Tofacitinib side effects: what 183,399 FDA adverse event reports show
Drug class
Not stated in label
Who reports
183,399 reports · 48% serious · 9,244 with death outcome · 80% female
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.
What it is
Tofacitinib is a pyrrolopyrimidine that is pyrrolo[2,3-d]pyrimidine substituted at position 4 by an N-methyl,N-(1-cyanoacetyl-4-methylpiperidin-3-yl)amino moiety.
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.
Causality screen of the 40 strongest signals
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). 1,220 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Synovial fluid analysis | 79 | 1,262.0 582.6–2,733.7ROR 1,262.6 · calibrated p 1e-14 ✓ | 101.2 EB05 83.8 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=79 · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 5,287 | 342.1 324.1–361.2ROR 352.3 · calibrated p 2e-12 ✓ | 85.0 EB05 83.1 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious PRR 102.1 · 92% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 470 | 278.1 234.9–329.2ROR 278.8 · calibrated p 3e-11 ✓ | 80.2 EB05 74.3 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=468 · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 2,192 | 276.3 255.6–298.7ROR 279.7 · calibrated p 2e-11 ✓ | 80.3 EB05 77.5 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=2,190 · 95% clinician | not reported in cached trials |
| Rheumatoid factor negative | 122 | 257.4 186.5–355.3ROR 257.6 · calibrated p 1e-10 ✓ | 77.7 EB05 66.8 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=121 · ♀ 0% (drug 80%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 3,937 | 250.4 236.8–264.9ROR 255.9 · calibrated p 4e-11 ✓ | 78.0 EB05 75.9 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=3,929 · 92% clinician | not reported in cached trials |
| Rheumatic fever | 2,897 | 228.9 214.9–243.9ROR 232.6 · calibrated p 1e-10 ✓ | 75.8 EB05 73.5 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=2,896 · 95% clinician | not reported in cached trials |
| Lupus vulgaris | 731 | 184.1 163.6–207.1ROR 184.8 · calibrated p 9e-10 ✓ | 70.1 EB05 65.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=731 · 97% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 4,332 | 166.2 158.7–174.2ROR 170.2 · calibrated p 2e-9 ✓ | 67.4 EB05 65.8 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 80.8 · 94% clinician | not reported in cached trials |
| Hepatic enzyme | 81 | 158.9 113.2–223.0ROR 159.0 · calibrated p 7e-9 ✓ | 65.2 EB05 54.2 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=80 · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,125 | 155.1 141.7–169.8ROR 156.1 · calibrated p 3e-9 ✓ | 65.5 EB05 62.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=1,125 · 94% clinician | not reported in cached trials |
| C-reactive protein | 518 | 153.2 134.2–175.0ROR 153.7 · calibrated p 4e-9 ✓ | 65.1 EB05 60.5 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=518 · 95% clinician | NCT01932372: 3/7,021 (0.0%) on Tofacitinib (serious AE) |
| Hand deformity | 7,050 | 134.5 129.9–139.2ROR 139.8 · calibrated p 8e-9 ✓ | 61.6 EB05 60.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 77.9 | not reported in cached trials |
| Granuloma skin | 445 | 133.4 116.3–153.1ROR 133.7 · calibrated p 1e-8 ✓ | 61.2 EB05 56.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=443 | not reported in cached trials |
| Synovitis | 9,435 | 125.9 122.3–129.7ROR 132.7 · calibrated p 1e-8 ✓ | 59.8 EB05 58.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 71.6 | NCT01932372: 1/7,021 (0.0%) on Tofacitinib (serious AE) |
| Swollen joint count | 128 | 124.5 96.8–160.1ROR 124.6 · calibrated p 3e-8 ✓ | 58.9 EB05 50.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=128 · 100% clinician | not reported in cached trials |
| Pemphigus | 6,427 | 123.0 118.8–127.4ROR 127.4 · calibrated p 2e-8 ✓ | 59.1 EB05 57.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 71.1 · 93% clinician | NCT01932372: 1/7,021 (0.0%) on Tofacitinib (serious AE) |
| Red blood cell sedimentation rate | 143 | 118.5 93.6–149.9ROR 118.5 · calibrated p 5e-8 ✓ | 57.6 EB05 50.1 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=143 · 100% clinician | not reported in cached trials |
| C-reactive protein abnormal | 3,219 | 115.9 110.4–121.8ROR 118.0 · calibrated p 3e-8 ✓ | 57.4 EB05 55.8 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=3,209 | NCT01932372: 3/7,021 (0.0%) on Tofacitinib (serious AE) |
| Facet joint syndrome | 1,570 | 113.9 106.1–122.1ROR 114.8 · calibrated p 4e-8 ✓ | 56.9 EB05 54.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=1,569 · 95% clinician | not reported in cached trials |
| X-ray abnormal | 817 | 96.7 88.0–106.2ROR 97.1 · calibrated p 1e-7 ✓ | 52.3 EB05 49.3 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=814 · 96% clinician | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 1,051 | 94.3 86.9–102.4ROR 94.9 · calibrated p 2e-7 ✓ | 51.6 EB05 49.0 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=1,040 | not reported in cached trials |
| Helicobacter infection | 4,568 | 93.0 89.4–96.7ROR 95.3 · calibrated p 2e-7 ✓ | 51.2 EB05 50.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 64.7 · 93% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 879 | 88.5 81.0–96.6ROR 88.9 · calibrated p 3e-7 ✓ | 49.8 EB05 47.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=877 · 96% clinician | not reported in cached trials |
| Dislocation of vertebra | 941 | 83.8 77.1–91.2ROR 84.3 · calibrated p 4e-7 ✓ | 48.3 EB05 45.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=941 · 94% clinician | NCT01932372: 2/7,021 (0.0%) on Tofacitinib (serious AE) |
| Grip strength | 97 | 82.2 63.2–106.8ROR 82.2 · calibrated p 7e-7 ✓ | 47.4 EB05 40.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=96 · 100% clinician | not reported in cached trials |
| Muscle injury | 3,301 | 76.9 73.6–80.4ROR 78.3 · calibrated p 7e-7 ✓ | 46.0 EB05 44.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 59.6 · 94% clinician | not reported in cached trials |
| Anticipatory anxiety | 108 | 76.0 59.5–97.0ROR 76.0 · calibrated p 1e-6 ✓ | 45.3 EB05 38.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=108 | not reported in cached trials |
| Subcutaneous drug absorption impaired | 217 | 75.6 63.6–89.8ROR 75.7 · calibrated p 1e-6 ✓ | 45.3 EB05 40.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=217 · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,554 | 75.1 71.5–79.0ROR 76.2 · calibrated p 8e-7 ✓ | 45.3 EB05 43.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=2,533 · 93% clinician | not reported in cached trials |
| Joint laxity | 116 | 70.9 56.2–89.4ROR 70.9 · calibrated p 2e-6 ✓ | 43.5 EB05 37.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=115 · 100% clinician | not reported in cached trials |
| Bone erosion | 1,294 | 65.7 61.3–70.3ROR 66.1 · calibrated p 2e-6 ✓ | 41.7 EB05 39.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=1,271 | not reported in cached trials |
| Retinitis | 604 | 64.7 58.5–71.5ROR 64.9 · calibrated p 3e-6 ✓ | 41.3 EB05 38.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=604 · 97% clinician | NCT01932372: 2/7,021 (0.0%) on Tofacitinib (serious AE) |
| Folliculitis | 3,673 | 63.0 60.5–65.6ROR 64.2 · calibrated p 3e-6 ✓ | 40.6 EB05 39.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 56.8 · 94% clinician | not reported in cached trials |
| Discouragement | 808 | 61.3 56.2–66.7ROR 61.5 · calibrated p 4e-6 ✓ | 39.9 EB05 37.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=237 | not reported in cached trials |
| Hypocholesterolaemia | 102 | 56.5 44.5–71.6ROR 56.5 · calibrated p 8e-6 ✓ | 37.6 EB05 31.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=102 · 100% clinician | not reported in cached trials |
| Pericarditis | 5,482 | 55.9 54.1–57.7ROR 57.6 · calibrated p 5e-6 ✓ | 37.6 EB05 36.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 45.4 · 93% clinician | NCT01932372: 1/7,021 (0.0%) on Tofacitinib (serious AE) |
| Seronegative arthritis | 368 | 55.6 49.1–63.0ROR 55.7 · calibrated p 7e-6 ✓ | 37.4 EB05 34.3 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=365 · 94% clinician | not reported in cached trials |
| Peripheral venous disease | 1,297 | 54.8 51.3–58.6ROR 55.2 · calibrated p 7e-6 ✓ | 37.1 EB05 35.4 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1,291 · 94% clinician | not reported in cached trials |
| Blood parathyroid hormone decreased | 473 | 52.9 47.5–59.1ROR 53.1 · calibrated p 1e-5 ✓ | 36.2 EB05 33.5 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=473 | 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 |
|---|---|---|---|
| Opportunistic infection | 5,219 | 4.54.4–4.6 | signal |
| Liver injury | 11,092 | 4.34.2–4.4 | signal |
| Interstitial lung disease | 3,182 | 3.93.8–4.0 | signal |
| Serious infection | 17,504 | 2.62.6–2.7 | signal |
| Tendon disorder | 747 | 2.32.1–2.4 | signal |
| Depression | 5,352 | 2.22.1–2.3 | signal |
| Hyperglycaemia / diabetes | 5,074 | 1.71.6–1.7 | raised |
| Fall / fracture | 5,132 | 1.51.5–1.6 | raised |
| Venous thromboembolism | 2,473 | 1.31.3–1.4 | raised |
| Malignancy | 3,514 | 1.11.0–1.1 | raised |
| Anaphylaxis / angioedema | 921 | 0.80.8–0.9 | lower than other drugs |
| Pancreatitis | 563 | 0.80.7–0.9 | lower than other drugs |
| Anaemia | 2,057 | 0.80.7–0.8 | lower than other drugs |
| Gi bleeding | 1,245 | 0.80.7–0.8 | lower than other drugs |
| Myocardial infarction | 1,256 | 0.70.7–0.7 | lower than other drugs |
| Stroke | 1,447 | 0.70.6–0.7 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Tofacitinib 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) | 43,848 | 3.9 3.9–3.9ROR 4.8 · calibrated p 0.255 | 3.8 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.0 · serious PRR 7.8 | not reported in cached trials |
| Pain | 26,023 | 5.0 5.0–5.1ROR 5.7 · calibrated p 0.173 | 4.8 EB05 4.8 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.9 · serious PRR 5.9 | NCT01932372: 2/7,021 (0.0%) on Tofacitinib (serious AE) |
| Arthralgia (joint pain) | 19,961 | 5.7 5.7–5.8ROR 6.3 · calibrated p 0.131 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.5 · serious PRR 8.3 | NCT01932372: 11/7,021 (0.2%) on Tofacitinib (serious AE) |
| Condition aggravated | 19,696 | 7.9 7.8–8.0ROR 8.7 · calibrated p 0.050 | 7.5 EB05 7.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.2 · serious PRR 8.7 | not reported in cached trials |
| Rheumatoid arthritis | 19,090 | 23.1 22.7–23.4ROR 25.6 · calibrated p 6e-4 ✓ | 19.3 EB05 19.1 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 16.9 · serious PRR 27.9 | NCT01932372: 48/7,021 (0.7%) on Tofacitinib (serious AE) |
| Fatigue (tiredness) | 16,848 | 2.5 2.5–2.5ROR 2.7 · calibrated p 0.745 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 4.1 | not reported in cached trials |
| Off label use (used outside approved label) | 15,125 | 2.0 2.0–2.0ROR 2.1 · calibrated p 0.998 | 2.0 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | age-adj. PRR 1.8 · serious PRR 3.3 | not reported in cached trials |
| Joint swelling | 14,712 | 15.8 15.5–16.1ROR 17.1 · calibrated p 0.004 ✓ | 14.0 EB05 13.8 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 10.8 · serious PRR 23.7 | NCT01932372: 1/7,021 (0.0%) on Tofacitinib (serious AE) |
| Headache | 13,624 | 2.5 2.5–2.6ROR 2.6 · calibrated p 0.754 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 3.6 | NCT01932372: 1/7,021 (0.0%) on Tofacitinib (serious AE) |
| Rash | 12,191 | 3.3 3.2–3.3ROR 3.4 · calibrated p 0.499 | 3.2 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.5 · serious PRR 7.1 | NCT01932372: 2/7,021 (0.0%) on Tofacitinib (serious AE) |
| Drug intolerance | 11,940 | 16.1 15.8–16.4ROR 17.1 · calibrated p 0.004 ✓ | 14.2 EB05 14.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 13.3 · serious PRR 26.5 | not reported in cached trials |
| Malaise (feeling unwell) | 10,710 | 2.8 2.8–2.9ROR 2.9 · calibrated p 0.644 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.8 · serious PRR 3.6 | NCT01932372: 2/7,021 (0.0%) on Tofacitinib (serious AE) |
| Pain in extremity | 10,414 | 4.1 4.1–4.2ROR 4.3 · calibrated p 0.321 | 4.0 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.4 · serious PRR 5.4 | NCT01932372: 5/7,021 (0.1%) on Tofacitinib (serious AE) |
| Abdominal discomfort | 10,362 | 7.5 7.4–7.6ROR 7.9 · calibrated p 0.069 | 7.1 EB05 7.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.7 · serious PRR 15.8 | NCT01932372: 1/7,021 (0.0%) on Tofacitinib (serious AE) |
| Nausea | 10,152 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.645 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 2.4 | NCT01932372: 2/7,021 (0.0%) on Tofacitinib (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.
- Lupus vulgaris — n=731, PRR 184.1
- Deep vein thrombosis postoperative — n=1,125, PRR 155.1
- Hand deformity — n=7,050, PRR 134.5
- Granuloma skin — n=445, PRR 133.4
- Synovitis — n=9,435, PRR 125.9 (also seen in trial arm)
- Swollen joint count — n=128, PRR 124.5
- Pemphigus — n=6,427, PRR 123.0 (also seen in trial arm)
- Facet joint syndrome — n=1,570, PRR 113.9
- Helicobacter infection — n=4,568, PRR 93.0
- Adjustment disorder with depressed mood — n=879, PRR 88.5
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Tofacitinib are pain, arthralgia, rheumatoid arthritis, fatigue, joint swelling, headache. 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 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 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 9926791 description (ChEBI)
- 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, 1,260 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.