Varenicline: uses, dosing, side effects & brands
Varenicline is a cholinergic receptor agonist sold in the U.S. under 3 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Cholinergic Receptor Agonist
- Available as
- Tablet · Kit · Spray/Inhaler
- Sold as
- 3 products — Chantix, Tyrvaya and Varenicline Tartrate
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $12 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How Chantix is dosed
From the FDA label for Chantix (application NDA021928). Other varenicline products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. ( 2.1 ) • An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. ( 2.1 ) • Renal impairment: Reduce the dose in patients with severe renal impairment (estimated creatinine clearance <30 mL/min). ( 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 CHANTIX dosing one week before this date. Alternatively, the patient can…
Everything below is the FDA label for Chantix (tablet, kit). Varenicline is also sold as spray/inhaler, and those are different medicines to take — follow the label for the one you were prescribed.
Chantix side effects
The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling: • Neuropsychiatric symptoms and suicidality [see Boxed Warning and 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) ] • Angioedema and hypersensitivity reactions [see Warnings and Precautions (5.6) ] • Serious skin reactions [see Warnings and Precautions (5.7) ] 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 adverse events in CHANTIX-treated patients were as follows: nausea (3% vs. 0.5% for placebo), insomnia (1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo). Smoking cessation, with or without treatment, is…
Who shouldn’t take Chantix
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 )
Chantix drug interactions
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. ( 7.1 ) • Effect of smoking cessation: Pharmacokinetics or pharmacodynamics of certain drugs may be altered due to smoking cessation with CHANTIX, 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.
Every varenicline product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $12 | View → | |
| 2 | Not yet rated | Prescription | Spray/Inhaler | Generic | $12 | View → | |
| 3 | Not yet rated | Prescription | Kit | Generic | $12 | View → |
What varenicline pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Varenicline recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long varenicline keeps
The date on a sealed pack is not the only one: some varenicline labels start a second clock once the product is opened or mixed, as short as 30 days.
Does varenicline expire? The in-use limits and storage rules from its labelsVarenicline and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for varenicline: levels in milk, effects in breastfed infants, and the drugs it would consider insteadVarenicline is a partial nicotine agonist used orally to assist smoking cessation and by nasal spray for dry eyes. One researcher points out that based on animal data on nicotine, varenicline might interfere with normal infant lung development and recommends against its use in nursing mothers. Because no information is available on the use of varenicline during breastfeeding, an alternate drug is preferred, especially while nursing a newborn or preterm infant. However, maternal drug exposure after the nasal spray is only about 7.5% that of the oral drug, so the spray is much less likely to affect the infant. If a mother chooses to breastfeed while taking varenicline, she should monitor her infant for seizures and excessive vomiting.
National Institute of Child Health and Human Development, record revised June 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about varenicline
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,741 reports naming varenicline, and the FDA flagged 89% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- nausea261 reports
- dizziness175 reports
- depression170 reports
- headache162 reports
- dyspnoea151 reports
- anxiety147 reports
- insomnia145 reports
- fatigue136 reports
Read these as a signal, not a rate. A report does not mean varenicline caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is Chantix?
CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes.
What kind of drug is varenicline?
The FDA classifies varenicline as a cholinergic receptor agonist. Cholinergic receptor agonists mimic acetylcholine and switch on its receptors, triggering the body's "rest and digest" responses. This boosts effects like saliva and tear flow, bladder and bowel emptying, and pupil constriction. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take varenicline with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run varenicline against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is varenicline sold under?
We track 3 varenicline-containing products in the U.S.: Chantix, Tyrvaya and Varenicline Tartrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does varenicline come in?
Across the brands we track, varenicline is currently marketed as tablet, kit and spray/inhaler, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic varenicline?
Yes. Our catalog lists 1 generic varenicline product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has varenicline been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions varenicline. The most recent: Varenicline Tablets (Nov 11, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Varenicline: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/varenicline
- MLA
- “Varenicline: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/varenicline.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for varenicline on DailyMed (NIH) ↗ — including its boxed warning in full.