Drug · FAERS side-effect profile with label screen
Durvalumab side effects: what 20,217 FDA adverse event reports show
Drug class
Programmed Death Ligand-1 Blocker
FDA label (Established Pharmacologic Class)
Brand names
Imfinzi
openFDA label
Who reports
20,217 reports · 95% serious · 6,343 with death outcome · 36% female
openFDA FAERS counts, all years, deduplication not applied
Used for
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the tr.
FDA label, Indications and Usage
What it is
Durvalumab is a programmed cell death ligand 1 (PD-L1) blocking antibody. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture.
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 9Labeled (related wording) 14Likely indication confounding 5Not in label — unassessed 12
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.
- 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. 971 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 |
|---|---|---|---|---|---|---|
| Epithelitis | 16 | 3,270.8 1,198.3–8,927.5ROR 3,273.4 · χ² 11,685 / p <1e-300 | 402.9 EB05 262.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Radiation pneumonitis | 807 | 630.1 577.8–687.2ROR 656.3 · χ² 313,228 / p <1e-300 | 386.6 EB05 364.7 · IC025 +8.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=763 · 96% clinician | no trial data cached |
| Non-small cell lung cancer recurrent | 62 | 298.9 225.3–396.6ROR 299.8 · χ² 14,014 / p <1e-300 | 216.1 EB05 174.6 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=62 · 97% clinician | no trial data cached |
| Immunotoxicity | 22 | 252.7 158.5–402.8ROR 252.9 · χ² 4,222 / p <1e-300 | 172.6 EB05 120.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Pulmonary radiation injury | 11 | 229.5 119.3–441.2ROR 229.6 · χ² 1,861 / p <1e-300 | 142.0 EB05 84.6 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Tumour hyperprogression | 36 | 187.7 131.6–267.8ROR 188.1 · χ² 5,492 / p <1e-300 | 146.6 EB05 110.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=36 · 94% clinician | no trial data cached |
| Arterial intramural haematoma | 11 | 162.9 86.2–307.8ROR 163.0 · χ² 1,390 / p <1e-300 | 113.5 EB05 67.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Liver carcinoma ruptured | 33 | 156.2 108.3–225.2ROR 156.4 · χ² 4,280 / p <1e-300 | 125.9 EB05 93.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=33 · 100% clinician | no trial data cached |
| Radiation interaction | 11 | 156.2 82.8–294.5ROR 156.2 · χ² 1,339 / p 2e-293 | 110.2 EB05 65.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Biliary tract infection | 74 | 143.0 112.2–182.3ROR 143.5 · χ² 9,029 / p <1e-300 | 121.7 EB05 100.1 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=74 | no trial data cached |
| Endocrine toxicity | 12 | 141.0 77.1–257.8ROR 141.1 · χ² 1,345 / p 9e-295 | 104.0 EB05 63.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Immune-mediated nephritis | 50 | 128.7 96.0–172.7ROR 129.0 · χ² 5,515 / p <1e-300 | 109.7 EB05 86.5 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=50 · ♀ 10% (drug 36%) · 98% clinician | no trial data cached |
| Myocarditis-myositis-myasthenia gravis overlap syndrome | 16 | 100.3 60.0–167.6ROR 100.4 · χ² 1,344 / p 2e-294 | 82.7 EB05 54.0 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Cholangitis infective | 23 | 99.6 64.9–152.8ROR 99.7 · χ² 1,957 / p <1e-300 | 84.7 EB05 59.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 87% (drug 36%) · 96% clinician | no trial data cached |
| Sicca syndrome | 15 | 97.0 57.2–164.8ROR 97.1 · χ² 1,216 / p 1e-266 | 80.0 EB05 51.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Immune-mediated pneumonitis | 19 | 90.3 56.5–144.4ROR 90.4 · χ² 1,461 / p <1e-300 | 76.9 EB05 52.0 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 | no trial data cached |
| Paraneoplastic neurological syndrome | 10 | 89.7 47.0–171.1ROR 89.7 · χ² 726 / p 3e-160 | 71.7 EB05 41.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Immune-mediated hepatic disorder | 144 | 84.4 71.3–100.0ROR 85.0 · χ² 10,892 / p <1e-300 | 77.3 EB05 67.3 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=144 · 99% clinician | no trial data cached |
| Immune-mediated lung disease | 123 | 78.5 65.4–94.2ROR 79.0 · χ² 8,666 / p <1e-300 | 72.2 EB05 62.1 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=123 | no trial data cached |
| Bacterial abdominal infection | 10 | 76.9 40.4–146.1ROR 76.9 · χ² 627 / p 9e-139 | 63.3 EB05 36.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Radiation oesophagitis | 25 | 73.0 48.7–109.5ROR 73.1 · χ² 1,591 / p <1e-300 | 65.0 EB05 46.3 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=25 | no trial data cached |
| Thrombophlebitis migrans | 21 | 71.8 46.1–111.7ROR 71.9 · χ² 1,304 / p 7e-286 | 63.5 EB05 43.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Immune-mediated cholangitis | 22 | 71.6 46.5–110.3ROR 71.7 · χ² 1,366 / p 2e-299 | 63.5 EB05 44.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=21 · 95% clinician | no trial data cached |
| Immune-mediated enterocolitis | 224 | 70.3 61.5–80.5ROR 71.1 · χ² 14,259 / p <1e-300 | 65.5 EB05 58.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=224 · 98% clinician | no trial data cached |
| Immune-mediated myocarditis | 93 | 66.7 54.1–82.2ROR 67.0 · χ² 5,585 / p <1e-300 | 61.9 EB05 52.0 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=93 · 98% clinician | no trial data cached |
| Immune-mediated dermatitis | 55 | 64.7 49.3–84.9ROR 64.9 · χ² 3,184 / p <1e-300 | 59.7 EB05 47.6 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=55 · 98% clinician | no trial data cached |
| Eastern cooperative oncology group performance status worsened | 72 | 63.7 50.2–80.8ROR 63.9 · χ² 4,125 / p <1e-300 | 59.1 EB05 48.5 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=71 · 100% clinician | no trial data cached |
| Immune-mediated hepatitis | 106 | 59.1 48.6–71.9ROR 59.4 · χ² 5,673 / p <1e-300 | 55.4 EB05 47.1 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=106 · 94% clinician | no trial data cached |
| Suspected drug-induced liver injury | 10 | 58.1 30.7–109.8ROR 58.1 · χ² 478 / p 3e-106 | 50.1 EB05 29.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Immune-mediated myasthenia gravis | 16 | 57.4 34.7–94.9ROR 57.4 · χ² 787 / p 2e-173 | 51.3 EB05 33.5 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Autoimmune nephritis | 11 | 55.1 30.1–101.1ROR 55.1 · χ² 504 / p 5e-112 | 48.3 EB05 28.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Immune-mediated renal disorder | 19 | 52.9 33.4–83.9ROR 53.0 · χ² 871 / p 8e-192 | 48.1 EB05 32.5 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Immune-mediated pancreatitis | 17 | 50.1 30.8–81.5ROR 50.1 · χ² 733 / p 8e-162 | 45.5 EB05 30.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=17 | no trial data cached |
| Metastases to adrenals | 40 | 47.2 34.4–64.7ROR 47.2 · χ² 1,684 / p <1e-300 | 44.2 EB05 33.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | no trial data cached |
| Immune-mediated encephalitis | 21 | 45.9 29.6–71.0ROR 45.9 · χ² 840 / p 7e-185 | 42.4 EB05 29.2 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=21 · 100% clinician | no trial data cached |
| Lymphoma transformation | 15 | 45.0 26.8–75.4ROR 45.0 · χ² 576 / p 1e-127 | 41.0 EB05 26.4 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Cholangitis | 248 | 43.4 38.3–49.3ROR 44.0 · χ² 9,825 / p <1e-300 | 41.6 EB05 37.4 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=248 · 97% clinician | no trial data cached |
| Adrenocorticotropic hormone deficiency | 34 | 42.0 29.8–59.2ROR 42.1 · χ² 1,269 / p 4e-278 | 39.6 EB05 29.6 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=34 · 100% clinician | no trial data cached |
| Immune-mediated adrenal insufficiency | 29 | 41.4 28.6–60.0ROR 41.5 · χ² 1,060 / p 7e-233 | 38.9 EB05 28.4 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=29 · 100% clinician | no trial data cached |
| Immune-mediated hypothyroidism | 41 | 41.1 30.1–56.1ROR 41.2 · χ² 1,503 / p <1e-300 | 38.9 EB05 29.9 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=41 · 98% 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 | 3,854 | 4.7 4.5–4.8ROR 5.5 · χ² 11,483 / p <1e-300 | 4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.8 | no trial data cached |
| Malignant neoplasm progression | 1,599 | 16.5 15.8–17.3ROR 17.9 · χ² 23,042 / p <1e-300 | 16.3 EB05 15.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Pneumonitis | 875 | 34.7 32.4–37.0ROR 36.2 · χ² 27,663 / p <1e-300 | 33.5 EB05 31.7 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.0 | no trial data cached |
| Radiation pneumonitis | 807 | 630.1 577.8–687.2ROR 656.3 · χ² 313,228 / p <1e-300 | 386.6 EB05 364.7 · IC025 +8.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=763 · 96% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 647 | 1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.143 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Pyrexia (fever) | 638 | 1.9 1.8–2.1ROR 1.9 · χ² 281 / p 2e-63 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Off label use (used outside approved label) | 580 | 0.7 0.6–0.8ROR 0.7 · χ² 82 / p 6e-20 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.7 · 94% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 481 | 0.9 0.8–1.0ROR 0.9 · χ² 8 / p 0.003 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 | no trial data cached |
| Interstitial lung disease | 480 | 10.4 9.5–11.4ROR 10.6 · χ² 4,034 / p <1e-300 | 10.3 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 99% clinician | no trial data cached |
| Pneumonia (lung infection) | 474 | 1.5 1.4–1.7ROR 1.5 · χ² 85 / p 1e-20 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 0.9 | no trial data cached |
| Fatigue (tiredness) | 452 | 0.6 0.6–0.7ROR 0.6 · χ² 122 / p 1e-28 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.5 | no trial data cached |
| Rash | 437 | 1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.183 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Asthenia (weakness) | 434 | 1.2 1.1–1.3ROR 1.2 · χ² 14 / p 9e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Anaemia (low red blood cells) | 425 | 2.3 2.1–2.5ROR 2.3 · χ² 317 / p 3e-71 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 · 92% clinician | no trial data cached |
| Neutrophil count decreased | 413 | 10.7 9.7–11.7ROR 10.9 · χ² 3,579 / p <1e-300 | 10.5 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · 99% 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.
- Immunotoxicity — n=22, PRR 252.7
- Tumour hyperprogression — n=36, PRR 187.7
- Liver carcinoma ruptured — n=33, PRR 156.2
- Cholangitis infective — n=23, PRR 99.6
- Thrombophlebitis migrans — n=21, PRR 71.8
- Immune-mediated enterocolitis — n=224, PRR 70.3
- Metastases to adrenals — n=40, PRR 47.2
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 Durvalumab?
In FDA FAERS, the most frequently co-reported reaction terms for Durvalumab are pneumonitis, radiation pneumonitis, diarrhoea, pyrexia, dyspnoea, interstitial lung disease. 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 Durvalumab have an FDA boxed warning?
No. The FDA label retrieved for Durvalumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Durvalumab 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 8baba4ea-2855-42fa-9bd9-5a7548d4cec3, effective 20260831; matched on
openfda.generic_name.exact:"DURVALUMAB") - 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, 1,011 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.