Drug
Cabotegravir
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 |