Drug · FAERS side-effect profile with label screen
Tremelimumab side effects: what 4,214 FDA adverse event reports show
Drug class
CTLA-4-directed Blocking Antibody
FDA label (Established Pharmacologic Class)
Brand names
Imjudo
openFDA label
Who reports
4,214 reports · 97% serious · 1,203 with death outcome · 27% female
openFDA FAERS counts, all years, deduplication not applied
Used for
IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalu.
FDA label, Indications and Usage
What it is
Tremelimumab-actl, a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking human IgG2 monoclonal antibody, is produced by recombinant DNA technology in NS0 cell suspension culture and has a molecular weight of 149 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 16Labeled (related wording) 8Reporting / coding artifact 1Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 13
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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 66 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 |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 173 | 45.6 39.4–52.8ROR 47.5 · χ² 7,434 / p <1e-300 | 44.9 EB05 39.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · 99% clinician | no trial data cached |
| Myocarditis | 98 | 43.4 35.7–52.8ROR 44.4 · χ² 3,985 / p <1e-300 | 42.7 EB05 36.1 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.6 · 97% clinician | no trial data cached |
| Adrenal insufficiency | 93 | 38.9 31.8–47.6ROR 39.8 · χ² 3,374 / p <1e-300 | 38.4 EB05 32.2 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.2 · 99% clinician | no trial data cached |
| Colitis | 186 | 24.7 21.4–28.4ROR 25.8 · χ² 4,188 / p <1e-300 | 24.5 EB05 21.7 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 · 97% clinician | no trial data cached |
| Pneumonitis | 101 | 18.6 15.4–22.6ROR 19.1 · χ² 1,665 / p <1e-300 | 18.5 EB05 15.7 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 · 96% clinician | no trial data cached |
| Hepatic encephalopathy | 30 | 16.0 11.2–22.9ROR 16.1 · χ² 407 / p 1e-90 | 15.7 EB05 11.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 100% clinician | no trial data cached |
| Liver disorder | 128 | 14.4 12.1–17.1ROR 14.8 · χ² 1,583 / p <1e-300 | 14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 · 100% clinician | no trial data cached |
| Hepatitis (liver inflammation) | 71 | 13.8 11.0–17.4ROR 14.1 · χ² 831 / p 5e-183 | 13.7 EB05 11.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · 93% clinician | no trial data cached |
| Malignant neoplasm progression | 280 | 13.7 12.2–15.4ROR 14.6 · χ² 3,292 / p <1e-300 | 13.6 EB05 12.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 · 95% clinician | no trial data cached |
| Hepatic function abnormal | 93 | 12.5 10.2–15.3ROR 12.8 · χ² 972 / p 9e-214 | 12.4 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · 99% clinician | no trial data cached |
| Drug-induced liver injury | 68 | 11.0 8.7–13.9ROR 11.2 · χ² 607 / p 3e-134 | 10.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 93% clinician | no trial data cached |
| Interstitial lung disease | 91 | 9.4 7.7–11.5ROR 9.6 · χ² 673 / p 9e-149 | 9.1 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · ♀ 5% (drug 27%) · 99% clinician | no trial data cached |
| Metastases to lung | 21 | 9.1 5.9–13.9ROR 9.1 · χ² 142 / p 4e-33 | 8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 95% clinician | no trial data cached |
| Hypothyroidism | 54 | 8.4 6.5–11.0ROR 8.5 · χ² 347 / p 9e-78 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 96% clinician | no trial data cached |
| Neutrophil count decreased | 67 | 8.2 6.5–10.4ROR 8.4 · χ² 419 / p 2e-93 | 7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 97% clinician | no trial data cached |
| Hyperthyroidism | 23 | 7.9 5.3–11.9ROR 8.0 · χ² 132 / p 7e-31 | 7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 96% clinician | no trial data cached |
| Metastases to bone | 25 | 7.6 5.1–11.3ROR 7.6 · χ² 137 / p 6e-32 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 100% clinician | no trial data cached |
| Erythema multiforme | 14 | 7.5 4.4–12.6ROR 7.5 · χ² 72 / p 1e-17 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Sudden death | 16 | 7.5 4.6–12.2ROR 7.5 · χ² 83 / p 4e-20 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.4 | no trial data cached |
| Metastases to central nervous system | 19 | 7.4 4.7–11.6ROR 7.4 · χ² 99 / p 2e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Upper gastrointestinal haemorrhage | 23 | 6.8 4.5–10.2ROR 6.8 · χ² 108 / p 2e-25 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · ♀ 0% (drug 27%) | no trial data cached |
| Intestinal perforation | 15 | 6.6 4.0–11.0ROR 6.7 · χ² 66 / p 2e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Skin disorder | 44 | 6.6 4.9–8.8ROR 6.6 · χ² 203 / p 2e-46 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 100% clinician | no trial data cached |
| Febrile neutropenia | 87 | 6.5 5.3–8.1ROR 6.7 · χ² 404 / p 5e-90 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 97% clinician | no trial data cached |
| Small intestinal obstruction | 16 | 6.5 4.0–10.6ROR 6.5 · χ² 69 / p 5e-17 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Tubulointerstitial nephritis | 22 | 5.8 3.9–8.9ROR 5.9 · χ² 84 / p 3e-20 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 100% clinician | no trial data cached |
| Hepatic failure | 35 | 5.8 4.1–8.0ROR 5.8 · χ² 133 / p 4e-31 | 5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 91% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 31 | 5.5 3.9–7.9ROR 5.6 · χ² 111 / p 4e-26 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 11 | 5.5 3.0–9.9ROR 5.5 · χ² 36 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Pericardial effusion | 25 | 5.4 3.7–8.0ROR 5.4 · χ² 85 / p 1e-20 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 96% clinician | no trial data cached |
| Liver function test increased | 23 | 5.4 3.6–8.1ROR 5.4 · χ² 77 / p 7e-19 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 96% clinician | no trial data cached |
| Appendicitis | 10 | 5.4 2.9–9.9ROR 5.4 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Dermatitis | 22 | 5.3 3.5–8.0ROR 5.3 · χ² 72 / p 1e-17 | 4.8 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 95% clinician | no trial data cached |
| Proteinuria | 20 | 5.3 3.4–8.2ROR 5.3 · χ² 65 / p 3e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 95% clinician | no trial data cached |
| Rash maculo-papular | 23 | 5.2 3.4–7.8ROR 5.2 · χ² 73 / p 6e-18 | 4.7 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 96% clinician | no trial data cached |
| Drug eruption | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 55 / p 6e-14 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Ascites | 30 | 5.1 3.6–7.3ROR 5.1 · χ² 94 / p 1e-22 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 100% clinician | no trial data cached |
| Clostridium difficile colitis | 10 | 4.7 2.5–8.7ROR 4.7 · χ² 25 / p 2e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Blood bilirubin increased | 25 | 4.6 3.1–6.8ROR 4.6 · χ² 67 / p 2e-16 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 3.1 · ♀ 50% (drug 27%) · 96% clinician | no trial data cached |
| Myelosuppression | 31 | 4.5 3.2–6.4ROR 4.6 · χ² 82 / p 7e-20 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 97% clinician | 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 |
|---|---|---|---|---|---|---|
| Death | 379 | 2.2 2.0–2.4ROR 2.3 · χ² 254 / p 2e-57 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.3 | no trial data cached |
| Malignant neoplasm progression | 280 | 13.7 12.2–15.4ROR 14.6 · χ² 3,292 / p <1e-300 | 13.6 EB05 12.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 · 95% clinician | no trial data cached |
| Pyrexia (fever) | 224 | 3.2 2.8–3.7ROR 3.3 · χ² 346 / p 2e-77 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 93% clinician | no trial data cached |
| Colitis | 186 | 24.7 21.4–28.4ROR 25.8 · χ² 4,188 / p <1e-300 | 24.5 EB05 21.7 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 · 97% clinician | no trial data cached |
| Cytokine release syndrome | 173 | 45.6 39.4–52.8ROR 47.5 · χ² 7,434 / p <1e-300 | 44.9 EB05 39.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · 99% clinician | no trial data cached |
| Liver disorder | 128 | 14.4 12.1–17.1ROR 14.8 · χ² 1,583 / p <1e-300 | 14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 · 100% clinician | no trial data cached |
| Pneumonitis | 101 | 18.6 15.4–22.6ROR 19.1 · χ² 1,665 / p <1e-300 | 18.5 EB05 15.7 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 · 96% clinician | no trial data cached |
| Myocarditis | 98 | 43.4 35.7–52.8ROR 44.4 · χ² 3,985 / p <1e-300 | 42.7 EB05 36.1 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.6 · 97% clinician | no trial data cached |
| Hepatic function abnormal | 93 | 12.5 10.2–15.3ROR 12.8 · χ² 972 / p 9e-214 | 12.4 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · 99% clinician | no trial data cached |
| Adrenal insufficiency | 93 | 38.9 31.8–47.6ROR 39.8 · χ² 3,374 / p <1e-300 | 38.4 EB05 32.2 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.2 · 99% clinician | no trial data cached |
| Interstitial lung disease | 91 | 9.4 7.7–11.5ROR 9.6 · χ² 673 / p 9e-149 | 9.1 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · ♀ 5% (drug 27%) · 99% clinician | no trial data cached |
| Sepsis (blood infection) | 88 | 3.9 3.2–4.8ROR 4.0 · χ² 190 / p 2e-43 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 94% clinician | no trial data cached |
| Platelet count decreased | 87 | 4.1 3.3–5.0ROR 4.1 · χ² 199 / p 2e-45 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · 95% clinician | no trial data cached |
| Febrile neutropenia | 87 | 6.5 5.3–8.1ROR 6.7 · χ² 404 / p 5e-90 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 97% clinician | no trial data cached |
| Dehydration | 72 | 2.7 2.1–3.4ROR 2.7 · χ² 75 / p 2e-18 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 · 90% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Cytokine release syndrome — n=173, PRR 45.6
- Hepatic encephalopathy — n=30, PRR 16.0
- Drug-induced liver injury — n=68, PRR 11.0
- Metastases to lung — n=21, PRR 9.1
- Metastases to bone — n=25, PRR 7.6
- Tubulointerstitial nephritis — n=22, PRR 5.8
- Pericardial effusion — n=25, PRR 5.4
- Proteinuria — n=20, PRR 5.3
- Ascites — n=30, PRR 5.1
- Myelosuppression — n=31, PRR 4.5
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 Tremelimumab?
In FDA FAERS, the most frequently co-reported reaction terms for Tremelimumab are pyrexia, colitis, cytokine release syndrome, liver disorder, pneumonitis, myocarditis. 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 Tremelimumab have an FDA boxed warning?
No. The FDA label retrieved for Tremelimumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tremelimumab 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 6690679c-be2f-4588-a2e4-89fff74dd6be, effective 20260831; matched on
openfda.generic_name.exact:"TREMELIMUMAB") - 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, 106 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.