Varenicline Tartrate side effects: what 79,553 FDA adverse event reports show

Varenicline Tartrate · 1,180 reaction terms · 244,091 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

79,553 reports · 41% serious · 1,637 with death outcome · 64% 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 10Labeled (related wording) 3Reporting / coding artifact 2Not in label — unassessed 25

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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,140 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Tobacco withdrawal symptoms	109	427.9 315.2–580.9ROR 428.5 · calibrated p 9e-13 ✓	157.6 EB05 134.3 · IC025 +6.2 3/3 methods agree	Labeled (related wording) related wording	serious n=38 · 83% consumer	not reported in cached trials
Tobacco user	793	299.5 270.5–331.7ROR 302.5 · calibrated p 1e-11 ✓	139.0 EB05 131.1 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=198 · 81% consumer	not reported in cached trials
Smoker	63	128.5 95.0–173.8ROR 128.6 · calibrated p 3e-8 ✓	84.1 EB05 68.1 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=62 · 74% consumer	not reported in cached trials
Exposure to contaminated air	19	123.1 71.3–212.5ROR 123.1 · calibrated p 2e-7 ✓	77.5 EB05 52.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Abnormal dreams	7,825	103.4 100.8–106.0ROR 114.6 · calibrated p 4e-8 ✓	74.2 EB05 72.8 · IC025 +6.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 81.3 · serious PRR 70.8 · 81% consumer	NCT01456936: 201/2,016 (10.0%) on Varenicline; 92/2,014 (4.6%) control
Hostility	419	51.3 46.2–57.0ROR 51.6 · calibrated p 1e-5 ✓	42.9 EB05 39.6 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=293 · 81% consumer	not reported in cached trials
Homicidal ideation	558	41.8 38.2–45.7ROR 42.1 · calibrated p 4e-5 ✓	36.1 EB05 33.6 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=533	not reported in cached trials
Violence-related symptom	175	33.2 28.4–38.9ROR 33.3 · calibrated p 2e-4 ✓	29.5 EB05 26.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=163	not reported in cached trials
Nightmare	3,347	28.0 27.1–29.0ROR 29.2 · calibrated p 3e-4 ✓	25.4 EB05 24.7 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 28.5 · serious PRR 23.7 · 73% consumer	not reported in cached trials
Suicidal behaviour	339	23.2 20.7–25.9ROR 23.3 · calibrated p 1e-3 ✓	21.3 EB05 19.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=332	NCT01456936: 1/2,014 (0.0%) control (serious AE)
Asthma-chronic obstructive pulmonary disease overlap syndrome	39	21.3 15.3–29.5ROR 21.3 · calibrated p 0.002 ✓	19.6 EB05 14.9 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=39 · ♀ 0% (drug 64%)	not reported in cached trials
Feeling of relaxation	49	20.1 15.0–26.9ROR 20.1 · calibrated p 0.002 ✓	18.6 EB05 14.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	100% consumer	not reported in cached trials
Anger	2,251	18.7 17.9–19.5ROR 19.2 · calibrated p 0.002 ✓	17.5 EB05 16.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 18.5 · serious PRR 26.5 · 72% consumer	not reported in cached trials
Marital problem	35	18.0 12.8–25.3ROR 18.0 · calibrated p 0.004 ✓	16.7 EB05 12.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=31 · ♀ 39% (drug 64%)	not reported in cached trials
Verbal abuse	31	17.6 12.2–25.3ROR 17.6 · calibrated p 0.005 ✓	16.3 EB05 11.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=23 · ♀ 0% (drug 64%)	not reported in cached trials
Flight of ideas	33	17.6 12.3–25.0ROR 17.6 · calibrated p 0.005 ✓	16.3 EB05 12.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=31	not reported in cached trials
Physical assault	125	16.7 13.9–20.0ROR 16.7 · calibrated p 0.005 ✓	15.7 EB05 13.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=121 · ♀ 35% (drug 64%)	not reported in cached trials
Boredom	20	16.3 10.4–25.7ROR 16.4 · calibrated p 0.007 ✓	14.9 EB05 9.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Frustration	207	15.9 13.8–18.3ROR 15.9 · calibrated p 0.006 ✓	15.0 EB05 13.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=119 · 83% consumer	not reported in cached trials
Aggression	2,768	15.3 14.8–15.9ROR 15.9 · calibrated p 0.006 ✓	14.5 EB05 14.1 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 12.9 · serious PRR 21.6	NCT01456936: 1/2,014 (0.0%) control (serious AE)
Morbid thoughts	64	15.1 11.7–19.4ROR 15.1 · calibrated p 0.008 ✓	14.2 EB05 11.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=49	not reported in cached trials
Personality change	503	14.9 13.7–16.3ROR 15.0 · calibrated p 0.007 ✓	14.2 EB05 13.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.2 · 71% consumer	not reported in cached trials
Flashback	31	14.9 10.4–21.4ROR 14.9 · calibrated p 0.009 ✓	13.8 EB05 10.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Delusional perception	22	14.6 9.5–22.4ROR 14.6 · calibrated p 0.011 ✓	13.3 EB05 8.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=21	not reported in cached trials
Oropharyngeal blistering	84	14.1 11.3–17.6ROR 14.1 · calibrated p 0.010 ✓	13.3 EB05 11.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=68 · 88% consumer	not reported in cached trials
Tobacco abuse	27	13.8 9.4–20.3ROR 13.8 · calibrated p 0.013 ✓	12.7 EB05 8.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious n=21	not reported in cached trials
Paranoia	848	13.5 12.6–14.5ROR 13.7 · calibrated p 0.010 ✓	12.9 EB05 12.2 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 10.1 · serious PRR 21.6	not reported in cached trials
Bipolar disorder	526	13.3 12.1–14.5ROR 13.3 · calibrated p 0.011 ✓	12.6 EB05 11.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.4	NCT01456936: 1/2,016 (0.0%) on Varenicline (serious AE)
Suicidal ideation (thoughts of suicide)	4,203	12.6 12.3–13.0ROR 13.3 · calibrated p 0.011 ✓	12.1 EB05 11.8 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 11.6 · serious PRR 16.9	NCT01456936: 2/2,016 (0.1%) on Varenicline; 3/2,014 (0.1%) control (serious AE)
Impatience	85	12.5 10.0–15.5ROR 12.5 · calibrated p 0.016 ✓	11.8 EB05 9.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=43 · 82% consumer	not reported in cached trials
Recalled product administered	382	11.9 10.8–13.2ROR 12.0 · calibrated p 0.017 ✓	11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=97 · 95% consumer	not reported in cached trials
Elevated mood	19	11.8 7.4–18.7ROR 11.8 · calibrated p 0.024 ✓	10.3 EB05 6.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Mood swings	1,351	11.6 11.0–12.3ROR 11.8 · calibrated p 0.018 ✓	11.2 EB05 10.7 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.4	not reported in cached trials
Abnormal behaviour	1,671	11.5 10.9–12.1ROR 11.7 · calibrated p 0.018 ✓	11.0 EB05 10.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	age-adj. PRR 13.2 · serious PRR 17.0	NCT01456936: 1/2,014 (0.0%) control (serious AE)
Thinking abnormal	765	11.2 10.4–12.0ROR 11.3 · calibrated p 0.021 ✓	10.7 EB05 10.1 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 12.1 · serious PRR 14.9 · 73% consumer	not reported in cached trials
Pre-existing condition improved	250	10.8 9.6–12.3ROR 10.9 · calibrated p 0.025 ✓	10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=33 · 82% consumer	not reported in cached trials
Personality disorder	104	10.8 8.9–13.1ROR 10.8 · calibrated p 0.026 ✓	10.2 EB05 8.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=78 · 71% consumer	NCT01456936: 1/2,014 (0.0%) control (serious AE)
Hypoaesthesia facial	60	10.8 8.3–13.9ROR 10.8 · calibrated p 0.027 ✓	10.1 EB05 8.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=40 · 70% consumer	not reported in cached trials
Sleep talking	67	10.7 8.4–13.7ROR 10.7 · calibrated p 0.027 ✓	10.1 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=26 · 76% consumer	not reported in cached trials
Alcohol use	145	10.6 9.0–12.6ROR 10.7 · calibrated p 0.027 ✓	10.1 EB05 8.8 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious n=115 · ♀ 36% (drug 64%)	NCT01456936: 1/2,016 (0.0%) on Varenicline (serious AE)

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Depression	9,838	9.59.3–9.7	signal
Suicidality	7,065	7.87.6–8.0	signal
Seizure	931	1.31.2–1.3	raised
Dependence / withdrawal	930	0.80.8–0.9	lower than other drugs
Myocardial infarction	637	0.80.8–0.9	lower than other drugs
Hyperglycaemia / diabetes	1,016	0.80.7–0.8	lower than other drugs
Stroke	571	0.60.6–0.7	lower than other drugs
Fall / fracture	852	0.60.6–0.6	lower than other drugs
Extrapyramidal	213	0.50.5–0.6	lower than other drugs
Pancreatitis	160	0.50.4–0.6	lower than other drugs
Hyponatraemia	145	0.50.4–0.6	lower than other drugs
Hypoglycaemia	166	0.50.4–0.5	lower than other drugs
Venous thromboembolism	321	0.40.3–0.4	lower than other drugs
Malignancy	555	0.40.4–0.4	lower than other drugs
Gi bleeding	265	0.40.3–0.4	lower than other drugs
Serious infection	995	0.30.3–0.4	lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Varenicline as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (8 of 40 signal terms matched).

NCT01456936 — Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With A (N=8144, PHASE4; 153 AE terms posted; arms: Varenicline 1.0 mg BID; Bupropion; NRT Patch; Placebo)
NCT01574703 — Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subje (N=4595, PHASE4; 135 AE terms posted; arms: Varenicline; Bupropion; NRT Patch; Placebo)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Nausea	14,464	4.9 4.8–5.0ROR 5.8 · calibrated p 0.165	4.8 EB05 4.8 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.0 · serious PRR 2.8 · 79% consumer	NCT01456936: 511/2,016 (25.3%) on Varenicline; 137/2,014 (6.8%) control
Depression	8,678	10.4 10.2–10.6ROR 11.5 · calibrated p 0.019 ✓	10.0 EB05 9.8 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 7.8 · serious PRR 15.0	NCT01456936: 1/2,016 (0.0%) on Varenicline (serious AE)
Abnormal dreams	7,825	103.4 100.8–106.0ROR 114.6 · calibrated p 4e-8 ✓	74.2 EB05 72.8 · IC025 +6.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 81.3 · serious PRR 70.8 · 81% consumer	NCT01456936: 201/2,016 (10.0%) on Varenicline; 92/2,014 (4.6%) control
Anxiety	5,948	5.6 5.5–5.7ROR 6.0 · calibrated p 0.152	5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.9 · serious PRR 8.4	NCT01456936: 2/2,022 (0.1%) on Varenicline (serious AE)
Drug ineffective (drug did not work)	5,649	1.1 1.1–1.2ROR 1.1 · calibrated p 0.400	1.1 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	age-adj. PRR 1.5 · serious PRR 0.9 · 84% consumer	not reported in cached trials
Insomnia (trouble sleeping)	5,572	5.6 5.5–5.7ROR 5.9 · calibrated p 0.153	5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.9 · serious PRR 5.9 · 77% consumer	NCT01456936: 189/2,016 (9.4%) on Varenicline; 139/2,014 (6.9%) control
Vomiting	4,598	2.6 2.5–2.7ROR 2.7 · calibrated p 0.732	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 1.6 · 76% consumer	not reported in cached trials
Suicidal ideation (thoughts of suicide)	4,203	12.6 12.3–13.0ROR 13.3 · calibrated p 0.011 ✓	12.1 EB05 11.8 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 11.6 · serious PRR 16.9	NCT01456936: 2/2,016 (0.1%) on Varenicline; 3/2,014 (0.1%) control (serious AE)
Headache	4,150	1.8 1.7–1.8ROR 1.8 · calibrated p 0.826	1.7 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.8 · 76% consumer	NCT01456936: 245/2,016 (12.2%) on Varenicline; 199/2,014 (9.9%) control
Feeling abnormal	3,990	4.4 4.3–4.6ROR 4.6 · calibrated p 0.281	4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.2 · serious PRR 5.5 · 77% consumer	not reported in cached trials
Malaise (feeling unwell)	3,989	2.4 2.3–2.5ROR 2.5 · calibrated p 0.822	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 1.7 · 84% consumer	not reported in cached trials
Nightmare	3,347	28.0 27.1–29.0ROR 29.2 · calibrated p 3e-4 ✓	25.4 EB05 24.7 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 28.5 · serious PRR 23.7 · 73% consumer	not reported in cached trials
Fatigue (tiredness)	3,174	1.1 1.0–1.1ROR 1.1 · calibrated p 0.360	1.1 EB05 1.0 · IC025 +0.0	Labeled adverse reaction exact term	age-adj. PRR 0.9 · serious PRR 1.1 · 75% consumer	NCT01456936: 124/2,016 (6.2%) on Varenicline; 83/2,014 (4.1%) control
Dizziness	3,032	1.6 1.6–1.7ROR 1.6 · calibrated p 0.727	1.6 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.8 · 73% consumer	NCT01456936: 1/2,022 (0.0%) on Varenicline (serious AE)
Aggression	2,768	15.3 14.8–15.9ROR 15.9 · calibrated p 0.006 ✓	14.5 EB05 14.1 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 12.9 · serious PRR 21.6	NCT01456936: 1/2,014 (0.0%) control (serious AE)

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.

Tobacco user — n=793, PRR 299.5
Violence-related symptom — n=175, PRR 33.2
Suicidal behaviour — n=339, PRR 23.2 (also seen in trial arm)
Feeling of relaxation — n=49, PRR 20.1
Anger — n=2,251, PRR 18.7
Marital problem — n=35, PRR 18.0
Flight of ideas — n=33, PRR 17.6
Physical assault — n=125, PRR 16.7
Boredom — n=20, PRR 16.3
Frustration — n=207, PRR 15.9

✓ 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 nausea, depression, abnormal dreams, anxiety, insomnia, vomiting. 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, field patient.drug.openfda.generic_name.exact, 1,180 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
ClinicalTrials.gov API v2 (query VARENICLINE, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.