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Drug

Cabotegravir

567 flagged reaction(s) · 15,814 total co-reports · max PRR 1,164.9
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 Product Use In Unapproved Therapeutic Environment 255 1,164.9 1,203.1 signal
2 Proctitis Gonococcal 3 1,104.2 1,104.7 signal
3 Oropharyngeal Gonococcal Infection 6 736.2 736.7 signal
4 Blood Hiv Rna Below Assay Limit 3 644.1 644.4 signal
5 Hiv Test False Positive 5 390.4 390.6 signal
6 Single Component Of A Two-component Product Administered 11 377.9 378.4 signal
7 Disseminated Mycobacterium Avium Complex Infection 26 364.1 365.3 signal
8 Viral Load Increased 434 327.0 345.6 signal
9 Viral Load Abnormal 17 288.2 288.8 signal
10 Blood Hiv Rna Increased 161 257.8 263.1 signal
11 Cd4 Lymphocyte Percentage Decreased 4 257.7 257.8 signal
12 Hiv Infection 156 142.2 145.0 signal
13 Virologic Failure 270 137.6 142.3 signal
14 Cryptosporidiosis Infection 26 135.9 136.3 signal
15 Viral Mutation Identified 164 120.7 123.2 signal
16 Product Administered By Wrong Person 16 118.8 119.0 signal
17 Injected Limb Mobility Decreased 5 93.4 93.4 signal
18 Abdominal Lymphadenopathy 26 81.6 81.9 signal
19 Hiv Viraemia 6 77.3 77.4 signal
20 Pathogen Resistance 250 73.8 76.1 signal
21 Congenital Cytomegalovirus Infection 4 72.6 72.6 signal
22 Acute Hepatitis B 9 72.0 72.1 signal
23 Gonorrhoea 7 69.4 69.4 signal
24 Cd4 Lymphocytes Increased 6 68.1 68.2 signal
25 Drug Monitoring Procedure Incorrectly Performed 15 60.0 60.1 signal
26 Syphilis 16 58.7 58.8 signal
27 Viraemia 29 55.6 55.8 signal
28 Viral Load Decreased 3 54.1 54.1 signal
29 Injection Site Plaque 4 51.5 51.6 signal
30 Toxic Neuropathy 7 47.5 47.5 signal
31 Substance Use 27 46.6 46.7 signal
32 Injection Site Granuloma 4 46.2 46.2 signal
33 Viral Load 3 45.7 45.8 signal
34 Injection Site Nodule 183 44.2 45.2 signal
35 Acute Hiv Infection 4 43.1 43.1 signal
36 Injection Site Abscess 39 41.7 41.9 signal
37 Monkeypox 4 41.6 41.6 signal
38 Cd4 Lymphocytes Decreased 33 40.5 40.7 signal
39 Herpes Simplex Test Positive 3 39.8 39.9 signal
40 Quarantine 3 38.5 38.5 signal
41 Human Immunodeficiency Virus Transmission 3 30.4 30.4 signal
42 Injection Site Discharge 56 29.0 29.2 signal
43 Injection Site Pustule 4 27.9 27.9 signal
44 Injection Site Cyst 3 26.9 26.9 signal
45 Drug Monitoring Procedure Not Performed 17 25.2 25.2 signal
46 Hepatitis B Reactivation 30 24.9 25.0 signal
47 Papilloma 3 24.9 24.9 signal
48 Injection Related Reaction 15 24.6 24.6 signal
49 Chlamydial Infection 7 24.3 24.4 signal
50 Product Complaint 227 24.0 24.6 signal
51 Local Reaction 6 21.5 21.5 signal
52 Viral Rash 3 19.5 19.5 signal
53 Hepatitis A 6 18.5 18.5 signal
54 Product Administered At Inappropriate Site 122 17.7 17.9 signal
55 Nodule 84 16.9 17.1 signal
56 Injection Site Discomfort 61 15.5 15.6 signal
57 Occupational Exposure To Product 38 15.4 15.5 signal
58 Induration 10 14.7 14.7 signal
59 Injection Site Indentation 11 14.2 14.2 signal
60 Exposure To Communicable Disease 4 14.0 14.0 signal
61 Injection Site Scab 5 13.7 13.7 signal
62 Product Preparation Issue 30 13.5 13.6 signal
63 Labelled Drug-drug Interaction Issue 7 13.1 13.1 signal
64 Injection Site Cellulitis 9 12.8 12.8 signal
65 Fat Tissue Increased 7 12.6 12.7 signal
66 Coronavirus Test Positive 5 12.6 12.6 signal
67 Injection Site Oedema 8 12.3 12.3 signal
68 Injection Site Infection 15 12.0 12.0 signal
69 Hiv Test Positive 3 11.8 11.8 signal
70 Injection Site Necrosis 9 11.5 11.5 signal
71 T-lymphocyte Count Decreased 3 11.5 11.5 signal
72 Labelled Drug-drug Interaction Medication Error 36 10.6 10.6 signal
73 Product Dose Omission Issue 1,118 10.3 11.8 signal
74 Injection Site Atrophy 6 9.5 9.5 signal
75 Hepatitis B 22 9.5 9.5 signal
76 Sciatic Nerve Injury 3 9.4 9.4 signal
77 Injection Site Induration 45 9.1 9.1 signal
78 Wrong Product Administered 22 8.7 8.7 signal
79 Depressive Symptom 11 8.2 8.2 signal
80 Injection Site Pain 925 8.0 8.9 signal
81 Injection Site Inflammation 15 7.9 8.0 signal
82 Wrong Technique In Device Usage Process 137 7.8 8.0 signal
83 Injection Site Hypoaesthesia 4 7.4 7.4 signal
84 Incorrect Route Of Product Administration 46 7.2 7.2 signal
85 Injection Site Mass 96 6.8 6.9 signal
86 Haematoma Muscle 3 6.7 6.7 signal
87 Exposure During Pregnancy 156 6.6 6.7 signal
88 Product Administration Error 48 6.3 6.3 signal
89 Intercepted Product Prescribing Error 3 6.1 6.1 signal
90 Prostatitis 7 6.0 6.0 signal
91 Skin Mass 15 5.9 5.9 signal
92 Discharge 3 5.7 5.7 signal
93 Product Storage Error 185 5.6 5.7 signal
94 Injection Site Scar 6 5.6 5.6 signal
95 Micturition Disorder 7 5.3 5.3 signal
96 Sciatica 32 5.3 5.3 signal
97 Injection Site Swelling 146 5.0 5.1 signal
98 Self-injurious Ideation 8 5.0 5.0 signal
99 Injection Site Warmth 38 4.8 4.8 signal
100 Contraindicated Product Prescribed 3 4.7 4.7 signal
101 Injection Site Reaction 118 4.5 4.5 signal
102 Product Dispensing Error 36 4.3 4.3 signal
103 Patient Dissatisfaction With Treatment 3 4.1 4.1 signal
104 Poor Quality Product Administered 15 3.8 3.8 signal
105 Abscess 23 3.8 3.8 signal
106 Alanine Aminotransferase Abnormal 3 3.7 3.7 no signal
107 Inappropriate Schedule Of Product Administration 252 3.7 3.8 signal
108 Foetal Distress Syndrome 3 3.7 3.7 no signal
109 Abscess Limb 6 3.7 3.7 signal
110 Appendicectomy 5 3.7 3.7 signal
111 Gait Inability 46 3.6 3.6 signal
112 Bipolar I Disorder 3 3.6 3.6 no signal
113 Major Depression 10 3.6 3.6 signal
114 Intercepted Medication Error 6 3.4 3.4 signal
115 Drug Level Decreased 13 3.3 3.3 signal
116 Product Distribution Issue 11 3.2 3.2 signal
117 Off Label Use 1,045 3.1 3.5 signal
118 Influenza Like Illness 98 3.1 3.1 signal
119 Psychotic Disorder 35 3.1 3.1 signal
120 Liver Function Test Increased 25 3.1 3.1 signal
121 Intercepted Product Storage Error 4 3.1 3.1 no signal
122 Tuberculosis 15 3.0 3.1 signal
123 Injection Site Vesicles 7 3.0 3.0 signal
124 Product Preparation Error 24 3.0 3.0 signal
125 Exposure Via Skin Contact 26 3.0 3.0 signal
126 Pregnancy On Oral Contraceptive 3 3.0 3.0 no signal
127 Mycobacterium Avium Complex Infection 3 2.9 2.9 no signal
128 Treatment Noncompliance 59 2.8 2.9 signal
129 Live Birth 9 2.8 2.8 signal
130 Musculoskeletal Pain 57 2.8 2.8 signal
131 Treatment Failure 88 2.8 2.8 signal
132 Muscle Rupture 4 2.7 2.7 no signal
133 Ectopic Pregnancy 3 2.5 2.5 no signal
134 Product Physical Consistency Issue 5 2.4 2.4 no signal
135 Injection Site Haematoma 13 2.3 2.3 signal
136 Injection Site Papule 4 2.3 2.3 no signal
137 Injection Site Extravasation 11 2.3 2.3 signal
138 Tachyphrenia 3 2.3 2.3 no signal
139 Papule 6 2.3 2.3 no signal
140 Mass 12 2.2 2.2 signal
141 Night Sweats 27 2.2 2.2 signal
142 Circumstance Or Information Capable Of Leading To Medication Error 27 2.1 2.1 signal
143 Cardiotoxicity 7 2.1 2.1 no signal
144 Erectile Dysfunction 20 2.0 2.0 signal
145 Respiratory Acidosis 3 2.0 2.0 no signal
146 Food Poisoning 4 2.0 2.0 no signal
147 Pyrexia 256 1.9 2.0 no signal
148 Hypertransaminasaemia 5 1.9 1.9 no signal
149 Attention Deficit Hyperactivity Disorder 3 1.9 1.9 no signal
150 Nerve Injury 8 1.9 1.9 no signal
151 Muscle Fatigue 3 1.9 1.9 no signal
152 Chills 83 1.8 1.9 no signal
153 Product Communication Issue 6 1.8 1.8 no signal
154 Presyncope 17 1.8 1.8 no signal
155 Skin Warm 4 1.8 1.8 no signal
156 Feeling Of Body Temperature Change 4 1.8 1.8 no signal
157 Depression 155 1.8 1.8 no signal
158 Rhinitis Allergic 3 1.8 1.8 no signal
159 Myalgia 114 1.8 1.8 no signal
160 Tenderness 7 1.8 1.8 no signal
161 Pain 407 1.7 1.8 no signal
162 Injection Site Erythema 81 1.7 1.7 no signal
163 Peripheral Coldness 9 1.7 1.7 no signal
164 Pregnancy With Implant Contraceptive 3 1.7 1.7 no signal
165 Abortion Induced 6 1.7 1.7 no signal
166 Muscle Atrophy 8 1.7 1.7 no signal
167 Multiple Injuries 4 1.6 1.6 no signal
168 Subcutaneous Abscess 3 1.6 1.6 no signal
169 Aggression 31 1.6 1.6 no signal
170 Herpes Simplex 4 1.6 1.6 no signal
171 Coronavirus Infection 4 1.6 1.6 no signal
172 Product Prescribing Error 14 1.5 1.5 no signal
173 Skin Hyperpigmentation 5 1.5 1.5 no signal
174 Hepatitis C 7 1.5 1.5 no signal
175 Abortion Spontaneous 23 1.5 1.5 no signal
176 Oropharyngeal Discomfort 5 1.5 1.5 no signal
177 Neutropenic Sepsis 4 1.5 1.5 no signal
178 Sleep Disorder Due To A General Medical Condition 9 1.5 1.5 no signal
179 Nonspecific Reaction 3 1.5 1.5 no signal
180 Panic Reaction 4 1.4 1.4 no signal
181 Injection Site Irritation 7 1.4 1.4 no signal
182 Injection Site Injury 3 1.4 1.4 no signal
183 Drug Resistance 14 1.4 1.4 no signal
184 Product Prescribing Issue 11 1.4 1.4 no signal
185 Neuralgia 13 1.4 1.4 no signal
186 Discomfort 32 1.4 1.4 no signal
187 Pharyngeal Swelling 5 1.4 1.4 no signal
188 Mouth Swelling 3 1.4 1.4 no signal
189 Aphthous Ulcer 4 1.4 1.4 no signal
190 Product Use Complaint 8 1.3 1.3 no signal
191 Incorrect Dose Administered 116 1.3 1.4 no signal
192 Mood Altered 14 1.3 1.3 no signal
193 Affective Disorder 4 1.3 1.3 no signal
194 Inability To Afford Medication 5 1.3 1.3 no signal
195 Loss Of Personal Independence In Daily Activities 24 1.3 1.3 no signal
196 Haematoma 13 1.3 1.3 no signal
197 Therapeutic Response Unexpected 22 1.3 1.3 no signal
198 Progressive Multifocal Leukoencephalopathy 4 1.3 1.3 no signal
199 Brain Fog 7 1.3 1.3 no signal
200 Gait Disturbance 92 1.3 1.3 no signal
201 Oral Mucosal Blistering 3 1.2 1.2 no signal
202 Proctalgia 3 1.2 1.2 no signal
203 Bipolar Disorder 5 1.2 1.2 no signal
204 Groin Pain 4 1.2 1.2 no signal
205 Injection Site Pruritus 30 1.2 1.2 no signal
206 Product Use Issue 84 1.2 1.2 no signal
207 Condition Aggravated 134 1.2 1.2 no signal
208 Feeling Hot 27 1.1 1.1 no signal
209 Underdose 32 1.1 1.1 no signal
210 Depressed Mood 23 1.1 1.1 no signal
211 Mental Disorder 19 1.1 1.1 no signal
212 Iron Deficiency Anaemia 4 1.1 1.1 no signal
213 Blood Testosterone Decreased 3 1.1 1.1 no signal
214 Abnormal Dreams 12 1.1 1.1 no signal
215 Hepatic Steatosis 8 1.1 1.1 no signal
216 Flank Pain 4 1.1 1.1 no signal
217 Lymphadenopathy 15 1.1 1.1 no signal
218 Joint Stiffness 11 1.1 1.1 no signal
219 Mobility Decreased 30 1.1 1.1 no signal
220 Illness 42 1.1 1.1 no signal
221 Clostridium Difficile Infection 9 1.1 1.1 no signal
222 Product Use In Unapproved Indication 101 1.1 1.1 no signal
223 Intercepted Product Preparation Error 5 1.1 1.1 no signal
224 Vitamin D Deficiency 4 1.1 1.1 no signal
225 Blood Creatine Phosphokinase Increased 12 1.1 1.1 no signal
226 Oral Disorder 3 1.1 1.1 no signal
227 Scar 7 1.1 1.1 no signal
228 Transaminases Increased 9 1.1 1.1 no signal
229 Nightmare 14 1.1 1.1 no signal
230 Anaphylactic Reaction 22 1.0 1.0 no signal
231 Sleep Disorder 28 1.0 1.0 no signal
232 Injury Associated With Device 8 1.0 1.0 no signal
233 Cold Sweat 7 1.0 1.0 no signal
234 Injection Site Rash 12 1.0 1.0 no signal
235 Emphysema 4 1.0 1.0 no signal
236 Helicobacter Infection 4 1.0 1.0 no signal
237 Low Density Lipoprotein Increased 3 1.0 1.0 no signal
238 Intercepted Product Administration Error 3 1.0 1.0 no signal
239 Menstruation Delayed 4 1.0 1.0 no signal
240 Bedridden 5 1.0 1.0 no signal
241 Mouth Ulceration 8 1.0 1.0 no signal
242 Ill-defined Disorder 23 1.0 1.0 no signal
243 Heavy Menstrual Bleeding 3 1.0 1.0 no signal
244 Mood Swings 12 1.0 1.0 no signal
245 Muscle Tightness 6 1.0 1.0 no signal
246 Skin Laceration 4 1.0 1.0 no signal
247 Muscle Disorder 3 1.0 1.0 no signal
248 Menstrual Disorder 3 1.0 1.0 no signal
249 Back Pain 85 1.0 1.0 no signal
250 Gastrointestinal Pain 4 1.0 1.0 no signal
251 Hyperaesthesia 3 0.9 0.9 no signal
252 Aspartate Aminotransferase Increased 19 0.9 0.9 no signal
253 Cellulitis 18 0.9 0.9 no signal
254 Swelling 33 0.9 0.9 no signal
255 Flushing 36 0.9 0.9 no signal
256 Rash Pruritic 19 0.9 0.9 no signal
257 Suicidal Ideation 32 0.9 0.9 no signal
258 Paraesthesia Oral 5 0.9 0.9 no signal
259 Pain In Extremity 102 0.9 0.9 no signal
260 Hypokinesia 5 0.9 0.9 no signal
261 Alanine Aminotransferase Increased 21 0.9 0.9 no signal
262 Facial Pain 3 0.9 0.9 no signal
263 Hyperlipidaemia 4 0.9 0.9 no signal
264 Therapy Cessation 17 0.9 0.9 no signal
265 Toxic Epidermal Necrolysis 5 0.9 0.9 no signal
266 Lip Swelling 11 0.9 0.9 no signal
267 Urticaria 55 0.9 0.9 no signal
268 Poor Quality Sleep 7 0.9 0.9 no signal
269 Wrong Technique In Product Usage Process 66 0.9 0.9 no signal
270 Type 2 Diabetes Mellitus 11 0.9 0.9 no signal
271 Adverse Drug Reaction 29 0.8 0.8 no signal
272 Rash 140 0.8 0.8 no signal
273 Lymphoma 5 0.8 0.8 no signal
274 Injection Site Discolouration 4 0.8 0.8 no signal
275 Stevens-johnson Syndrome 7 0.8 0.8 no signal
276 Rhinorrhoea 20 0.8 0.8 no signal
277 Anxiety 87 0.8 0.8 no signal
278 Accidental Exposure To Product 30 0.8 0.8 no signal
279 Sars-cov-2 Test Positive 4 0.8 0.8 no signal
280 Product Dose Omission In Error 8 0.8 0.8 no signal
281 Lethargy 17 0.8 0.8 no signal
282 Weight Decreased 82 0.8 0.8 no signal
283 Unintended Pregnancy 3 0.7 0.7 no signal
284 Burning Sensation 20 0.7 0.7 no signal
285 Skin Reaction 4 0.7 0.7 no signal
286 Suicide Attempt 17 0.7 0.7 no signal
287 Syncope 28 0.7 0.7 no signal
288 Hyperhidrosis 36 0.7 0.7 no signal
289 Movement Disorder 9 0.7 0.7 no signal
290 Ocular Discomfort 3 0.7 0.7 no signal
291 Apathy 4 0.7 0.7 no signal
292 Arthralgia 114 0.7 0.7 no signal
293 Tooth Fracture 3 0.7 0.7 no signal
294 Rash Papular 6 0.7 0.7 no signal
295 Hepatic Enzyme Increased 18 0.7 0.7 no signal
296 Limb Discomfort 8 0.7 0.7 no signal
297 Muscle Spasms 47 0.7 0.7 no signal
298 Intentional Dose Omission 7 0.7 0.7 no signal
299 Swollen Tongue 8 0.7 0.7 no signal
300 Neuropathy Peripheral 24 0.7 0.7 no signal
301 Headache 158 0.7 0.7 no signal
302 Wound 7 0.7 0.7 no signal
303 Obesity 4 0.7 0.7 no signal
304 Oropharyngeal Pain 23 0.6 0.6 no signal
305 Spinal Operation 3 0.6 0.6 no signal
306 Glomerular Filtration Rate Decreased 3 0.6 0.6 no signal
307 Hypoaesthesia 37 0.6 0.6 no signal
308 Incorrect Product Administration Duration 5 0.6 0.6 no signal
309 Hypersomnia 7 0.6 0.6 no signal
310 Body Temperature Increased 5 0.6 0.6 no signal
311 Fatigue 189 0.6 0.6 no signal
312 Photosensitivity Reaction 4 0.6 0.6 no signal
313 Hypersensitivity 45 0.6 0.6 no signal
314 Weight Increased 54 0.6 0.6 no signal
315 Paraesthesia 38 0.6 0.6 no signal
316 Dermatitis Allergic 3 0.6 0.6 no signal
317 Ocular Hyperaemia 11 0.6 0.6 no signal
318 Musculoskeletal Discomfort 4 0.6 0.6 no signal
319 Nervous System Disorder 7 0.6 0.6 no signal
320 Hunger 3 0.6 0.6 no signal
321 Stress 16 0.6 0.6 no signal
322 Chromaturia 5 0.6 0.6 no signal
323 Gastroenteritis Viral 4 0.6 0.6 no signal
324 Nephrolithiasis 10 0.6 0.6 no signal
325 Respiratory Distress 6 0.6 0.6 no signal
326 Musculoskeletal Stiffness 19 0.6 0.6 no signal
327 Eye Swelling 8 0.6 0.6 no signal
328 Chest Discomfort 22 0.6 0.6 no signal
329 Erythema 44 0.6 0.6 no signal
330 Injection Site Haemorrhage 17 0.6 0.6 no signal
331 Malaise 94 0.6 0.6 no signal
332 Rash Erythematous 10 0.6 0.6 no signal
333 Expired Product Administered 7 0.6 0.6 no signal
334 Bronchospasm 3 0.5 0.5 no signal
335 Paralysis 3 0.5 0.5 no signal
336 Angina Pectoris 6 0.5 0.5 no signal
337 Anger 7 0.5 0.5 no signal
338 Oral Herpes 4 0.5 0.5 no signal
339 Angioedema 9 0.5 0.5 no signal
340 Insomnia 54 0.5 0.5 no signal
341 Muscular Weakness 23 0.5 0.5 no signal
342 Extra Dose Administered 8 0.5 0.5 no signal
343 Swelling Face 13 0.5 0.5 no signal
344 Covid-19 35 0.5 0.5 no signal
345 Foetal Exposure During Pregnancy 16 0.5 0.5 no signal
346 Musculoskeletal Chest Pain 3 0.5 0.5 no signal
347 Skin Ulcer 5 0.5 0.5 no signal
348 Panic Attack 7 0.5 0.5 no signal
349 Pruritus 72 0.5 0.5 no signal
350 Premature Delivery 3 0.5 0.5 no signal
351 Impaired Work Ability 4 0.5 0.5 no signal
352 Dizziness 92 0.5 0.5 no signal
353 Back Disorder 3 0.5 0.5 no signal
354 Skin Lesion 5 0.5 0.5 no signal
355 Pallor 5 0.5 0.5 no signal
356 Mania 3 0.5 0.5 no signal
357 Staphylococcal Infection 6 0.5 0.5 no signal
358 Rash Maculo-papular 4 0.5 0.5 no signal
359 Pancreatitis Acute 4 0.5 0.5 no signal
360 Throat Irritation 8 0.5 0.5 no signal
361 Drug Interaction 28 0.5 0.5 no signal
362 Dysgeusia 13 0.5 0.5 no signal
363 Dyspepsia 17 0.5 0.5 no signal
364 Surgery 10 0.5 0.4 no signal
365 Nasal Congestion 10 0.4 0.4 no signal
366 Head Discomfort 3 0.4 0.4 no signal
367 Blood Triglycerides Increased 3 0.4 0.4 no signal
368 Acute Myocardial Infarction 5 0.4 0.4 no signal
369 Skin Exfoliation 14 0.4 0.4 no signal
370 Road Traffic Accident 7 0.4 0.4 no signal
371 Gout 3 0.4 0.4 no signal
372 Oedema 9 0.4 0.4 no signal
373 Toothache 3 0.4 0.4 no signal
374 Contraindicated Product Administered 5 0.4 0.4 no signal
375 Hyperglycaemia 6 0.4 0.4 no signal
376 Drug Ineffective 217 0.4 0.4 no signal
377 Abdominal Pain 38 0.4 0.4 no signal
378 End Stage Renal Disease 3 0.4 0.4 no signal
379 Medication Error 9 0.4 0.4 no signal
380 Feeling Abnormal 39 0.4 0.4 no signal
381 Chest Pain 30 0.4 0.4 no signal
382 Middle Insomnia 3 0.4 0.4 no signal
383 Neck Pain 9 0.4 0.4 no signal
384 Hepatic Cirrhosis 3 0.4 0.4 no signal
385 Tubulointerstitial Nephritis 3 0.4 0.4 no signal
386 Proteinuria 3 0.4 0.4 no signal
387 Glycosylated Haemoglobin Increased 4 0.4 0.4 no signal
388 Diarrhoea 102 0.4 0.4 no signal
389 Nausea 125 0.4 0.4 no signal
390 Tachycardia 14 0.4 0.4 no signal
391 Incorrect Dose Administered By Device 4 0.4 0.4 no signal
392 Nasopharyngitis 29 0.4 0.4 no signal
393 Diabetes Mellitus 12 0.4 0.4 no signal
394 Drug Reaction With Eosinophilia And Systemic Symptoms 4 0.4 0.4 no signal
395 Peripheral Swelling 24 0.4 0.4 no signal
396 Hepatitis 4 0.4 0.4 no signal
397 Anaphylactic Shock 4 0.4 0.4 no signal
398 Diplopia 4 0.4 0.4 no signal
399 Haemorrhoids 3 0.4 0.4 no signal
400 Bone Pain 9 0.4 0.4 no signal
401 Blood Creatinine Increased 10 0.4 0.4 no signal
402 Upper Respiratory Tract Infection 7 0.4 0.4 no signal
403 Eye Pruritus 5 0.4 0.4 no signal
404 Blood Pressure Abnormal 3 0.4 0.4 no signal
405 Hospitalisation 23 0.4 0.4 no signal
406 Menstruation Irregular 4 0.4 0.4 no signal
407 Product Physical Issue 3 0.4 0.4 no signal
408 Skin Disorder 5 0.4 0.4 no signal
409 Irritability 9 0.4 0.4 no signal
410 Stomatitis 9 0.4 0.4 no signal
411 Productive Cough 7 0.4 0.4 no signal
412 Rib Fracture 3 0.4 0.4 no signal
413 Contusion 14 0.4 0.4 no signal
414 Mental Status Changes 4 0.4 0.4 no signal
415 Rash Macular 5 0.4 0.4 no signal
416 Renal Impairment 12 0.4 0.4 no signal
417 Feeling Cold 4 0.4 0.4 no signal
418 Influenza 16 0.4 0.4 no signal
419 Dyspnoea 80 0.4 0.4 no signal
420 Joint Injury 3 0.4 0.4 no signal
421 Injection Site Bruising 11 0.4 0.4 no signal
422 Crying 5 0.4 0.4 no signal
423 Accidental Overdose 5 0.4 0.4 no signal
424 Dysstasia 4 0.4 0.4 no signal
425 Laboratory Test Abnormal 4 0.4 0.4 no signal
426 Dysuria 5 0.4 0.4 no signal
427 Urinary Incontinence 4 0.4 0.4 no signal
428 Somnolence 27 0.4 0.3 no signal
429 Sneezing 3 0.4 0.4 no signal
430 Decreased Appetite 31 0.3 0.3 no signal
431 Respiratory Disorder 4 0.3 0.3 no signal
432 Hot Flush 10 0.3 0.3 no signal
433 Cough 37 0.3 0.3 no signal
434 Abdominal Discomfort 22 0.3 0.3 no signal
435 Skin Discolouration 6 0.3 0.3 no signal
436 Blood Pressure Increased 20 0.3 0.3 no signal
437 Renal Disorder 6 0.3 0.3 no signal
438 Palpitations 15 0.3 0.3 no signal
439 Hypertension 27 0.3 0.3 no signal
440 Diabetic Ketoacidosis 3 0.3 0.3 no signal
441 Blister 7 0.3 0.3 no signal
442 Gastrooesophageal Reflux Disease 10 0.3 0.3 no signal
443 Injection Site Urticaria 3 0.3 0.3 no signal
444 Deep Vein Thrombosis 8 0.3 0.3 no signal
445 Eye Disorder 4 0.3 0.3 no signal
446 Visual Impairment 15 0.3 0.3 no signal
447 Herpes Zoster 7 0.3 0.3 no signal
448 Vomiting 57 0.3 0.3 no signal
449 Osteonecrosis 4 0.3 0.3 no signal
450 Blood Alkaline Phosphatase Increased 3 0.3 0.3 no signal
451 Fungal Infection 4 0.3 0.3 no signal
452 Asthenia 45 0.3 0.3 no signal
453 Abdominal Pain Lower 3 0.3 0.3 no signal
454 Inflammation 6 0.3 0.3 no signal
455 Dysphagia 11 0.3 0.3 no signal
456 Pulmonary Embolism 11 0.3 0.3 no signal
457 Gastritis 3 0.3 0.3 no signal
458 Throat Tightness 3 0.3 0.3 no signal
459 Blood Bilirubin Increased 3 0.3 0.3 no signal
460 Limb Injury 3 0.3 0.3 no signal
461 Restlessness 4 0.3 0.3 no signal
462 Eye Pain 6 0.3 0.3 no signal
463 Adverse Event 10 0.3 0.3 no signal
464 Drug Hypersensitivity 21 0.3 0.3 no signal
465 Arthropathy 6 0.3 0.3 no signal
466 Blood Cholesterol Increased 5 0.3 0.3 no signal
467 Dysarthria 4 0.3 0.3 no signal
468 Migraine 10 0.3 0.3 no signal
469 Disease Recurrence 5 0.3 0.3 no signal
470 Infection 15 0.3 0.3 no signal
471 Liver Function Test Abnormal 3 0.3 0.3 no signal
472 Gastrointestinal Disorder 9 0.3 0.3 no signal
473 Therapy Interrupted 7 0.3 0.3 no signal
474 Lacrimation Increased 3 0.3 0.3 no signal
475 Abnormal Behaviour 4 0.3 0.3 no signal
476 Dermatitis Atopic 5 0.3 0.3 no signal
477 Oesophageal Carcinoma 3 0.3 0.3 no signal
478 Premature Baby 3 0.3 0.3 no signal
479 Aphasia 3 0.3 0.3 no signal
480 Vertigo 6 0.3 0.3 no signal
481 Drug-induced Liver Injury 3 0.3 0.3 no signal
482 Alopecia 19 0.3 0.3 no signal
483 No Adverse Event 17 0.3 0.2 no signal
484 Seizure 11 0.3 0.2 no signal
485 Loss Of Consciousness 12 0.2 0.2 no signal
486 Drug Intolerance 9 0.2 0.2 no signal
487 Intentional Product Misuse 8 0.2 0.2 no signal
488 Acne 7 0.2 0.2 no signal
489 Cholelithiasis 3 0.2 0.2 no signal
490 Heart Rate Increased 9 0.2 0.2 no signal
491 Haematochezia 5 0.2 0.2 no signal
492 Hypotension 18 0.2 0.2 no signal
493 Pneumonia 29 0.2 0.2 no signal
494 Transient Ischaemic Attack 3 0.2 0.2 no signal
495 Flatulence 5 0.2 0.2 no signal
496 Lower Respiratory Tract Infection 4 0.2 0.2 no signal
497 Urinary Tract Infection 15 0.2 0.2 no signal
498 Device Use Error 3 0.2 0.2 no signal
499 Abdominal Pain Upper 18 0.2 0.2 no signal
500 Haematuria 3 0.2 0.2 no signal
501 Tinnitus 4 0.2 0.2 no signal
502 Abdominal Distension 9 0.2 0.2 no signal
503 Electrocardiogram Qt Prolonged 3 0.2 0.2 no signal
504 Completed Suicide 7 0.2 0.2 no signal
505 Dry Eye 4 0.2 0.2 no signal
506 Agitation 6 0.2 0.2 no signal
507 Hepatic Function Abnormal 3 0.2 0.2 no signal
508 Intestinal Obstruction 3 0.2 0.2 no signal
509 Chronic Kidney Disease 6 0.2 0.2 no signal
510 Sinusitis 8 0.2 0.2 no signal
511 Cerebrovascular Accident 13 0.2 0.2 no signal
512 Speech Disorder 4 0.2 0.2 no signal
513 Nervousness 4 0.2 0.2 no signal
514 Arthritis 6 0.2 0.2 no signal
515 Device Difficult To Use 5 0.2 0.2 no signal
516 Pancreatitis 4 0.2 0.2 no signal
517 Blood Pressure Decreased 5 0.2 0.2 no signal
518 Dehydration 10 0.2 0.2 no signal
519 Dry Mouth 6 0.2 0.2 no signal
520 Lung Neoplasm Malignant 3 0.2 0.2 no signal
521 Pollakiuria 3 0.2 0.2 no signal
522 Eye Irritation 4 0.2 0.2 no signal
523 Device Leakage 3 0.2 0.2 no signal
524 Vaginal Haemorrhage 3 0.2 0.2 no signal
525 Fall 23 0.2 0.2 no signal
526 Dysphonia 4 0.2 0.2 no signal
527 Dry Skin 9 0.2 0.2 no signal
528 Liver Disorder 3 0.2 0.2 no signal
529 Joint Swelling 8 0.2 0.2 no signal
530 Vision Blurred 9 0.2 0.2 no signal
531 Thrombocytopenia 7 0.2 0.2 no signal
532 Asthma 7 0.2 0.2 no signal
533 Blood Glucose Decreased 3 0.2 0.2 no signal
534 Death 52 0.2 0.2 no signal
535 Acute Kidney Injury 9 0.2 0.2 no signal
536 Myocardial Infarction 10 0.1 0.1 no signal
537 Maternal Exposure During Pregnancy 5 0.1 0.1 no signal
538 Disturbance In Attention 3 0.1 0.1 no signal
539 Sepsis 6 0.1 0.1 no signal
540 Bronchitis 4 0.1 0.1 no signal
541 Oxygen Saturation Decreased 3 0.1 0.1 no signal
542 Cardiac Disorder 5 0.1 0.1 no signal
543 Memory Impairment 7 0.1 0.1 no signal
544 Wheezing 3 0.1 0.1 no signal
545 Cataract 3 0.1 0.1 no signal
546 Tremor 8 0.1 0.1 no signal
547 Intentional Overdose 3 0.1 0.1 no signal
548 Constipation 10 0.1 0.1 no signal
549 Amnesia 3 0.1 0.1 no signal
550 Neoplasm Malignant 3 0.1 0.1 no signal
551 Blood Glucose Increased 8 0.1 0.1 no signal
552 Epistaxis 3 0.1 0.1 no signal
553 Haemoglobin Decreased 4 0.1 0.1 no signal
554 Cardiac Failure 3 0.1 0.1 no signal
555 Overdose 8 0.1 0.1 no signal
556 General Physical Health Deterioration 4 0.1 0.1 no signal
557 Balance Disorder 3 0.1 0.1 no signal
558 Emotional Distress 4 0.1 0.1 no signal
559 Psoriasis 4 0.1 0.1 no signal
560 Renal Failure 4 0.1 0.1 no signal
561 Toxicity To Various Agents 5 0.1 0.1 no signal
562 Malignant Neoplasm Progression 3 0.1 0.1 no signal
563 Rheumatoid Arthritis 3 0.1 0.1 no signal
564 Oedema Peripheral 3 0.1 0.1 no signal
565 Product Quality Issue 3 0.1 0.1 no signal
566 Anaemia 4 0.1 0.1 no signal
567 Confusional State 3 0.0 0.0 no signal