Drug · FAERS side-effect profile with label screen
Vedolizumab side effects: what 85,584 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Entyvio, Entyvio Pen
openFDA label
Who reports
85,584 reports · 87% serious · 4,219 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD). ( 1 )
FDA label, Indications and Usage
What it is
Vedolizumab, an integrin receptor antagonist, is a humanized IgG 1 monoclonal antibody produced in Chinese hamster ovary cells that binds to the human α4β7 integrin. ENTYVIO has an approximate molecular weight of 147 kilodaltons.
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 1Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 32
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). 1,223 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 |
|---|---|---|---|---|---|---|
| Therapeutic reaction time decreased | 2,741 | 4,046.1 3,455.2–4,738.1ROR 4,179.9 · calibrated p 3e-25 ✓ | 227.7 EB05 220.6 · IC025 +7.7 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Lab value / disease marker | serious n=2,432 | not reported in cached trials |
| Vaginal flatulence | 190 | 408.2 323.2–515.5ROR 409.1 · calibrated p 9e-13 ✓ | 149.7 EB05 132.7 · IC025 +6.5 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=190 · ♀ 100% (drug 56%) | not reported in cached trials |
| Gastrointestinal anastomotic stenosis | 37 | 153.5 101.6–231.8ROR 153.6 · calibrated p 1e-8 ✓ | 89.9 EB05 68.1 · IC025 +4.8 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=37 · ♀ 0% (drug 56%) | not reported in cached trials |
| Colitis ulcerative | 15,612 | 132.3 129.9–134.7ROR 161.5 · calibrated p 2e-9 ✓ | 85.7 EB05 84.6 · IC025 +6.4 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 661.8 (538.8–812.8) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 125.9 · serious PRR 60.4 | NCT00790933: 120/2,243 (5.3%) on Vedolizumab (serious AE) |
| Loss of therapeutic response | 1,023 | 125.6 116.5–135.4ROR 127.1 · calibrated p 2e-8 ✓ | 82.7 EB05 78.6 · IC025 +6.2 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=976 | not reported in cached trials |
| Subcutaneous drug absorption impaired | 176 | 117.0 97.7–140.1ROR 117.2 · calibrated p 4e-8 ✓ | 78.4 EB05 69.1 · IC025 +5.8 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=176 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Ileocaecal resection | 106 | 114.9 91.2–144.8ROR 115.0 · calibrated p 6e-8 ✓ | 77.0 EB05 65.5 · IC025 +5.5 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=106 · 100% clinician | not reported in cached trials |
| Steroid dependence | 241 | 97.0 83.5–112.6ROR 97.2 · calibrated p 2e-7 ✓ | 69.0 EB05 62.0 · IC025 +5.7 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=241 · ♀ 27% (drug 56%) | not reported in cached trials |
| Mucous stools | 1,318 | 89.5 84.1–95.3ROR 90.9 · calibrated p 2e-7 ✓ | 65.5 EB05 62.6 · IC025 +5.9 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=1,308 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 165 | 80.4 67.4–95.8ROR 80.5 · calibrated p 7e-7 ✓ | 60.1 EB05 52.8 · IC025 +5.4 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Lab value / disease marker | serious n=165 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Catheter site injury | 50 | 75.7 55.1–104.0ROR 75.7 · calibrated p 2e-6 ✓ | 56.6 EB05 44.6 · IC025 +4.7 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=48 | not reported in cached trials |
| Defaecation urgency | 1,521 | 68.3 64.5–72.2ROR 69.5 · calibrated p 2e-6 ✓ | 53.4 EB05 51.2 · IC025 +5.6 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=1,480 | not reported in cached trials |
| Proctocolectomy | 62 | 62.9 47.6–83.2ROR 63.0 · calibrated p 5e-6 ✓ | 49.4 EB05 39.9 · IC025 +4.7 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=62 | not reported in cached trials |
| Adjustment disorder with depressed mood | 406 | 61.7 55.3–68.8ROR 62.0 · calibrated p 4e-6 ✓ | 49.2 EB05 45.3 · IC025 +5.4 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=406 · ♀ 100% (drug 56%) · 96% clinician | not reported in cached trials |
| Frequent bowel movements | 5,258 | 59.4 57.7–61.2ROR 63.2 · calibrated p 3e-6 ✓ | 47.8 EB05 46.8 · IC025 +5.5 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 563.4 (406.1–781.7) | Not in label — unassessed | age-adj. PRR 62.4 · serious PRR 48.2 | not reported in cached trials |
| Arthritis enteropathic | 64 | 59.2 45.1–77.9ROR 59.3 · calibrated p 7e-6 ✓ | 47.1 EB05 38.2 · IC025 +4.7 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=62 · ♀ 76% (drug 56%) | not reported in cached trials |
| Gastrointestinal stoma output increased | 87 | 56.6 44.8–71.5ROR 56.6 · calibrated p 8e-6 ✓ | 45.6 EB05 38.1 · IC025 +4.8 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Lab value / disease marker | serious n=85 | not reported in cached trials |
| Intestinal anastomosis complication | 51 | 56.0 41.3–76.0ROR 56.1 · calibrated p 1e-5 ✓ | 44.9 EB05 35.5 · IC025 +4.5 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Reporting / coding artifact | serious n=51 · ♀ 100% (drug 56%) · 100% clinician | NCT00790933: 6/2,243 (0.3%) on Vedolizumab (serious AE) |
| Faecal calprotectin increased | 581 | 56.0 51.2–61.3ROR 56.4 · calibrated p 6e-6 ✓ | 45.6 EB05 42.5 · IC025 +5.3 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=554 | not reported in cached trials |
| Colon dysplasia | 52 | 54.6 40.4–73.8ROR 54.7 · calibrated p 1e-5 ✓ | 44.0 EB05 34.9 · IC025 +4.5 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Labeled (related wording) related wording | serious n=52 | NCT00790933: 3/2,243 (0.1%) on Vedolizumab (serious AE) |
| Pouchitis | 157 | 54.4 45.8–64.7ROR 54.5 · calibrated p 9e-6 ✓ | 44.4 EB05 38.8 · IC025 +5.0 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=151 | NCT00790933: 1/2,243 (0.0%) on Vedolizumab (serious AE) |
| Dislocation of vertebra | 402 | 53.9 48.4–60.1ROR 54.2 · calibrated p 9e-6 ✓ | 44.1 EB05 40.6 · IC025 +5.2 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=402 · ♀ 100% (drug 56%) · 96% clinician | NCT00790933: 1/2,243 (0.0%) on Vedolizumab (serious AE) |
| Catarrh | 157 | 52.4 44.1–62.3ROR 52.5 · calibrated p 1e-5 ✓ | 43.0 EB05 37.6 · IC025 +5.0 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=157 · ♀ 20% (drug 56%) · 90% clinician | not reported in cached trials |
| Bile acid malabsorption | 47 | 50.7 37.0–69.5ROR 50.7 · calibrated p 2e-5 ✓ | 41.4 EB05 32.4 · IC025 +4.4 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=47 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| X-ray abnormal | 296 | 48.6 42.9–55.0ROR 48.7 · calibrated p 2e-5 ✓ | 40.5 EB05 36.8 · IC025 +5.1 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Lab value / disease marker | serious n=296 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Female genital tract fistula | 284 | 48.3 42.5–54.8ROR 48.4 · calibrated p 2e-5 ✓ | 40.3 EB05 36.5 · IC025 +5.0 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=282 · ♀ 100% (drug 56%) | NCT00790933: 3/2,243 (0.1%) on Vedolizumab (serious AE) |
| Terminal ileitis | 97 | 46.9 37.7–58.2ROR 46.9 · calibrated p 2e-5 ✓ | 39.1 EB05 33.0 · IC025 +4.7 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=97 · 100% clinician | not reported in cached trials |
| Rectal tenesmus | 197 | 46.6 40.0–54.2ROR 46.7 · calibrated p 2e-5 ✓ | 39.0 EB05 34.7 · IC025 +4.9 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=195 | not reported in cached trials |
| Gastrointestinal mucosa hyperaemia | 47 | 46.3 33.9–63.3ROR 46.4 · calibrated p 3e-5 ✓ | 38.5 EB05 30.1 · IC025 +4.3 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=46 · 100% clinician | not reported in cached trials |
| Colorectal adenoma | 51 | 46.3 34.3–62.5ROR 46.3 · calibrated p 3e-5 ✓ | 38.5 EB05 30.4 · IC025 +4.4 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=51 | not reported in cached trials |
| Ileectomy | 53 | 45.4 33.8–60.9ROR 45.4 · calibrated p 4e-5 ✓ | 37.9 EB05 30.1 · IC025 +4.4 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=53 · 100% clinician | not reported in cached trials |
| Large intestinal stenosis | 293 | 42.5 37.5–48.1ROR 42.6 · calibrated p 4e-5 ✓ | 36.2 EB05 32.8 · IC025 +4.9 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=292 | not reported in cached trials |
| Stoma site abscess | 36 | 42.5 29.8–60.5ROR 42.5 · calibrated p 6e-5 ✓ | 35.6 EB05 26.9 · IC025 +4.1 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=35 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Proctitis | 414 | 42.3 38.1–47.0ROR 42.5 · calibrated p 4e-5 ✓ | 36.1 EB05 33.3 · IC025 +5.0 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=399 | NCT00790933: 1/2,243 (0.0%) on Vedolizumab (serious AE) |
| Pseudopolyp | 53 | 42.2 31.5–56.5ROR 42.3 · calibrated p 5e-5 ✓ | 35.7 EB05 28.3 · IC025 +4.3 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=51 | NCT00790933: 1/2,243 (0.0%) on Vedolizumab (serious AE) |
| Intestinal anastomosis | 92 | 41.9 33.6–52.3ROR 42.0 · calibrated p 5e-5 ✓ | 35.6 EB05 29.9 · IC025 +4.6 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=92 | NCT00790933: 6/2,243 (0.3%) on Vedolizumab (serious AE) |
| Stomal hernia | 53 | 41.7 31.1–55.8ROR 41.7 · calibrated p 6e-5 ✓ | 35.3 EB05 28.0 · IC025 +4.3 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=53 | not reported in cached trials |
| Anastomotic ulcer | 66 | 41.1 31.7–53.4ROR 41.2 · calibrated p 6e-5 ✓ | 35.0 EB05 28.4 · IC025 +4.4 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=66 | not reported in cached trials |
| Faecal volume decreased | 69 | 40.7 31.5–52.5ROR 40.7 · calibrated p 6e-5 ✓ | 34.6 EB05 28.3 · IC025 +4.4 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Lab value / disease marker | serious n=68 | not reported in cached trials |
| Lupus vulgaris | 169 | 40.4 34.3–47.6ROR 40.5 · calibrated p 5e-5 ✓ | 34.6 EB05 30.5 · IC025 +4.7 3/3 methods agree vs other Integrin Receptor Antagonists: only this drug | Not in label — unassessed | serious n=169 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
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 |
|---|---|---|---|
| Gi bleeding | 2,897 | 3.93.8–4.1 | signal |
| Pancreatitis | 637 | 1.91.8–2.1 | raised |
| Serious infection | 5,934 | 1.91.8–1.9 | raised |
| Interstitial lung disease | 662 | 1.71.6–1.8 | raised |
| Opportunistic infection | 865 | 1.61.5–1.7 | raised |
| Anaemia | 1,822 | 1.51.4–1.6 | raised |
| Venous thromboembolism | 1,158 | 1.31.2–1.4 | raised |
| Liver injury | 1,434 | 1.21.1–1.2 | raised |
| Depression | 1,207 | 1.11.0–1.1 | no difference |
| Malignancy | 1,548 | 1.01.0–1.1 | no difference |
| Fall / fracture | 1,534 | 1.00.9–1.0 | no difference |
| Hyperglycaemia / diabetes | 1,124 | 0.80.7–0.8 | lower than other drugs |
| Tendon disorder | 116 | 0.70.6–0.9 | lower than other drugs |
| Rhabdomyolysis / myopathy | 238 | 0.70.6–0.8 | lower than other drugs |
| Stroke | 708 | 0.70.6–0.7 | lower than other drugs |
| Anaphylaxis / angioedema | 333 | 0.60.6–0.7 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Vedolizumab 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 (9 of 40 signal terms matched).
- NCT00790933 — An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease (N=2243, PHASE3; 446 AE terms posted; arms: Vedolizumab 300 mg)
- NCT00783692 — Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (N=1116, PHASE3; 155 AE terms posted; arms: Placebo; VDZ/PBO; VDZ/VDZ)
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 22,325 | 6.4 6.4–6.5ROR 8.4 · calibrated p 0.058 | 6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 96.4 (90.3–103.0) | Reporting / coding artifact | age-adj. PRR 8.0 · serious PRR 7.3 | not reported in cached trials |
| Colitis ulcerative | 15,612 | 132.3 129.9–134.7ROR 161.5 · calibrated p 2e-9 ✓ | 85.7 EB05 84.6 · IC025 +6.4 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 661.8 (538.8–812.8) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 125.9 · serious PRR 60.4 | NCT00790933: 120/2,243 (5.3%) on Vedolizumab (serious AE) |
| Drug ineffective (drug did not work) | 9,920 | 1.9 1.8–1.9ROR 2.0 · calibrated p 0.923 | 1.8 EB05 1.8 · IC025 +0.9 vs other Integrin Receptor Antagonists: PRR 5.5 (5.4–5.7) | Reporting / coding artifact | age-adj. PRR 2.3 · serious PRR 3.1 | not reported in cached trials |
| Diarrhoea (diarrhea) | 8,699 | 3.3 3.3–3.4ROR 3.6 · calibrated p 0.459 | 3.3 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 15.0 (14.4–15.7) | Not in label — unassessed | age-adj. PRR 3.7 · serious PRR 3.7 | NCT00790933: 9/2,243 (0.4%) on Vedolizumab (serious AE) |
| Abdominal pain | 7,453 | 8.1 7.9–8.3ROR 8.8 · calibrated p 0.050 | 7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 44.6 (41.2–48.3) | Labeled adverse reaction exact term | age-adj. PRR 8.0 · serious PRR 6.8 | NCT00790933: 50/2,243 (2.2%) on Vedolizumab (serious AE) |
| Fatigue (tiredness) | 6,307 | 2.0 1.9–2.0ROR 2.1 · calibrated p 0.984 | 2.0 EB05 1.9 · IC025 +0.9 vs other Integrin Receptor Antagonists: PRR 1.2 (1.2–1.3) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.3 | NCT00790933: 3/2,243 (0.1%) on Vedolizumab (serious AE) |
| Haematochezia (blood in stool) | 6,141 | 30.6 29.9–31.4ROR 32.9 · calibrated p 2e-4 ✓ | 27.3 EB05 26.7 · IC025 +4.7 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 257.5 (209.7–316.2) | Not in label — unassessed | age-adj. PRR 30.7 · serious PRR 19.8 | NCT00790933: 1/2,243 (0.0%) on Vedolizumab (serious AE) |
| Frequent bowel movements | 5,258 | 59.4 57.7–61.2ROR 63.2 · calibrated p 3e-6 ✓ | 47.8 EB05 46.8 · IC025 +5.5 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 563.4 (406.1–781.7) | Not in label — unassessed | age-adj. PRR 62.4 · serious PRR 48.2 | not reported in cached trials |
| Arthralgia (joint pain) | 4,739 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.650 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 6.0 (5.7–6.3) | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.9 | NCT00790933: 3/2,243 (0.1%) on Vedolizumab (serious AE) |
| Malaise (feeling unwell) | 4,327 | 2.4 2.4–2.5ROR 2.5 · calibrated p 0.813 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 2.3 (2.2–2.3) | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.6 | NCT00790933: 2/2,243 (0.1%) on Vedolizumab (serious AE) |
| Nausea | 4,156 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.512 | 1.3 EB05 1.3 · IC025 +0.3 vs other Integrin Receptor Antagonists: PRR 3.7 (3.6–3.9) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.5 | NCT00790933: 7/2,243 (0.3%) on Vedolizumab (serious AE) |
| Headache | 4,117 | 1.6 1.6–1.7ROR 1.6 · calibrated p 0.735 | 1.6 EB05 1.6 · IC025 +0.6 vs other Integrin Receptor Antagonists: PRR 1.6 (1.5–1.6) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 2.0 | NCT00790933: 4/2,243 (0.2%) on Vedolizumab (serious AE) |
| Inappropriate schedule of product administration | 4,036 | 5.7 5.5–5.9ROR 5.9 · calibrated p 0.155 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 28.1 (25.7–30.7) | Reporting / coding artifact | age-adj. PRR 6.0 · serious PRR 8.7 | not reported in cached trials |
| Product dose omission issue | 3,817 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.504 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 16.2 (15.1–17.3) | Reporting / coding artifact | age-adj. PRR 3.5 · serious PRR 7.4 | not reported in cached trials |
| Weight decreased (weight loss) | 3,189 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.663 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Integrin Receptor Antagonists: PRR 8.6 (8.1–9.1) | Not in label — unassessed | age-adj. PRR 2.9 · serious PRR 2.7 | NCT00790933: 2/2,243 (0.1%) on Vedolizumab (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.
- Vaginal flatulence — n=190, PRR 408.2
- Gastrointestinal anastomotic stenosis — n=37, PRR 153.5
- Loss of therapeutic response — n=1,023, PRR 125.6
- Subcutaneous drug absorption impaired — n=176, PRR 117.0
- Ileocaecal resection — n=106, PRR 114.9
- Steroid dependence — n=241, PRR 97.0
- Mucous stools — n=1,318, PRR 89.5
- Catheter site injury — n=50, PRR 75.7
- Defaecation urgency — n=1,521, PRR 68.3
- Proctocolectomy — n=62, PRR 62.9
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 Vedolizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Vedolizumab are colitis ulcerative, diarrhoea, abdominal pain, fatigue, haematochezia, frequent bowel movements. 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 Vedolizumab have an FDA boxed warning?
No. The FDA label retrieved for Vedolizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vedolizumab 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 6e94621c-1a95-4af9-98d1-52b9e6f1949c, effective 20260429; matched on
openfda.generic_name.exact:"VEDOLIZUMAB" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,263 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
VEDOLIZUMAB, 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.