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Drug

Ramelteon

413 flagged reaction(s) · 13,299 total co-reports · max PRR 130.8
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 Initial Insomnia 447 130.8 139.3 signal
2 Middle Insomnia 390 61.1 64.5 signal
3 Poor Quality Sleep 218 29.4 30.2 signal
4 Abnormal Dreams 133 13.7 13.9 signal
5 Nightmare 145 11.9 12.2 signal
6 Pneumonia Aspiration 98 11.3 11.4 signal
7 Altered State Of Consciousness 80 10.6 10.7 signal
8 Disseminated Intravascular Coagulation 43 8.7 8.8 signal
9 Drug Eruption 52 8.4 8.5 signal
10 Delirium 99 8.2 8.3 signal
11 Hepatic Function Abnormal 98 7.6 7.7 signal
12 Drug Dispensing Error 39 7.2 7.2 signal
13 Feeling Jittery 47 7.0 7.1 signal
14 Inappropriate Antidiuretic Hormone Secretion 23 6.5 6.5 signal
15 Restlessness 81 6.3 6.4 signal
16 Ileus 27 6.3 6.3 signal
17 Somnolence 418 5.9 6.2 signal
18 Hypersomnia 57 5.7 5.7 signal
19 Interstitial Lung Disease 94 5.6 5.6 signal
20 Neuroleptic Malignant Syndrome 23 5.5 5.5 signal
21 Cerebral Infarction 45 5.3 5.3 signal
22 Prescribed Overdose 35 5.2 5.2 signal
23 Atelectasis 17 5.0 5.0 signal
24 Parkinsonism 16 4.7 4.7 signal
25 Restless Legs Syndrome 29 4.6 4.6 signal
26 Hallucination, Visual 32 4.4 4.4 signal
27 Iron Deficiency Anaemia 14 4.4 4.4 signal
28 Insomnia 398 4.3 4.4 signal
29 Schizophrenia 18 4.2 4.2 signal
30 Oesophagitis 16 4.2 4.2 signal
31 Psychomotor Hyperactivity 24 4.1 4.1 signal
32 Sedation 37 4.1 4.1 signal
33 Hyperlipidaemia 17 4.1 4.1 signal
34 Sleep Apnoea Syndrome 27 4.0 4.0 signal
35 Acute Respiratory Failure 27 4.0 4.0 signal
36 Depressed Level Of Consciousness 55 4.0 4.0 signal
37 Subarachnoid Haemorrhage 14 3.9 3.9 signal
38 Hallucination 101 3.8 3.9 signal
39 Hepatic Steatosis 25 3.8 3.8 signal
40 Delusion 20 3.7 3.7 signal
41 Thinking Abnormal 24 3.7 3.7 signal
42 Bipolar Disorder 14 3.7 3.7 signal
43 Melaena 28 3.6 3.6 signal
44 Malnutrition 14 3.6 3.6 signal
45 Toxic Epidermal Necrolysis 19 3.6 3.6 signal
46 Obesity 20 3.6 3.6 signal
47 Mitral Valve Incompetence 14 3.5 3.5 signal
48 Respiratory Depression 15 3.5 3.5 signal
49 Renal Impairment 102 3.5 3.5 signal
50 Sudden Death 13 3.5 3.5 signal
51 Decreased Activity 13 3.5 3.5 signal
52 Colon Cancer 18 3.4 3.4 signal
53 Salivary Hypersecretion 12 3.4 3.4 signal
54 Hallucination, Auditory 19 3.4 3.4 signal
55 Blood Lactate Dehydrogenase Increased 19 3.4 3.4 signal
56 Lymphocyte Count Decreased 21 3.4 3.4 signal
57 Chronic Kidney Disease 91 3.4 3.4 signal
58 Sluggishness 12 3.4 3.4 signal
59 Erythema Multiforme 11 3.4 3.4 signal
60 Economic Problem 18 3.3 3.3 signal
61 Drug Toxicity 16 3.3 3.3 signal
62 Mania 19 3.3 3.3 signal
63 Paranoia 20 3.3 3.3 signal
64 Serotonin Syndrome 22 3.3 3.3 signal
65 End Stage Renal Disease 21 3.3 3.3 signal
66 Libido Decreased 14 3.2 3.2 signal
67 Subdural Haematoma 16 3.2 3.2 signal
68 Dyskinesia 45 3.2 3.2 signal
69 Emphysema 11 3.1 3.1 signal
70 Respiratory Failure 79 3.1 3.1 signal
71 Rhabdomyolysis 45 3.1 3.1 signal
72 Tubulointerstitial Nephritis 20 3.0 3.1 signal
73 Euphoric Mood 11 3.0 3.1 signal
74 Blood Alkaline Phosphatase Increased 26 3.0 3.0 signal
75 Diabetic Ketoacidosis 25 3.0 3.0 signal
76 Intentional Overdose 66 3.0 3.0 signal
77 Sinus Bradycardia 10 2.9 3.0 signal
78 Eating Disorder 22 2.9 2.9 signal
79 Ventricular Tachycardia 17 2.9 2.9 signal
80 Cholecystitis 12 2.9 2.9 signal
81 Hypokalaemia 46 2.9 2.9 signal
82 Agitation 73 2.8 2.8 signal
83 Pulmonary Congestion 13 2.8 2.8 signal
84 Blood Pressure Decreased 65 2.8 2.8 signal
85 Hyperkalaemia 34 2.8 2.8 signal
86 Product Prescribing Error 23 2.8 2.8 signal
87 Nervousness 51 2.8 2.8 signal
88 Extrapyramidal Disorder 24 2.7 2.7 signal
89 Hypocalcaemia 18 2.7 2.7 signal
90 Thirst 17 2.7 2.7 signal
91 Haematocrit Decreased 19 2.7 2.7 signal
92 Blood Urea Increased 16 2.7 2.7 signal
93 Liver Disorder 42 2.7 2.7 signal
94 Urinary Retention 31 2.7 2.7 signal
95 Aspiration 10 2.6 2.6 signal
96 Ascites 27 2.6 2.6 signal
97 Sinus Tachycardia 13 2.6 2.6 signal
98 Orthostatic Hypotension 16 2.6 2.6 signal
99 Hypothyroidism 29 2.6 2.6 signal
100 Cardiac Failure 73 2.6 2.6 signal
101 Device Related Infection 14 2.6 2.6 signal
102 Prescribed Underdose 18 2.6 2.6 signal
103 Activities Of Daily Living Impaired 18 2.6 2.6 signal
104 Pulmonary Arterial Hypertension 13 2.5 2.6 signal
105 Blood Creatine Phosphokinase Increased 26 2.5 2.5 signal
106 Epilepsy 27 2.5 2.5 signal
107 Osteomyelitis 16 2.5 2.5 signal
108 C-reactive Protein Increased 32 2.5 2.5 signal
109 Impaired Driving Ability 10 2.5 2.5 signal
110 Febrile Neutropenia 58 2.5 2.5 signal
111 Neutrophil Count Increased 9 2.5 2.5 signal
112 Bacterial Infection 16 2.5 2.5 signal
113 Electrocardiogram Qt Prolonged 31 2.5 2.5 signal
114 Feeling Abnormal 207 2.5 2.5 signal
115 Hepatic Encephalopathy 8 2.4 2.4 signal
116 Cytomegalovirus Infection 14 2.4 2.4 signal
117 Hypercholesterolaemia 8 2.4 2.4 signal
118 Alanine Aminotransferase Increased 51 2.4 2.4 signal
119 Type 2 Diabetes Mellitus 28 2.4 2.4 signal
120 Aspartate Aminotransferase Increased 44 2.4 2.4 signal
121 Nocturia 10 2.4 2.4 signal
122 Gastroenteritis 12 2.4 2.4 signal
123 Diabetes Mellitus 63 2.3 2.4 signal
124 Hyponatraemia 46 2.3 2.3 signal
125 Hunger 11 2.3 2.3 signal
126 Ligament Sprain 8 2.3 2.3 signal
127 Suicide Attempt 49 2.3 2.3 signal
128 Cardiomegaly 10 2.3 2.3 signal
129 Blood Potassium Increased 13 2.3 2.3 signal
130 Anaemia 151 2.3 2.3 signal
131 Platelet Count Decreased 84 2.3 2.3 signal
132 Cerebral Haemorrhage 28 2.2 2.2 signal
133 Irritability 47 2.2 2.2 signal
134 Erectile Dysfunction 20 2.2 2.2 signal
135 Hiatus Hernia 10 2.2 2.2 signal
136 Drug Prescribing Error 15 2.2 2.2 signal
137 Gamma-glutamyltransferase Increased 17 2.2 2.2 signal
138 Bacteraemia 9 2.2 2.2 signal
139 Brain Neoplasm 7 2.2 2.2 no signal
140 Aggression 38 2.2 2.2 signal
141 Covid-19 Pneumonia 9 2.2 2.2 signal
142 Incontinence 8 2.2 2.2 no signal
143 Bradycardia 40 2.1 2.2 signal
144 Adrenal Insufficiency 9 2.1 2.1 signal
145 Shock 17 2.1 2.1 signal
146 Hypoglycaemia 36 2.1 2.1 signal
147 Femur Fracture 23 2.1 2.1 signal
148 Tardive Dyskinesia 21 2.1 2.1 signal
149 Cytokine Release Syndrome 14 2.1 2.1 signal
150 Renal Disorder 34 2.1 2.1 signal
151 No Therapeutic Response 9 2.1 2.1 signal
152 Pharyngitis 9 2.1 2.1 no signal
153 Amenorrhoea 12 2.1 2.1 signal
154 Ventricular Fibrillation 8 2.1 2.1 no signal
155 Pancreatitis Acute 16 2.0 2.0 signal
156 Neutrophil Count Decreased 29 2.0 2.0 signal
157 Pleural Effusion 43 2.0 2.0 signal
158 Infusion Site Pain 9 2.0 2.0 no signal
159 Dermatitis Contact 8 2.0 2.0 no signal
160 Abnormal Behaviour 28 2.0 2.0 signal
161 Drug Ineffective 923 2.0 2.1 signal
162 Fear 19 2.0 2.0 signal
163 Photophobia 13 2.0 2.0 no signal
164 Acute Kidney Injury 106 2.0 2.0 no signal
165 Intentional Self-injury 14 2.0 2.0 no signal
166 Cellulitis 35 2.0 2.0 no signal
167 Metastases To Lung 8 2.0 2.0 no signal
168 Dysarthria 26 2.0 2.0 no signal
169 Fracture 13 2.0 2.0 no signal
170 Disturbance In Attention 37 2.0 2.0 no signal
171 Mental Status Changes 19 2.0 2.0 no signal
172 Oedema 37 2.0 2.0 no signal
173 Treatment Noncompliance 37 1.9 1.9 no signal
174 Anxiety 194 1.9 2.0 no signal
175 Muscle Tightness 11 1.9 1.9 no signal
176 Disorientation 27 1.9 1.9 no signal
177 Decreased Appetite 157 1.9 2.0 no signal
178 Suicidal Ideation 62 1.9 1.9 no signal
179 Stomatitis 41 1.9 1.9 no signal
180 White Blood Cell Count Increased 26 1.9 1.9 no signal
181 Sleep Disorder 47 1.9 1.9 no signal
182 Hypophagia 17 1.9 1.9 no signal
183 Jaundice 18 1.9 1.9 no signal
184 Transfusion 7 1.9 1.9 no signal
185 Akathisia 9 1.9 1.9 no signal
186 Small Intestinal Obstruction 8 1.9 1.9 no signal
187 Skin Laceration 7 1.8 1.9 no signal
188 Septic Shock 28 1.8 1.9 no signal
189 Rash Generalised 17 1.8 1.8 no signal
190 Respiratory Arrest 18 1.8 1.8 no signal
191 Intervertebral Disc Degeneration 6 1.8 1.8 no signal
192 Dysphagia 61 1.8 1.8 no signal
193 Haemoptysis 18 1.8 1.8 no signal
194 Anhedonia 17 1.8 1.8 no signal
195 Depression 146 1.8 1.8 no signal
196 Seasonal Allergy 9 1.8 1.8 no signal
197 Arteriosclerosis 6 1.8 1.8 no signal
198 Renal Failure 85 1.8 1.8 no signal
199 Poisoning 8 1.8 1.8 no signal
200 Foot Fracture 12 1.8 1.8 no signal
201 Sciatica 10 1.8 1.8 no signal
202 Laceration 6 1.8 1.8 no signal
203 Impaired Gastric Emptying 8 1.8 1.8 no signal
204 Head Discomfort 11 1.8 1.8 no signal
205 Glaucoma 12 1.8 1.8 no signal
206 Fall 207 1.8 1.8 no signal
207 Pulmonary Hypertension 13 1.8 1.8 no signal
208 Sensory Disturbance 10 1.8 1.8 no signal
209 Anger 21 1.8 1.8 no signal
210 Mental Impairment 15 1.8 1.8 no signal
211 Fibromyalgia 15 1.8 1.8 no signal
212 Psychotic Disorder 18 1.7 1.7 no signal
213 Multiple Organ Dysfunction Syndrome 17 1.7 1.7 no signal
214 Photosensitivity Reaction 10 1.7 1.7 no signal
215 Gastroenteritis Viral 11 1.7 1.7 no signal
216 Osteoporosis 25 1.7 1.7 no signal
217 Drug Interaction 96 1.7 1.7 no signal
218 Convulsion 35 1.7 1.7 no signal
219 Pneumocystis Jirovecii Pneumonia 6 1.7 1.7 no signal
220 Hypoaesthesia Oral 9 1.7 1.7 no signal
221 Medication Error 33 1.7 1.7 no signal
222 Cardio-respiratory Arrest 25 1.7 1.7 no signal
223 Red Blood Cell Count Decreased 17 1.7 1.7 no signal
224 Palpitations 69 1.7 1.7 no signal
225 Mood Altered 16 1.7 1.7 no signal
226 Drug-induced Liver Injury 18 1.7 1.7 no signal
227 Proteinuria 11 1.7 1.7 no signal
228 Peripheral Coldness 8 1.7 1.7 no signal
229 Peritonitis 12 1.7 1.7 no signal
230 Diplopia 15 1.6 1.6 no signal
231 Pharyngeal Oedema 9 1.6 1.6 no signal
232 Panic Attack 21 1.6 1.6 no signal
233 Head Injury 18 1.6 1.6 no signal
234 Loss Of Consciousness 73 1.6 1.6 no signal
235 Migraine 54 1.6 1.6 no signal
236 Tremor 94 1.6 1.6 no signal
237 Muscle Twitching 13 1.6 1.6 no signal
238 Irritable Bowel Syndrome 12 1.6 1.6 no signal
239 Laryngitis 6 1.6 1.6 no signal
240 Apathy 8 1.6 1.6 no signal
241 Hyperglycaemia 20 1.6 1.6 no signal
242 Mental Disorder 24 1.6 1.6 no signal
243 Dizziness 273 1.6 1.6 no signal
244 Urinary Tract Infection 93 1.6 1.6 no signal
245 Heart Rate Increased 54 1.6 1.6 no signal
246 Overdose 118 1.6 1.6 no signal
247 Dental Caries 6 1.5 1.6 no signal
248 Dementia 15 1.5 1.5 no signal
249 Stevens-johnson Syndrome 12 1.5 1.5 no signal
250 Blood Cholesterol Increased 25 1.5 1.5 no signal
251 Amnesia 35 1.5 1.5 no signal
252 Personality Change 5 1.5 1.5 no signal
253 Upper Gastrointestinal Haemorrhage 9 1.5 1.5 no signal
254 Bedridden 7 1.5 1.5 no signal
255 Face Oedema 9 1.5 1.5 no signal
256 Pericardial Effusion 12 1.5 1.5 no signal
257 Dizziness Postural 5 1.5 1.5 no signal
258 Pancytopenia 29 1.5 1.5 no signal
259 Epistaxis 39 1.5 1.5 no signal
260 Dehydration 69 1.5 1.5 no signal
261 Palmar-plantar Erythrodysaesthesia Syndrome 12 1.5 1.5 no signal
262 Coeliac Disease 5 1.5 1.5 no signal
263 Drug Reaction With Eosinophilia And Systemic Symptoms 13 1.5 1.5 no signal
264 Blood Triglycerides Increased 9 1.4 1.4 no signal
265 Body Temperature Decreased 5 1.4 1.4 no signal
266 Myoclonus 6 1.4 1.4 no signal
267 Intervertebral Disc Protrusion 11 1.4 1.4 no signal
268 Road Traffic Accident 21 1.4 1.4 no signal
269 Wrist Fracture 6 1.4 1.4 no signal
270 Renal Injury 15 1.4 1.4 no signal
271 Rash Maculo-papular 11 1.4 1.4 no signal
272 Glomerular Filtration Rate Decreased 6 1.4 1.4 no signal
273 Drug Effect Decreased 27 1.4 1.4 no signal
274 Therapeutic Response Unexpected 22 1.4 1.4 no signal
275 Hyperbilirubinaemia 5 1.4 1.4 no signal
276 Arrhythmia 23 1.4 1.4 no signal
277 Dysgeusia 36 1.4 1.4 no signal
278 Limb Injury 13 1.4 1.4 no signal
279 Memory Impairment 66 1.4 1.4 no signal
280 White Blood Cell Count Decreased 52 1.4 1.4 no signal
281 Increased Appetite 9 1.4 1.4 no signal
282 Liver Function Test Abnormal 14 1.4 1.4 no signal
283 Haemoglobin Decreased 49 1.4 1.4 no signal
284 Deep Vein Thrombosis 31 1.4 1.4 no signal
285 Haematemesis 12 1.3 1.3 no signal
286 Intentional Drug Misuse 10 1.3 1.3 no signal
287 Cardiac Arrest 39 1.3 1.3 no signal
288 Seizure 54 1.3 1.3 no signal
289 Lactic Acidosis 15 1.3 1.3 no signal
290 Hyperhidrosis 60 1.3 1.3 no signal
291 Completed Suicide 39 1.3 1.3 no signal
292 Anorexia 6 1.3 1.3 no signal
293 Pruritus Generalised 10 1.3 1.3 no signal
294 Tooth Fracture 5 1.3 1.3 no signal
295 Diabetes Mellitus Inadequate Control 8 1.3 1.3 no signal
296 Withdrawal Syndrome 19 1.3 1.3 no signal
297 Ejection Fraction Decreased 7 1.3 1.3 no signal
298 Swollen Tongue 14 1.3 1.3 no signal
299 Throat Tightness 12 1.3 1.3 no signal
300 Cyanosis 7 1.3 1.3 no signal
301 Vertigo 27 1.3 1.3 no signal
302 Status Epilepticus 5 1.3 1.3 no signal
303 Rebound Effect 5 1.3 1.3 no signal
304 Glycosylated Haemoglobin Increased 11 1.2 1.2 no signal
305 Myocardial Ischaemia 5 1.2 1.2 no signal
306 Pancreatitis 23 1.2 1.2 no signal
307 Nerve Compression 4 1.2 1.2 no signal
308 Central Nervous System Lesion 6 1.2 1.2 no signal
309 Ovarian Cancer 4 1.2 1.2 no signal
310 Vasculitis 5 1.2 1.2 no signal
311 Eyelid Oedema 5 1.2 1.2 no signal
312 Coordination Abnormal 6 1.2 1.2 no signal
313 Grand Mal Convulsion 4 1.2 1.2 no signal
314 Posterior Reversible Encephalopathy Syndrome 4 1.2 1.2 no signal
315 Cardiac Failure Congestive 34 1.2 1.2 no signal
316 Gastrointestinal Haemorrhage 35 1.2 1.2 no signal
317 Angina Pectoris 12 1.2 1.2 no signal
318 Myelodysplastic Syndrome 6 1.2 1.2 no signal
319 Affect Lability 4 1.2 1.2 no signal
320 Malignant Neoplasm Progression 42 1.2 1.2 no signal
321 Oral Herpes 8 1.2 1.2 no signal
322 Crying 15 1.2 1.2 no signal
323 Underdose 30 1.2 1.2 no signal
324 Disability 8 1.2 1.2 no signal
325 Muscle Spasticity 5 1.2 1.2 no signal
326 Speech Disorder 21 1.1 1.1 no signal
327 Metastases To Liver 7 1.1 1.1 no signal
328 Coma 19 1.1 1.1 no signal
329 Ovarian Cyst 4 1.1 1.1 no signal
330 Hypothermia 4 1.1 1.1 no signal
331 Bone Marrow Failure 8 1.1 1.1 no signal
332 Gallbladder Disorder 7 1.1 1.1 no signal
333 Thyroid Disorder 6 1.1 1.1 no signal
334 Lymphoma 6 1.1 1.1 no signal
335 Dysmenorrhoea 5 1.1 1.1 no signal
336 Herpes Zoster 22 1.1 1.1 no signal
337 Breast Pain 4 1.1 1.1 no signal
338 Pneumonitis 10 1.1 1.1 no signal
339 Eructation 7 1.1 1.1 no signal
340 Generalised Tonic-clonic Seizure 6 1.0 1.0 no signal
341 Musculoskeletal Disorder 7 1.0 1.0 no signal
342 Toxicity To Various Agents 61 1.0 1.0 no signal
343 Application Site Rash 5 1.0 1.0 no signal
344 Drug Level Increased 6 1.0 1.0 no signal
345 Osteonecrosis Of Jaw 9 1.0 1.0 no signal
346 Device Occlusion 5 1.0 1.0 no signal
347 Dialysis 5 1.0 1.0 no signal
348 Therapeutic Response Decreased 21 1.0 1.0 no signal
349 Incorrect Dose Administered 78 1.0 1.0 no signal
350 Mood Swings 11 1.0 1.0 no signal
351 Unevaluable Event 26 1.0 1.0 no signal
352 Eosinophilia 6 1.0 1.0 no signal
353 Cytopenia 4 1.0 1.0 no signal
354 Muscle Rigidity 4 1.0 1.0 no signal
355 Pelvic Pain 6 0.9 0.9 no signal
356 Impaired Work Ability 7 0.9 0.9 no signal
357 Agranulocytosis 6 0.9 0.9 no signal
358 Abasia 8 0.9 0.9 no signal
359 Hospitalisation 48 0.9 0.9 no signal
360 Metastases To Central Nervous System 4 0.9 0.9 no signal
361 Anaphylactic Shock 8 0.9 0.9 no signal
362 Knee Operation 3 0.9 0.9 no signal
363 Dystonia 6 0.9 0.9 no signal
364 Wrong Technique In Product Usage Process 62 0.9 0.9 no signal
365 Plasma Cell Myeloma 12 0.9 0.9 no signal
366 No Adverse Event 54 0.9 0.9 no signal
367 Malignant Melanoma 4 0.9 0.9 no signal
368 Product Taste Abnormal 4 0.8 0.8 no signal
369 Helicobacter Infection 3 0.8 0.8 no signal
370 Drug Level Decreased 3 0.8 0.8 no signal
371 Injection Site Discomfort 3 0.8 0.8 no signal
372 Lung Neoplasm Malignant 12 0.8 0.8 no signal
373 Emotional Disorder 9 0.8 0.8 no signal
374 Metrorrhagia 5 0.8 0.8 no signal
375 Tooth Loss 6 0.8 0.8 no signal
376 Bone Density Decreased 9 0.8 0.8 no signal
377 Product Dispensing Error 6 0.8 0.8 no signal
378 Gastric Cancer 7 0.8 0.8 no signal
379 Wrong Technique In Drug Usage Process 10 0.8 0.8 no signal
380 Acute Myeloid Leukaemia 4 0.7 0.7 no signal
381 Multiple Sclerosis 12 0.7 0.7 no signal
382 Hepatitis C 3 0.7 0.7 no signal
383 Expired Product Administered 8 0.7 0.7 no signal
384 Myelosuppression 8 0.7 0.7 no signal
385 Emotional Distress 28 0.7 0.7 no signal
386 Neoplasm Progression 8 0.7 0.6 no signal
387 Menstruation Irregular 6 0.6 0.6 no signal
388 Hair Texture Abnormal 3 0.6 0.6 no signal
389 Blood Glucose Increased 42 0.6 0.6 no signal
390 Inappropriate Schedule Of Drug Administration 16 0.6 0.6 no signal
391 Drug Effect Incomplete 8 0.6 0.6 no signal
392 Needle Issue 6 0.6 0.6 no signal
393 Drug Withdrawal Syndrome 18 0.6 0.6 no signal
394 Menorrhagia 4 0.6 0.6 no signal
395 Bone Loss 3 0.6 0.6 no signal
396 Circumstance Or Information Capable Of Leading To Medication Error 6 0.5 0.5 no signal
397 Application Site Pruritus 4 0.5 0.5 no signal
398 Incorrect Drug Administration Duration 5 0.5 0.5 no signal
399 Device Use Issue 3 0.5 0.5 no signal
400 Injection Site Rash 5 0.5 0.5 no signal
401 Drug Dose Omission 27 0.5 0.5 no signal
402 Gynaecomastia 5 0.5 0.5 no signal
403 Therapeutic Response Shortened 5 0.4 0.4 no signal
404 Skin Irritation 7 0.4 0.4 no signal
405 Pharmaceutical Product Complaint 4 0.4 0.4 no signal
406 Multiple Sclerosis Relapse 10 0.4 0.4 no signal
407 Device Dislocation 6 0.4 0.4 no signal
408 Pancreatic Carcinoma 4 0.4 0.4 no signal
409 Drug Dependence 22 0.4 0.4 no signal
410 Colorectal Cancer 6 0.4 0.4 no signal
411 Product Adhesion Issue 4 0.3 0.3 no signal
412 Renal Cancer 4 0.2 0.2 no signal
413 Wrong Technique In Device Usage Process 3 0.2 0.2 no signal