Drug · FAERS side-effect profile with label screen
Certolizumab Pegol side effects: what 116,499 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Cimzia
openFDA label
Who reports
116,499 reports · 65% serious · 6,589 with death outcome · 80% female
openFDA FAERS counts, all years, deduplication not applied
Used for
CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventi.
FDA label, Indications and Usage
What it is
Xaliproden is a tetrahydropyridine that is 1,2,3,6-tetrahydropyridine which is substituted on the nitrogen by a 2-(2-naphthyl)ethyl group and at position 4 by a m-trifluoromethylphenyl group.
PubChem CID 128919 (ChEBI)
Boxed warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and 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 1Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 12Not in label — unassessed 21
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.
- 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.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Basfi score increased | 34 | 1,200.9 469.7–3,070.4ROR 1,201.2 · calibrated p 3e-13 ✓ | 142.6 EB05 106.7 · IC025 +5.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Lab value / disease marker | 100% consumer | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 5,583 | 688.5 649.9–729.5ROR 723.1 · calibrated p 1e-15 ✓ | 141.3 EB05 138.2 · IC025 +7.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.2–4.5) | Lab value / disease marker | serious PRR 126.5 · 93% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 489 | 508.0 426.7–604.8ROR 510.1 · calibrated p 7e-14 ✓ | 131.1 EB05 121.7 · IC025 +6.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.5–4.3) | Lab value / disease marker | serious n=489 · 95% clinician | not reported in cached trials |
| Swollen joint count increased | 2,201 | 442.7 409.5–478.6ROR 451.2 · calibrated p 2e-13 ✓ | 126.8 EB05 122.4 · IC025 +6.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.9–4.2) | Lab value / disease marker | serious n=2,199 · 95% clinician | not reported in cached trials |
| Pemphigus | 8,765 | 441.6 424.8–459.1ROR 477.5 · calibrated p 9e-14 ✓ | 126.8 EB05 124.6 · IC025 +6.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.5 (4.5–4.6) | Not in label — unassessed | serious PRR 113.5 | not reported in cached trials |
| Rheumatic fever | 2,988 | 398.6 373.7–425.1ROR 409.0 · calibrated p 5e-13 ✓ | 123.0 EB05 119.3 · IC025 +6.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.9–4.2) | Labeled (related wording) related wording | serious n=2,987 · 94% clinician | not reported in cached trials |
| Basdai score increased | 42 | 390.4 227.1–671.1ROR 390.5 · calibrated p 2e-11 ✓ | 116.0 EB05 89.4 · IC025 +5.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Lab value / disease marker | 100% consumer | not reported in cached trials |
| Hepatic enzyme | 91 | 341.9 240.5–486.2ROR 342.2 · calibrated p 1e-11 ✓ | 114.4 EB05 96.0 · IC025 +5.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 7.7 (6.0–9.9) | Not in label — unassessed | serious n=91 · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 3,718 | 332.1 314.6–350.6ROR 343.0 · calibrated p 3e-12 ✓ | 115.9 EB05 112.8 · IC025 +6.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.8–4.1) | Lab value / disease marker | serious n=3,716 · 92% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,249 | 321.1 292.6–352.3ROR 324.5 · calibrated p 5e-12 ✓ | 114.4 EB05 109.2 · IC025 +6.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.7–4.2) | Not in label — unassessed | serious n=1,249 · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 4,669 | 320.0 305.0–335.6ROR 333.3 · calibrated p 3e-12 ✓ | 114.4 EB05 111.7 · IC025 +6.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Not in label — unassessed | serious PRR 101.9 · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 755 | 317.5 281.8–357.6ROR 319.5 · calibrated p 6e-12 ✓ | 113.8 EB05 107.1 · IC025 +6.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.6–4.2) | Not in label — unassessed | serious n=755 · 96% clinician | not reported in cached trials |
| C-reactive protein | 568 | 305.8 267.0–350.3ROR 307.3 · calibrated p 9e-12 ✓ | 112.2 EB05 104.6 · IC025 +6.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.8–4.5) | Lab value / disease marker | serious n=567 · 96% clinician | not reported in cached trials |
| Grip strength | 139 | 272.7 209.2–355.6ROR 273.1 · calibrated p 5e-11 ✓ | 106.3 EB05 92.2 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 5.4 (4.5–6.6) | Not in label — unassessed | serious n=139 · 100% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 161 | 243.0 191.5–308.3ROR 243.3 · calibrated p 1e-10 ✓ | 101.6 EB05 89.1 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.2 (2.7–3.8) | Lab value / disease marker | serious n=159 · 100% clinician | not reported in cached trials |
| Hand deformity | 7,256 | 226.5 218.9–234.4ROR 241.5 · calibrated p 7e-11 ✓ | 99.8 EB05 97.9 · IC025 +6.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (4.0–4.2) | Not in label — unassessed | serious PRR 96.7 · 91% clinician | not reported in cached trials |
| Facet joint syndrome | 1,708 | 214.8 200.2–230.5ROR 218.0 · calibrated p 2e-10 ✓ | 97.4 EB05 93.6 · IC025 +6.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.6–4.0) | Not in label — unassessed | serious n=1,708 · 95% clinician | not reported in cached trials |
| Covid-19 immunisation | 449 | 205.4 179.3–235.3ROR 206.2 · calibrated p 4e-10 ✓ | 95.1 EB05 88.0 · IC025 +6.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Not in label — unassessed | serious n=327 | not reported in cached trials |
| Swollen joint count | 123 | 181.0 140.8–232.8ROR 181.2 · calibrated p 2e-9 ✓ | 88.7 EB05 76.3 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 5.0 (4.0–6.1) | Not in label — unassessed | serious n=123 · 100% clinician | not reported in cached trials |
| Axial spondyloarthritis | 419 | 178.7 156.1–204.7ROR 179.4 · calibrated p 1e-9 ✓ | 89.0 EB05 82.1 · IC025 +6.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 38.9 (32.5–46.5) | Likely indication confounding term in indications; also in warnings | serious n=306 | not reported in cached trials |
| Muscle injury | 3,918 | 165.4 158.4–172.7ROR 171.1 · calibrated p 2e-9 ✓ | 85.9 EB05 83.6 · IC025 +6.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.5 (4.4–4.6) | Not in label — unassessed | serious PRR 83.0 · 94% clinician | not reported in cached trials |
| Helicobacter infection | 4,758 | 158.4 152.4–164.7ROR 165.1 · calibrated p 2e-9 ✓ | 84.0 EB05 82.0 · IC025 +6.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.1–4.3) | Not in label — unassessed | serious PRR 79.1 · 94% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 938 | 157.5 144.2–171.9ROR 158.7 · calibrated p 3e-9 ✓ | 83.6 EB05 79.2 · IC025 +6.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.5–4.0) | Not in label — unassessed | serious n=938 · 96% clinician | not reported in cached trials |
| Health assessment questionnaire score increased | 47 | 156.6 105.7–231.9ROR 156.7 · calibrated p 1e-8 ✓ | 80.8 EB05 63.2 · IC025 +5.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Lab value / disease marker | 100% consumer | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,918 | 149.9 142.8–157.5ROR 153.8 · calibrated p 4e-9 ✓ | 81.5 EB05 79.1 · IC025 +6.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.5) | Not in label — unassessed | serious n=2,916 · 94% clinician | not reported in cached trials |
| Synovial fluid analysis | 39 | 146.5 95.9–224.0ROR 146.6 · calibrated p 2e-8 ✓ | 77.6 EB05 59.2 · IC025 +4.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 7.1 (4.9–10.4) | Reporting / coding artifact | serious n=39 · 100% clinician | not reported in cached trials |
| Folliculitis | 4,447 | 136.6 131.4–142.0ROR 142.0 · calibrated p 7e-9 ✓ | 77.4 EB05 75.6 · IC025 +6.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.5) | Not in label — unassessed | serious PRR 80.9 · 94% clinician | not reported in cached trials |
| X-ray abnormal | 750 | 130.9 119.1–143.8ROR 131.7 · calibrated p 1e-8 ✓ | 75.5 EB05 71.0 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.4–4.0) | Lab value / disease marker | serious n=750 · 97% clinician | not reported in cached trials |
| Synovitis | 7,397 | 125.4 121.8–129.1ROR 133.9 · calibrated p 1e-8 ✓ | 73.7 EB05 72.3 · IC025 +6.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.5–3.6) | Not in label — unassessed | serious PRR 68.8 · 91% clinician | not reported in cached trials |
| Rheumatoid factor negative | 72 | 123.4 91.4–166.8ROR 123.5 · calibrated p 4e-8 ✓ | 71.7 EB05 58.9 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Reporting / coding artifact | serious n=72 · ♀ 47% (drug 80%) | not reported in cached trials |
| Dislocation of vertebra | 892 | 120.8 111.0–131.5ROR 121.7 · calibrated p 3e-8 ✓ | 72.0 EB05 68.2 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.4 (3.2–3.7) | Not in label — unassessed | serious n=892 · 95% clinician | not reported in cached trials |
| Influenza immunisation | 34 | 109.2 71.2–167.4ROR 109.2 · calibrated p 2e-7 ✓ | 65.5 EB05 49.0 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Not in label — unassessed | serious n=30 · 100% consumer | not reported in cached trials |
| C-reactive protein abnormal | 2,354 | 104.7 99.5–110.2ROR 106.9 · calibrated p 7e-8 ✓ | 66.1 EB05 63.9 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.0 (2.9–3.1) | Lab value / disease marker | serious n=2,353 · 92% clinician | not reported in cached trials |
| Retinitis | 611 | 104.1 94.2–115.0ROR 104.6 · calibrated p 9e-8 ✓ | 65.7 EB05 61.5 · IC025 +5.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.2–3.8) | Not in label — unassessed | serious n=611 · 96% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 8,125 | 102.9 100.2–105.7ROR 110.6 · calibrated p 5e-8 ✓ | 65.4 EB05 64.2 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.3–4.4) | Not in label — unassessed | serious PRR 84.3 · 91% clinician | not reported in cached trials |
| Blood iron abnormal | 344 | 97.2 85.2–110.9ROR 97.5 · calibrated p 2e-7 ✓ | 62.8 EB05 57.5 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.4 (5.7–7.3) | Lab value / disease marker | serious n=343 | not reported in cached trials |
| Pericarditis | 5,784 | 95.8 92.8–98.9ROR 100.7 · calibrated p 1e-7 ✓ | 62.4 EB05 61.1 · IC025 +5.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.1–4.3) | Labeled adverse reaction exact term | serious PRR 56.2 · 93% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 185 | 92.6 77.5–110.6ROR 92.7 · calibrated p 2e-7 ✓ | 60.7 EB05 53.7 · IC025 +5.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.4 (2.9–3.9) | Not in label — unassessed | serious n=185 · 100% clinician | not reported in cached trials |
| Seronegative arthritis | 356 | 83.6 73.7–94.8ROR 83.9 · calibrated p 5e-7 ✓ | 56.9 EB05 52.1 · IC025 +5.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.3–4.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=356 · 94% clinician | not reported in cached trials |
| Peripheral venous disease | 1,261 | 83.1 77.7–88.8ROR 84.0 · calibrated p 4e-7 ✓ | 56.8 EB05 54.2 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.5–3.9) | Labeled (related wording) related wording | serious n=1,259 · 94% clinician | NCT01500278: 1/516 (0.2%) on Certolizumab Pegol (serious AE) |
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 |
|---|---|---|---|
| Liver injury | 8,754 | 5.45.2–5.5 | signal |
| Interstitial lung disease | 2,239 | 4.34.1–4.5 | signal |
| Serious infection | 13,287 | 3.13.1–3.2 | signal |
| Opportunistic infection | 1,957 | 2.62.5–2.7 | signal |
| Tendon disorder | 516 | 2.52.3–2.7 | signal |
| Hyperglycaemia / diabetes | 4,136 | 2.22.1–2.2 | signal |
| Depression | 2,244 | 1.41.4–1.5 | raised |
| Anaphylaxis / angioedema | 888 | 1.31.2–1.4 | raised |
| Pancreatitis | 490 | 1.11.0–1.2 | raised |
| Fall / fracture | 1,976 | 0.90.9–1.0 | lower than other drugs |
| Malignancy | 1,856 | 0.90.8–0.9 | lower than other drugs |
| Gi bleeding | 603 | 0.60.5–0.6 | lower than other drugs |
| Rhabdomyolysis / myopathy | 256 | 0.60.5–0.6 | lower than other drugs |
| Arrhythmia / qt | 552 | 0.50.5–0.6 | lower than other drugs |
| Venous thromboembolism | 601 | 0.50.5–0.5 | lower than other drugs |
| Myocardial infarction | 445 | 0.40.4–0.4 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Certolizumab Pegol 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 (1 of 40 signal terms matched).
- NCT00717236 — Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (N=1648, PHASE3; 134 AE terms posted; arms: Certolizumab Pegol (CZP); Placebo; Open Label Certolizumab Pegol (CZP))
- NCT01500278 — Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimum (N=915, PHASE4; 134 AE terms posted; arms: CZP+MTX (SS); ADA+MTX (SS))
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) | 27,043 | 3.8 3.7–3.8ROR 4.6 · calibrated p 0.284 | 3.7 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.7 (2.7–2.7) | Reporting / coding artifact | age-adj. PRR 4.2 · serious PRR 7.0 | not reported in cached trials |
| Rheumatoid arthritis | 19,803 | 38.1 37.6–38.6ROR 45.7 · calibrated p 2e-5 ✓ | 31.5 EB05 31.2 · IC025 +5.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.5–3.5) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 34.8 · serious PRR 32.7 | NCT00717236: 3/954 (0.3%) on Certolizumab Pegol (serious AE) |
| Pain | 15,933 | 4.8 4.7–4.8ROR 5.4 · calibrated p 0.199 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.9 (2.9–2.9) | Labeled adverse reaction exact term | age-adj. PRR 4.3 · serious PRR 5.5 | NCT00717236: 2/846 (0.2%) on Certolizumab Pegol (serious AE) |
| Fatigue (tiredness) | 13,664 | 3.2 3.2–3.3ROR 3.5 · calibrated p 0.485 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.1 (3.0–3.1) | Labeled adverse reaction exact term | age-adj. PRR 2.9 · serious PRR 4.7 | not reported in cached trials |
| Off label use (used outside approved label) | 11,624 | 2.4 2.4–2.5ROR 2.6 · calibrated p 0.776 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 1.8 (1.8–1.9) | Reporting / coding artifact | age-adj. PRR 3.0 · serious PRR 3.3 | not reported in cached trials |
| Rash | 11,096 | 4.7 4.6–4.8ROR 5.1 · calibrated p 0.225 | 4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.4 (3.4–3.5) | Labeled adverse reaction exact term | age-adj. PRR 4.8 · serious PRR 8.0 | not reported in cached trials |
| Arthralgia (joint pain) | 10,982 | 4.9 4.8–5.0ROR 5.3 · calibrated p 0.206 | 4.8 EB05 4.7 · IC025 +2.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.0 (2.0–2.0) | Labeled adverse reaction exact term | age-adj. PRR 4.8 · serious PRR 6.6 | NCT00717236: 1/954 (0.1%) on Certolizumab Pegol (serious AE) |
| Alopecia (hair loss) | 10,171 | 9.8 9.6–9.9ROR 10.6 · calibrated p 0.026 ✓ | 9.3 EB05 9.1 · IC025 +3.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.8–3.9) | Labeled adverse reaction exact term | age-adj. PRR 8.1 · serious PRR 16.9 | not reported in cached trials |
| Joint swelling | 9,855 | 16.0 15.6–16.3ROR 17.3 · calibrated p 0.004 ✓ | 14.7 EB05 14.5 · IC025 +3.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.9 (2.8–2.9) | Not in label — unassessed | age-adj. PRR 15.7 · serious PRR 21.4 | NCT01500278: 1/516 (0.2%) on Certolizumab Pegol (serious AE) |
| Maternal exposure during pregnancy | 9,706 | 22.2 21.7–22.6ROR 24.1 · calibrated p 8e-4 ✓ | 19.8 EB05 19.5 · IC025 +4.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.6 (6.5–6.7) | Reporting / coding artifact | serious PRR 19.6 | not reported in cached trials |
| Abdominal discomfort | 9,593 | 10.9 10.7–11.1ROR 11.8 · calibrated p 0.018 ✓ | 10.3 EB05 10.2 · IC025 +3.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.9–4.0) | Not in label — unassessed | age-adj. PRR 10.2 · serious PRR 20.2 | not reported in cached trials |
| Systemic lupus erythematosus | 9,181 | 63.0 61.6–64.5ROR 68.3 · calibrated p 2e-6 ✓ | 46.7 EB05 45.9 · IC025 +5.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (4.1–4.2) | Labeled (related wording) related wording | age-adj. PRR 52.2 · serious PRR 42.7 | not reported in cached trials |
| Pemphigus | 8,765 | 441.6 424.8–459.1ROR 477.5 · calibrated p 9e-14 ✓ | 126.8 EB05 124.6 · IC025 +6.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.5 (4.5–4.6) | Not in label — unassessed | serious PRR 113.5 | not reported in cached trials |
| Swelling | 8,755 | 18.5 18.1–18.9ROR 20.0 · calibrated p 0.002 ✓ | 16.9 EB05 16.6 · IC025 +4.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.8–3.9) | Labeled adverse reaction exact term | age-adj. PRR 17.3 · serious PRR 23.7 | NCT01500278: 1/516 (0.2%) on Certolizumab Pegol (serious AE) |
| Drug intolerance | 8,727 | 17.9 17.5–18.3ROR 19.2 · calibrated p 0.002 ✓ | 16.3 EB05 16.0 · IC025 +4.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.1 (3.0–3.2) | Reporting / coding artifact | age-adj. PRR 22.5 · serious PRR 23.2 | not reported in cached trials |
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.
- Pemphigus — n=8,765, PRR 441.6
- Hepatic enzyme — n=91, PRR 341.9
- Deep vein thrombosis postoperative — n=1,249, PRR 321.1
- Duodenal ulcer perforation — n=4,669, PRR 320.0
- Lupus vulgaris — n=755, PRR 317.5
- Grip strength — n=139, PRR 272.7
- Hand deformity — n=7,256, PRR 226.5
- Facet joint syndrome — n=1,708, PRR 214.8
- Covid-19 immunisation — n=449, PRR 205.4
- Swollen joint count — n=123, PRR 181.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Certolizumab Pegol ↔ Rheumatoid Arthritis.
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 Certolizumab Pegol?
In FDA FAERS, the most frequently co-reported reaction terms for Certolizumab Pegol are rheumatoid arthritis, pain, fatigue, rash, arthralgia, alopecia. 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 Certolizumab Pegol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .
Do FAERS signals prove that Certolizumab Pegol 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 b4c2c9dc-a0bb-4d64-a667-a67ebe88392d, effective 20260224; matched on
openfda.generic_name.exact:"CERTOLIZUMAB PEGOL" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 128919 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
CERTOLIZUMAB PEGOL, 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.