Varenicline — Membership Pricing

Other medications in Mental Health

• Venlafaxine
• Vilazodone
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zuranolone
• Acamprosate
• Alprazolam

What Varenicline is approved for (FDA label)

Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )

Source: Read the full FDA label on DailyMed. Label effective date: September 21, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Varenicline (FDA label)

Round, biconvex tablets: 0.5 mg (white to off-white, debossed with “M 33” on one side and plain on the other side) and Capsule, biconvex tablets: 1 mg (white to off-white, debossed with “M 34” on one side and plain on the other side). Tablets: 0.5 mg and 1 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 09e23664-936d-4c7f-86e5-5f924cb0c8b4. SPL document ID: 9aa5b5fe-9ac9-4779-8080-c9bfd42e405b. Label effective date: September 21, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Varenicline (FDA label)

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 varenicline tablets (>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 varenicline tablets, 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 varenicline tablets-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 associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. Most common adverse reactions (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (e.g., vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Source: FDA prescribing information (DailyMed). Set ID: 09e23664-936d-4c7f-86e5-5f924cb0c8b4. SPL document ID: 9aa5b5fe-9ac9-4779-8080-c9bfd42e405b. Label effective date: September 21, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Varenicline (FDA label)

Varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets. History of serious hypersensitivity or skin reactions to varenicline tablets. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 09e23664-936d-4c7f-86e5-5f924cb0c8b4. SPL document ID: 9aa5b5fe-9ac9-4779-8080-c9bfd42e405b. Label effective date: September 21, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Varenicline (FDA label)

• 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 varenicline tablets for the occurrence of such symptoms and instruct them to discontinue varenicline tablets and contact a healthcare provider if they experience such adverse events. ( 5.1 ) • Seizures: New or worsening seizures have been observed in patients taking varenicline tablets. Varenicline tablets 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.

Source: FDA prescribing information (DailyMed). Set ID: 09e23664-936d-4c7f-86e5-5f924cb0c8b4. SPL document ID: 9aa5b5fe-9ac9-4779-8080-c9bfd42e405b. Label effective date: September 21, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Varenicline (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: 09e23664-936d-4c7f-86e5-5f924cb0c8b4. SPL document ID: 9aa5b5fe-9ac9-4779-8080-c9bfd42e405b. Label effective date: September 21, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.