination with other smoking cessation therapies has not been established. Coadministration of varenicline and transdermal nicotine resulted in a high rate of discontinuation due to adverse events. ( 7.1 ) • Effect of Smoking Cessation on Other Drugs: Pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) may be altered, necessitating dose adjustment. ( 7.2 ) 7.1 Use with Other Drugs for Smoking Cessation Safety and efficacy of varenicline tablets in combination with other smoking cessation therapies have not been studied. Bupropion Varenicline (1 mg twice daily) did not alter the steady-state pharmacokinetics of bupropion (150 mg twice daily) in 46 smokers. The safety of the combination of bupropion and varenicline has not been established. Nicotine Replacement Therapy (NRT) Although co-administration of varenicline (1 mg twice daily) and transdermal nicotine (21 mg/day) for up to 12 days did not affect nicotine pharmacokinetics, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone. In this study, eight of twenty-two (36%) patients treated with the combination of varenicline and NRT prematurely discontinued treatment due to adverse events, compared to 1 of 17 (6%) of patients treated with NRT and placebo. 7.2 Effect of Smoking Cessation on Other Drugs Physiological changes resulting from smoking cessation, with or without treatment with varenicline tablets, may alter the pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) for which dosage adjustment may be necessary.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿20 supplements and herbs with documented Varenicline interactions, ranked by severity Check Varenicline against a supplement or herb →

Before taking Varenicline

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  • Do not use the tablets if you have had a serious allergic or skin reaction to varenicline.
  • Tell your prescriber about seizures, psychiatric illness or heart disease.
  • Severe kidney disease or dialysis requires a dose adjustment.
  • Not recommended for those 16 or younger (tablets).
  • Older adults: no dose change by age, but kidney function may matter.
  • Pregnancy: available data have not suggested an increased risk of major birth defects, but studies can't confirm or rule out risk.
  • Breastfeeding: no human milk data; watch your infant for seizures and excessive vomiting.

Varenicline overdose

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In an overdose, standard supportive measures should be used. Varenicline can be removed by dialysis in people with end-stage kidney disease, but there is no experience using dialysis after an overdose.

What Varenicline does in the body

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Varenicline stimulates α4β2 nicotinic receptors weakly while blocking nicotine from activating them. This lowers the activation of the brain's dopamine reward system that is believed to underlie the reinforcement felt from smoking.

How your body processes Varenicline

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After the tablets are swallowed, absorption is nearly complete and peak blood levels occur in about 3 to 4 hours. Food does not affect absorption. Steady levels are reached within 4 days. Varenicline is barely metabolized, with about 92% leaving unchanged in urine, and its half-life is about 24 hours. Levels rise in people with moderate to severe kidney impairment.

How to store Varenicline

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Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) (see USP Controlled Room Temperature).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

20

Supplements & herbs that interact with Varenicline

20 supplements and herbal products have documented interactions with Varenicline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 10
  • Minor · 9
ACTIVATED CHARCOAL Major BEER Moderate COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate +12 more
Every supplement checked against Varenicline — ranked by severity The full interaction hub: 1 major · 10 moderate · 9 minor · every one linked to its full report. Check Varenicline against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Varenicline: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Varenicline — the kind of thing our pharmacy team would talk through with you at the counter.

What is varenicline for?

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The tablets, including Chantix, help you quit smoking. Tyrvaya is a varenicline nasal spray used for dry eye disease. They are different products with different uses.

How do I take the tablets?

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You take them by mouth, starting at a lower dose in the first week and then twice daily. You usually begin about a week before your quit date, and treatment lasts 12 weeks. Food doesn't change how it's absorbed. Follow your prescriber and the label.

What side effects should I expect?

▾
Nausea is the most common, and it often eases. Vivid dreams, trouble sleeping, constipation, gas, vomiting and headache can also happen. If nausea is hard to handle, talk to your prescriber, since a lower dose may help.

When should I stop it and call my doctor?

▾
Stop the tablets and call right away if you feel agitated or depressed, have unusual changes in behavior or thinking, or have thoughts of suicide. Also stop and get help for seizures, swelling of the face, tongue or throat, a rash with mouth sores, or sleepwalking. Seek emergency care for heart attack or stroke signs.

Can I drink alcohol or drive on it?

▾
Cut back on alcohol until you know how it affects you, because some people feel more intoxicated and act unusually. Be careful driving or using machinery too, since dizziness or sleepiness has led to accidents.

Is it safe in pregnancy?

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Available data have not suggested an increased risk of major birth defects, but studies can't fully settle the question. Smoking during pregnancy carries known risks. Talk with your prescriber about the best plan for you.

Is Varenicline available over the counter?

▾
No. Varenicline is a prescription medicine: every Varenicline product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Varenicline first available?

▾
The earliest FDA record we hold for Varenicline is from 2006: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Varenicline was first used.

Who makes Varenicline?

▾
31 companies currently list Varenicline products in the FDA's NDC Directory, including A-S Medication Solutions, Apotex Corp, Dr. Reddys Laboratories Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Varenicline on HelloPharmacist

📊Varenicline supplement interactions20 checked — ranked by severity 🌿Drug & Supplement CheckerVarenicline vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Varenicline NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Varenicline Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Varenicline forms and strengths (how it comes)

Varenicline is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Chantix
How this form is used
What it may be used for
  • Chantix and varenicline tablets are used as an aid to smoking cessation treatment.
Important instructions
  • Chantix and varenicline tablets are taken by mouth, starting about one week before the quit date, or you can quit between days 8 and 35 of treatment.
  • Chantix and varenicline tablets start at a lower dose for the first week, then continue twice daily for 12 weeks.
  • An additional 12 weeks of Chantix or varenicline tablets is recommended for people who quit successfully.
Available strengths 5 strengths
0.5 mg 0.5 mg/561 1 mg 1 mg/561 1 kg/kg
103 FDA-listed product records ⓘ

Nasal spray

In the nose
Brands Tyrvaya
How this form is used
What it may be used for
  • Tyrvaya is used to treat the signs and symptoms of dry eye disease.
Important instructions
  • Tyrvaya is sprayed once in each nostril twice daily, about 12 hours apart.
  • Prime Tyrvaya with seven sprays into the air away from your face before first use.
  • If Tyrvaya has not been used for more than 5 days, re-prime with 1 spray. Do not shake.
  • If you miss a Tyrvaya dose, resume at the next scheduled dose time.
Available strengths 1 strength
0.03 mg/0.05 mL
4 FDA-listed product records ⓘ

Varenicline on the U.S. market: products, makers and brands

How Varenicline appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

31 companies list 88 Varenicline product records with the FDA, mostly as tablet, nasal spray; the earliest marketing or approval year on record is 2006. Brand names on the directory include Chantix, Tyrvaya; the rest are generics.

2
Dose forms ⓘ
31
Labelers (makers, repackagers, distributors)
4
Brand names
88
FDA-listed product records ⓘ
2006
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Kit (33) · Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions8%
Apotex Corp6%
Dr. Reddys Laboratories Inc.5%
Ajanta Pharma USA Inc.3%
Ascend Laboratories, LLC3%
Aurobindo Pharma Limited3%
Other makers72%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Varenicline is used (Medicaid data)

A general measure of how commonly Varenicline is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Varenicline is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

417,684
Medicaid prescriptions filled (Q1–Q4 2025)
$33.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Varenicline prescribed? Of the 1,601 medications we measure, Varenicline ranks #283 by Medicaid prescriptions — more than 82% of them.

Where Varenicline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #283 of 1,601
#278 Ziprasidone 438,206 Rx #279 Ciclopirox Topical 437,507 Rx #280 Diltiazem 435,096 Rx #281 Warfarin 433,961 Rx #282 Acetaminophen, Butalbi... 425,589 Rx #283 Varenicline 417,684 Rx #284 Human Insulin Injectio... 414,373 Rx #285 Loperamide 409,237 Rx #286 Tacrolimus Topical 408,485 Rx #287 Cyclosporine 403,927 Rx #288 Betamethasone 403,381 Rx

Utilization by Varenicline product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg oral tablet is the most-dispensed Varenicline product — about 60% of these Medicaid prescriptions.

varenicline 1 MG Oral Tablet Most dispensed

251,780 Medicaid prescriptions (Q1–Q4 2025) 60% of Varenicline prescriptions shown $17.6M gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 14 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636676

varenicline 0.5 MG Oral Tablet

33,415 Medicaid prescriptions (Q1–Q4 2025) 8% of Varenicline prescriptions shown $1.9M gross reimbursement (before rebates) ≈ $58 per prescription (gross)

Summed across the 13 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636671

varenicline 0.03 MG/ACTUAT Nasal Spray

8,153 Medicaid prescriptions (Q1–Q4 2025) 2% of Varenicline prescriptions shown $5.6M gross reimbursement (before rebates) ≈ $686 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2572365

Other Varenicline products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

124,336 Medicaid prescriptions (Q1–Q4 2025) 30% of Varenicline prescriptions shown $7.9M gross reimbursement (before rebates) ≈ $64 per prescription (gross)

Summed across the 13 of 64 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Varenicline, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 41 of 155 listed Varenicline NDCs with Medicaid activity.

Compare Varenicline products

A representative set of FDA-listed product records for Varenicline — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 88 of 88 products — FDA National Drug Code Directory. See every product, package size and price: browse all 88 Varenicline NDCs →

Varenicline recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Varenicline recalls since July 2021, covering 3 product listings. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Nov 11, 2025 · Dr. Reddy's Laboratories, Inc.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
  • Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 Lots: Lot # F2400244, Exp Date: 10/31/2026 FDA record D-0219-2026 →
Ongoing Class II Aug 13, 2021 · Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
  • Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56. Lots: Lots 00018777, 00019289, 00019593, 00019682, 00019846, 00019977, 00020295, 00020448, 00020458, 00020480, 00021024, 00021073, 00021074, CW1565, CW1566, CW1567, CW1568, CW1569, CW1570, CW1571, CW1572, CW1573, CW1574, CW1575, CW1578, CW1579,… FDA record D-0810-2021 →
  • Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56. Lots: Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023 FDA record D-0809-2021 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Varenicline RxCUI 591622 2 dose forms · 3 strengths
  1. Dose form (SCDF) Nasal Spray RxCUI 2572364 In current FDA listings
    Clinical drug / strength (SCD) 0.03 MG/ACTUAT RxCUI 2572365
  2. Dose form (SCDF) Oral Tablet RxCUI 636670 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 636671 1 MG RxCUI 636676

Look up RxCUI 591622 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Varenicline costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 1 mg $3.41–$3.41 per tablet NDC details & price history
Tablet, Film Coated · Oral 0.5 mg $7.85 per tablet NDC details & price history
Tablet, Film Coated · Oral 1 mg/561 $0.403–$0.428 per tablet NDC details & price history
Tablet, Film Coated · Oral 0.5 mg/561 $0.337 per tablet NDC details & price history
Spray · Nasal 0.03 mg/0.05 mL $79.63 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Varenicline brand names

Varenicline is sold under 2 brand names in the FDA directory — Chantix, Tyrvaya. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Chantix Tyrvaya

Who makes Varenicline: manufacturers and labelers

31 companies list Varenicline products with the FDA. By number of product records, the largest are A-S Medication Solutions, Apotex Corp, Dr. Reddys Laboratories Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 7 Apotex Corp 5 Dr. Reddys Laboratories Inc. 4 Ajanta Pharma USA Inc. 3 Ascend Laboratories, LLC 3 Aurobindo Pharma Limited 3 AvKARE 3 Camber Pharmaceuticals, Inc. 3 Florida Pharmaceutical Products, LLC 3 Glenmark Pharmaceuticals Inc., USA 3 Indoco Remedies Limited 3 Kanchan Healthcare Inc 3 Leading Pharma, LLC 3 Lupin Pharmaceuticals, Inc. 3 Macleods Pharmaceuticals Limited 3 Major Pharmaceuticals 3 Micro Labs Limited 3 NorthStar RxLLC 3 Par Health USA, LLC 3 Pfizer Laboratories Div Pfizer Inc 3 Umedica Laboratories USA Inc. 3 American Health Packaging 2 Aphena Pharma Solutions - Tennessee, LLC 2 Bryant Ranch Prepack 2

…and 7 more on the FDA NDC directory.

Varenicline drug class (RxNorm)

Varenicline belongs to the Partial Cholinergic Nicotinic Agonist class.

Pharmacologic class Partial Cholinergic Nicotinic Agonist, Cholinergic Receptor Agonist
Drug family (ATC) Drugs used in nicotine dependence, Other ophthalmologicals
How it works Cholinergic Agonists, Partial Cholinergic Nicotinic Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Varenicline page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 15, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Varenicline.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Varenicline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
41
Finished products in the current FDA directory
88
Companies listing them (makers, repackagers, distributors)
31
FDA labeler codes behind them ⓘ
33
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Apr 15, 2023
Composite sections available
24
Linked SPL Set ID
4233fb78-ac6c-49f3-aad8-7e4bee18cac6
Linked SPL Document ID
5b7b6e3b-f427-4000-b252-968f3adbaa3b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →