LOW-VOLUME · SEX-BALANCED
varenicline Side Effects
varenicline (also sold as Chantix) is a LOW-VOLUME FAERS extract #384 of 524 by FAERS report count. Still opens on SEX-BALANCED: 58% of sex-coded reports are female (3,007 F / 2,179 M).
Data updated 2026-05-15
- 5,766
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
varenicline reporting skew - 58% of sex-coded reports are female (3,007 F / 2,179 M). Volume band LOW-VOLUME #384 of 524 by FAERS report count; caseload WATCHLIST.
Thinner FAERS extract for varenicline (Chantix) (5,766 reports #384 of 524 by FAERS report count). 58% of sex-coded reports are female (3,007 F / 2,179 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2007–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
SNEEZING leads 732 of 5,766 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (1,668 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 65 reports (1.1% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 20 |
| DEATH | 19 |
| TOXICITY TO VARIOUS AGENTS | 11 |
| ACCIDENTAL OVERDOSE | 3 |
| CARDIAC ARREST | 3 |
| FALL | 3 |
| PRODUCT PRESCRIBING ERROR | 3 |
| ACUTE KIDNEY INJURY | 2 |
| ACUTE RESPIRATORY FAILURE | 2 |
| AMNESIA | 2 |
| ATRIAL FIBRILLATION | 2 |
| BALANCE DISORDER | 2 |
| CARDIO-RESPIRATORY ARREST | 2 |
| HYPERKALAEMIA | 2 |
| INTENTIONAL OVERDOSE | 2 |
| INTENTIONAL SELF-INJURY | 2 |
| ABDOMINAL DISTENSION | 1 |
| ACCIDENT | 1 |
| ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD | 1 |
Reactions in Hospitalization Reports
Hospitalization is lighter here (469). Reactions in that subset:
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 47 |
| SUICIDAL IDEATION | 39 |
| VOMITING | 39 |
| DEPRESSION | 35 |
| DRUG-INDUCED LIVER INJURY | 32 |
| HEPATIC CIRRHOSIS | 32 |
| ANXIETY | 31 |
| HEPATOTOXICITY | 31 |
| HEPATIC ENCEPHALOPATHY | 29 |
| HEPATIC NECROSIS | 29 |
| PNEUMONIA | 29 |
| SUICIDE ATTEMPT | 29 |
| DYSPNOEA | 28 |
| NAUSEA | 28 |
| FATIGUE | 27 |
| CONFUSIONAL STATE | 25 |
| DIZZINESS | 24 |
| ASTHENIA | 23 |
| DIARRHOEA | 22 |
| FALL | 22 |
How to read varenicline FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-LIGHT)
FAERS holds 5,766 voluntary reports linked to varenicline (Chantix), 2007-2025. Death is listed on 65 (1.1%). Hospitalization appears on 469 (8.1%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with varenicline
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-LIGHT stamps.
ABS(total_reports) peer at 5,762 FAERS cases (Δ 4 lighter vs varenicline); DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 5,825 FAERS cases (Δ 59 heavier vs varenicline); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 5,840 FAERS cases (Δ 74 heavier vs varenicline); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 5,878 FAERS cases (Δ 112 heavier vs varenicline); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 61.0 pp vs varenicline's DEATH-MARKED): CASELOAD · HOSP-MID.
varenicline stamps WATCHLIST · SEX-BALANCED; class peers and methodology beat restating the same FAERS caveats on every effects URL.