Drug

Avelumab

115 flagged reaction(s) · 3,480 total co-reports · max PRR 30.2

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Myocarditis	65	30.2	30.6	signal
2	Adrenal Insufficiency	61	26.8	27.2	signal
3	Neoplasm Progression	125	18.7	19.2	signal
4	Disease Progression	382	17.0	18.7	signal
5	Hypothyroidism	86	14.2	14.4	signal
6	Pneumonitis	73	14.1	14.4	signal
7	Hyperthyroidism	37	13.4	13.5	signal
8	Hepatitis	58	11.9	12.0	signal
9	Infusion Related Reaction	146	11.6	12.0	signal
10	Interstitial Lung Disease	102	11.1	11.3	signal
11	Colitis	78	10.8	11.0	signal
12	Metastases To Central Nervous System	23	9.4	9.4	signal
13	Transaminases Increased	37	8.7	8.8	signal
14	Palmar-plantar Erythrodysaesthesia Syndrome	37	8.3	8.3	signal
15	Thyroid Disorder	21	7.1	7.2	signal
16	Device Related Infection	20	6.8	6.8	signal
17	Ankylosing Spondylitis	16	6.4	6.4	signal
18	Hepatic Function Abnormal	44	6.2	6.3	signal
19	Polyneuropathy	14	6.2	6.2	signal
20	Haematuria	39	5.9	6.0	signal
21	Cytokine Release Syndrome	21	5.8	5.8	signal
22	Proteinuria	20	5.5	5.6	signal
23	Hypomagnesaemia	14	5.3	5.3	signal
24	Mucosal Inflammation	26	5.2	5.2	signal
25	Hepatotoxicity	22	5.2	5.2	signal
26	Eyelid Ptosis	10	5.1	5.2	signal
27	Febrile Neutropenia	60	4.7	4.8	signal
28	Nephropathy Toxic	10	4.7	4.7	signal
29	Feeling Cold	25	4.7	4.7	signal
30	Chills	103	4.6	4.7	signal
31	Dermatitis	18	4.5	4.6	signal
32	Blood Thyroid Stimulating Hormone Increased	8	4.5	4.5	signal
33	Neuropathy Peripheral	81	4.5	4.6	signal
34	Immune System Disorder	11	4.4	4.4	signal
35	Wrist Fracture	10	4.4	4.4	signal
36	Taste Disorder	16	4.2	4.2	signal
37	Hypocalcaemia	15	4.2	4.2	signal
38	Acute Myeloid Leukaemia	12	4.0	4.0	signal
39	Urosepsis	7	4.0	4.0	signal
40	General Physical Health Deterioration	86	3.9	4.0	signal
41	Tubulointerstitial Nephritis	14	3.9	3.9	signal
42	Hyperglycaemia	27	3.9	3.9	signal
43	Ileus	9	3.8	3.8	signal
44	Pericarditis	12	3.8	3.8	signal
45	Inappropriate Antidiuretic Hormone Secretion	7	3.6	3.6	signal
46	Vasculitis	8	3.6	3.6	signal
47	Hypoxia	24	3.6	3.6	signal
48	Cardiomyopathy	10	3.5	3.5	signal
49	Metastases To Bone	11	3.5	3.5	signal
50	Thrombocytopenia	74	3.5	3.5	signal
51	Sudden Death	7	3.4	3.4	signal
52	Spinal Fracture	13	3.4	3.4	signal
53	Small Intestinal Obstruction	8	3.4	3.4	signal
54	Oxygen Saturation Decreased	36	3.4	3.4	signal
55	Hyponatraemia	36	3.3	3.4	signal
56	Anaphylactic Shock	16	3.3	3.3	signal
57	Multiple Organ Dysfunction Syndrome	17	3.2	3.2	signal
58	Uveitis	8	3.1	3.1	signal
59	Cholecystitis	7	3.1	3.1	signal
60	Pancreatitis	31	3.1	3.1	signal
61	Neurotoxicity	10	3.0	3.0	signal
62	Acute Kidney Injury	87	3.0	3.0	signal
63	Hypercalcaemia	7	3.0	3.0	signal
64	Blood Lactate Dehydrogenase Increased	9	3.0	3.0	signal
65	Pemphigus	7	2.9	2.9	signal
66	Dysphonia	32	2.9	2.9	signal
67	Blood Creatine Phosphokinase Increased	16	2.9	2.9	signal
68	Malignant Neoplasm Progression	55	2.8	2.8	signal
69	Erythema Multiforme	5	2.8	2.8	signal
70	Intestinal Perforation	6	2.8	2.8	signal
71	Toxic Epidermal Necrolysis	8	2.8	2.8	signal
72	Renal Impairment	44	2.7	2.8	signal
73	Neutrophil Count Decreased	21	2.7	2.7	signal
74	Metastases To Liver	9	2.7	2.7	signal
75	Lymphocyte Count Decreased	9	2.7	2.7	signal
76	Lung Infection	8	2.7	2.7	signal
77	Diabetic Ketoacidosis	12	2.6	2.6	signal
78	Skin Reaction	7	2.6	2.6	signal
79	Rash Maculo-papular	11	2.6	2.6	signal
80	Hepatic Cytolysis	6	2.6	2.6	signal
81	Therapy Partial Responder	7	2.4	2.4	signal
82	Hepatic Failure	14	2.4	2.4	signal
83	Pulmonary Embolism	44	2.4	2.4	signal
84	Wound Infection	5	2.4	2.4	no signal
85	Gastrointestinal Pain	5	2.4	2.4	no signal
86	Drug Eruption	8	2.4	2.4	signal
87	Skin Disorder	15	2.4	2.4	signal
88	Ejection Fraction Decreased	7	2.4	2.4	signal
89	Death	374	2.3	2.4	signal
90	Haematotoxicity	4	2.3	2.3	no signal
91	Aphonia	6	2.2	2.3	no signal
92	Disseminated Intravascular Coagulation	6	2.2	2.2	no signal
93	Bronchospasm	6	2.2	2.2	no signal
94	Autoimmune Disorder	4	2.2	2.2	no signal
95	Altered State Of Consciousness	9	2.2	2.2	signal
96	Hospice Care	4	2.1	2.1	no signal
97	Acute Myocardial Infarction	12	2.1	2.1	signal
98	Drug Reaction With Eosinophilia And Systemic Symptoms	10	2.0	2.0	signal
99	Neutropenia	53	2.0	2.1	signal
100	Hyperbilirubinaemia	4	2.0	2.0	no signal
101	Cardiac Failure	31	2.0	2.0	signal
102	Hip Fracture	12	2.0	2.0	no signal
103	Fracture	7	1.9	1.9	no signal
104	Device Occlusion	5	1.9	1.9	no signal
105	Lymphopenia	5	1.9	1.9	no signal
106	Hepatocellular Injury	5	1.8	1.8	no signal
107	Metastases To Lung	4	1.8	1.8	no signal
108	Myelodysplastic Syndrome	5	1.8	1.8	no signal
109	Cytopenia	4	1.7	1.8	no signal
110	Posterior Reversible Encephalopathy Syndrome	3	1.6	1.6	no signal
111	Thrombotic Microangiopathy	3	1.6	1.6	no signal
112	Pneumocystis Jirovecii Pneumonia	3	1.6	1.6	no signal
113	Coronary Artery Occlusion	4	1.5	1.5	no signal
114	Status Epilepticus	3	1.4	1.4	no signal
115	Myelosuppression	6	0.9	0.9	no signal