Adalimumab-Ryvk side effects: what 911 FDA adverse event reports show
Drug class
Tumor necrosis factor (tnf) blocker
Brand names
Simlandi
Who reports
911 reports · 81% serious · 72 with death outcome · 63% female
Used for
SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis .
What it is
Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions.
Boxed warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ] .
Causality screen of the 26 strongest signals
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.
- 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.
- 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. 17 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 |
|---|---|---|---|---|---|---|
| Drug effect less than expected | 36 | 58.7 42.6–80.9ROR 61.1 · χ² 1,982 / p <1e-300 | 56.9 EB05 42.9 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=36 | no trial data cached |
| Insurance issue | 34 | 52.6 37.8–73.2ROR 54.6 · χ² 1,668 / p <1e-300 | 51.1 EB05 38.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 72.8 | no trial data cached |
| Ankylosing spondylitis | 26 | 45.9 31.4–67.0ROR 47.2 · χ² 1,095 / p 2e-240 | 44.4 EB05 31.8 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 37.2 | no trial data cached |
| Uveitis | 24 | 40.8 27.5–60.6ROR 41.9 · χ² 892 / p 3e-196 | 39.6 EB05 28.0 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 30.9 | no trial data cached |
| Drug level decreased | 14 | 31.4 18.7–52.9ROR 31.9 · χ² 382 / p 2e-85 | 30.2 EB05 19.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 27.6 | no trial data cached |
| Colitis ulcerative | 38 | 19.6 14.3–26.7ROR 20.4 · χ² 652 / p 5e-144 | 19.4 EB05 14.7 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.0 · ♀ 37% (drug 63%) | no trial data cached |
| Psoriatic arthropathy | 31 | 17.7 12.5–25.0ROR 18.3 · χ² 472 / p 5e-105 | 17.5 EB05 12.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.9 | no trial data cached |
| Abscess | 12 | 17.3 9.8–30.3ROR 17.5 · χ² 168 / p 1e-38 | 16.2 EB05 9.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.6 | no trial data cached |
| Impaired quality of life | 10 | 16.0 8.6–29.6ROR 16.1 · χ² 126 / p 2e-29 | 14.4 EB05 7.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Intentional dose omission | 19 | 15.9 10.2–24.9ROR 16.3 · χ² 252 / p 6e-57 | 15.4 EB05 10.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 22.1 | no trial data cached |
| Rheumatoid arthritis | 71 | 14.4 11.5–18.0ROR 15.5 · χ² 877 / p 5e-193 | 14.3 EB05 11.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.6 | no trial data cached |
| Frequent bowel movements | 15 | 12.8 7.7–21.1ROR 13.0 · χ² 152 / p 4e-35 | 11.6 EB05 6.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Inappropriate schedule of product administration | 88 | 11.4 9.4–13.9ROR 12.5 · χ² 833 / p 2e-183 | 11.3 EB05 9.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 20.0 | no trial data cached |
| Haematochezia (blood in stool) | 26 | 10.8 7.4–15.8ROR 11.1 · χ² 223 / p 1e-50 | 10.1 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Product substitution issue | 26 | 10.4 7.1–15.1ROR 10.6 · χ² 211 / p 4e-48 | 9.6 EB05 6.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 | no trial data cached |
| Therapy interrupted | 30 | 10.0 7.0–14.2ROR 10.3 · χ² 234 / p 4e-53 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 15.7 | no trial data cached |
| Surgery | 25 | 9.9 6.7–14.6ROR 10.1 · χ² 192 / p 7e-44 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Product dose omission issue | 113 | 9.1 7.7–10.8ROR 10.3 · χ² 818 / p 3e-180 | 8.9 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 21.0 | no trial data cached |
| Injection site pruritus | 22 | 7.6 5.0–11.5ROR 7.7 · χ² 120 / p 4e-28 | 6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 32.9 | no trial data cached |
| Device malfunction | 21 | 7.2 4.7–10.9ROR 7.3 · χ² 106 / p 4e-25 | 6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 81% consumer | no trial data cached |
| Exposure during pregnancy | 17 | 6.3 3.9–10.0ROR 6.4 · χ² 70 / p 2e-17 | 5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Injection site erythema (redness where injected) | 27 | 5.0 3.5–7.3ROR 5.1 · χ² 83 / p 3e-20 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.6 · 70% consumer | no trial data cached |
| Injection site swelling | 12 | 3.6 2.1–6.4ROR 3.7 · χ² 20 / p 3e-6 | 3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.6 | no trial data cached |
| Psoriasis | 20 | 3.5 2.3–5.4ROR 3.6 · χ² 34 / p 3e-9 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.1 | no trial data cached |
| Injection site pain (pain where injected) | 45 | 3.4 2.6–4.5ROR 3.5 · χ² 75 / p 2e-18 | 3.3 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Product storage error | 10 | 2.7 1.4–4.9ROR 2.7 · χ² 9 / p 0.002 | 2.5 EB05 1.5 · IC025 +0.2 | Reporting / coding artifact | serious PRR 18.3 | 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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 113 | 9.1 7.7–10.8ROR 10.3 · χ² 818 / p 3e-180 | 8.9 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 21.0 | no trial data cached |
| Inappropriate schedule of product administration | 88 | 11.4 9.4–13.9ROR 12.5 · χ² 833 / p 2e-183 | 11.3 EB05 9.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 20.0 | no trial data cached |
| Rheumatoid arthritis | 71 | 14.4 11.5–18.0ROR 15.5 · χ² 877 / p 5e-193 | 14.3 EB05 11.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.6 | no trial data cached |
| Injection site pain (pain where injected) | 45 | 3.4 2.6–4.5ROR 3.5 · χ² 75 / p 2e-18 | 3.3 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Colitis ulcerative | 38 | 19.6 14.3–26.7ROR 20.4 · χ² 652 / p 5e-144 | 19.4 EB05 14.7 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.0 · ♀ 37% (drug 63%) | no trial data cached |
| Drug effect less than expected | 36 | 58.7 42.6–80.9ROR 61.1 · χ² 1,982 / p <1e-300 | 56.9 EB05 42.9 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=36 | no trial data cached |
| Insurance issue | 34 | 52.6 37.8–73.2ROR 54.6 · χ² 1,668 / p <1e-300 | 51.1 EB05 38.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 72.8 | no trial data cached |
| Psoriatic arthropathy | 31 | 17.7 12.5–25.0ROR 18.3 · χ² 472 / p 5e-105 | 17.5 EB05 12.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.9 | no trial data cached |
| Therapy interrupted | 30 | 10.0 7.0–14.2ROR 10.3 · χ² 234 / p 4e-53 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 15.7 | no trial data cached |
| Injection site erythema (redness where injected) | 27 | 5.0 3.5–7.3ROR 5.1 · χ² 83 / p 3e-20 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.6 · 70% consumer | no trial data cached |
| Product substitution issue | 26 | 10.4 7.1–15.1ROR 10.6 · χ² 211 / p 4e-48 | 9.6 EB05 6.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 | no trial data cached |
| Haematochezia (blood in stool) | 26 | 10.8 7.4–15.8ROR 11.1 · χ² 223 / p 1e-50 | 10.1 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Ankylosing spondylitis | 26 | 45.9 31.4–67.0ROR 47.2 · χ² 1,095 / p 2e-240 | 44.4 EB05 31.8 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 37.2 | no trial data cached |
| Surgery | 25 | 9.9 6.7–14.6ROR 10.1 · χ² 192 / p 7e-44 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Uveitis | 24 | 40.8 27.5–60.6ROR 41.9 · χ² 892 / p 3e-196 | 39.6 EB05 28.0 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 30.9 | 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.
- Insurance issue — n=34, PRR 52.6
- Haematochezia — n=26, PRR 10.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: TNF-inhibitors (adalimumab) ↔ Drug-induced lupus.
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 Adalimumab-Ryvk?
In FDA FAERS, the most frequently co-reported reaction terms for Adalimumab-Ryvk are rheumatoid arthritis, injection site pain, colitis ulcerative, insurance issue, psoriatic arthropathy, injection site erythema. 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 Adalimumab-Ryvk have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ] .
Do FAERS signals prove that Adalimumab-Ryvk 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 12f609c9-2088-bb05-e063-6394a90a9ecc, effective 20251031; matched on
openfda.generic_name.exact:"ADALIMUMAB-RYVK") - 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, 43 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.