Drug · FAERS side-effect profile with label screen
Obinutuzumab side effects: what 16,345 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
16,345 reports · 84% serious · 2,164 with death outcome · 41% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Lab value / disease marker 1No label text to screen 39
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 976 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 |
|---|---|---|---|---|---|---|
| Follicular lymphoma refractory | 26 | 996.1 595.9–1,664.9ROR 997.6 · χ² 13,904 / p <1e-300 | 395.0 EB05 283.3 · IC025 +4.9 3/3 methods agree | No label text to screen | serious n=26 · 100% clinician | no trial data cached |
| Follicular lymphoma recurrent | 31 | 979.8 613.1–1,565.7ROR 981.6 · χ² 16,529 / p <1e-300 | 411.6 EB05 303.8 · IC025 +5.2 3/3 methods agree | No label text to screen | serious n=31 · 100% clinician | no trial data cached |
| Follicular lymphoma | 176 | 334.1 283.2–394.2ROR 337.7 · χ² 45,969 / p <1e-300 | 257.1 EB05 226.8 · IC025 +7.0 3/3 methods agree | No label text to screen | serious n=170 | no trial data cached |
| Mantle cell lymphoma refractory | 13 | 328.7 178.6–604.9ROR 329.0 · χ² 3,115 / p <1e-300 | 189.0 EB05 117.6 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=13 | no trial data cached |
| Autologous haematopoietic stem cell transplant | 14 | 242.5 136.9–429.4ROR 242.7 · χ² 2,626 / p <1e-300 | 159.7 EB05 101.1 · IC025 +3.8 3/3 methods agree | No label text to screen | serious n=14 | no trial data cached |
| Apoptotic colonopathy | 11 | 198.7 105.2–375.1ROR 198.8 · χ² 1,703 / p <1e-300 | 132.8 EB05 79.1 · IC025 +3.3 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Meningitis enteroviral | 11 | 180.6 96.0–339.6ROR 180.7 · χ² 1,565 / p <1e-300 | 124.6 EB05 74.2 · IC025 +3.3 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Chronic lymphocytic leukaemia recurrent | 83 | 174.6 138.9–219.5ROR 175.5 · χ² 12,436 / p <1e-300 | 148.3 EB05 123.4 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=78 | no trial data cached |
| Bacillus bacteraemia | 13 | 171.2 95.9–305.5ROR 171.3 · χ² 1,790 / p <1e-300 | 123.9 EB05 77.1 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=13 | no trial data cached |
| Lymphoma transformation | 40 | 160.0 115.2–222.3ROR 160.4 · χ² 5,471 / p <1e-300 | 133.2 EB05 102.1 · IC025 +5.2 3/3 methods agree | No label text to screen | serious n=40 | no trial data cached |
| B-lymphocyte abnormalities | 15 | 151.7 88.8–259.1ROR 151.8 · χ² 1,873 / p <1e-300 | 115.9 EB05 74.6 · IC025 +3.8 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Reticulocytopenia | 13 | 126.4 71.5–223.5ROR 126.5 · χ² 1,359 / p 1e-297 | 98.8 EB05 61.4 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=13 | no trial data cached |
| Refractory cancer | 17 | 109.1 66.5–179.0ROR 109.2 · χ² 1,578 / p <1e-300 | 90.6 EB05 59.9 · IC025 +3.9 3/3 methods agree | No label text to screen | serious n=17 | no trial data cached |
| Leukaemic infiltration | 10 | 98.8 51.9–187.9ROR 98.8 · χ² 809 / p 3e-178 | 78.5 EB05 45.5 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=10 | no trial data cached |
| B-cell lymphoma recurrent | 37 | 93.9 67.3–131.1ROR 94.1 · χ² 3,081 / p <1e-300 | 83.8 EB05 63.5 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=33 · 92% clinician | no trial data cached |
| Listeria sepsis | 16 | 81.9 49.4–135.7ROR 82.0 · χ² 1,126 / p 4e-247 | 70.7 EB05 46.2 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=16 | no trial data cached |
| Organic brain syndrome | 11 | 79.0 43.0–145.3ROR 79.1 · χ² 726 / p 4e-160 | 66.3 EB05 39.5 · IC025 +3.1 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Aspergillus infection | 367 | 76.9 69.3–85.4ROR 78.6 · χ² 25,855 / p <1e-300 | 72.3 EB05 66.3 · IC025 +5.9 3/3 methods agree | No label text to screen | serious n=366 | no trial data cached |
| Tumour flare | 38 | 75.5 54.5–104.7ROR 75.7 · χ² 2,567 / p <1e-300 | 69.0 EB05 52.4 · IC025 +4.7 3/3 methods agree | No label text to screen | serious n=38 · 100% clinician | no trial data cached |
| Hypertensive cardiomyopathy | 15 | 71.8 42.7–120.8ROR 71.9 · χ² 925 / p 1e-203 | 62.8 EB05 40.4 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Cerebral aspergillosis | 31 | 68.2 47.5–97.8ROR 68.3 · χ² 1,883 / p <1e-300 | 62.4 EB05 46.0 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=31 · ♀ 0% (drug 41%) · 94% clinician | no trial data cached |
| Post-acute covid-19 syndrome | 53 | 57.4 43.6–75.6ROR 57.6 · χ² 2,757 / p <1e-300 | 54.0 EB05 42.8 · IC025 +4.7 3/3 methods agree | No label text to screen | serious n=51 · 100% clinician | no trial data cached |
| Cytopenia | 469 | 52.4 47.8–57.3ROR 53.9 · χ² 22,650 / p <1e-300 | 50.2 EB05 46.5 · IC025 +5.4 3/3 methods agree | No label text to screen | serious PRR 35.0 | no trial data cached |
| Tumour lysis syndrome | 325 | 49.5 44.4–55.3ROR 50.5 · χ² 14,828 / p <1e-300 | 47.6 EB05 43.4 · IC025 +5.3 3/3 methods agree | No label text to screen | serious PRR 32.4 · 93% clinician | no trial data cached |
| Hypogammaglobulinaemia | 238 | 49.4 43.4–56.2ROR 50.1 · χ² 10,820 / p <1e-300 | 47.4 EB05 42.6 · IC025 +5.2 3/3 methods agree | No label text to screen | serious n=233 · 98% clinician | no trial data cached |
| Bacillus infection | 21 | 44.5 28.8–68.8ROR 44.6 · χ² 822 / p 5e-181 | 41.6 EB05 28.7 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=21 · 100% clinician | no trial data cached |
| Cytomegalovirus chorioretinitis | 58 | 39.7 30.6–51.6ROR 39.9 · χ² 2,085 / p <1e-300 | 38.1 EB05 30.6 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=57 · 91% clinician | no trial data cached |
| Retroperitoneal lymphadenopathy | 15 | 37.6 22.5–62.7ROR 37.6 · χ² 483 / p 2e-107 | 35.0 EB05 22.5 · IC025 +3.2 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Mantle cell lymphoma recurrent | 12 | 36.9 20.8–65.5ROR 36.9 · χ² 373 / p 2e-83 | 34.1 EB05 20.8 · IC025 +2.9 3/3 methods agree | No label text to screen | serious n=12 | no trial data cached |
| Measles | 15 | 36.7 22.0–61.3ROR 36.7 · χ² 472 / p 6e-105 | 34.3 EB05 22.0 · IC025 +3.2 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Cytomegalovirus enterocolitis | 21 | 36.3 23.5–56.0ROR 36.4 · χ² 667 / p 2e-147 | 34.3 EB05 23.7 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=20 · 90% clinician | no trial data cached |
| Humoral immune defect | 10 | 35.4 18.9–66.4ROR 35.4 · χ² 293 / p 7e-66 | 32.5 EB05 18.8 · IC025 +2.7 3/3 methods agree | No label text to screen | serious n=9 | no trial data cached |
| Covid-19 pneumonia | 316 | 35.0 31.3–39.1ROR 35.7 · χ² 10,126 / p <1e-300 | 34.0 EB05 31.0 · IC025 +4.8 3/3 methods agree | No label text to screen | serious PRR 23.6 · 97% clinician | no trial data cached |
| Cytokine release syndrome | 506 | 35.0 32.0–38.1ROR 36.0 · χ² 16,225 / p <1e-300 | 34.0 EB05 31.6 · IC025 +4.9 3/3 methods agree | No label text to screen | serious PRR 23.1 · 98% clinician | no trial data cached |
| Bladder hypertrophy | 11 | 33.0 18.1–60.0ROR 33.0 · χ² 302 / p 7e-68 | 30.6 EB05 18.1 · IC025 +2.7 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Neutropenic infection | 24 | 32.6 21.8–48.9ROR 32.7 · χ² 687 / p 1e-151 | 31.1 EB05 22.0 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=24 · ♀ 62% (drug 41%) · 100% clinician | no trial data cached |
| Diffuse large b-cell lymphoma recurrent | 53 | 32.4 24.7–42.6ROR 32.5 · χ² 1,543 / p <1e-300 | 31.3 EB05 24.9 · IC025 +4.2 3/3 methods agree | No label text to screen | serious n=53 | no trial data cached |
| Blood immunoglobulin g decreased | 58 | 31.2 24.1–40.5ROR 31.3 · χ² 1,628 / p <1e-300 | 30.2 EB05 24.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=57 | no trial data cached |
| Diffuse large b-cell lymphoma refractory | 22 | 31.0 20.3–47.4ROR 31.1 · χ² 595 / p 9e-132 | 29.6 EB05 20.6 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=22 · 100% clinician | no trial data cached |
| Chronic lymphocytic leukaemia | 111 | 30.5 25.3–36.8ROR 30.7 · χ² 3,069 / p <1e-300 | 29.7 EB05 25.4 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=109 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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) | 1,864 | 2.8 2.6–2.9ROR 3.0 · χ² 2,172 / p <1e-300 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 91% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 1,355 | 12.9 12.3–13.6ROR 14.0 · χ² 14,866 / p <1e-300 | 12.8 EB05 12.3 · IC025 +3.6 3/3 methods agree | No label text to screen | serious PRR 8.6 | no trial data cached |
| Covid-19 | 1,091 | 7.9 7.5–8.4ROR 8.4 · χ² 6,636 / p <1e-300 | 7.9 EB05 7.5 · IC025 +2.9 3/3 methods agree | No label text to screen | serious PRR 8.7 · 94% clinician | no trial data cached |
| Febrile neutropenia | 1,042 | 20.5 19.3–21.7ROR 21.8 · χ² 19,044 / p <1e-300 | 20.2 EB05 19.2 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 13.9 | no trial data cached |
| Pyrexia (fever) | 994 | 3.7 3.5–3.9ROR 3.9 · χ² 1,972 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen | serious PRR 2.8 | no trial data cached |
| Thrombocytopenia (low platelets) | 927 | 10.7 10.1–11.4ROR 11.3 · χ² 8,154 / p <1e-300 | 10.6 EB05 10.1 · IC025 +3.3 3/3 methods agree | No label text to screen | serious PRR 7.1 | no trial data cached |
| Disease progression | 926 | 10.1 9.5–10.8ROR 10.7 · χ² 7,602 / p <1e-300 | 10.0 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 854 | 16.8 15.7–17.9ROR 17.7 · χ² 12,533 / p <1e-300 | 16.6 EB05 15.7 · IC025 +3.9 3/3 methods agree | No label text to screen | serious PRR 10.7 · 94% clinician | no trial data cached |
| Pneumonia (lung infection) | 790 | 3.1 2.9–3.4ROR 3.2 · χ² 1,164 / p 2e-255 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen | serious PRR 2.2 | no trial data cached |
| Anaemia (low red blood cells) | 722 | 4.9 4.5–5.2ROR 5.0 · χ² 2,225 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.2 3/3 methods agree | No label text to screen | serious PRR 3.6 | no trial data cached |
| Infection | 608 | 5.4 5.0–5.9ROR 5.6 · χ² 2,196 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 4.6 | no trial data cached |
| Atrial fibrillation | 598 | 7.9 7.3–8.6ROR 8.2 · χ² 3,593 / p <1e-300 | 7.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen | serious PRR 5.5 | no trial data cached |
| Death | 545 | 0.8 0.7–0.9ROR 0.8 · χ² 25 / p 3e-7 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.6 | no trial data cached |
| Nausea | 526 | 0.9 0.8–0.9ROR 0.8 · χ² 13 / p 1e-4 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | No label text to screen | serious PRR 0.8 | no trial data cached |
| Myelosuppression | 520 | 19.9 18.3–21.7ROR 20.5 · χ² 9,180 / p <1e-300 | 19.6 EB05 18.2 · IC025 +4.1 3/3 methods agree | No label text to screen | serious PRR 13.0 · 98% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Obinutuzumab?
In FDA FAERS, the most frequently co-reported reaction terms for Obinutuzumab are neutropenia, covid-19, febrile neutropenia, pyrexia, thrombocytopenia, infusion related reaction. 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 Obinutuzumab have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Obinutuzumab 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 1,016 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.