Drug · FAERS side-effect profile with label screen
Ocrelizumab side effects: what 61,582 FDA adverse event reports show
Drug class
CD20-directed Cytolytic Antibody
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Ocrevus
openFDA label
Who reports
61,582 reports · 50% serious · 1,519 with death outcome · 73% female
openFDA FAERS counts, all years, deduplication not applied
Used for
OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more.
FDA label, Indications and Usage
What it is
Ocrelizumab is a recombinant humanized monoclonal antibody directed against CD20-expressing B-cells. Ocrelizumab is a glycosylated immunoglobulin G1 (IgG1) with a molecular mass of approximately 145 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 adverse reaction 3Labeled (related wording) 2Likely indication confounding 3Reporting / coding artifact 4Lab value / disease marker 14Not in label — unassessed 14
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). 1,144 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 |
|---|---|---|---|---|---|---|
| Sars-cov-2 antibody test negative | 258 | 397.9 332.2–476.5ROR 399.5 · calibrated p 8e-13 ✓ | 179.9 EB05 162.2 · IC025 +6.9 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Reporting / coding artifact | serious n=153 · 73% consumer | not reported in cached trials |
| Magnetic resonance imaging spinal abnormal | 61 | 351.9 245.7–504.1ROR 352.3 · calibrated p 9e-12 ✓ | 163.3 EB05 131.7 · IC025 +5.7 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=57 · 77% consumer | not reported in cached trials |
| Cd19 lymphocytes decreased | 62 | 314.4 222.3–444.6ROR 314.7 · calibrated p 2e-11 ✓ | 154.9 EB05 125.2 · IC025 +5.7 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 264.6 (160.0–437.6) | Lab value / disease marker | serious n=28 | not reported in cached trials |
| Jc polyomavirus test positive | 552 | 302.8 270.0–339.7ROR 305.5 · calibrated p 9e-12 ✓ | 158.6 EB05 147.8 · IC025 +7.0 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 981.5 (731.9–1,316.3) | Lab value / disease marker | serious n=287 | not reported in cached trials |
| Relapsing multiple sclerosis | 114 | 202.9 160.8–256.0ROR 203.3 · calibrated p 6e-10 ✓ | 124.1 EB05 106.1 · IC025 +6.0 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 405.4 (261.3–629.0) | Likely indication confounding term in indications; also in warnings | serious n=113 | not reported in cached trials |
| B-lymphocyte count decreased | 495 | 198.4 177.6–221.6ROR 200.0 · calibrated p 4e-10 ✓ | 124.3 EB05 115.4 · IC025 +6.6 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 84.2 (74.6–94.9) | Lab value / disease marker | serious n=302 | not reported in cached trials |
| B-lymphocyte count increased | 68 | 197.9 146.6–267.0ROR 198.1 · calibrated p 1e-9 ✓ | 120.6 EB05 98.4 · IC025 +5.6 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Lab value / disease marker | serious n=36 | not reported in cached trials |
| B-lymphocyte abnormalities | 47 | 169.1 119.1–240.2ROR 169.2 · calibrated p 5e-9 ✓ | 107.8 EB05 84.4 · IC025 +5.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=38 · ♀ 100% (drug 73%) | not reported in cached trials |
| Multiple sclerosis pseudo relapse | 82 | 112.5 87.6–144.4ROR 112.6 · calibrated p 7e-8 ✓ | 82.8 EB05 68.9 · IC025 +5.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 102.9 (74.7–141.8) | Labeled (related wording) related wording | serious n=74 · 72% consumer | not reported in cached trials |
| Antibody test negative | 41 | 87.9 62.4–124.0ROR 88.0 · calibrated p 6e-7 ✓ | 67.7 EB05 52.1 · IC025 +4.7 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Reporting / coding artifact | serious n=17 · 100% consumer | not reported in cached trials |
| Paranasal sinus mucosal hypertrophy | 24 | 86.4 55.1–135.3ROR 86.4 · calibrated p 1e-6 ✓ | 65.4 EB05 46.3 · IC025 +4.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=20 | not reported in cached trials |
| B-lymphocyte count abnormal | 20 | 82.6 50.7–134.8ROR 82.7 · calibrated p 2e-6 ✓ | 62.7 EB05 42.8 · IC025 +3.9 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Lab value / disease marker | – | not reported in cached trials |
| Magnetic resonance imaging abnormal | 230 | 82.6 71.5–95.4ROR 82.9 · calibrated p 5e-7 ✓ | 66.1 EB05 59.2 · IC025 +5.6 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 577.4 (403.3–826.6) | Reporting / coding artifact | serious n=175 | not reported in cached trials |
| Blood immunoglobulin m decreased | 172 | 70.8 60.1–83.4ROR 71.0 · calibrated p 2e-6 ✓ | 58.2 EB05 51.3 · IC025 +5.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 57.3 (47.4–69.4) | Lab value / disease marker | serious n=77 | not reported in cached trials |
| Paraesthesia ear | 23 | 63.1 40.4–98.5ROR 63.1 · calibrated p 8e-6 ✓ | 51.1 EB05 35.9 · IC025 +4.0 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=23 · ♀ 100% (drug 73%) | NCT03085810: 98/1,225 (8.0%) on Ocrelizumab |
| Cystitis noninfective | 208 | 62.4 53.8–72.4ROR 62.6 · calibrated p 3e-6 ✓ | 52.5 EB05 46.8 · IC025 +5.3 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=169 · 77% consumer | not reported in cached trials |
| Magnetic resonance imaging head abnormal | 88 | 53.6 42.8–67.2ROR 53.7 · calibrated p 1e-5 ✓ | 45.9 EB05 38.4 · IC025 +4.9 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=78 · 77% consumer | not reported in cached trials |
| Atonic urinary bladder | 26 | 52.1 34.5–78.8ROR 52.1 · calibrated p 2e-5 ✓ | 43.9 EB05 31.5 · IC025 +4.0 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=25 · 100% consumer | not reported in cached trials |
| Human papilloma virus test positive | 52 | 49.4 37.0–66.1ROR 49.5 · calibrated p 2e-5 ✓ | 42.6 EB05 33.7 · IC025 +4.5 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Lab value / disease marker | serious n=24 · ♀ 100% (drug 73%) | not reported in cached trials |
| Primary progressive multiple sclerosis | 60 | 48.0 36.7–63.0ROR 48.1 · calibrated p 2e-5 ✓ | 41.6 EB05 33.5 · IC025 +4.5 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Likely indication confounding term in indications; also in warnings | serious n=57 | not reported in cached trials |
| T-lymphocyte count increased | 23 | 47.5 30.7–73.5ROR 47.5 · calibrated p 4e-5 ✓ | 40.4 EB05 28.4 · IC025 +3.8 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Lab value / disease marker | ♀ 100% (drug 73%) | not reported in cached trials |
| Blood immunoglobulin g decreased | 275 | 43.2 38.1–49.0ROR 43.4 · calibrated p 3e-5 ✓ | 38.3 EB05 34.6 · IC025 +5.0 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 56.8 (48.9–66.0) | Lab value / disease marker | serious n=168 | not reported in cached trials |
| Immunoglobulins decreased | 153 | 42.8 36.2–50.6ROR 42.9 · calibrated p 4e-5 ✓ | 37.9 EB05 33.1 · IC025 +4.8 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 63.4 (51.5–78.0) | Lab value / disease marker | serious n=96 | not reported in cached trials |
| Nasal herpes | 22 | 41.4 26.6–64.4ROR 41.4 · calibrated p 9e-5 ✓ | 35.9 EB05 25.0 · IC025 +3.6 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | ♀ 100% (drug 73%) | not reported in cached trials |
| Sars-cov-2 test positive | 1,427 | 40.6 38.5–42.9ROR 41.6 · calibrated p 4e-5 ✓ | 36.3 EB05 34.8 · IC025 +5.1 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 237.4 (215.6–261.4) | Lab value / disease marker | serious n=246 · 76% consumer | not reported in cached trials |
| Decreased vibratory sense | 33 | 36.7 25.6–52.6ROR 36.7 · calibrated p 1e-4 ✓ | 32.6 EB05 24.3 · IC025 +3.9 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Ear pruritus | 301 | 32.1 28.6–36.2ROR 32.3 · calibrated p 2e-4 ✓ | 29.4 EB05 26.7 · IC025 +4.6 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 47.3 (41.2–54.3) | Labeled (related wording) related wording | serious n=118 | not reported in cached trials |
| Relapsing-remitting multiple sclerosis | 71 | 30.4 23.9–38.8ROR 30.5 · calibrated p 3e-4 ✓ | 27.8 EB05 22.8 · IC025 +4.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 123.7 (86.0–177.8) | Labeled adverse reaction exact term | serious n=68 | not reported in cached trials |
| T-lymphocyte count decreased | 54 | 29.1 22.1–38.5ROR 29.2 · calibrated p 4e-4 ✓ | 26.7 EB05 21.2 · IC025 +4.0 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 354.5 (193.6–649.1) | Lab value / disease marker | serious n=26 | not reported in cached trials |
| Expanded disability status scale score increased | 93 | 27.4 22.2–33.8ROR 27.4 · calibrated p 5e-4 ✓ | 25.3 EB05 21.3 · IC025 +4.1 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 70.9 (53.9–93.2) | Lab value / disease marker | serious n=86 | not reported in cached trials |
| Genital herpes | 114 | 27.2 22.5–32.9ROR 27.2 · calibrated p 5e-4 ✓ | 25.1 EB05 21.5 · IC025 +4.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Labeled adverse reaction exact term | serious n=66 · ♀ 94% (drug 73%) | NCT03085810: 1/1,225 (0.1%) on Ocrelizumab (serious AE) |
| Maternal exposure before pregnancy | 486 | 26.1 23.8–28.7ROR 26.3 · calibrated p 5e-4 ✓ | 24.3 EB05 22.5 · IC025 +4.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 276.5 (230.8–331.3) | Reporting / coding artifact | serious n=280 · ♀ 100% (drug 73%) | not reported in cached trials |
| Babesiosis | 20 | 26.0 16.5–41.0ROR 26.0 · calibrated p 1e-3 ✓ | 23.7 EB05 16.2 · IC025 +3.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Labeled adverse reaction exact term | serious n=19 | not reported in cached trials |
| Bacterial vulvovaginitis | 20 | 25.5 16.2–40.2ROR 25.6 · calibrated p 0.001 ✓ | 23.3 EB05 15.9 · IC025 +3.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Nail bed inflammation | 22 | 25.2 16.3–38.9ROR 25.2 · calibrated p 0.001 ✓ | 23.1 EB05 16.0 · IC025 +3.3 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=21 · 100% consumer | not reported in cached trials |
| Blood immunoglobulin a decreased | 43 | 24.0 17.6–32.7ROR 24.0 · calibrated p 0.001 ✓ | 22.3 EB05 17.2 · IC025 +3.7 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 22.4 (16.0–31.3) | Lab value / disease marker | serious n=24 | not reported in cached trials |
| Covid-19 | 11,573 | 23.8 23.4–24.2ROR 29.0 · calibrated p 3e-4 ✓ | 22.2 EB05 21.9 · IC025 +4.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 110.2 (110.2–110.2) | Not in label — unassessed | serious PRR 15.5 | NCT03085810: 23/1,225 (1.9%) on Ocrelizumab (serious AE) |
| West nile viral infection | 47 | 23.5 17.5–31.5ROR 23.5 · calibrated p 0.001 ✓ | 21.8 EB05 17.1 · IC025 +3.7 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Borrelia infection | 20 | 23.2 14.7–36.4ROR 23.2 · calibrated p 0.002 ✓ | 21.3 EB05 14.5 · IC025 +3.1 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: only this drug | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Multiple sclerosis | 3,026 | 22.8 22.0–23.6ROR 23.9 · calibrated p 8e-4 ✓ | 21.4 EB05 20.8 · IC025 +4.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 128.1 (122.1–134.4) | Likely indication confounding term in indications; also in warnings | serious PRR 32.7 · 71% consumer | NCT03085810: 9/1,225 (0.7%) on Ocrelizumab (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ocrelizumab 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 (4 of 40 signal terms matched).
- NCT03085810 — Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remit (N=1225, PHASE3; 157 AE terms posted; arms: Ocrelizumab; Substudy - Conventional Infusion; Substudy - Shorter Infusion)
- NCT03599245 — This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Par (N=1055, PHASE3; 151 AE terms posted; arms: CASTING Cohort; ENSEMBLE Cohort)
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 |
|---|---|---|---|---|---|---|
| Covid-19 | 11,573 | 23.8 23.4–24.2ROR 29.0 · calibrated p 3e-4 ✓ | 22.2 EB05 21.9 · IC025 +4.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 110.2 (110.2–110.2) | Not in label — unassessed | serious PRR 15.5 | NCT03085810: 23/1,225 (1.9%) on Ocrelizumab (serious AE) |
| Fatigue (tiredness) | 6,216 | 2.7 2.7–2.8ROR 2.9 · calibrated p 0.649 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 22.9 (22.9–22.9) | Labeled adverse reaction exact term | serious PRR 3.2 · 75% consumer | NCT03085810: 201/1,225 (16.4%) on Ocrelizumab |
| Urinary tract infection (bladder infection) | 3,781 | 7.7 7.5–8.0ROR 8.2 · calibrated p 0.063 | 7.6 EB05 7.4 · IC025 +2.9 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 77.5 (75.0–80.0) | Not in label — unassessed | serious PRR 9.5 | NCT03085810: 5/1,225 (0.4%) on Ocrelizumab (serious AE) |
| Headache | 3,265 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.842 | 1.8 EB05 1.7 · IC025 +0.8 vs other CD20-directed Cytolytic Antibodys: PRR 18.7 (18.3–19.2) | Labeled adverse reaction exact term | serious PRR 2.3 · 73% consumer | NCT03085810: 1/1,225 (0.1%) on Ocrelizumab (serious AE) |
| Multiple sclerosis | 3,026 | 22.8 22.0–23.6ROR 23.9 · calibrated p 8e-4 ✓ | 21.4 EB05 20.8 · IC025 +4.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 128.1 (122.1–134.4) | Likely indication confounding term in indications; also in warnings | serious PRR 32.7 · 71% consumer | NCT03085810: 9/1,225 (0.7%) on Ocrelizumab (serious AE) |
| Multiple sclerosis relapse | 2,727 | 13.9 13.4–14.5ROR 14.5 · calibrated p 0.008 ✓ | 13.4 EB05 13.0 · IC025 +3.7 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 107.6 (102.5–112.8) | Labeled (related wording) related wording | serious PRR 20.1 | NCT03085810: 9/1,225 (0.7%) on Ocrelizumab (serious AE) |
| Gait disturbance | 2,716 | 4.9 4.7–5.1ROR 5.0 · calibrated p 0.229 | 4.8 EB05 4.7 · IC025 +2.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 47.5 (45.8–49.2) | Not in label — unassessed | serious PRR 5.7 · 78% consumer | not reported in cached trials |
| Asthenia (weakness) | 2,706 | 2.5 2.4–2.6ROR 2.5 · calibrated p 0.802 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 28.3 (27.4–29.2) | Not in label — unassessed | serious PRR 2.7 · 73% consumer | not reported in cached trials |
| Nasopharyngitis (common cold) | 2,569 | 4.8 4.6–5.0ROR 4.9 · calibrated p 0.240 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 25.6 (24.8–26.4) | Labeled adverse reaction exact term | serious PRR 5.5 · 74% consumer | NCT03085810: 320/1,225 (26.1%) on Ocrelizumab |
| Pain | 2,540 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.591 | 1.4 EB05 1.4 · IC025 +0.4 vs other CD20-directed Cytolytic Antibodys: PRR 10.1 (9.8–10.3) | Labeled adverse reaction exact term | serious PRR 1.6 · 77% consumer | NCT03085810: 1/1,225 (0.1%) on Ocrelizumab (serious AE) |
| Fall | 2,527 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.745 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 45.5 (43.8–47.3) | Not in label — unassessed | serious PRR 2.7 · 75% consumer | not reported in cached trials |
| Pneumonia (lung infection) | 2,448 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.750 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 15.0 (14.5–15.5) | Labeled (related wording) related wording | serious PRR 2.9 | NCT03085810: 17/1,225 (1.4%) on Ocrelizumab (serious AE) |
| Off label use (used outside approved label) | 2,445 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.278 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other CD20-directed Cytolytic Antibodys: PRR 4.6 (4.5–4.7) | Reporting / coding artifact | serious PRR 1.3 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,440 | 0.6 0.6–0.7ROR 0.6 · calibrated p 0.091 | 0.6 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC vs other CD20-directed Cytolytic Antibodys: PRR 5.9 (5.7–6.1) | Reporting / coding artifact | serious PRR 0.9 · 77% consumer | not reported in cached trials |
| Infusion related reaction (reaction during infusion) | 2,215 | 11.8 11.3–12.3ROR 12.2 · calibrated p 0.016 ✓ | 11.4 EB05 11.0 · IC025 +3.4 3/3 methods agree vs other CD20-directed Cytolytic Antibodys: PRR 12.9 (12.5–13.4) | Labeled (related wording) related wording | serious PRR 9.0 | NCT03085810: 6/1,225 (0.5%) on Ocrelizumab (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.
- Magnetic resonance imaging spinal abnormal — n=61, PRR 351.9
- B-lymphocyte abnormalities — n=47, PRR 169.1
- Paranasal sinus mucosal hypertrophy — n=24, PRR 86.4
- Paraesthesia ear — n=23, PRR 63.1 (also seen in trial arm)
- Cystitis noninfective — n=208, PRR 62.4
- Magnetic resonance imaging head abnormal — n=88, PRR 53.6
- Atonic urinary bladder — n=26, PRR 52.1
- Nasal herpes — n=22, PRR 41.4
- Decreased vibratory sense — n=33, PRR 36.7
- Bacterial vulvovaginitis — n=20, PRR 25.5
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 Ocrelizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Ocrelizumab are covid-19, fatigue, urinary tract infection, headache, multiple sclerosis, multiple sclerosis relapse. 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 Ocrelizumab have an FDA boxed warning?
No. The FDA label retrieved for Ocrelizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ocrelizumab 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 9da42362-3bb5-4b83-b4bb-b59fd4e55f0d, effective 20260514; matched on
openfda.generic_name.exact:"OCRELIZUMAB") - 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, 1,184 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
OCRELIZUMAB, 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.