OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Tremelimumab

106 flagged reaction(s) · 3,981 total co-reports · max PRR 45.6
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 Cytokine Release Syndrome 173 45.6 47.5 signal
2 Myocarditis 98 43.4 44.4 signal
3 Adrenal Insufficiency 93 38.9 39.8 signal
4 Colitis 186 24.7 25.8 signal
5 Pneumonitis 101 18.6 19.1 signal
6 Hepatic Encephalopathy 30 16.0 16.1 signal
7 Liver Disorder 128 14.4 14.8 signal
8 Hepatitis 71 13.8 14.1 signal
9 Malignant Neoplasm Progression 280 13.7 14.6 signal
10 Hepatic Function Abnormal 93 12.5 12.8 signal
11 Drug-induced Liver Injury 68 11.0 11.2 signal
12 Interstitial Lung Disease 91 9.4 9.6 signal
13 Metastases To Lung 21 9.1 9.1 signal
14 Hypothyroidism 54 8.4 8.5 signal
15 Neutrophil Count Decreased 67 8.2 8.4 signal
16 Hyperthyroidism 23 7.9 8.0 signal
17 Metastases To Bone 25 7.6 7.6 signal
18 Erythema Multiforme 14 7.5 7.5 signal
19 Sudden Death 16 7.5 7.5 signal
20 Metastases To Central Nervous System 19 7.4 7.4 signal
21 Upper Gastrointestinal Haemorrhage 23 6.8 6.8 signal
22 Intestinal Perforation 15 6.6 6.7 signal
23 Skin Disorder 44 6.6 6.6 signal
24 Febrile Neutropenia 87 6.5 6.7 signal
25 Small Intestinal Obstruction 16 6.5 6.5 signal
26 Tubulointerstitial Nephritis 22 5.8 5.9 signal
27 Hepatic Failure 35 5.8 5.8 signal
28 Multiple Organ Dysfunction Syndrome 31 5.5 5.6 signal
29 Pneumocystis Jirovecii Pneumonia 11 5.5 5.5 signal
30 Pericardial Effusion 25 5.4 5.4 signal
31 Liver Function Test Increased 23 5.4 5.4 signal
32 Appendicitis 10 5.4 5.4 signal
33 Dermatitis 22 5.3 5.3 signal
34 Proteinuria 20 5.3 5.3 signal
35 Rash Maculo-papular 23 5.2 5.2 signal
36 Drug Eruption 18 5.1 5.1 signal
37 Ascites 30 5.1 5.1 signal
38 Clostridium Difficile Colitis 10 4.7 4.7 signal
39 Blood Bilirubin Increased 25 4.6 4.6 signal
40 Myelosuppression 31 4.5 4.6 signal
41 Hepatic Cirrhosis 17 4.5 4.5 signal
42 Presyncope 22 4.5 4.5 signal
43 Transaminases Increased 20 4.5 4.5 signal
44 Skin Infection 10 4.5 4.5 signal
45 Ileus 11 4.4 4.5 signal
46 Aspartate Aminotransferase Increased 47 4.4 4.4 signal
47 Cardiomyopathy 13 4.4 4.4 signal
48 Metastases To Liver 15 4.3 4.3 signal
49 Pancreatitis 45 4.2 4.3 signal
50 Thyroid Disorder 13 4.2 4.2 signal
51 Platelet Count Decreased 87 4.1 4.1 signal
52 Encephalopathy 20 4.1 4.1 signal
53 Sepsis 88 3.9 4.0 signal
54 Inappropriate Antidiuretic Hormone Secretion 8 3.9 3.9 signal
55 Pericarditis 13 3.9 3.9 signal
56 Cerebral Infarction 19 3.9 3.9 signal
57 Stevens-johnson Syndrome 17 3.8 3.8 signal
58 Pleural Effusion 45 3.7 3.7 signal
59 Renal Disorder 34 3.6 3.6 signal
60 Blood Creatine Phosphokinase Increased 21 3.6 3.6 signal
61 Alanine Aminotransferase Increased 44 3.6 3.6 signal
62 Hyperglycaemia 26 3.6 3.6 signal
63 Jaundice 19 3.5 3.5 signal
64 Eyelid Ptosis 7 3.4 3.4 signal
65 Gastroenteritis 10 3.4 3.4 signal
66 Vasculitis 8 3.4 3.4 signal
67 Cholecystitis 8 3.3 3.4 signal
68 Cytopenia 8 3.3 3.3 signal
69 Photosensitivity Reaction 11 3.3 3.3 signal
70 Haematotoxicity 6 3.2 3.2 signal
71 Pyrexia 224 3.2 3.3 signal
72 Pneumonia Aspiration 16 3.2 3.2 signal
73 Pneumothorax 10 3.1 3.1 signal
74 Drug Reaction With Eosinophilia And Systemic Symptoms 16 3.1 3.1 signal
75 Septic Shock 27 3.1 3.1 signal
76 Acute Respiratory Distress Syndrome 11 3.1 3.1 signal
77 Thrombotic Microangiopathy 6 3.1 3.1 signal
78 Hyponatraemia 34 3.0 3.0 signal
79 Hepatotoxicity 13 2.9 2.9 signal
80 Skin Ulcer 15 2.9 2.9 signal
81 Eosinophilia 10 2.8 2.9 signal
82 Disseminated Intravascular Coagulation 8 2.8 2.8 signal
83 Altered State Of Consciousness 12 2.8 2.8 signal
84 Gastrointestinal Pain 6 2.7 2.7 signal
85 Diabetic Ketoacidosis 13 2.7 2.7 signal
86 Gamma-glutamyltransferase Increased 12 2.7 2.7 signal
87 Dehydration 72 2.7 2.7 signal
88 Nephropathy Toxic 6 2.7 2.7 signal
89 Toxic Epidermal Necrolysis 8 2.6 2.6 signal
90 Autoimmune Disorder 5 2.6 2.6 no signal
91 Gastric Haemorrhage 6 2.6 2.6 signal
92 Thrombocytopenia 55 2.5 2.5 signal
93 Pancreatitis Acute 11 2.5 2.5 signal
94 Hepatic Cytolysis 6 2.4 2.4 no signal
95 Agranulocytosis 9 2.4 2.4 signal
96 Hepatic Cancer 11 2.3 2.3 signal
97 Death 379 2.2 2.3 signal
98 Blood Thyroid Stimulating Hormone Increased 4 2.2 2.2 no signal
99 Cytomegalovirus Infection 7 2.1 2.1 no signal
100 Palmar-plantar Erythrodysaesthesia Syndrome 9 1.9 1.9 no signal
101 Disease Progression 45 1.9 1.9 no signal
102 Uveitis 5 1.8 1.8 no signal
103 Acute Hepatic Failure 5 1.8 1.8 no signal
104 Neoplasm Progression 12 1.7 1.7 no signal
105 Rebound Effect 3 1.3 1.3 no signal
106 Pancreatic Carcinoma 6 1.0 1.0 no signal