Mirikizumab-Mrkz side effects: what 793 FDA adverse event reports show
Brand names
Omvoh
Who reports
793 reports · 50% serious · 26 with death outcome · 50% female
Used for
OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults. OMVOH TM is an interleukin-23 antagonist indicated for the treatment of: moderately to severely active ulcerative colitis in adults ( 1 ) moderately to severely active Crohn's disease in adults ( 1 )
What it is
Mirikizumab-mrkz is a humanized immunoglobulin G4 (IgG4) variant monoclonal antibody that is directed against the p19 subunit of IL-23 and does not bind IL-12. Mirikizumab-mrkz is produced in .
Boxed warning
None in the current label
Causality screen of the 9 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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 4 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 |
|---|---|---|---|---|---|---|
| Colitis ulcerative | 123 | 73.1 62.1–86.0ROR 86.4 · χ² 8,672 / p <1e-300 | 72.1 EB05 62.1 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 61.8 · 73% consumer | no trial data cached |
| Frequent bowel movements | 22 | 21.6 14.3–32.7ROR 22.2 · χ² 413 / p 4e-92 | 21.2 EB05 14.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.9 · ♀ 30% (drug 50%) | no trial data cached |
| Pneumocystis jirovecii pneumonia | 5 | 13.2 5.5–31.7ROR 13.3 · χ² 45 / p 1e-11 | 8.9 EB05 3.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Injection site discomfort | 5 | 12.8 5.3–30.7ROR 12.9 · χ² 43 / p 2e-11 | 8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Haematochezia (blood in stool) | 24 | 11.5 7.8–17.1ROR 11.8 · χ² 221 / p 3e-50 | 10.8 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Injection site pain (pain where injected) | 86 | 7.5 6.1–9.1ROR 8.3 · χ² 484 / p 1e-107 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 · ♀ 74% (drug 50%) · 84% consumer | no trial data cached |
| Abortion spontaneous | 8 | 5.3 2.6–10.5ROR 5.3 · χ² 24 / p 6e-7 | 4.2 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Injection site mass | 5 | 3.6 1.5–8.6ROR 3.6 · χ² 7 / p 0.004 | 2.9 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | – | no trial data cached |
| Injection site haemorrhage | 9 | 3.0 1.6–5.7ROR 3.0 · χ² 10 / p 7e-4 | 2.7 EB05 1.6 · IC025 +0.3 | Labeled (related wording) related wording | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Colitis ulcerative | 123 | 73.1 62.1–86.0ROR 86.4 · χ² 8,672 / p <1e-300 | 72.1 EB05 62.1 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 61.8 · 73% consumer | no trial data cached |
| Injection site pain (pain where injected) | 86 | 7.5 6.1–9.1ROR 8.3 · χ² 484 / p 1e-107 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 · ♀ 74% (drug 50%) · 84% consumer | no trial data cached |
| Haematochezia (blood in stool) | 24 | 11.5 7.8–17.1ROR 11.8 · χ² 221 / p 3e-50 | 10.8 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Frequent bowel movements | 22 | 21.6 14.3–32.7ROR 22.2 · χ² 413 / p 4e-92 | 21.2 EB05 14.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.9 · ♀ 30% (drug 50%) | no trial data cached |
| Injection site haemorrhage | 9 | 3.0 1.6–5.7ROR 3.0 · χ² 10 / p 7e-4 | 2.7 EB05 1.6 · IC025 +0.3 | Labeled (related wording) related wording | – | no trial data cached |
| Abortion spontaneous | 8 | 5.3 2.6–10.5ROR 5.3 · χ² 24 / p 6e-7 | 4.2 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Injection site mass | 5 | 3.6 1.5–8.6ROR 3.6 · χ² 7 / p 0.004 | 2.9 EB05 1.4 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | – | no trial data cached |
| Injection site discomfort | 5 | 12.8 5.3–30.7ROR 12.9 · χ² 43 / p 2e-11 | 8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 5 | 13.2 5.5–31.7ROR 13.3 · χ² 45 / p 1e-11 | 8.9 EB05 3.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Injection site rash | 4 | 3.5 1.3–9.3ROR 3.5 · χ² 5 / p 0.014 | 2.7 EB05 1.2 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious n=2 | no trial data cached |
| Cytomegalovirus infection | 4 | 6.4 2.4–16.9ROR 6.4 · χ² 13 / p 1e-4 | 4.0 EB05 1.7 · IC025 +0.2 | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Diarrhoea haemorrhagic | 4 | 11.3 4.2–30.0ROR 11.3 · χ² 28 / p 6e-8 | 6.6 EB05 2.4 · IC025 +0.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Accidental underdose | 3 | 5.4 1.8–16.9ROR 5.5 · χ² 7 / p 0.004 | 3.4 EB05 1.3 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious n=1 | no trial data cached |
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.
- Frequent bowel movements — n=22, PRR 21.6
- Haematochezia — n=24, PRR 11.5
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 Mirikizumab-Mrkz?
In FDA FAERS, the most frequently co-reported reaction terms for Mirikizumab-Mrkz are colitis ulcerative, injection site pain, haematochezia, frequent bowel movements, injection site haemorrhage, abortion spontaneous. 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 Mirikizumab-Mrkz have an FDA boxed warning?
No. The FDA label retrieved for Mirikizumab-Mrkz has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Mirikizumab-Mrkz 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 472cbe04-263e-433d-9a0f-58c1b50b715a, effective 20260616; matched on
openfda.generic_name.exact:"MIRIKIZUMAB-MRKZ") - 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, 13 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
Page generated 2026-10-08. 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.