Upadacitinib side effects: what 81,026 FDA adverse event reports show

Upadacitinib · Rinvoq · 1,236 reaction terms · 228,813 drug–reaction co-reports · data 2026-09-14

Drug class

Janus Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Rinvoq

openFDA label

Who reports

81,026 reports · 68% serious · 3,016 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.1 ) Limitati.

FDA label, Indications and Usage

What it is

RINVOQ and RINVOQ LQ are formulated with upadacitinib, a JAK inhibitor. Upadacitinib has the following chemical name: (3 S ,4 R )-3-Ethyl-4-(3 H -imidazo[1,2- a ]pyrrolo[2,3- e ]pyrazin-8-yl)- N -(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate (2:1).

FDA label, Description section

Boxed warning

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )].

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 adverse reaction 2Labeled (related wording) 2Reporting / coding artifact 12Not in label — unassessed 24

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). 1,196 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
Ostomy bag placement	130	112.5 91.5–138.2ROR 112.6 · calibrated p 6e-8 ✓	77.4 EB05 66.9 · IC025 +5.6 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=130 · ♀ 50% (drug 70%) · 75% consumer	not reported in cached trials
Semen discolouration	81	94.9 73.6–122.5ROR 95.0 · calibrated p 3e-7 ✓	68.3 EB05 56.7 · IC025 +5.2 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	♀ 0% (drug 70%)	not reported in cached trials
Subcutaneous drug absorption impaired	105	61.7 49.8–76.3ROR 61.8 · calibrated p 4e-6 ✓	49.4 EB05 42.0 · IC025 +5.0 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=105 · ♀ 100% (drug 70%) · 100% clinician	not reported in cached trials
Stoma creation	125	59.0 48.6–71.6ROR 59.1 · calibrated p 6e-6 ✓	47.7 EB05 41.1 · IC025 +5.0 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=124 · 72% consumer	not reported in cached trials
Eczema herpeticum	83	57.7 45.5–73.2ROR 57.7 · calibrated p 7e-6 ✓	46.7 EB05 38.9 · IC025 +4.8 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 423.9 (236.4–760.1)	Labeled adverse reaction exact term	serious n=56 · ♀ 39% (drug 70%)	not reported in cached trials
Epidural injection	31	48.7 33.1–71.5ROR 48.7 · calibrated p 3e-5 ✓	40.1 EB05 29.6 · IC025 +4.0 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=31 · 100% consumer	not reported in cached trials
Ileocaecal resection	48	43.6 32.1–59.2ROR 43.6 · calibrated p 5e-5 ✓	36.9 EB05 28.9 · IC025 +4.3 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=48 · ♀ 45% (drug 70%) · 100% clinician	not reported in cached trials
Intestinal anastomosis	81	38.2 30.3–48.3ROR 38.3 · calibrated p 8e-5 ✓	33.1 EB05 27.5 · IC025 +4.4 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=81 · ♀ 48% (drug 70%)	not reported in cached trials
Ileostomy	288	33.2 29.4–37.6ROR 33.3 · calibrated p 2e-4 ✓	29.5 EB05 26.7 · IC025 +4.6 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Labeled adverse reaction exact term	serious n=288 · 70% consumer	not reported in cached trials
Spinal nerve stimulator implantation	38	32.8 23.4–45.9ROR 32.8 · calibrated p 2e-4 ✓	28.8 EB05 21.9 · IC025 +3.9 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=37 · 100% consumer	not reported in cached trials
Product residue present	540	29.3 26.8–32.0ROR 29.5 · calibrated p 3e-4 ✓	26.3 EB05 24.5 · IC025 +4.5 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=356	not reported in cached trials
Tenoplasty	34	28.9 20.3–41.2ROR 28.9 · calibrated p 5e-4 ✓	25.7 EB05 19.3 · IC025 +3.7 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=34 · 100% consumer	not reported in cached trials
Medical device implantation	150	28.3 23.9–33.5ROR 28.4 · calibrated p 4e-4 ✓	25.5 EB05 22.3 · IC025 +4.3 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=148 · 100% consumer	not reported in cached trials
Colectomy total	54	27.6 20.8–36.5ROR 27.6 · calibrated p 5e-4 ✓	24.8 EB05 19.7 · IC025 +3.9 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=54 · ♀ 0% (drug 70%)	not reported in cached trials
Shoulder arthroplasty	251	27.0 23.7–30.7ROR 27.0 · calibrated p 5e-4 ✓	24.4 EB05 22.0 · IC025 +4.3 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=240 · 93% consumer	not reported in cached trials
Spinal operation	1,047	24.4 22.9–26.0ROR 24.7 · calibrated p 7e-4 ✓	22.4 EB05 21.3 · IC025 +4.4 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 4,345.0 (2,654.3–7,112.4)	Reporting / coding artifact	serious PRR 19.9 · 94% consumer	not reported in cached trials
Incision site impaired healing	30	22.9 15.8–33.3ROR 22.9 · calibrated p 0.001 ✓	20.8 EB05 15.3 · IC025 +3.4 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=28 · ♀ 100% (drug 70%) · 100% consumer	not reported in cached trials
Disease risk factor	31	22.1 15.3–31.9ROR 22.1 · calibrated p 0.002 ✓	20.2 EB05 14.8 · IC025 +3.4 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=27 · 100% consumer	not reported in cached trials
Elbow operation	47	21.6 16.1–29.1ROR 21.6 · calibrated p 0.002 ✓	19.9 EB05 15.5 · IC025 +3.6 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=46 · 100% consumer	not reported in cached trials
Neck surgery	171	20.7 17.8–24.2ROR 20.8 · calibrated p 0.002 ✓	19.2 EB05 16.9 · IC025 +3.9 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=162 · 92% consumer	not reported in cached trials
Shoulder operation	307	20.3 18.0–22.8ROR 20.3 · calibrated p 0.002 ✓	18.8 EB05 17.1 · IC025 +4.0 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=298 · 93% consumer	not reported in cached trials
Medical procedure	119	20.2 16.8–24.3ROR 20.2 · calibrated p 0.002 ✓	18.7 EB05 16.1 · IC025 +3.8 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=118 · 100% consumer	not reported in cached trials
Knee operation	672	19.2 17.7–20.7ROR 19.3 · calibrated p 0.002 ✓	17.9 EB05 16.8 · IC025 +4.0 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 6,374.3 (3,028.9–13,414.4)	Reporting / coding artifact	serious PRR 16.5 · 93% consumer	not reported in cached trials
Limb operation	329	19.1 17.1–21.4ROR 19.2 · calibrated p 0.002 ✓	17.8 EB05 16.3 · IC025 +3.9 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=323 · 95% consumer	not reported in cached trials
Ankle operation	100	18.9 15.5–23.2ROR 19.0 · calibrated p 0.003 ✓	17.6 EB05 14.9 · IC025 +3.7 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=98 · 88% consumer	not reported in cached trials
Colectomy	383	18.9 17.1–21.0ROR 19.0 · calibrated p 0.003 ✓	17.7 EB05 16.2 · IC025 +3.9 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=382 · ♀ 47% (drug 70%) · 82% consumer	not reported in cached trials
Wrist surgery	63	18.9 14.6–24.4ROR 18.9 · calibrated p 0.003 ✓	17.6 EB05 14.2 · IC025 +3.5 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=63 · 100% consumer	not reported in cached trials
Knee arthroplasty	1,409	18.7 17.7–19.7ROR 19.0 · calibrated p 0.003 ✓	17.5 EB05 16.7 · IC025 +4.0 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 10,395.1 (5,401.1–20,006.7)	Not in label — unassessed	serious PRR 15.1 · 84% consumer	not reported in cached trials
Gastrointestinal scarring	47	18.5 13.8–24.9ROR 18.5 · calibrated p 0.003 ✓	17.2 EB05 13.4 · IC025 +3.4 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=46 · ♀ 45% (drug 70%) · 100% consumer	not reported in cached trials
Foot operation	321	18.0 16.1–20.2ROR 18.1 · calibrated p 0.003 ✓	16.9 EB05 15.4 · IC025 +3.9 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=314 · 93% consumer	not reported in cached trials
Fracture pain	34	17.6 12.5–25.0ROR 17.7 · calibrated p 0.005 ✓	16.4 EB05 12.1 · IC025 +3.2 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=33 · ♀ 100% (drug 70%) · 100% clinician	not reported in cached trials
Joint arthroplasty	114	17.5 14.5–21.2ROR 17.5 · calibrated p 0.004 ✓	16.4 EB05 14.0 · IC025 +3.6 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=112 · 80% consumer	not reported in cached trials
Arthrodesis	62	16.7 12.9–21.6ROR 16.8 · calibrated p 0.005 ✓	15.7 EB05 12.6 · IC025 +3.4 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 374.2 (197.2–710.1)	Not in label — unassessed	serious n=62 · 100% consumer	not reported in cached trials
Hip surgery	314	16.2 14.4–18.1ROR 16.2 · calibrated p 0.005 ✓	15.3 EB05 13.9 · IC025 +3.7 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=306 · 95% consumer	not reported in cached trials
Small intestinal resection	66	15.6 12.2–20.0ROR 15.6 · calibrated p 0.007 ✓	14.7 EB05 11.9 · IC025 +3.3 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=66 · ♀ 43% (drug 70%)	not reported in cached trials
Dental operation	139	15.6 13.1–18.5ROR 15.6 · calibrated p 0.006 ✓	14.7 EB05 12.7 · IC025 +3.5 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=136 · 100% consumer	not reported in cached trials
Intervertebral disc operation	70	15.5 12.2–19.8ROR 15.6 · calibrated p 0.007 ✓	14.6 EB05 11.9 · IC025 +3.3 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=69 · 100% consumer	not reported in cached trials
Bone operation	37	15.4 11.0–21.4ROR 15.4 · calibrated p 0.008 ✓	14.3 EB05 10.7 · IC025 +3.1 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Reporting / coding artifact	serious n=37 · ♀ 100% (drug 70%) · 100% consumer	not reported in cached trials
Spinal fusion surgery	224	15.2 13.3–17.4ROR 15.3 · calibrated p 0.007 ✓	14.4 EB05 12.9 · IC025 +3.6 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=214 · 88% consumer	not reported in cached trials
Oral surgery	127	14.9 12.5–17.8ROR 14.9 · calibrated p 0.008 ✓	14.1 EB05 12.1 · IC025 +3.5 3/3 methods agree vs other Janus Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=126 · 100% consumer	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Upadacitinib 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 (0 of 40 signal terms matched).

NCT03104400 — A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis (N=1705, PHASE3; 356 AE terms posted; arms: Upadacitinib 15 mg Period 1 (Weeks 1 to ; Upadacitinib 30 mg Period 1 (Weeks 1 to ; Adalimumab 40 mg Period 1 (Weeks 1 to 56; Placebo Period 1 (Weeks 1 to 24))
NCT02629159 — A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who (N=1629, PHASE3; 76 AE terms posted; arms: Placebo; Adalimumab; Upadacitinib; Placebo / Upadacitinib)

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
Pain	5,353	2.3 2.2–2.3ROR 2.4 · calibrated p 0.879	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 2,008.1 (1,734.1–2,325.4)	Labeled adverse reaction exact term	serious PRR 2.0 · 87% consumer	NCT03104400: 1/366 (0.3%) on Upadacitinib (serious AE)
Arthralgia (joint pain)	4,797	3.0 2.9–3.1ROR 3.1 · calibrated p 0.581	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 1,703.3 (1,476.3–1,965.1)	Not in label — unassessed	serious PRR 3.3 · 82% consumer	NCT03104400: 1/443 (0.2%) on Upadacitinib (serious AE)
Drug ineffective (drug did not work)	4,660	0.9 0.9–0.9ROR 0.9 · calibrated p 0.249	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Janus Kinase Inhibitors: PRR 241.5 (228.8–255.0)	Reporting / coding artifact	serious PRR 1.2	not reported in cached trials
Rheumatoid arthritis	3,290	7.7 7.5–8.0ROR 8.0 · calibrated p 0.066	7.5 EB05 7.3 · IC025 +2.9 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 615.4 (553.8–683.7)	Labeled — boxed warning exact term	serious PRR 5.6 · 82% consumer	NCT02629159: 1/304 (0.3%) on Upadacitinib; 1/652 (0.2%) control (serious AE)
Covid-19	3,207	4.8 4.6–4.9ROR 4.9 · calibrated p 0.244	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 474.3 (431.7–521.1)	Not in label — unassessed	serious PRR 4.1	NCT03104400: 4/443 (0.9%) on Upadacitinib; 1/177 (0.6%) control (serious AE)
Pain in extremity	2,806	2.5 2.4–2.6ROR 2.5 · calibrated p 0.802	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 1,444.3 (1,213.7–1,718.7)	Not in label — unassessed	serious PRR 2.7 · 87% consumer	not reported in cached trials
Fatigue (tiredness)	2,692	0.9 0.9–0.9ROR 0.9 · calibrated p 0.239	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Janus Kinase Inhibitors: PRR 955.9 (826.7–1,105.2)	Labeled adverse reaction exact term	serious PRR 1.0 · 83% consumer	not reported in cached trials
Surgery	2,550	11.9 11.4–12.3ROR 12.2 · calibrated p 0.016 ✓	11.4 EB05 11.0 · IC025 +3.4 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 9,959.8 (6,187.6–16,031.7)	Reporting / coding artifact	serious PRR 10.7 · 90% consumer	not reported in cached trials
Fall	2,493	1.9 1.9–2.0ROR 2.0 · calibrated p 0.932	1.9 EB05 1.9 · IC025 +0.9 vs other Janus Kinase Inhibitors: PRR 1,334.9 (1,117.4–1,594.8)	Not in label — unassessed	serious PRR 1.8 · 87% consumer	NCT02629159: 1/327 (0.3%) on Upadacitinib; 1/304 (0.3%) control (serious AE)
Headache	1,970	0.8 0.8–0.8ROR 0.8 · calibrated p 0.189	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Janus Kinase Inhibitors: PRR 493.6 (435.7–559.2)	Labeled adverse reaction exact term	serious PRR 0.9 · 73% consumer	NCT03104400: 1/429 (0.2%) on Upadacitinib (serious AE)
Pneumonia (lung infection)	1,944	1.6 1.5–1.6ROR 1.6 · calibrated p 0.689	1.6 EB05 1.5 · IC025 +0.6 vs other Janus Kinase Inhibitors: PRR 457.7 (405.5–516.7)	Labeled — boxed warning synonym match	serious PRR 1.2	NCT03104400: 2/423 (0.5%) on Upadacitinib (serious AE)
Death	1,913	0.6 0.5–0.6ROR 0.6 · calibrated p 0.070	0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC vs other Janus Kinase Inhibitors: PRR 536.0 (469.9–611.3)	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 0.5	NCT03104400: 1/443 (0.2%) on Upadacitinib (serious AE)
Therapy interrupted	1,839	7.1 6.7–7.4ROR 7.2 · calibrated p 0.091	6.9 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Janus Kinase Inhibitors: PRR 678.4 (583.8–788.3)	Reporting / coding artifact	serious PRR 1.3 · 96% clinician	not reported in cached trials
Diarrhoea (diarrhea)	1,805	0.7 0.7–0.8ROR 0.7 · calibrated p 0.140	0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other Janus Kinase Inhibitors: PRR 713.4 (610.8–833.2)	Not in label — unassessed	serious PRR 0.8 · 71% consumer	NCT03104400: 7/443 (1.6%) on Upadacitinib; 10/423 (2.4%) control
Back pain	1,755	2.0 1.9–2.1ROR 2.0 · calibrated p 0.934	2.0 EB05 1.9 · IC025 +0.9 vs other Janus Kinase Inhibitors: PRR 1,942.2 (1,504.1–2,507.7)	Labeled (related wording) related wording	serious PRR 2.2 · 88% consumer	NCT03104400: 1/366 (0.3%) on Upadacitinib (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.

Ostomy bag placement — n=130, PRR 112.5
Semen discolouration — n=81, PRR 94.9
Subcutaneous drug absorption impaired — n=105, PRR 61.7
Stoma creation — n=125, PRR 59.0
Epidural injection — n=31, PRR 48.7
Ileocaecal resection — n=48, PRR 43.6
Intestinal anastomosis — n=81, PRR 38.2
Spinal nerve stimulator implantation — n=38, PRR 32.8
Tenoplasty — n=34, PRR 28.9
Medical device implantation — n=150, PRR 28.3

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 Upadacitinib?

In FDA FAERS, the most frequently co-reported reaction terms for Upadacitinib are pain, arthralgia, rheumatoid arthritis, covid-19, pain in extremity, fatigue. 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 Upadacitinib 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 RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )].

Do FAERS signals prove that Upadacitinib 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 2966aec7-2ef0-923c-d8ff-fe1a957bf095, effective 20260630; matched on openfda.generic_name.exact:"UPADACITINIB")
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, 1,236 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 UPADACITINIB, 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.