OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Lorlatinib

273 flagged reaction(s) · 13,137 total co-reports · max PRR 59.6
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 Hypercholesterolaemia 186 59.6 61.2 signal
2 Neoplasm Progression 621 54.1 59.3 signal
3 Hyperlipidaemia 175 44.5 45.6 signal
4 Blood Triglycerides Increased 177 30.3 31.1 signal
5 Metastases To Central Nervous System 123 29.1 29.6 signal
6 Blood Cholesterol Increased 348 22.6 23.7 signal
7 Hallucination, Auditory 109 20.7 21.0 signal
8 Hallucination 404 16.3 17.2 signal
9 Oedema 269 15.0 15.6 signal
10 Hallucination, Visual 96 13.8 14.0 signal
11 Cognitive Disorder 187 12.1 12.4 signal
12 Pericardial Effusion 92 12.1 12.2 signal
13 Blood Thyroid Stimulating Hormone Increased 36 11.8 11.8 signal
14 Nervous System Disorder 106 10.2 10.3 signal
15 Pleural Effusion 184 9.1 9.3 signal
16 Brain Oedema 38 9.1 9.1 signal
17 Metastases To Liver 50 8.6 8.6 signal
18 Psychotic Disorder 83 8.5 8.6 signal
19 Pneumonitis 75 8.4 8.4 signal
20 Carpal Tunnel Syndrome 38 8.2 8.2 signal
21 Full Blood Count Abnormal 28 8.0 8.0 signal
22 Malignant Neoplasm Progression 239 7.1 7.3 signal
23 Generalised Oedema 28 6.8 6.9 signal
24 Mood Altered 61 6.8 6.8 signal
25 Brain Fog 31 6.4 6.4 signal
26 Oedema Peripheral 253 6.2 6.4 signal
27 Neuropathy Peripheral 195 6.2 6.4 signal
28 Nerve Compression 19 6.2 6.2 signal
29 Polyneuropathy 24 6.1 6.1 signal
30 Neurotoxicity 35 6.1 6.1 signal
31 Glycosylated Haemoglobin Increased 49 5.9 5.9 signal
32 Weight Fluctuation 20 5.8 5.8 signal
33 Speech Disorder 96 5.5 5.6 signal
34 Weight Increased 399 5.4 5.7 signal
35 Blood Pressure Systolic Increased 34 5.2 5.2 signal
36 Mental Disorder 72 5.0 5.0 signal
37 Metastases To Lung 19 5.0 5.0 signal
38 Hunger 22 4.9 4.9 signal
39 Personality Change 15 4.8 4.8 signal
40 Gait Inability 53 4.8 4.8 signal
41 Drug Resistance 40 4.7 4.7 signal
42 Metastases To Bone 25 4.6 4.6 signal
43 Dyspnoea Exertional 57 4.6 4.6 signal
44 Death 1,304 4.6 5.4 signal
45 Cerebral Infarction 37 4.6 4.6 signal
46 Delirium 52 4.5 4.6 signal
47 Delusion 22 4.3 4.3 signal
48 Haemoptysis 39 4.2 4.2 signal
49 Altered State Of Consciousness 30 4.2 4.2 signal
50 Increased Appetite 26 4.2 4.2 signal
51 Peripheral Swelling 211 4.1 4.2 signal
52 Memory Impairment 187 4.1 4.2 signal
53 Atelectasis 13 4.0 4.0 signal
54 Thinking Abnormal 25 4.0 4.0 signal
55 Aphasia 40 4.0 4.0 signal
56 Pulmonary Oedema 59 4.0 4.0 signal
57 Disease Progression 154 3.9 4.0 signal
58 Ascites 38 3.9 3.9 signal
59 Dysarthria 48 3.8 3.9 signal
60 Haemoglobin Decreased 128 3.7 3.8 signal
61 Anger 42 3.7 3.7 signal
62 Irritability 74 3.7 3.7 signal
63 Decreased Activity 13 3.6 3.7 signal
64 Brain Neoplasm 11 3.6 3.6 signal
65 Electrocardiogram Qt Prolonged 43 3.6 3.6 signal
66 Mood Swings 38 3.6 3.6 signal
67 Paralysis 17 3.6 3.6 signal
68 Cerebral Haemorrhage 42 3.5 3.5 signal
69 Pulmonary Embolism 111 3.5 3.5 signal
70 Leukocytosis 21 3.5 3.5 signal
71 Lung Neoplasm Malignant 47 3.4 3.4 signal
72 Thrombotic Microangiopathy 11 3.4 3.4 signal
73 Hypothyroidism 36 3.4 3.4 signal
74 Cardiomegaly 14 3.4 3.4 signal
75 Liver Function Test Increased 24 3.4 3.4 signal
76 Hemiparesis 19 3.4 3.4 signal
77 Hepatotoxicity 24 3.3 3.3 signal
78 Coordination Abnormal 15 3.2 3.2 signal
79 Mania 17 3.1 3.1 signal
80 Pericarditis 17 3.1 3.1 signal
81 Drug-induced Liver Injury 31 3.0 3.0 signal
82 Pulmonary Hypertension 21 3.0 3.0 signal
83 Fluid Retention 50 3.0 3.0 signal
84 Aspartate Aminotransferase Increased 52 2.9 3.0 signal
85 Subdural Haematoma 14 2.9 2.9 signal
86 Hepatic Steatosis 18 2.9 2.9 signal
87 Sleep Disorder 67 2.9 2.9 signal
88 Gamma-glutamyltransferase Increased 21 2.8 2.9 signal
89 Cardiac Failure 76 2.8 2.9 signal
90 Full Blood Count Decreased 19 2.8 2.8 signal
91 Blood Iron Decreased 11 2.8 2.8 signal
92 Disorientation 37 2.8 2.8 signal
93 Ataxia 11 2.8 2.8 signal
94 Pancytopenia 51 2.8 2.8 signal
95 Hepatomegaly 9 2.7 2.7 signal
96 Mental Impairment 22 2.7 2.7 signal
97 Haematocrit Decreased 18 2.7 2.7 signal
98 Proteinuria 17 2.7 2.7 signal
99 Pulmonary Arterial Hypertension 13 2.7 2.7 signal
100 Blood Urea Increased 15 2.7 2.7 signal
101 Motor Dysfunction 9 2.7 2.7 signal
102 Blood Alkaline Phosphatase Increased 22 2.7 2.7 signal
103 Hypersomnia 25 2.6 2.6 signal
104 Iron Deficiency Anaemia 8 2.6 2.6 signal
105 Tinnitus 40 2.6 2.6 signal
106 Spinal Pain 10 2.6 2.6 signal
107 Head Discomfort 15 2.6 2.6 signal
108 Platelet Count Increased 11 2.5 2.5 signal
109 Abdominal Distension 87 2.5 2.5 signal
110 Confusional State 134 2.5 2.5 signal
111 Face Oedema 14 2.5 2.5 signal
112 Blood Creatine Phosphokinase Increased 24 2.5 2.5 signal
113 Blood Lactate Dehydrogenase Increased 13 2.5 2.5 signal
114 Hepatic Function Abnormal 30 2.4 2.4 signal
115 Hyperglycaemia 29 2.4 2.4 signal
116 Flatulence 45 2.4 2.4 signal
117 Blood Creatinine Increased 52 2.4 2.4 signal
118 Diabetes Mellitus 60 2.4 2.4 signal
119 Loss Of Personal Independence In Daily Activities 37 2.3 2.3 signal
120 Heart Rate Increased 77 2.3 2.4 signal
121 Hyperbilirubinaemia 8 2.3 2.3 signal
122 Euphoric Mood 8 2.3 2.3 signal
123 Epilepsy 23 2.3 2.3 signal
124 Amnesia 49 2.3 2.3 signal
125 Joint Range Of Motion Decreased 10 2.2 2.3 signal
126 Emotional Disorder 23 2.2 2.2 signal
127 Blood Potassium Increased 12 2.2 2.2 signal
128 Swelling 69 2.2 2.2 signal
129 Respiratory Disorder 22 2.2 2.2 signal
130 Affect Lability 7 2.2 2.2 no signal
131 Central Nervous System Lesion 10 2.2 2.2 signal
132 Disturbance In Attention 38 2.1 2.1 signal
133 Pallor 19 2.1 2.1 signal
134 Blood Sodium Decreased 13 2.1 2.1 signal
135 Blood Pressure Increased 105 2.1 2.1 signal
136 Depressed Level Of Consciousness 27 2.1 2.1 signal
137 Abnormal Dreams 19 2.1 2.1 signal
138 Renal Impairment 57 2.0 2.1 signal
139 Neutrophil Count Increased 7 2.0 2.0 no signal
140 Diabetes Mellitus Inadequate Control 12 2.0 2.0 signal
141 Cholecystitis 8 2.0 2.0 no signal
142 Alanine Aminotransferase Increased 41 2.0 2.0 signal
143 Therapy Partial Responder 10 2.0 2.0 no signal
144 Nightmare 23 2.0 2.0 no signal
145 Neuralgia 16 2.0 2.0 no signal
146 Aggression 33 2.0 2.0 no signal
147 Feeding Disorder 13 2.0 2.0 no signal
148 Mental Status Changes 18 1.9 1.9 no signal
149 Depressed Mood 34 1.9 1.9 no signal
150 Appendicitis 6 1.9 1.9 no signal
151 Paranoia 11 1.9 1.9 no signal
152 Dysphonia 37 1.9 1.9 no signal
153 Thrombosis 51 1.9 1.9 no signal
154 Hyperthyroidism 9 1.9 1.9 no signal
155 Blood Calcium Decreased 7 1.9 1.9 no signal
156 Apathy 9 1.9 1.9 no signal
157 Stress 44 1.8 1.8 no signal
158 Respiratory Failure 44 1.8 1.8 no signal
159 Restlessness 22 1.8 1.8 no signal
160 Dysphagia 56 1.8 1.8 no signal
161 Oxygen Saturation Decreased 33 1.8 1.8 no signal
162 Movement Disorder 19 1.8 1.8 no signal
163 Hypoaesthesia 88 1.8 1.8 no signal
164 Liver Disorder 26 1.8 1.8 no signal
165 Thyroid Disorder 9 1.8 1.8 no signal
166 Interstitial Lung Disease 28 1.7 1.7 no signal
167 Ejection Fraction Decreased 9 1.7 1.7 no signal
168 Visual Impairment 71 1.7 1.7 no signal
169 Urinary Incontinence 17 1.7 1.7 no signal
170 Pneumothorax 9 1.7 1.7 no signal
171 Hypercalcaemia 7 1.7 1.7 no signal
172 Balance Disorder 49 1.7 1.7 no signal
173 Breast Pain 6 1.7 1.7 no signal
174 Musculoskeletal Stiffness 49 1.7 1.7 no signal
175 Muscle Atrophy 7 1.7 1.7 no signal
176 Deep Vein Thrombosis 36 1.7 1.7 no signal
177 Blood Glucose Increased 104 1.7 1.7 no signal
178 Taste Disorder 11 1.6 1.7 no signal
179 Liver Function Test Abnormal 16 1.6 1.6 no signal
180 Red Blood Cell Sedimentation Rate Increased 6 1.6 1.6 no signal
181 Cardiomyopathy 8 1.6 1.6 no signal
182 Blindness 22 1.6 1.6 no signal
183 Blood Glucose Abnormal 10 1.6 1.6 no signal
184 Liver Injury 13 1.6 1.6 no signal
185 Lymphadenopathy 19 1.6 1.6 no signal
186 Off Label Use 461 1.6 1.6 no signal
187 Mobility Decreased 38 1.6 1.6 no signal
188 Platelet Count Decreased 56 1.6 1.6 no signal
189 Therapy Change 5 1.6 1.6 no signal
190 Fear 14 1.6 1.6 no signal
191 Musculoskeletal Chest Pain 8 1.6 1.6 no signal
192 Eating Disorder 11 1.5 1.5 no signal
193 Intentional Dose Omission 14 1.5 1.5 no signal
194 Lower Respiratory Tract Infection 23 1.5 1.5 no signal
195 Swelling Face 33 1.5 1.5 no signal
196 Body Temperature Decreased 5 1.5 1.5 no signal
197 Aphonia 7 1.5 1.5 no signal
198 Multiple Organ Dysfunction Syndrome 14 1.5 1.5 no signal
199 Deafness 13 1.5 1.5 no signal
200 Sensory Disturbance 8 1.5 1.5 no signal
201 Paraesthesia 78 1.5 1.5 no signal
202 Muscle Tightness 8 1.5 1.5 no signal
203 Eyelid Ptosis 5 1.5 1.5 no signal
204 Therapeutic Response Unexpected 22 1.5 1.5 no signal
205 Impaired Quality Of Life 7 1.5 1.5 no signal
206 Product Dose Omission In Error 13 1.5 1.5 no signal
207 Arrhythmia 23 1.5 1.5 no signal
208 Psychomotor Hyperactivity 8 1.4 1.4 no signal
209 Seizure 55 1.4 1.4 no signal
210 Discomfort 29 1.4 1.4 no signal
211 Dysstasia 14 1.4 1.4 no signal
212 Abnormal Behaviour 19 1.4 1.4 no signal
213 Product Prescribing Error 11 1.4 1.4 no signal
214 Joint Swelling 55 1.4 1.4 no signal
215 Pancreatitis 24 1.4 1.4 no signal
216 Bradycardia 24 1.4 1.4 no signal
217 Transaminases Increased 10 1.4 1.4 no signal
218 Nephropathy Toxic 5 1.3 1.3 no signal
219 Nerve Injury 5 1.3 1.3 no signal
220 Pain In Extremity 132 1.3 1.4 no signal
221 Drug Effective For Unapproved Indication 13 1.3 1.3 no signal
222 Jaundice 12 1.3 1.3 no signal
223 Crying 16 1.3 1.3 no signal
224 Nervousness 23 1.3 1.3 no signal
225 Bone Disorder 8 1.3 1.3 no signal
226 Dementia 12 1.3 1.3 no signal
227 Blood Test Abnormal 6 1.3 1.3 no signal
228 Posterior Reversible Encephalopathy Syndrome 4 1.3 1.3 no signal
229 Limb Discomfort 13 1.3 1.3 no signal
230 Accident 5 1.3 1.3 no signal
231 Impaired Work Ability 9 1.3 1.3 no signal
232 Joint Stiffness 11 1.3 1.3 no signal
233 Disease Recurrence 20 1.3 1.3 no signal
234 Type 2 Diabetes Mellitus 14 1.2 1.2 no signal
235 Hypokinesia 6 1.2 1.2 no signal
236 Schizophrenia 5 1.2 1.2 no signal
237 Vitreous Floaters 4 1.2 1.2 no signal
238 Agitation 30 1.2 1.2 no signal
239 Myalgia 69 1.2 1.2 no signal
240 Ageusia 10 1.2 1.2 no signal
241 Hip Arthroplasty 6 1.2 1.2 no signal
242 Febrile Neutropenia 26 1.2 1.2 no signal
243 Ischaemic Stroke 7 1.2 1.2 no signal
244 Poor Quality Product Administered 4 1.2 1.2 no signal
245 Diabetic Ketoacidosis 9 1.1 1.1 no signal
246 Hypoacusis 16 1.1 1.1 no signal
247 Body Height Decreased 4 1.1 1.1 no signal
248 Pulmonary Thrombosis 4 1.1 1.1 no signal
249 Bipolar Disorder 4 1.1 1.1 no signal
250 Coronary Artery Disease 11 1.1 1.1 no signal
251 Hypertensive Crisis 4 1.1 1.1 no signal
252 Intestinal Perforation 4 1.1 1.1 no signal
253 Impaired Driving Ability 4 1.1 1.1 no signal
254 Neoplasm 4 1.0 1.0 no signal
255 Cerebrovascular Accident 59 1.0 1.0 no signal
256 Osteonecrosis Of Jaw 8 1.0 1.0 no signal
257 Extrapyramidal Disorder 8 1.0 1.0 no signal
258 Therapy Interrupted 22 1.0 1.0 no signal
259 Suicide Attempt 19 0.9 0.9 no signal
260 Toxic Skin Eruption 3 0.9 0.9 no signal
261 Menstruation Delayed 3 0.9 0.9 no signal
262 Blood Glucose Fluctuation 3 0.8 0.8 no signal
263 Osteonecrosis 9 0.8 0.8 no signal
264 Suicidal Ideation 24 0.8 0.8 no signal
265 Abnormal Weight Gain 3 0.7 0.7 no signal
266 Myelosuppression 8 0.7 0.7 no signal
267 Tuberculosis 3 0.7 0.7 no signal
268 Menstruation Irregular 6 0.7 0.7 no signal
269 Palmar-plantar Erythrodysaesthesia Syndrome 5 0.6 0.6 no signal
270 Product Physical Issue 4 0.6 0.6 no signal
271 Amenorrhoea 3 0.5 0.5 no signal
272 Extra Dose Administered 6 0.5 0.5 no signal
273 Completed Suicide 10 0.4 0.4 no signal