OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Afatinib

222 flagged reaction(s) · 14,369 total co-reports · max PRR 68.5
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 Metastases To Central Nervous System 270 68.5 71.4 signal
2 Malignant Neoplasm Progression 1,691 53.7 71.9 signal
3 Stomatitis 485 25.6 27.6 signal
4 Metastases To Bone 90 17.6 17.8 signal
5 Drug Resistance 141 17.6 17.9 signal
6 Therapy Partial Responder 79 16.8 17.0 signal
7 Metastases To Lung 57 15.8 15.9 signal
8 Mucosal Inflammation 117 14.4 14.6 signal
9 Metastases To Liver 77 14.0 14.2 signal
10 Skin Fissures 71 12.0 12.1 signal
11 Oral Pain 78 11.1 11.2 signal
12 Diarrhoea 2,121 10.5 15.1 signal
13 Interstitial Lung Disease 149 9.8 10.0 signal
14 Pneumonitis 81 9.6 9.7 signal
15 Pleural Effusion 181 9.5 9.7 signal
16 Skin Disorder 88 8.4 8.5 signal
17 Pulmonary Mass 36 7.7 7.8 signal
18 Dehydration 316 7.6 7.9 signal
19 Mouth Ulceration 49 7.4 7.5 signal
20 Electrolyte Imbalance 26 7.2 7.2 signal
21 Acne 168 7.0 7.2 signal
22 Rash 884 6.5 7.4 signal
23 Central Nervous System Lesion 28 6.5 6.5 signal
24 Neoplasm Progression 70 6.4 6.4 signal
25 Decreased Appetite 450 6.2 6.6 signal
26 Neoplasm 22 6.1 6.1 signal
27 Epistaxis 139 5.9 6.0 signal
28 Feeding Disorder 36 5.8 5.8 signal
29 Disease Progression 205 5.5 5.7 signal
30 Skin Reaction 24 5.4 5.5 signal
31 Glossodynia 38 5.4 5.4 signal
32 Scab 19 5.3 5.4 signal
33 Dermatitis 33 5.1 5.1 signal
34 Pneumothorax 25 5.0 5.0 signal
35 Folliculitis 16 4.9 4.9 signal
36 Ileus 19 4.9 4.9 signal
37 Dry Skin 199 4.8 4.9 signal
38 Palmar-plantar Erythrodysaesthesia Syndrome 35 4.8 4.8 signal
39 Hair Texture Abnormal 20 4.7 4.7 signal
40 Conjunctivitis 27 4.7 4.7 signal
41 Eating Disorder 31 4.6 4.6 signal
42 Pericardial Effusion 31 4.3 4.3 signal
43 Brain Oedema 17 4.3 4.3 signal
44 Lung Infection 21 4.2 4.3 signal
45 Hypokalaemia 60 4.2 4.2 signal
46 Brain Neoplasm 12 4.2 4.2 signal
47 Skin Ulcer 33 4.1 4.1 signal
48 Rash Maculo-papular 28 4.0 4.0 signal
49 Skin Infection 14 4.0 4.0 signal
50 Haemoptysis 35 4.0 4.0 signal
51 Drug Eruption 22 4.0 4.0 signal
52 Brain Injury 12 3.8 3.8 signal
53 Blood Potassium Decreased 34 3.6 3.6 signal
54 Blood Creatinine Increased 73 3.6 3.6 signal
55 Lung Neoplasm Malignant 46 3.5 3.6 signal
56 Gastroenteritis 16 3.5 3.5 signal
57 Oesophagitis 12 3.5 3.5 signal
58 Lip Swelling 36 3.5 3.5 signal
59 Lung Disorder 53 3.4 3.5 signal
60 Eye Discharge 11 3.4 3.4 signal
61 Dry Mouth 83 3.3 3.3 signal
62 Hypophagia 26 3.3 3.3 signal
63 Dry Eye 49 3.2 3.2 signal
64 Respiratory Failure 73 3.2 3.2 signal
65 Cerebral Infarction 24 3.1 3.1 signal
66 Hyperbilirubinaemia 10 3.1 3.1 signal
67 Dysgeusia 72 3.1 3.1 signal
68 Localised Infection 23 3.0 3.0 signal
69 Laceration 9 3.0 3.0 signal
70 Ulcer 15 3.0 3.0 signal
71 Oral Discomfort 13 3.0 3.0 signal
72 Rhinorrhoea 60 3.0 3.0 signal
73 Lymphopenia 13 2.9 2.9 signal
74 Skin Lesion 25 2.9 2.9 signal
75 Intestinal Perforation 10 2.8 2.8 signal
76 Clostridium Difficile Infection 19 2.8 2.8 signal
77 Vomiting 407 2.8 2.9 signal
78 Urosepsis 8 2.8 2.8 signal
79 Dysphagia 81 2.7 2.7 signal
80 Spinal Pain 10 2.7 2.7 signal
81 Proteinuria 16 2.7 2.7 signal
82 Pulmonary Thrombosis 9 2.6 2.6 signal
83 Skin Exfoliation 68 2.6 2.6 signal
84 Ageusia 20 2.5 2.6 signal
85 Gastritis 21 2.5 2.5 signal
86 Hyponatraemia 44 2.5 2.5 signal
87 Pain Of Skin 21 2.5 2.5 signal
88 Stevens-johnson Syndrome 17 2.4 2.4 signal
89 Pneumonia Aspiration 19 2.4 2.4 signal
90 Erythema Multiforme 7 2.4 2.4 signal
91 Taste Disorder 15 2.4 2.4 signal
92 Ascites 22 2.4 2.4 signal
93 Diarrhoea Haemorrhagic 7 2.4 2.4 signal
94 Weight Decreased 207 2.4 2.4 signal
95 Gingival Bleeding 10 2.3 2.3 signal
96 Transaminases Increased 16 2.3 2.3 signal
97 Cystitis 23 2.3 2.3 signal
98 Hypoxia 25 2.3 2.3 signal
99 Alopecia 139 2.2 2.3 signal
100 Lymphadenopathy 25 2.2 2.3 signal
101 Lacrimation Increased 21 2.2 2.2 signal
102 Gastric Ulcer 13 2.2 2.2 signal
103 Melaena 15 2.2 2.2 signal
104 Rash Macular 23 2.1 2.1 signal
105 Candida Infection 11 2.1 2.1 signal
106 Drug Effect Incomplete 24 2.1 2.1 signal
107 Rash Generalised 17 2.1 2.1 signal
108 Laryngitis 7 2.1 2.1 no signal
109 Disseminated Intravascular Coagulation 9 2.0 2.0 no signal
110 Acute Kidney Injury 97 2.0 2.0 signal
111 Drug Intolerance 61 2.0 2.0 signal
112 Asthenia 237 2.0 2.0 signal
113 Nephropathy Toxic 7 2.0 2.0 no signal
114 Eye Infection 7 2.0 2.0 no signal
115 Alanine Aminotransferase Increased 38 2.0 2.0 no signal
116 Nausea 486 2.0 2.0 no signal
117 Dyspnoea Exertional 23 2.0 2.0 no signal
118 Colitis 23 1.9 1.9 no signal
119 Anaemia 115 1.9 1.9 no signal
120 Death 518 1.9 2.0 no signal
121 Salivary Hypersecretion 6 1.9 1.9 no signal
122 Toxic Epidermal Necrolysis 9 1.9 1.9 no signal
123 Hepatic Failure 18 1.9 1.9 no signal
124 Pneumonia 191 1.9 1.9 no signal
125 Hepatotoxicity 13 1.9 1.9 no signal
126 Hypocalcaemia 11 1.9 1.9 no signal
127 Pancreatitis Acute 13 1.9 1.9 no signal
128 Hypomagnesaemia 8 1.8 1.8 no signal
129 Swollen Tongue 18 1.8 1.8 no signal
130 Pulmonary Fibrosis 11 1.8 1.8 no signal
131 Chromaturia 13 1.8 1.8 no signal
132 Rash Pruritic 31 1.8 1.8 no signal
133 Aphonia 8 1.8 1.8 no signal
134 Hepatic Cytolysis 7 1.8 1.8 no signal
135 Hepatic Function Abnormal 21 1.8 1.8 no signal
136 Osteonecrosis Of Jaw 14 1.8 1.8 no signal
137 Treatment Failure 46 1.8 1.8 no signal
138 Epilepsy 17 1.8 1.8 no signal
139 Hair Colour Changes 7 1.8 1.8 no signal
140 Skin Haemorrhage 8 1.8 1.8 no signal
141 Flatulence 31 1.7 1.7 no signal
142 Cardiac Failure 44 1.7 1.7 no signal
143 Pulmonary Embolism 52 1.7 1.7 no signal
144 Liver Disorder 24 1.7 1.7 no signal
145 Gamma-glutamyltransferase Increased 12 1.7 1.7 no signal
146 Rash Papular 12 1.7 1.7 no signal
147 Oropharyngeal Pain 49 1.7 1.7 no signal
148 Shock 12 1.7 1.7 no signal
149 Drug-induced Liver Injury 16 1.7 1.7 no signal
150 Musculoskeletal Chest Pain 8 1.6 1.6 no signal
151 Blood Creatine Phosphokinase Increased 15 1.6 1.6 no signal
152 Liver Function Test Abnormal 15 1.6 1.6 no signal
153 Haematemesis 13 1.6 1.6 no signal
154 Acute Respiratory Distress Syndrome 9 1.6 1.6 no signal
155 Cholecystitis 6 1.6 1.6 no signal
156 Pneumocystis Jirovecii Pneumonia 5 1.6 1.6 no signal
157 Blister 28 1.6 1.6 no signal
158 Drug Level Increased 8 1.5 1.5 no signal
159 Peritonitis 10 1.5 1.5 no signal
160 Jaundice 13 1.5 1.5 no signal
161 Fungal Infection 16 1.5 1.5 no signal
162 Limb Injury 13 1.5 1.5 no signal
163 Renal Disorder 22 1.5 1.5 no signal
164 Hemiparesis 8 1.5 1.5 no signal
165 Oral Herpes 9 1.5 1.5 no signal
166 Diplopia 12 1.5 1.5 no signal
167 Nodule 6 1.5 1.5 no signal
168 Eye Haemorrhage 6 1.4 1.4 no signal
169 Pancytopenia 25 1.4 1.4 no signal
170 Malignant Melanoma 6 1.4 1.4 no signal
171 Quality Of Life Decreased 6 1.4 1.4 no signal
172 Pruritus 164 1.4 1.4 no signal
173 Blood Thyroid Stimulating Hormone Increased 4 1.4 1.4 no signal
174 Agranulocytosis 8 1.4 1.4 no signal
175 Therapeutic Response Unexpected 19 1.3 1.3 no signal
176 Blood Urine Present 8 1.3 1.3 no signal
177 Altered State Of Consciousness 9 1.3 1.3 no signal
178 Faeces Discoloured 9 1.3 1.3 no signal
179 Ocular Hyperaemia 19 1.3 1.3 no signal
180 Hospice Care 4 1.3 1.3 no signal
181 Neoplasm Malignant 27 1.3 1.3 no signal
182 Eye Disorder 13 1.3 1.3 no signal
183 Neutrophil Count Decreased 16 1.3 1.3 no signal
184 Eye Pruritus 13 1.3 1.3 no signal
185 Dry Throat 4 1.3 1.3 no signal
186 Bone Marrow Failure 8 1.2 1.2 no signal
187 Ejection Fraction Decreased 6 1.2 1.2 no signal
188 Haematochezia 21 1.2 1.2 no signal
189 Breast Pain 4 1.2 1.2 no signal
190 Uveitis 5 1.2 1.2 no signal
191 Ocular Discomfort 4 1.2 1.2 no signal
192 Acute Hepatic Failure 5 1.2 1.2 no signal
193 Pruritus Generalised 8 1.2 1.2 no signal
194 Haemorrhage 37 1.1 1.1 no signal
195 Status Epilepticus 4 1.1 1.1 no signal
196 Gastric Haemorrhage 4 1.1 1.1 no signal
197 Colon Cancer 5 1.1 1.1 no signal
198 Pelvic Pain 6 1.0 1.0 no signal
199 Skin Irritation 15 1.0 1.0 no signal
200 Blood Count Abnormal 5 1.0 1.0 no signal
201 Haematotoxicity 3 1.0 1.0 no signal
202 Gastric Disorder 11 1.0 1.0 no signal
203 Therapy Change 3 1.0 1.0 no signal
204 Toxicity To Various Agents 52 1.0 1.0 no signal
205 Hypoacusis 13 1.0 1.0 no signal
206 Adverse Reaction 4 1.0 1.0 no signal
207 Toxic Skin Eruption 3 0.9 0.9 no signal
208 Inappropriate Antidiuretic Hormone Secretion 3 0.9 0.9 no signal
209 Femur Fracture 9 0.9 0.9 no signal
210 Local Swelling 5 0.9 0.9 no signal
211 Fistula 3 0.8 0.8 no signal
212 Myelosuppression 9 0.8 0.8 no signal
213 Lymphoma 4 0.8 0.8 no signal
214 Madarosis 3 0.8 0.8 no signal
215 Drug Reaction With Eosinophilia And Systemic Symptoms 6 0.7 0.7 no signal
216 Neurotoxicity 4 0.7 0.7 no signal
217 Hepatocellular Injury 3 0.7 0.7 no signal
218 Diabetic Ketoacidosis 5 0.7 0.7 no signal
219 Gastric Cancer 5 0.6 0.6 no signal
220 Skin Burning Sensation 10 0.4 0.4 no signal
221 Oesophageal Carcinoma 3 0.3 0.3 no signal
222 Renal Cancer 3 0.2 0.2 no signal