Varenicline tartrate

What Varenicline tartrate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CHANTIX 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 )

— FDA label: Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Chantix, Pfizer Laboratories Div Pfizer Inc; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 35 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 35 FDA labels for this medicine have a boxed warning.

Varenicline tartrate side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

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)]
• …

— FDA label: Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026. This is part of the section. Read the full label on DailyMed →

Varenicline tartrate drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Based on varenicline characteristics and clinical experience to date, CHANTIX has 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.

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(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 CHANTIX 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 CHANTIX, may alter the pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) for which dosage adjustment may be necessary.

— FDA label: Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026. Read the full label on DailyMed →

Varenicline tartrate dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

• Begin CHANTIX dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment. (2.1)
• Starting Week: 0.5 mg once daily on days 1–3 and 0.5 mg twice daily on days 4–7. (2.1)
• Continuing Weeks: 1 mg twice daily for a total of 12 weeks.

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(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 CHANTIX for patients who are sure that they are not able or willing to quit abruptly. Patients should begin CHANTIX 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 Recommended 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 CHANTIX dosing one week before this date. Alternatively, the patient can begin CHANTIX dosing and then quit smoking between days 8 and 35 of treatment. CHANTIX should be taken orally after eating and with a full glass of water. The recommended dose of CHANTIX is 1 mg twice daily following a 1-week titration as follows: Days 1 – 3: 0.5 mg once daily Days 4 – 7: 0.5 mg twice daily Day 8 – end of treatment: 1 mg twice daily Patients should be treated with CHANTIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHANTIX is recommended to further increase the likelihood of long-term abstinence. For patients who are sure that they are not able or willing to quit abruptly, consider a gradual approach to quitting smoking with CHANTIX. Patients should begin CHANTIX 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 CHANTIX treatment for an additional 12 weeks, for a total of 24 weeks of treatment.

— FDA label: Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026. This is part of the section. Read the full label on DailyMed →

Varenicline tartrate in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see Data]. Smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see Clinical Considerations).

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In animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (MRHD). Additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the MRHD [see Data]. The estimated background risk of oral clefts is increased by approximately 30% in infants of women who smoke during pregnancy, compared to pregnant women who do not smoke. The background risk of other major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Smoking during pregnancy causes increased risks of orofacial clefts, premature rupture of membranes, placenta previa, placental abruption, ectopic pregnancy, fetal growth restriction and low birth weight, stillbirth, preterm delivery and shortened gestation, neonatal death, sudden infant death syndrome and reduction of lung function in infants. It is not known whether quitting smoking with CHANTIX during pregnancy reduces these risks. Data Human Data A population-based observational cohort study using the national registers of Denmark and Sweden compared pregnancy and birth outcomes among women exposed to varenicline (N=335, includes 317 first trimester exposed) with women who smoked during pregnancy (N=78,412) and with non-smoking pregnant women (N=806,438). The prevalence of major malformations, the primary outcome, was similar in all groups, including between smoking and non-smoking groups. The prevalence of adverse perinatal outcomes in the varenicline-exposed cohort was not greater than in the cohort of women who smoked, and differed somewhat between the three cohorts. The prevalences of the primary and secondary outcomes are shown in Table 6. Table 6. Summary of Primary and Secondary Outcomes for Three Birth Cohorts Outcome Varenicline Cohort (n=335) Smoking Cohort (n=78,412) Non-Smoking Cohort (n=806,438) Major congenital malformation Included only live births in the cohorts.

— FDA label: Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026. This is part of the section. Read the full label on DailyMed →

When Varenicline tartrate should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

CHANTIX 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)

— FDA label: Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026. Read the full label on DailyMed →

Varenicline tartrate overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

In case of overdose, standard supportive measures should be instituted as required. Varenicline has been shown to be dialyzed in patients with end-stage renal disease [see Clinical Pharmacology (12.3)], however, there is no experience in dialysis following overdose.

— FDA label: Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• A-S Medication Solutions7 products
• Apotex Corp.4 products
• Kanchan Healthcare Inc2 products
• Indoco Remedies Limited2 products
• Par Health USA, LLC2 products
• Marlex Pharmaceuticals, Inc.2 products
• Ajanta Pharma USA Inc.2 products
• Macleods Pharmaceuticals Limited2 products
• Aurobindo Pharma Limited2 products
• Lupin Pharmaceuticals, Inc.2 products
• Pfizer Laboratories Div Pfizer Inc2 products
• Ascend Laboratories, LLC2 products
• Glenmark Pharmaceuticals Inc., USA2 products
• Leading Pharma, LLC2 products
• Zydus Lifesciences Limited2 products
• Camber Pharmaceuticals, Inc.2 products
• Micro Labs Limited2 products
• Aphena Pharma Solutions - Tennessee, LLC2 products
• American Health Packaging2 products
• Dr.Reddys Laboratories Inc2 products
• Zydus Pharmaceuticals USA Inc.2 products
• Florida Pharmaceutical Products, LLC2 products
• Bryant Ranch Prepack2 products
• Major Pharmaceuticals2 products
• AvKARE2 products
• Umedica Laboratories USA Inc.2 products
• NorthStar RxLLC2 products
• Proficient Rx LP1 product
• Remedyrepack Inc.1 product
• Harrow Eye, LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (16)

• ANDA201785Ph Health · August 11, 2021
• ANDA201962Apotex · January 25, 2023
• ANDA216723Zydus · June 12, 2023
• ANDA217151Pharmazone · July 25, 2023
• ANDA214255Mankind Pharma · August 1, 2023
• ANDA214557Alkem Labs Ltd · August 23, 2023
• ANDA214571Hetero Labs Ltd III · October 23, 2023
• ANDA211862Lupin · December 4, 2023
• ANDA217283Ne Rx Pharma · March 6, 2024
• ANDA213019Ajanta Pharma Ltd · March 19, 2024
• ANDA215931DR Reddys · October 1, 2024
• ANDA219106Regcon Holdings · October 29, 2024
• ANDA215048Macleods Pharms · December 9, 2024
• ANDA214595Aurobindo Pharma · May 2, 2025
• ANDA218302Micro Labs · October 29, 2025
• ANDA218985Umedica · January 9, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. November 11, 2025 · Class III · Ongoing · D-0219-2026

   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 — Dr. Reddy's Laboratories, Inc.

2. August 13, 2021 · Class II · Ongoing · D-0810-2021

   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. — Pfizer Inc.

3. August 13, 2021 · Class II · Ongoing · D-0811-2021

   CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

   Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: Se — Pfizer Inc.

4. August 13, 2021 · Class II · Ongoing · D-0809-2021

   CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

   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. — Pfizer Inc.

5. June 9, 2021 · Class II · Ongoing · D-0699-2021

   CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

   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 — Pfizer Inc.

6. June 9, 2021 · Class II · Ongoing · D-0701-2021

   CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs 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 — Pfizer Inc.

7. June 9, 2021 · Class II · Ongoing · D-0700-2021

   CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

   Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069 — Pfizer Inc.

8. March 15, 2021 · Class II · Terminated · D-0555-2021

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56 — Cardinal Health Inc.

9. March 15, 2021 · Class II · Terminated · D-0556-2021

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017 — Cardinal Health Inc.

10. March 15, 2021 · Class II · Terminated · D-0554-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017 — Cardinal Health Inc.

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• ChantixBrand page: products, maker and price
• TyrvayaBrand page: products, maker and price
• A-S Medication SolutionsMaker or distributor
• Apotex Corp.Maker or distributor
• Kanchan Healthcare IncMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Chantix, Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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