Drug · FAERS side-effect profile with label screen
Varenicline side effects: what 3,074 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,074 reports · 42% serious · 59 with death outcome · 34% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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 )
FDA label, Indications and Usage
What it is
Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate .
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 14Labeled (related wording) 6Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 15
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 143 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sneezing | 740 | 118.6 110.7–127.1ROR 135.0 · χ² 83,376 / p <1e-300 | 114.3 EB05 107.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Abnormal dreams | 211 | 26.5 23.2–30.3ROR 27.4 · χ² 5,118 / p <1e-300 | 26.2 EB05 23.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.6 · 93% clinician | no trial data cached |
| Nightmare | 213 | 21.4 18.7–24.4ROR 22.1 · χ² 4,094 / p <1e-300 | 21.2 EB05 18.9 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · ♀ 10% (drug 34%) · 96% clinician | no trial data cached |
| Throat irritation | 180 | 14.0 12.1–16.2ROR 14.4 · χ² 2,157 / p <1e-300 | 13.9 EB05 12.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.0 | no trial data cached |
| Rhinorrhoea (runny nose) | 232 | 12.5 11.0–14.2ROR 13.0 · χ² 2,445 / p <1e-300 | 12.4 EB05 11.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 0.7 | no trial data cached |
| Eye pain | 184 | 11.6 10.0–13.4ROR 11.9 · χ² 1,767 / p <1e-300 | 11.5 EB05 10.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.4 | no trial data cached |
| Hepatic encephalopathy | 29 | 10.8 7.5–15.5ROR 10.8 · χ² 247 / p 5e-56 | 10.1 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 29.1 · ♀ 100% (drug 34%) | no trial data cached |
| Ocular discomfort | 32 | 10.2 7.2–14.5ROR 10.3 · χ² 257 / p 4e-58 | 9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Lacrimation increased | 88 | 10.2 8.3–12.6ROR 10.4 · χ² 723 / p 2e-159 | 10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Eye irritation | 141 | 8.8 7.5–10.3ROR 9.0 · χ² 965 / p 4e-212 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Product use complaint | 39 | 8.7 6.4–12.0ROR 8.8 · χ² 259 / p 1e-58 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Device delivery system issue | 65 | 8.6 6.8–11.0ROR 8.7 · χ² 431 / p 5e-96 | 8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product packaging quantity issue | 27 | 8.6 5.9–12.5ROR 8.6 · χ² 173 / p 7e-40 | 7.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 218 | 8.3 7.2–9.4ROR 8.5 · χ² 1,386 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 · 93% clinician | no trial data cached |
| Epistaxis (nosebleed) | 177 | 8.2 7.1–9.5ROR 8.4 · χ² 1,113 / p 2e-244 | 8.1 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Photophobia (light sensitivity) | 41 | 7.6 5.6–10.3ROR 7.7 · χ² 229 / p 5e-52 | 7.1 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Eye discharge | 22 | 7.5 4.9–11.3ROR 7.5 · χ² 117 / p 2e-27 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Agitation | 153 | 7.2 6.2–8.4ROR 7.4 · χ² 814 / p 3e-179 | 7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 97% clinician | no trial data cached |
| Mood swings | 63 | 6.9 5.4–8.8ROR 6.9 · χ² 309 / p 2e-69 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 94% clinician | no trial data cached |
| Hepatic cirrhosis | 35 | 6.5 4.7–9.0ROR 6.5 · χ² 157 / p 2e-36 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.2 · ♀ 91% (drug 34%) | no trial data cached |
| Anger | 57 | 5.8 4.5–7.5ROR 5.9 · χ² 223 / p 1e-50 | 5.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Ocular hyperaemia | 76 | 5.6 4.5–7.1ROR 5.7 · χ² 286 / p 2e-64 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Hepatotoxicity (liver damage) | 36 | 5.6 4.1–7.8ROR 5.7 · χ² 133 / p 6e-31 | 5.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · ♀ 100% (drug 34%) | no trial data cached |
| Product administration error | 32 | 5.6 3.9–7.9ROR 5.6 · χ² 115 / p 4e-27 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Depression | 361 | 5.5 5.0–6.1ROR 5.8 · χ² 1,331 / p 1e-291 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 94% clinician | no trial data cached |
| Dry eye | 71 | 5.1 4.0–6.4ROR 5.1 · χ² 229 / p 5e-52 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.5 | no trial data cached |
| Irritability | 86 | 5.0 4.0–6.1ROR 5.0 · χ² 268 / p 2e-60 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · ♀ 11% (drug 34%) · 91% clinician | no trial data cached |
| Paranoia | 23 | 4.6 3.1–6.9ROR 4.6 · χ² 61 / p 2e-15 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 100% clinician | no trial data cached |
| Mood altered | 36 | 4.6 3.3–6.4ROR 4.6 · χ² 98 / p 2e-23 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Dry throat | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Neuroleptic malignant syndrome | 15 | 4.4 2.6–7.3ROR 4.4 · χ² 36 / p 1e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Full blood count abnormal | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 15.3 | no trial data cached |
| Sedation | 31 | 4.1 2.9–5.9ROR 4.1 · χ² 70 / p 3e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 100% clinician | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 12 | 4.1 2.3–7.2ROR 4.1 · χ² 25 / p 3e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Ear discomfort | 12 | 4.1 2.3–7.2ROR 4.1 · χ² 25 / p 3e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Eye inflammation | 11 | 4.0 2.2–7.3ROR 4.0 · χ² 22 / p 1e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Eye swelling | 41 | 3.8 2.8–5.2ROR 3.9 · χ² 84 / p 3e-20 | 3.7 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Mania | 18 | 3.8 2.4–6.0ROR 3.8 · χ² 34 / p 2e-9 | 3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Drug-induced liver injury | 33 | 3.7 2.6–5.2ROR 3.7 · χ² 63 / p 1e-15 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 100% (drug 34%) | no trial data cached |
| Sinus disorder | 21 | 3.7 2.4–5.6ROR 3.7 · χ² 38 / p 3e-10 | 3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sneezing | 740 | 118.6 110.7–127.1ROR 135.0 · χ² 83,376 / p <1e-300 | 114.3 EB05 107.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Nausea | 582 | 2.6 2.4–2.8ROR 2.7 · χ² 572 / p 1e-126 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Vomiting | 390 | 2.9 2.6–3.2ROR 3.0 · χ² 489 / p 1e-108 | 2.9 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Depression | 361 | 5.5 5.0–6.1ROR 5.8 · χ² 1,331 / p 1e-291 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 94% clinician | no trial data cached |
| Headache | 303 | 1.7 1.5–1.9ROR 1.7 · χ² 85 / p 2e-20 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Rhinorrhoea (runny nose) | 232 | 12.5 11.0–14.2ROR 13.0 · χ² 2,445 / p <1e-300 | 12.4 EB05 11.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 0.7 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 218 | 8.3 7.2–9.4ROR 8.5 · χ² 1,386 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 · 93% clinician | no trial data cached |
| Nightmare | 213 | 21.4 18.7–24.4ROR 22.1 · χ² 4,094 / p <1e-300 | 21.2 EB05 18.9 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · ♀ 10% (drug 34%) · 96% clinician | no trial data cached |
| Abnormal dreams | 211 | 26.5 23.2–30.3ROR 27.4 · χ² 5,118 / p <1e-300 | 26.2 EB05 23.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.6 · 93% clinician | no trial data cached |
| Cough | 204 | 2.5 2.2–2.9ROR 2.6 · χ² 189 / p 2e-43 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Insomnia (trouble sleeping) | 196 | 2.5 2.2–2.9ROR 2.6 · χ² 185 / p 2e-42 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Eye pain | 184 | 11.6 10.0–13.4ROR 11.9 · χ² 1,767 / p <1e-300 | 11.5 EB05 10.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.4 | no trial data cached |
| Throat irritation | 180 | 14.0 12.1–16.2ROR 14.4 · χ² 2,157 / p <1e-300 | 13.9 EB05 12.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.0 | no trial data cached |
| Epistaxis (nosebleed) | 177 | 8.2 7.1–9.5ROR 8.4 · χ² 1,113 / p 2e-244 | 8.1 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Anxiety | 163 | 2.0 1.7–2.3ROR 2.0 · χ² 79 / p 3e-19 | 2.0 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Sneezing — n=740, PRR 118.6
- Rhinorrhoea — n=232, PRR 12.5
- Hepatic encephalopathy — n=29, PRR 10.8
- Lacrimation increased — n=88, PRR 10.2
- Eye discharge — n=22, PRR 7.5
- Hepatic cirrhosis — n=35, PRR 6.5
- Anger — n=57, PRR 5.8
- Ocular hyperaemia — n=76, PRR 5.6
- Hepatotoxicity — n=36, PRR 5.6
- Mood altered — n=36, PRR 4.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Varenicline (Chantix) ↔ Suicidal ideation / depression.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Varenicline?
In FDA FAERS, the most frequently co-reported reaction terms for Varenicline are sneezing, nausea, vomiting, depression, headache, rhinorrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Varenicline have an FDA boxed warning?
No. The FDA label retrieved for Varenicline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Varenicline causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 09e23664-936d-4c7f-86e5-5f924cb0c8b4, effective 20260921; matched on
openfda.generic_name.exact:"VARENICLINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 183 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.