Varenicline
وارنیکلین
🧠 Nervous SystemNicotinic partial agonist
Market / country: 🇺🇸 USA
Chantix (US) · Champix (GB)
🧮 Dose calculator
Smoking cessation · Regimen source: FDA Varenicline · 2
- • Days 1–3: 0.5 mg once daily; days 4–7: 0.5 mg twice daily; then 1 mg twice daily to 12 weeks. CrCl <30: max 0.5 mg twice daily. FDA Varenicline · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ History of serious hypersensitivity or skin reactions to varenicline. FDA Varenicline · 4
- ⛔ Not recommended in patients 16 years or younger. FDA Varenicline · 8.4
Formulations
- 0.5 mg tablet — tablet 🇺🇸 USA FDA Varenicline · 3
- 1 mg tablet — tablet 🇺🇸 USA FDA Varenicline · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Varenicline · 8.1
“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] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Varenicline · 8.2
“Risk Summary There are no data on the presence of varenicline in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Varenicline · 8.4
“Varenicline tablets is not recommended for use in pediatric patients 16 years of age or younger because its efficacy in this population was not demonstrated.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Varenicline · 8.5
“Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.2) ].”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA218985
- DailyMed (FDA label)FDA Varenicline
- MedlinePlus (NIH)VareniclineVarenicline Nasal Spray
- WHO ATC/DDDN07BA03
- Darooyab (Iran)Varenicline
🇮🇷 Registered in Iran Darooyab · G-4345/Varenicline
Dosage forms with Iranian generic codes, per Darooyab.
- 10674 · VARENICLINE 1MG TAB · قرص وارنیکلین ۱ میلیگرم
- 10675 · VARENICLINE 500MCG TAB · قرص وارنیکلین ۵۰۰ میکروگرم
- 16352 · VARENICLINE 500MCG/1MG TAB · قرص وارنیکلین ۵۰۰ میکروگرم / ۱ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Varenicline · 3FDA Varenicline · 2FDA Varenicline · 4FDA Varenicline · 8.4FDA Varenicline · 8.1FDA Varenicline · 8.2FDA Varenicline · 8.5FDA Varenicline · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4345/Varenicline
- Clinical review⚠ Unverified