Avelumab side effects: what 2,239 FDA adverse event reports show

Avelumab · 115 reaction terms · 3,480 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

2,239 reports · 96% serious · 440 with death outcome · 33% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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

Reporting / coding artifact 3No label text to screen 37

What the badges mean

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.
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. 75 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Myocarditis	65	30.2 23.7–38.4ROR 30.6 · χ² 1,794 / p <1e-300	29.8 EB05 24.2 · IC025 +4.2 3/3 methods agree	No label text to screen	–	no trial data cached
Adrenal insufficiency	61	26.8 20.8–34.4ROR 27.2 · χ² 1,480 / p <1e-300	26.4 EB05 21.3 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Neoplasm progression	125	18.7 15.7–22.2ROR 19.2 · χ² 2,069 / p <1e-300	18.6 EB05 16.0 · IC025 +3.8 3/3 methods agree	No label text to screen	–	no trial data cached
Disease progression	382	17.0 15.4–18.7ROR 18.7 · χ² 5,743 / p <1e-300	16.9 EB05 15.5 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Hypothyroidism	86	14.2 11.5–17.4ROR 14.4 · χ² 1,037 / p 1e-227	14.0 EB05 11.7 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial data cached
Pneumonitis	73	14.1 11.3–17.8ROR 14.4 · χ² 877 / p 4e-193	14.0 EB05 11.5 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Hyperthyroidism	37	13.4 9.7–18.5ROR 13.5 · χ² 411 / p 9e-92	13.1 EB05 9.7 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Hepatitis (liver inflammation)	58	11.9 9.2–15.3ROR 12.0 · χ² 566 / p 2e-125	11.6 EB05 9.2 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Infusion related reaction (reaction during infusion)	146	11.6 9.9–13.6ROR 12.0 · χ² 1,401 / p <1e-300	11.5 EB05 10.0 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Interstitial lung disease	102	11.1 9.1–13.4ROR 11.3 · χ² 923 / p 5e-203	10.9 EB05 9.2 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Colitis	78	10.8 8.7–13.5ROR 11.0 · χ² 687 / p 1e-151	10.6 EB05 8.7 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Metastases to central nervous system	23	9.4 6.3–14.1ROR 9.4 · χ² 164 / p 7e-38	8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Transaminases increased	37	8.7 6.3–12.0ROR 8.8 · χ² 245 / p 2e-55	8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	37	8.3 6.0–11.4ROR 8.3 · χ² 229 / p 4e-52	7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Thyroid disorder	21	7.1 4.7–10.9ROR 7.2 · χ² 105 / p 8e-25	6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Device related infection	20	6.8 4.4–10.5ROR 6.8 · χ² 93 / p 3e-22	6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Ankylosing spondylitis	16	6.4 3.9–10.5ROR 6.4 · χ² 68 / p 9e-17	5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree	No label text to screen	–	no trial data cached
Hepatic function abnormal	44	6.2 4.6–8.3ROR 6.3 · χ² 187 / p 6e-43	5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Polyneuropathy	14	6.2 3.6–10.4ROR 6.2 · χ² 55 / p 5e-14	5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Haematuria (blood in urine)	39	5.9 4.4–8.1ROR 6.0 · χ² 156 / p 5e-36	5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Cytokine release syndrome	21	5.8 3.8–8.8ROR 5.8 · χ² 78 / p 5e-19	5.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	No label text to screen	–	no trial data cached
Proteinuria	20	5.5 3.6–8.6ROR 5.6 · χ² 70 / p 3e-17	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	No label text to screen	–	no trial data cached
Hypomagnesaemia	14	5.3 3.1–8.9ROR 5.3 · χ² 44 / p 1e-11	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Mucosal inflammation	26	5.2 3.6–7.7ROR 5.2 · χ² 85 / p 2e-20	4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree	No label text to screen	–	no trial data cached
Hepatotoxicity (liver damage)	22	5.2 3.4–7.9ROR 5.2 · χ² 70 / p 3e-17	4.7 EB05 3.3 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Eyelid ptosis	10	5.1 2.8–9.6ROR 5.2 · χ² 29 / p 3e-8	4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Febrile neutropenia	60	4.7 3.7–6.1ROR 4.8 · χ² 174 / p 6e-40	4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Nephropathy toxic	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	No label text to screen	–	no trial data cached
Feeling cold	25	4.7 3.2–6.9ROR 4.7 · χ² 69 / p 5e-17	4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Chills	103	4.6 3.8–5.6ROR 4.7 · χ² 287 / p 1e-64	4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Dermatitis	18	4.5 2.9–7.2ROR 4.6 · χ² 46 / p 5e-12	4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Neuropathy peripheral (nerve damage in hands/feet)	81	4.5 3.6–5.6ROR 4.6 · χ² 216 / p 3e-49	4.4 EB05 3.6 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Immune system disorder	11	4.4 2.4–7.9ROR 4.4 · χ² 25 / p 2e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	No label text to screen	–	no trial data cached
Wrist fracture	10	4.4 2.3–8.1ROR 4.4 · χ² 23 / p 1e-6	3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree	No label text to screen	–	no trial data cached
Taste disorder	16	4.2 2.6–6.8ROR 4.2 · χ² 36 / p 1e-9	3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree	No label text to screen	–	no trial data cached
Hypocalcaemia (low calcium)	15	4.2 2.5–6.9ROR 4.2 · χ² 33 / p 5e-9	3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Acute myeloid leukaemia	12	4.0 2.3–7.1ROR 4.0 · χ² 24 / p 4e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	No label text to screen	–	no trial data cached
General physical health deterioration	86	3.9 3.2–4.8ROR 4.0 · χ² 185 / p 2e-42	3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Tubulointerstitial nephritis	14	3.9 2.3–6.6ROR 3.9 · χ² 27 / p 8e-8	3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree	No label text to screen	–	no trial data cached
Hyperglycaemia (high blood sugar)	27	3.9 2.7–5.7ROR 3.9 · χ² 55 / p 6e-14	3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	No label text to screen	–	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
Disease progression	382	17.0 15.4–18.7ROR 18.7 · χ² 5,743 / p <1e-300	16.9 EB05 15.5 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Death	374	2.3 2.1–2.5ROR 2.4 · χ² 276 / p 3e-62	2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree	Outcome field, not a reaction	–	no trial data cached
Infusion related reaction (reaction during infusion)	146	11.6 9.9–13.6ROR 12.0 · χ² 1,401 / p <1e-300	11.5 EB05 10.0 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Neoplasm progression	125	18.7 15.7–22.2ROR 19.2 · χ² 2,069 / p <1e-300	18.6 EB05 16.0 · IC025 +3.8 3/3 methods agree	No label text to screen	–	no trial data cached
Chills	103	4.6 3.8–5.6ROR 4.7 · χ² 287 / p 1e-64	4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Interstitial lung disease	102	11.1 9.1–13.4ROR 11.3 · χ² 923 / p 5e-203	10.9 EB05 9.2 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Acute kidney injury (sudden kidney damage)	87	3.0 2.4–3.7ROR 3.0 · χ² 114 / p 7e-27	2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree	No label text to screen	–	no trial data cached
General physical health deterioration	86	3.9 3.2–4.8ROR 4.0 · χ² 185 / p 2e-42	3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Hypothyroidism	86	14.2 11.5–17.4ROR 14.4 · χ² 1,037 / p 1e-227	14.0 EB05 11.7 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial data cached
Neuropathy peripheral (nerve damage in hands/feet)	81	4.5 3.6–5.6ROR 4.6 · χ² 216 / p 3e-49	4.4 EB05 3.6 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Colitis	78	10.8 8.7–13.5ROR 11.0 · χ² 687 / p 1e-151	10.6 EB05 8.7 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Thrombocytopenia (low platelets)	74	3.5 2.8–4.3ROR 3.5 · χ² 128 / p 5e-30	3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree	No label text to screen	–	no trial data cached
Pneumonitis	73	14.1 11.3–17.8ROR 14.4 · χ² 877 / p 4e-193	14.0 EB05 11.5 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Myocarditis	65	30.2 23.7–38.4ROR 30.6 · χ² 1,794 / p <1e-300	29.8 EB05 24.2 · IC025 +4.2 3/3 methods agree	No label text to screen	–	no trial data cached
Adrenal insufficiency	61	26.8 20.8–34.4ROR 27.2 · χ² 1,480 / p <1e-300	26.4 EB05 21.3 · IC025 +4.0 3/3 methods agree	No label text to screen	–	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 Avelumab?

In FDA FAERS, the most frequently co-reported reaction terms for Avelumab are infusion related reaction, neoplasm progression, chills, interstitial lung disease, acute kidney injury, hypothyroidism. 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 Avelumab 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 Avelumab 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, field patient.drug.openfda.generic_name.exact, 115 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.