Prescription medicine

Varenicline Brand names: Chantix, Tyrvaya

Varenicline (Chantix) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.316 per varenicline 1 mg tablet in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the varenicline FDA label on DailyMed (effective January 23, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 21928 record on Drugs@FDA; every varenicline label on DailyMed.

Highlights of the record

FDA label of January 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
CHANTIX is indicated for use as an aid to smoking-cessation treatment.

Forms and strengths

0.5 mg
1 mg
0.03 mg/.05ml
0.5 mg/561
1 mg/561

Film-coated tablet; kit; tablet; spray.

On the market

Earliest approval on file: May 10, 2006 Chantix, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 22 first August 11, 2021; 20 with a marketed status in Drugs@FDA
Labelers listed (NDC): 30 of which 27 under generic applications, 4 under brand applications, repackagers included
Last listed patent: October 19, 2035 Tyrvaya spray; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $0.316 per tablet Varenicline 1 mg tablet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 10 since 2013 0 Class I among all firms' recalls; latest November 11, 2025; 1 more by firms not listed as its makers
FAERS reports: 79,556 through July 30, 2026

What is varenicline used for?

From the label: indications and usage
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 )

Conditions named in the indications of varenicline's FDA labels, with every medicine labeled for each:

Quitting smoking

From other varenicline labels
Quitting smoking: Varenicline tablets are indicated for use as an aid to smoking cessation treatment.

FDA pharmacologic class: Cholinergic Receptor Agonist and Partial Cholinergic Nicotinic Agonist.

Source: FDA drug label (CHANTIX), NDA021928 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective January 23, 2026 (SPL set f0ff4f27-5185-4881-a749-c6b7a0ca5696), via openFDA; the full label on DailyMed

What does the patient leaflet for varenicline say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: 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 without a history of mental health problems. Stop taking CHANTIX and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take CHANTIX. In many people, these symptoms went away after stopping CHANTIX, but in some people symptoms continued after stopping CHANTIX. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking CHANTIX, tell your healthcare provider if you have ever had depression or other mental health problems. […]

From the patient leaflet: What should I avoid while taking CHANTIX?
Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you feel sleepy, dizzy, or have trouble concentrating, making it hard to drive or perform other activities safely. • Decrease the amount of alcoholic beverages that you drink during treatment with CHANTIX until you know if CHANTIX affects your ability to tolerate alcohol. Some people have experienced the following when drinking alcohol during treatment with CHANTIX: o increased drunkenness (intoxication) o unusual or sometimes aggressive behavior o no memory of things that have happened

From the patient leaflet: How should I store CHANTIX?
Store CHANTIX at room temperature, between 68°F to 77°F (20°C to 25°C). • Keep CHANTIX and all medicines out of the reach of children.

Is there a generic for varenicline (Chantix)?

The FDA approved the first generic varenicline on August 11, 2021. 22 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists varenicline from 27 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Chantix tablets; a patent listed only for Tyrvaya spray runs to October 19, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2006 earliest approval on file
2021 first generic approved
2035 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for varenicline (Chantix)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.316 per Varenicline 1 mg tablet, down 35% from $0.484 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Varenicline 1 mg tablet (generic)
Chantix 1 mg cont month box (brand)

$3.41

$0.316

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Varenicline 0.5 mg tablet	Generic	$0.312 per tablet	$9.35	-32%
Varenicline 1 mg tablet	Generic	$0.316 per tablet	$9.48	-35%
Varenicline starting month box	Generic	$0.397 per unit	n/a	-19%
Chantix 1 mg cont month box	Brand	$3.41 per unit	n/a	n/a
Chantix 1 mg tablet	Brand	$3.41 per tablet	$102.24	n/a
Chantix starting month box	Brand	$3.41 per unit	n/a	n/a
Tyrvaya 0.03 mg nasal spray	Brand	$79.63 per mL	n/a	+2%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has varenicline been recalled?

The FDA's Enforcement Report lists 11 recalls naming varenicline since 2013: 0 Class I (the most serious), 10 Class II, 1 Class III; 7 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of varenicline and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
November 11, 2025	Class III	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.
August 13, 2021	Class II	Pfizer Inc.	CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
June 9, 2021	Class II	Pfizer Inc.	CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
June 9, 2021	Class II	Pfizer Inc.	CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
March 15, 2021	Class II	Cardinal Health Inc.	CGMP Deviations: Intermittent exposure to temperature excursion during storage.
July 2, 2013	Class II	Aidapak Services, LLC not a listed maker	Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the varenicline label say about other medicines?

The varenicline label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Bupropion	drug interactions	Bupropion Varenicline (1 mg twice daily) did not alter the steady-state pharmacokinetics of bupropion (150 mg twice daily) in 46 smokers.
Nicotine	drug interactions	Coadministration of varenicline and transdermal nicotine resulted in a high rate of discontinuation due to adverse events.
Theophylline	drug interactions	Effect of Smoking Cessation on Other Drugs: Pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) may be altered, necessitating dose adjustment.
Warfarin	drug interactions	Effect of Smoking Cessation on Other Drugs: Pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) may be altered, necessitating dose adjustment.

Check varenicline against other medicines

What do FAERS reports show for varenicline?

The FDA Adverse Event Reporting System holds 79,556 reports that list varenicline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,637 are coded as a death and 7,357 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Nausea (named in the label)14,464
Depression8,681
Abnormal Dreams (named in the label)7,827
Anxiety (named in the label)5,950
Drug Ineffective (a use or a product term, not a reaction)5,650
Insomnia (named in the label)5,574
Vomiting (named in the label)4,598
Suicidal Ideation (named in the label)4,203

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

How does varenicline compare with medicines for the same use?

1 side-by-side page set varenicline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

Bupropion

What next?

Other cholinergic receptor agonists: the pharmacologic class, with prices and generics
Varenicline side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other