Last reviewed · How we verify
VARENICLINE
At a glance
| Generic name | VARENICLINE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2006 |
Approved indications
Common side effects
- Nausea
- Abnormal dreams
- Constipation
- Flatulence
- Vomiting
- Insomnia
Serious adverse events
- Nicotine withdrawal symptoms
- Exacerbation of underlying psychiatric illness
Key clinical trials
- Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 (PHASE2)
- A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation (PHASE2, PHASE3)
- Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder (EARLY_PHASE1)
- Varenicline for Smoking Reduction in Veterans Not Ready To Quit (PHASE4)
- A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse (NA)
- Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation (PHASE4)
- Preoperative Smoking Cessation in Patients Undergoing Surgery (NA)
- Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VARENICLINE CI brief — competitive landscape report
- VARENICLINE updates RSS · CI watch RSS