Risankizumab-Rzaa side effects: what 81,276 FDA adverse event reports show

Risankizumab-Rzaa · Skyrizi · 1,215 reaction terms · 193,700 drug–reaction co-reports · data 2026-09-14

Drug class

Interleukin-23 Antagonist

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Skyrizi

openFDA label

Who reports

81,276 reports · 66% serious · 2,905 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) moderately to severely active Crohn's disease in adults.

FDA label, Indications and Usage

What it is

Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa.

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 (related wording) 1Likely indication confounding 2Reporting / coding artifact 8Lab value / disease marker 1Not in label — unassessed 28

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). 1,175 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
Stoma creation	180	94.3 79.5–111.9ROR 94.5 · calibrated p 2e-7 ✓	68.5 EB05 60.5 · IC025 +5.6 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=179 · 90% consumer	no trial arm names this drug
Ostomy bag placement	110	88.8 71.5–110.4ROR 88.9 · calibrated p 4e-7 ✓	65.3 EB05 55.7 · IC025 +5.4 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=110 · 95% consumer	no trial arm names this drug
Stoma closure	50	51.1 37.7–69.3ROR 51.2 · calibrated p 2e-5 ✓	42.1 EB05 33.2 · IC025 +4.4 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=50 · 100% consumer	no trial arm names this drug
Gastrointestinal scarring	111	48.4 39.5–59.2ROR 48.4 · calibrated p 2e-5 ✓	40.5 EB05 34.6 · IC025 +4.8 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=108 · 95% consumer	no trial arm names this drug
Ileocaecal resection	50	45.6 33.7–61.6ROR 45.6 · calibrated p 4e-5 ✓	38.3 EB05 30.2 · IC025 +4.3 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=50	no trial arm names this drug
Sleeve gastrectomy	33	42.5 29.4–61.4ROR 42.5 · calibrated p 6e-5 ✓	35.8 EB05 26.7 · IC025 +4.0 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=33 · 100% consumer	no trial arm names this drug
Ileostomy closure	44	39.8 29.0–54.7ROR 39.9 · calibrated p 8e-5 ✓	34.1 EB05 26.5 · IC025 +4.1 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=44 · 100% consumer	no trial arm names this drug
Intestinal anastomosis	78	36.5 28.8–46.3ROR 36.5 · calibrated p 1e-4 ✓	31.8 EB05 26.3 · IC025 +4.4 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=78 · 74% consumer	no trial arm names this drug
Small intestinal resection	133	33.5 28.0–40.1ROR 33.5 · calibrated p 2e-4 ✓	29.6 EB05 25.6 · IC025 +4.5 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=133 · 84% consumer	no trial arm names this drug
Incision site discharge	25	28.9 19.1–43.8ROR 29.0 · calibrated p 5e-4 ✓	25.6 EB05 18.2 · IC025 +3.5 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=24 · 100% consumer	no trial arm names this drug
Skin operation	31	28.6 19.7–41.4ROR 28.6 · calibrated p 5e-4 ✓	25.4 EB05 18.8 · IC025 +3.6 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Reporting / coding artifact	serious n=29 · 100% consumer	no trial arm names this drug
Ileostomy	252	28.5 25.0–32.5ROR 28.6 · calibrated p 4e-4 ✓	25.7 EB05 23.1 · IC025 +4.4 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 1,971.9 (878.0–4,428.6)	Not in label — unassessed	serious n=252 · 86% consumer	no trial arm names this drug
Precancerous condition	64	27.9 21.5–36.1ROR 27.9 · calibrated p 5e-4 ✓	25.1 EB05 20.3 · IC025 +4.0 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=62 · 100% consumer	no trial arm names this drug
Proctectomy	26	27.8 18.6–41.7ROR 27.8 · calibrated p 6e-4 ✓	24.8 EB05 17.7 · IC025 +3.5 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=26 · 77% consumer	no trial arm names this drug
Nail psoriasis	60	27.7 21.2–36.1ROR 27.7 · calibrated p 5e-4 ✓	24.9 EB05 20.0 · IC025 +4.0 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 234.8 (126.4–436.0)	Likely indication confounding shares a disease stem with the indications wording	serious n=28 · 100% consumer	no trial arm names this drug
Medical device implantation	146	27.4 23.1–32.5ROR 27.4 · calibrated p 5e-4 ✓	24.7 EB05 21.6 · IC025 +4.2 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=146 · 100% consumer	no trial arm names this drug
Intestinal operation	146	26.7 22.5–31.6ROR 26.7 · calibrated p 5e-4 ✓	24.2 EB05 21.0 · IC025 +4.2 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Reporting / coding artifact	serious n=146 · 92% consumer	no trial arm names this drug
Intestinal resection	463	24.4 22.2–26.8ROR 24.5 · calibrated p 8e-4 ✓	22.3 EB05 20.7 · IC025 +4.3 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=463 · 94% consumer	no trial arm names this drug
Ileectomy	28	23.2 15.8–34.2ROR 23.2 · calibrated p 0.001 ✓	21.1 EB05 15.2 · IC025 +3.3 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=28 · 100% consumer	no trial arm names this drug
Abdominoplasty	27	23.1 15.6–34.3ROR 23.1 · calibrated p 0.001 ✓	21.0 EB05 15.1 · IC025 +3.3 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=27 · ♀ 100% (drug 57%) · 100% consumer	no trial arm names this drug
Faecal calprotectin abnormal	33	22.7 15.9–32.4ROR 22.7 · calibrated p 0.002 ✓	20.7 EB05 15.4 · IC025 +3.4 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=27	no trial arm names this drug
Medical procedure	129	22.0 18.4–26.3ROR 22.0 · calibrated p 0.001 ✓	20.3 EB05 17.5 · IC025 +3.9 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Reporting / coding artifact	serious n=129 · 95% consumer	no trial arm names this drug
Tenoplasty	26	21.5 14.4–32.0ROR 21.5 · calibrated p 0.002 ✓	19.6 EB05 14.0 · IC025 +3.2 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=25 · 100% consumer	no trial arm names this drug
Colon operation	91	21.4 17.3–26.5ROR 21.4 · calibrated p 0.002 ✓	19.7 EB05 16.5 · IC025 +3.8 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Reporting / coding artifact	serious n=88 · 91% consumer	no trial arm names this drug
Injection site papule	342	21.0 18.8–23.5ROR 21.1 · calibrated p 0.002 ✓	19.5 EB05 17.8 · IC025 +4.1 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Labeled (related wording) related wording	serious n=71 · 97% consumer	no trial arm names this drug
Incision site impaired healing	27	20.4 13.8–30.2ROR 20.4 · calibrated p 0.003 ✓	18.7 EB05 13.4 · IC025 +3.2 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=27 · 100% consumer	no trial arm names this drug
Abdominal operation	85	18.3 14.7–22.9ROR 18.4 · calibrated p 0.003 ✓	17.1 EB05 14.2 · IC025 +3.6 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Reporting / coding artifact	serious n=84 · 92% consumer	no trial arm names this drug
Obstruction	263	18.1 16.0–20.5ROR 18.2 · calibrated p 0.003 ✓	16.9 EB05 15.3 · IC025 +3.8 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=263 · 88% consumer	no trial arm names this drug
Gastrointestinal stoma output increased	30	17.8 12.3–25.8ROR 17.8 · calibrated p 0.004 ✓	16.5 EB05 11.9 · IC025 +3.1 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Lab value / disease marker	serious n=30 · 100% consumer	no trial arm names this drug
Shoulder operation	272	17.7 15.7–20.1ROR 17.8 · calibrated p 0.003 ✓	16.6 EB05 15.0 · IC025 +3.8 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 1,064.2 (597.4–1,895.7)	Reporting / coding artifact	serious n=266 · 96% consumer	no trial arm names this drug
Metabolic surgery	71	17.4 13.7–22.2ROR 17.5 · calibrated p 0.004 ✓	16.3 EB05 13.3 · IC025 +3.5 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=70 · 100% consumer	no trial arm names this drug
Gastric operation	58	17.3 13.3–22.6ROR 17.4 · calibrated p 0.004 ✓	16.2 EB05 12.9 · IC025 +3.4 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Reporting / coding artifact	serious n=58 · 100% consumer	no trial arm names this drug
Colectomy	346	16.9 15.2–18.9ROR 17.0 · calibrated p 0.004 ✓	15.9 EB05 14.5 · IC025 +3.8 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 2,707.5 (1,208.7–6,065.0)	Not in label — unassessed	serious n=344 · 94% consumer	no trial arm names this drug
Knee operation	586	16.5 15.2–17.9ROR 16.6 · calibrated p 0.005 ✓	15.6 EB05 14.5 · IC025 +3.8 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 1,310.1 (848.6–2,022.6)	Reporting / coding artifact	serious PRR 15.0 · 97% consumer	no trial arm names this drug
Psoriasis	7,867	16.5 16.1–16.8ROR 18.1 · calibrated p 0.003 ✓	15.5 EB05 15.2 · IC025 +3.9 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 165.0 (159.1–171.0)	Likely indication confounding term in indications; also in warnings	serious PRR 16.2 · 92% consumer	no trial arm names this drug
Stenosis	111	16.4 13.5–19.8ROR 16.4 · calibrated p 0.005 ✓	15.4 EB05 13.1 · IC025 +3.5 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=109 · 74% consumer	no trial arm names this drug
Small intestinal stenosis	63	16.2 12.5–20.9ROR 16.2 · calibrated p 0.006 ✓	15.2 EB05 12.2 · IC025 +3.4 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=63	no trial arm names this drug
Fungal foot infection	25	16.0 10.7–24.0ROR 16.0 · calibrated p 0.007 ✓	14.7 EB05 10.2 · IC025 +2.9 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	100% consumer	no trial arm names this drug
Precancerous skin lesion	86	15.9 12.8–19.8ROR 15.9 · calibrated p 0.006 ✓	15.0 EB05 12.5 · IC025 +3.4 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=81 · 100% consumer	no trial arm names this drug
Gastrointestinal stenosis	26	15.7 10.6–23.3ROR 15.7 · calibrated p 0.008 ✓	14.5 EB05 10.1 · IC025 +2.9 3/3 methods agree vs other Interleukin-23 Antagonists: only this drug	Not in label — unassessed	serious n=26 · 100% consumer	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Risankizumab-Rzaa (searched RISANKIZUMAB-RZAA).

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
Psoriasis	7,867	16.5 16.1–16.8ROR 18.1 · calibrated p 0.003 ✓	15.5 EB05 15.2 · IC025 +3.9 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 165.0 (159.1–171.0)	Likely indication confounding term in indications; also in warnings	serious PRR 16.2 · 92% consumer	no trial arm names this drug
Drug ineffective (drug did not work)	3,590	0.7 0.7–0.7ROR 0.7 · calibrated p 0.125	0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC vs other Interleukin-23 Antagonists: PRR 68.5 (65.7–71.4)	Reporting / coding artifact	serious PRR 0.8 · 80% consumer	no trial arm names this drug
Pain	3,225	1.4 1.3–1.4ROR 1.4 · calibrated p 0.554	1.4 EB05 1.3 · IC025 +0.4 vs other Interleukin-23 Antagonists: PRR 226.7 (209.7–245.0)	Labeled adverse reaction exact term	serious PRR 1.2 · 93% consumer	no trial arm names this drug
Fatigue (tiredness)	3,093	1.0 1.0–1.1ROR 1.0 · calibrated p 0.325	1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Interleukin-23 Antagonists: PRR 300.0 (273.9–328.6)	Labeled adverse reaction exact term	serious PRR 0.9 · 92% consumer	no trial arm names this drug
Arthralgia (joint pain)	3,089	1.9 1.9–2.0ROR 2.0 · calibrated p 0.926	1.9 EB05 1.9 · IC025 +0.9 vs other Interleukin-23 Antagonists: PRR 151.7 (142.0–162.1)	Labeled adverse reaction exact term	serious PRR 1.9 · 88% consumer	no trial arm names this drug
Pruritus (itching)	2,698	1.8 1.8–1.9ROR 1.9 · calibrated p 0.875	1.8 EB05 1.8 · IC025 +0.8 vs other Interleukin-23 Antagonists: PRR 184.9 (171.0–200.0)	Labeled adverse reaction exact term	serious PRR 1.4 · 90% consumer	no trial arm names this drug
Device issue	2,375	7.2 6.9–7.5ROR 7.4 · calibrated p 0.085	7.0 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 56.3 (53.5–59.3)	Reporting / coding artifact	serious PRR 8.8 · 97% consumer	no trial arm names this drug
Covid-19	2,262	3.3 3.2–3.5ROR 3.4 · calibrated p 0.511	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 190.3 (174.4–207.8)	Labeled adverse reaction exact term	serious PRR 2.6 · 86% consumer	no trial arm names this drug
Surgery	2,223	10.3 9.8–10.7ROR 10.5 · calibrated p 0.027 ✓	9.9 EB05 9.5 · IC025 +3.2 3/3 methods agree vs other Interleukin-23 Antagonists: PRR 729.9 (618.0–862.0)	Reporting / coding artifact	serious PRR 9.8 · 93% consumer	no trial arm names this drug
Death	2,204	0.7 0.6–0.7ROR 0.6 · calibrated p 0.106	0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC vs other Interleukin-23 Antagonists: PRR 344.9 (306.9–387.7)	Outcome field, not a reaction	serious PRR 0.6 · 71% consumer	no trial arm names this drug
Fall	2,165	1.7 1.6–1.8ROR 1.7 · calibrated p 0.771	1.7 EB05 1.6 · IC025 +0.7 vs other Interleukin-23 Antagonists: PRR 710.8 (601.8–839.6)	Not in label — unassessed	serious PRR 1.7 · 93% consumer	no trial arm names this drug
Diarrhoea (diarrhea)	2,009	0.8 0.8–0.8ROR 0.8 · calibrated p 0.184	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Interleukin-23 Antagonists: PRR 178.3 (162.8–195.3)	Not in label — unassessed	serious PRR 0.9 · 87% consumer	no trial arm names this drug
Headache	1,896	0.8 0.7–0.8ROR 0.8 · calibrated p 0.170	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Interleukin-23 Antagonists: PRR 142.4 (130.8–155.1)	Labeled adverse reaction exact term	serious PRR 0.6 · 86% consumer	no trial arm names this drug
Rash	1,504	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 Interleukin-23 Antagonists: PRR 110.9 (101.5–121.0)	Labeled adverse reaction exact term	serious PRR 0.8 · 80% consumer	no trial arm names this drug
Nausea	1,462	0.5 0.5–0.5ROR 0.5 · calibrated p 0.039 ✓	0.5 EB05 0.5 · IC025 -1.2 PRR-only: not supported by EBGM or IC vs other Interleukin-23 Antagonists: PRR 188.6 (168.8–210.7)	Not in label — unassessed	serious PRR 0.5 · 85% consumer	no trial arm names this drug

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.

Stoma creation — n=180, PRR 94.3
Ostomy bag placement — n=110, PRR 88.8
Stoma closure — n=50, PRR 51.1
Gastrointestinal scarring — n=111, PRR 48.4
Ileocaecal resection — n=50, PRR 45.6
Sleeve gastrectomy — n=33, PRR 42.5
Ileostomy closure — n=44, PRR 39.8
Intestinal anastomosis — n=78, PRR 36.5
Small intestinal resection — n=133, PRR 33.5
Incision site discharge — n=25, PRR 28.9

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 Risankizumab-Rzaa?

In FDA FAERS, the most frequently co-reported reaction terms for Risankizumab-Rzaa are psoriasis, pain, fatigue, arthralgia, pruritus, covid-19. 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 Risankizumab-Rzaa have an FDA boxed warning?

No. The FDA label retrieved for Risankizumab-Rzaa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Risankizumab-Rzaa 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 7148c8eb-b39e-e20a-6494-a6df82392858, effective 20260615; matched on openfda.generic_name.exact:"RISANKIZUMAB-RZAA")
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, 1,215 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 RISANKIZUMAB-RZAA, 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.