Tofacitinib Citrate side effects: what 13,034 FDA adverse event reports show

Tofacitinib Citrate · 1,018 reaction terms · 266,252 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

13,034 reports · 94% serious · 3,465 with death outcome · 80% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.

FDA label, Indications and Usage

What it is

Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1).

FDA label, Description section

Boxed warning

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fung.

FDA 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 (related wording) 3Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 9Not in label — unassessed 23

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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, 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). 978 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
Hepatic enzyme	74	1,834.5 1,313.4–2,562.3ROR 1,845.0 · calibrated p 1e-19 ✓	696.8 EB05 573.5 · IC025 +6.6 3/3 methods agree	Labeled (related wording) related wording	serious n=74 · 100% clinician	not reported in cached trials
Thiopurine methyltransferase decreased	18	1,784.9 910.4–3,499.4ROR 1,787.4 · calibrated p 5e-17 ✓	443.1 EB05 296.5 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=18	not reported in cached trials
Lupus vulgaris	549	1,391.4 1,242.4–1,558.4ROR 1,452.6 · calibrated p 3e-19 ✓	722.9 EB05 673.6 · IC025 +8.7 3/3 methods agree	Not in label — unassessed	serious n=549 · 97% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	293	1,270.1 1,090.3–1,479.7ROR 1,299.3 · calibrated p 2e-18 ✓	674.5 EB05 612.2 · IC025 +8.1 3/3 methods agree	Lab value / disease marker	serious n=293 · 94% clinician	not reported in cached trials
Synovial fluid analysis	36	1,142.3 744.5–1,752.7ROR 1,145.5 · calibrated p 1e-16 ✓	490.5 EB05 370.2 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious n=36 · 100% clinician	not reported in cached trials
Swollen joint count increased	1,240	1,069.8 997.5–1,147.3ROR 1,182.2 · calibrated p 4e-18 ✓	633.1 EB05 604.1 · IC025 +8.9 3/3 methods agree	Lab value / disease marker	serious n=1,240 · 94% clinician	not reported in cached trials
Rheumatic fever	1,627	961.4 906.2–1,020.0ROR 1,098.4 · calibrated p 8e-18 ✓	594.8 EB05 570.9 · IC025 +8.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,627 · 94% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	2,521	890.0 850.3–931.6ROR 1,103.2 · calibrated p 8e-18 ✓	568.1 EB05 549.7 · IC025 +8.9 3/3 methods agree	Lab value / disease marker	serious PRR 348.9 · 93% clinician	not reported in cached trials
Rheumatoid factor positive	2,033	880.8 836.7–927.3ROR 1,043.4 · calibrated p 2e-17 ✓	563.7 EB05 543.4 · IC025 +8.9 3/3 methods agree	Lab value / disease marker	serious n=2,033 · 93% clinician	not reported in cached trials
Swollen joint count	82	808.1 619.7–1,053.7ROR 813.2 · calibrated p 8e-16 ✓	476.0 EB05 395.6 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=82 · 95% clinician	not reported in cached trials
Deep vein thrombosis postoperative	638	779.9 710.5–856.0ROR 819.9 · calibrated p 3e-16 ✓	515.1 EB05 482.4 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious n=638 · 95% clinician	not reported in cached trials
Angiolymphoid hyperplasia with eosinophilia	11	758.8 370.0–1,556.3ROR 759.4 · calibrated p 5e-13 ✓	271.5 EB05 161.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Hypocholesterolaemia	97	743.5 584.5–945.7ROR 749.0 · calibrated p 2e-15 ✓	460.4 EB05 388.5 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=97 · 97% clinician	not reported in cached trials
Duodenal ulcer perforation	2,044	623.4 594.1–654.2ROR 739.2 · calibrated p 8e-16 ✓	446.0 EB05 430.0 · IC025 +8.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 272.6 · 93% clinician	not reported in cached trials
Adjustment disorder with depressed mood	549	604.5 548.7–665.9ROR 631.0 · calibrated p 5e-15 ✓	431.4 EB05 401.9 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious n=549 · 95% clinician	not reported in cached trials
Dislocation of vertebra	593	586.9 535.0–643.9ROR 614.9 · calibrated p 7e-15 ✓	422.8 EB05 395.0 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious n=593 · 94% clinician	NCT01932372: 2/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Facet joint syndrome	830	577.1 534.0–623.6ROR 616.2 · calibrated p 6e-15 ✓	419.3 EB05 395.9 · IC025 +8.3 3/3 methods agree	Not in label — unassessed	serious n=830 · 95% clinician	not reported in cached trials
X-ray abnormal	441	529.7 476.2–589.1ROR 548.2 · calibrated p 2e-14 ✓	390.6 EB05 360.9 · IC025 +7.9 3/3 methods agree	Lab value / disease marker	serious n=441 · 97% clinician	not reported in cached trials
Pemphigus	2,940	500.0 481.4–519.2ROR 645.3 · calibrated p 4e-15 ✓	379.5 EB05 368.1 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious PRR 232.5 · 92% clinician	NCT01932372: 1/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Hand deformity	2,984	476.8 459.4–494.9ROR 618.1 · calibrated p 6e-15 ✓	366.0 EB05 355.1 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious PRR 243.2 · 92% clinician	not reported in cached trials
C-reactive protein	206	473.7 405.8–552.9ROR 481.3 · calibrated p 1e-13 ✓	353.0 EB05 314.4 · IC025 +7.4 3/3 methods agree	Lab value / disease marker	serious n=206 · 93% clinician	NCT01932372: 3/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Grip strength	51	454.6 333.1–620.3ROR 456.4 · calibrated p 5e-13 ✓	312.1 EB05 246.6 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=51 · 98% clinician	not reported in cached trials
Retinitis	367	454.6 405.3–509.8ROR 467.7 · calibrated p 1e-13 ✓	347.1 EB05 318.3 · IC025 +7.7 3/3 methods agree	Not in label — unassessed	serious n=367 · 96% clinician	NCT01932372: 2/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Seronegative arthritis	229	413.3 357.8–477.6ROR 420.7 · calibrated p 4e-13 ✓	319.4 EB05 286.1 · IC025 +7.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=229 · 94% clinician	not reported in cached trials
Helicobacter infection	2,079	413.2 395.0–432.3ROR 491.4 · calibrated p 7e-14 ✓	327.0 EB05 315.4 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious PRR 211.3 · 94% clinician	not reported in cached trials
Short stature	52	400.5 295.6–542.6ROR 402.1 · calibrated p 2e-12 ✓	286.3 EB05 226.7 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=52 · ♀ 46% (drug 80%) · 92% clinician	not reported in cached trials
Peripheral venous disease	752	374.0 346.1–404.2ROR 396.9 · calibrated p 6e-13 ✓	300.5 EB05 282.9 · IC025 +7.9 3/3 methods agree	Labeled (related wording) related wording	serious n=752 · 96% clinician	not reported in cached trials
Intestinal intraepithelial lymphocytes increased	12	366.1 195.5–685.7ROR 366.5 · calibrated p 9e-11 ✓	202.3 EB05 123.3 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=12	not reported in cached trials
Synovitis	3,105	335.0 323.5–346.8ROR 439.4 · calibrated p 2e-13 ✓	276.3 EB05 268.2 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious PRR 176.5 · 93% clinician	NCT01932372: 1/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Pericarditis	2,654	305.3 294.0–317.1ROR 383.1 · calibrated p 9e-13 ✓	255.7 EB05 247.7 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious PRR 157.4 · 93% clinician	NCT01932372: 1/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Muscle injury	1,282	298.3 281.7–315.8ROR 330.7 · calibrated p 4e-12 ✓	250.3 EB05 239.0 · IC025 +7.7 3/3 methods agree	Not in label — unassessed	serious PRR 165.9 · 96% clinician	not reported in cached trials
Drug tolerance decreased	412	277.9 250.7–308.2ROR 287.0 · calibrated p 2e-11 ✓	234.1 EB05 215.7 · IC025 +7.4 3/3 methods agree	Likely indication confounding term in indications	serious n=412 · 94% clinician	not reported in cached trials
Microvillous inclusion disease	11	272.7 143.9–516.9ROR 272.9 · calibrated p 1e-9 ✓	166.3 EB05 99.1 · IC025 +3.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	not reported in cached trials
Acquired porphyria	10	264.4 135.4–516.4ROR 264.6 · calibrated p 2e-9 ✓	158.8 EB05 92.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Folliculitis	1,439	260.7 247.3–275.0ROR 293.0 · calibrated p 1e-11 ✓	223.4 EB05 213.9 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 160.4 · 95% clinician	not reported in cached trials
C-reactive protein abnormal	888	259.2 241.9–277.6ROR 278.1 · calibrated p 2e-11 ✓	221.9 EB05 209.9 · IC025 +7.5 3/3 methods agree	Lab value / disease marker	serious n=888 · 92% clinician	NCT01932372: 3/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Glossodynia (burning tongue/mouth pain)	2,973	247.1 238.7–255.8ROR 319.8 · calibrated p 5e-12 ✓	213.6 EB05 207.3 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 188.8 · 92% clinician	not reported in cached trials
Overlap syndrome	91	244.7 196.4–305.0ROR 246.4 · calibrated p 1e-10 ✓	203.1 EB05 170.5 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=91 · 92% clinician	not reported in cached trials
Breast cancer stage iii	819	234.9 218.7–252.3ROR 250.6 · calibrated p 5e-11 ✓	203.8 EB05 192.3 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious n=819 · 95% clinician	not reported in cached trials
Porphyria acute	164	217.0 184.5–255.3ROR 219.8 · calibrated p 2e-10 ✓	186.9 EB05 164.1 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=164 · 96% clinician	not reported in cached trials

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
Liver injury	3,723	20.119.6–20.7	signal
Interstitial lung disease	960	16.315.3–17.3	signal
Hyperglycaemia / diabetes	2,034	9.59.1–9.9	signal
Depression	1,185	6.86.4–7.2	signal
Serious infection	2,716	5.75.5–5.9	signal
Anaphylaxis / angioedema	303	3.93.5–4.4	signal
Pancreatitis	182	3.63.1–4.2	signal
Gi bleeding	340	3.02.7–3.3	signal
Opportunistic infection	249	2.92.6–3.3	signal
Venous thromboembolism	318	2.42.1–2.6	signal
Rhabdomyolysis / myopathy	117	2.31.9–2.8	raised
Tendon disorder	45	1.91.4–2.5	raised
Malignancy	388	1.71.5–1.8	raised
Kidney injury	394	1.41.3–1.5	raised
Fall / fracture	301	1.31.1–1.4	raised
Suicidality	181	1.21.0–1.4	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Tofacitinib Citrate 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 (7 of 40 signal terms matched).

NCT01932372 — Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis (N=9968, phase n/a; 608 AE terms posted; arms: XELJANZ (Safety Analysis Set); XELJANZ (MTX Adherent Comparative Safety; Control (MTX Adherent Comparative Safety)

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
Drug ineffective (drug did not work)	5,216	6.4 6.3–6.5ROR 10.0 · calibrated p 0.032 ✓	6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 6.8 · serious PRR 10.7	not reported in cached trials
Rheumatoid arthritis	3,950	58.2 56.7–59.8ROR 83.1 · calibrated p 4e-7 ✓	56.2 EB05 54.7 · IC025 +5.7 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 44.1 · serious PRR 41.8	NCT01932372: 48/7,021 (0.7%) on Tofacitinib Citrate (serious AE)
Off label use (used outside approved label)	3,888	7.2 7.0–7.4ROR 9.9 · calibrated p 0.034 ✓	7.2 EB05 7.0 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 7.0 · serious PRR 7.9 · 93% clinician	not reported in cached trials
Pain	3,589	9.4 9.2–9.7ROR 12.6 · calibrated p 0.014 ✓	9.4 EB05 9.1 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 8.0 · serious PRR 9.0	NCT01932372: 2/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Drug intolerance	3,505	60.8 59.1–62.6ROR 82.8 · calibrated p 5e-7 ✓	58.6 EB05 57.0 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 57.1 · serious PRR 58.0	not reported in cached trials
Fatigue (tiredness)	3,404	7.1 6.9–7.3ROR 9.2 · calibrated p 0.042 ✓	7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 5.6 · serious PRR 8.2 · 90% clinician	not reported in cached trials
Rash	3,379	12.6 12.3–13.0ROR 16.7 · calibrated p 0.004 ✓	12.5 EB05 12.2 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 10.3 · serious PRR 17.0 · 91% clinician	NCT01932372: 2/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Joint swelling	3,264	44.8 43.5–46.2ROR 59.4 · calibrated p 4e-6 ✓	43.6 EB05 42.3 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 34.2 · serious PRR 45.7 · 91% clinician	NCT01932372: 1/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Synovitis	3,105	335.0 323.5–346.8ROR 439.4 · calibrated p 2e-13 ✓	276.3 EB05 268.2 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious PRR 176.5 · 93% clinician	NCT01932372: 1/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Systemic lupus erythematosus	3,032	150.9 146.0–156.0ROR 196.3 · calibrated p 5e-10 ✓	137.8 EB05 133.7 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 119.4 · serious PRR 86.2 · 91% clinician	NCT01932372: 4/7,021 (0.1%) on Tofacitinib Citrate (serious AE)
Abdominal discomfort	2,995	29.3 28.4–30.3ROR 37.8 · calibrated p 7e-5 ✓	28.8 EB05 28.0 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 24.3 · serious PRR 39.4 · 91% clinician	NCT01932372: 1/7,021 (0.0%) on Tofacitinib Citrate (serious AE)
Condition aggravated	2,994	16.1 15.6–16.6ROR 20.6 · calibrated p 0.002 ✓	15.9 EB05 15.5 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 12.9 · serious PRR 14.7 · 92% clinician	not reported in cached trials
Hand deformity	2,984	476.8 459.4–494.9ROR 618.1 · calibrated p 6e-15 ✓	366.0 EB05 355.1 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious PRR 243.2 · 92% clinician	not reported in cached trials
Alopecia (hair loss)	2,973	24.7 23.9–25.5ROR 31.7 · calibrated p 2e-4 ✓	24.3 EB05 23.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	age-adj. PRR 19.3 · serious PRR 31.6 · 91% clinician	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	2,973	247.1 238.7–255.8ROR 319.8 · calibrated p 5e-12 ✓	213.6 EB05 207.3 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious PRR 188.8 · 92% clinician	not reported in cached trials

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.

Lupus vulgaris — n=549, PRR 1,391.4
Swollen joint count — n=82, PRR 808.1
Deep vein thrombosis postoperative — n=638, PRR 779.9
Hypocholesterolaemia — n=97, PRR 743.5
Adjustment disorder with depressed mood — n=549, PRR 604.5
Dislocation of vertebra — n=593, PRR 586.9 (also seen in trial arm)
Facet joint syndrome — n=830, PRR 577.1
Pemphigus — n=2,940, PRR 500.0 (also seen in trial arm)
Hand deformity — n=2,984, PRR 476.8
Grip strength — n=51, PRR 454.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tofacitinib ↔ Arthralgia.

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 Tofacitinib Citrate?

In FDA FAERS, the most frequently co-reported reaction terms for Tofacitinib Citrate are rheumatoid arthritis, pain, fatigue, rash, joint swelling, synovitis. 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 Tofacitinib Citrate have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with tofacitinib tablets are at increased risk for developing serious bacterial, fung.

Do FAERS signals prove that Tofacitinib Citrate 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 253635c8-1ea7-41ba-b216-dea5e3305c47, effective 20260901; matched on openfda.generic_name.exact:"TOFACITINIB")
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, 1,018 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 TOFACITINIB, 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.