Drug
Simethicone
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 | Flatulence | 267 | 21.3 | 22.5 | signal |
| 2 | Eructation | 52 | 12.3 | 12.4 | signal |
| 3 | Malnutrition | 24 | 9.7 | 9.8 | signal |
| 4 | Abdominal Distension | 224 | 9.7 | 10.1 | signal |
| 5 | Gastrointestinal Pain | 22 | 9.0 | 9.1 | signal |
| 6 | Atelectasis | 19 | 8.8 | 8.8 | signal |
| 7 | Impaired Gastric Emptying | 24 | 8.5 | 8.5 | signal |
| 8 | Small Intestinal Obstruction | 22 | 8.1 | 8.1 | signal |
| 9 | Coeliac Disease | 17 | 7.8 | 7.8 | signal |
| 10 | Irritable Bowel Syndrome | 37 | 7.8 | 7.8 | signal |
| 11 | Hiatus Hernia | 22 | 7.6 | 7.6 | signal |
| 12 | Sleep Apnoea Syndrome | 31 | 7.3 | 7.3 | signal |
| 13 | Gallbladder Disorder | 28 | 7.0 | 7.1 | signal |
| 14 | Seasonal Allergy | 22 | 7.0 | 7.0 | signal |
| 15 | Flank Pain | 14 | 6.7 | 6.7 | signal |
| 16 | Gastritis | 38 | 6.5 | 6.5 | signal |
| 17 | Mitral Valve Incompetence | 16 | 6.3 | 6.4 | signal |
| 18 | Intervertebral Disc Degeneration | 13 | 6.3 | 6.3 | signal |
| 19 | Cholelithiasis | 45 | 6.2 | 6.2 | signal |
| 20 | Blood Iron Decreased | 16 | 6.1 | 6.1 | signal |
| 21 | Frequent Bowel Movements | 36 | 6.0 | 6.0 | signal |
| 22 | Oral Pain | 30 | 6.0 | 6.0 | signal |
| 23 | Ileus | 16 | 5.8 | 5.9 | signal |
| 24 | Cardiomegaly | 16 | 5.8 | 5.8 | signal |
| 25 | Bacteraemia | 15 | 5.7 | 5.7 | signal |
| 26 | Cholecystitis | 15 | 5.7 | 5.7 | signal |
| 27 | Faeces Discoloured | 27 | 5.6 | 5.6 | signal |
| 28 | Clostridium Difficile Colitis | 13 | 5.5 | 5.5 | signal |
| 29 | Renal Tubular Necrosis | 12 | 5.5 | 5.5 | signal |
| 30 | Hospice Care | 12 | 5.5 | 5.5 | signal |
| 31 | Constipation | 263 | 5.5 | 5.7 | signal |
| 32 | Haematocrit Decreased | 24 | 5.4 | 5.4 | signal |
| 33 | Hypophagia | 30 | 5.3 | 5.3 | signal |
| 34 | Dyspepsia | 112 | 5.1 | 5.2 | signal |
| 35 | Candida Infection | 19 | 5.1 | 5.1 | signal |
| 36 | Gastrooesophageal Reflux Disease | 91 | 5.1 | 5.2 | signal |
| 37 | Haemorrhoids | 22 | 5.1 | 5.1 | signal |
| 38 | Sinus Disorder | 22 | 5.0 | 5.0 | signal |
| 39 | Increased Tendency To Bruise | 10 | 4.9 | 4.9 | signal |
| 40 | Nocturia | 13 | 4.8 | 4.8 | signal |
| 41 | Deformity | 10 | 4.8 | 4.8 | signal |
| 42 | Dermatitis Contact | 12 | 4.7 | 4.8 | signal |
| 43 | Gastroenteritis Viral | 19 | 4.7 | 4.7 | signal |
| 44 | Renal Failure Acute | 45 | 4.7 | 4.7 | signal |
| 45 | Activities Of Daily Living Impaired | 21 | 4.7 | 4.7 | signal |
| 46 | Musculoskeletal Chest Pain | 16 | 4.6 | 4.6 | signal |
| 47 | Vitamin D Deficiency | 10 | 4.6 | 4.6 | signal |
| 48 | Infusion Site Pain | 13 | 4.6 | 4.6 | signal |
| 49 | Cardiomyopathy | 15 | 4.6 | 4.6 | signal |
| 50 | Pulmonary Mass | 15 | 4.5 | 4.5 | signal |
| 51 | Oesophagitis | 11 | 4.5 | 4.5 | signal |
| 52 | Intestinal Obstruction | 37 | 4.4 | 4.5 | signal |
| 53 | Dry Throat | 10 | 4.4 | 4.4 | signal |
| 54 | Gastric Disorder | 34 | 4.4 | 4.4 | signal |
| 55 | Generalised Oedema | 12 | 4.4 | 4.4 | signal |
| 56 | Abdominal Pain Upper | 198 | 4.3 | 4.5 | signal |
| 57 | Gastroenteritis | 14 | 4.3 | 4.3 | signal |
| 58 | Weight Fluctuation | 10 | 4.3 | 4.3 | signal |
| 59 | Fluid Overload | 14 | 4.3 | 4.3 | signal |
| 60 | Supraventricular Tachycardia | 9 | 4.2 | 4.2 | signal |
| 61 | Diverticulitis | 26 | 4.2 | 4.2 | signal |
| 62 | Body Height Decreased | 10 | 4.2 | 4.2 | signal |
| 63 | Adrenal Insufficiency | 11 | 4.1 | 4.1 | signal |
| 64 | Osteopenia | 14 | 4.1 | 4.1 | signal |
| 65 | Upper Respiratory Tract Infection | 42 | 4.1 | 4.1 | signal |
| 66 | Abdominal Discomfort | 152 | 4.1 | 4.2 | signal |
| 67 | Red Blood Cell Count Decreased | 26 | 4.1 | 4.1 | signal |
| 68 | Sinus Congestion | 12 | 4.0 | 4.0 | signal |
| 69 | Dehydration | 118 | 4.0 | 4.0 | signal |
| 70 | Ascites | 26 | 4.0 | 4.0 | signal |
| 71 | Rectal Haemorrhage | 38 | 4.0 | 4.0 | signal |
| 72 | Respiratory Tract Congestion | 14 | 4.0 | 4.0 | signal |
| 73 | Cholecystectomy | 10 | 4.0 | 4.0 | signal |
| 74 | Cystitis | 28 | 3.9 | 3.9 | signal |
| 75 | Ear Pain | 17 | 3.9 | 3.9 | signal |
| 76 | Ventricular Extrasystoles | 9 | 3.9 | 3.9 | signal |
| 77 | Appendicitis | 8 | 3.9 | 3.9 | signal |
| 78 | Abdominal Pain | 199 | 3.8 | 4.0 | signal |
| 79 | Carpal Tunnel Syndrome | 12 | 3.8 | 3.8 | signal |
| 80 | Splenomegaly | 10 | 3.8 | 3.8 | signal |
| 81 | Rotator Cuff Syndrome | 11 | 3.8 | 3.8 | signal |
| 82 | Oral Candidiasis | 11 | 3.8 | 3.8 | signal |
| 83 | Back Injury | 9 | 3.7 | 3.7 | signal |
| 84 | Blood Pressure Fluctuation | 20 | 3.7 | 3.7 | signal |
| 85 | Abdominal Pain Lower | 21 | 3.7 | 3.7 | signal |
| 86 | Dyspnoea Exertional | 31 | 3.7 | 3.7 | signal |
| 87 | Pleural Effusion | 50 | 3.7 | 3.7 | signal |
| 88 | Urinary Tract Infection | 139 | 3.7 | 3.7 | signal |
| 89 | Dysuria | 30 | 3.7 | 3.7 | signal |
| 90 | Eye Infection | 9 | 3.6 | 3.6 | signal |
| 91 | Therapeutic Response Unexpected | 36 | 3.6 | 3.6 | signal |
| 92 | Retching | 17 | 3.6 | 3.6 | signal |
| 93 | Fistula | 9 | 3.6 | 3.6 | signal |
| 94 | Eating Disorder | 17 | 3.6 | 3.6 | signal |
| 95 | Heart Rate Irregular | 18 | 3.6 | 3.6 | signal |
| 96 | Head Injury | 25 | 3.6 | 3.6 | signal |
| 97 | Foot Fracture | 15 | 3.5 | 3.5 | signal |
| 98 | Ventricular Tachycardia | 13 | 3.5 | 3.5 | signal |
| 99 | Temperature Intolerance | 8 | 3.5 | 3.5 | signal |
| 100 | Electrolyte Imbalance | 9 | 3.5 | 3.5 | signal |
| 101 | Gastrointestinal Disorder | 69 | 3.5 | 3.5 | signal |
| 102 | Choking | 15 | 3.5 | 3.5 | signal |
| 103 | Nasal Congestion | 45 | 3.5 | 3.5 | signal |
| 104 | Iron Deficiency Anaemia | 7 | 3.4 | 3.4 | signal |
| 105 | Bone Disorder | 14 | 3.4 | 3.4 | signal |
| 106 | Sinusitis | 78 | 3.4 | 3.4 | signal |
| 107 | Cataract | 45 | 3.4 | 3.4 | signal |
| 108 | Mental Status Changes | 21 | 3.4 | 3.4 | signal |
| 109 | Pulmonary Congestion | 10 | 3.4 | 3.4 | signal |
| 110 | Dysphonia | 44 | 3.4 | 3.4 | signal |
| 111 | Feeding Disorder | 15 | 3.4 | 3.4 | signal |
| 112 | Fungal Infection | 25 | 3.4 | 3.4 | signal |
| 113 | Rhinorrhoea | 48 | 3.3 | 3.4 | signal |
| 114 | Pain In Jaw | 21 | 3.3 | 3.3 | signal |
| 115 | Blood Potassium Increased | 12 | 3.3 | 3.3 | signal |
| 116 | Incorrect Drug Administration Duration | 21 | 3.3 | 3.3 | signal |
| 117 | Autoimmune Disorder | 7 | 3.3 | 3.3 | signal |
| 118 | Intervertebral Disc Protrusion | 16 | 3.3 | 3.3 | signal |
| 119 | International Normalised Ratio Increased | 21 | 3.3 | 3.3 | signal |
| 120 | Gout | 13 | 3.2 | 3.3 | signal |
| 121 | Hypothyroidism | 23 | 3.2 | 3.3 | signal |
| 122 | Leukocytosis | 13 | 3.2 | 3.2 | signal |
| 123 | Device Occlusion | 10 | 3.2 | 3.2 | signal |
| 124 | Diarrhoea | 461 | 3.2 | 3.5 | signal |
| 125 | Economic Problem | 11 | 3.2 | 3.2 | signal |
| 126 | Device Related Infection | 11 | 3.2 | 3.2 | signal |
| 127 | Blood Urea Increased | 12 | 3.2 | 3.2 | signal |
| 128 | Laboratory Test Abnormal | 21 | 3.2 | 3.2 | signal |
| 129 | Blood Calcium Decreased | 8 | 3.2 | 3.2 | signal |
| 130 | Chromaturia | 16 | 3.2 | 3.2 | signal |
| 131 | Micturition Urgency | 8 | 3.2 | 3.2 | signal |
| 132 | Decreased Appetite | 163 | 3.2 | 3.2 | signal |
| 133 | Bladder Disorder | 7 | 3.2 | 3.2 | signal |
| 134 | Weight Decreased | 196 | 3.2 | 3.2 | signal |
| 135 | Limb Injury | 19 | 3.1 | 3.2 | signal |
| 136 | Scar | 12 | 3.1 | 3.1 | signal |
| 137 | Subdural Haematoma | 10 | 3.1 | 3.1 | signal |
| 138 | Ovarian Cyst | 7 | 3.1 | 3.1 | signal |
| 139 | Full Blood Count Decreased | 14 | 3.1 | 3.1 | signal |
| 140 | Skin Haemorrhage | 10 | 3.1 | 3.1 | signal |
| 141 | Viral Infection | 23 | 3.1 | 3.1 | signal |
| 142 | Dry Mouth | 56 | 3.1 | 3.1 | signal |
| 143 | Gastric Haemorrhage | 8 | 3.1 | 3.1 | signal |
| 144 | Incorrect Product Administration Duration | 14 | 3.1 | 3.1 | signal |
| 145 | Abscess | 11 | 3.1 | 3.1 | signal |
| 146 | Pulmonary Arterial Hypertension | 10 | 3.1 | 3.1 | signal |
| 147 | Eye Discharge | 7 | 3.1 | 3.1 | signal |
| 148 | Multi-organ Failure | 12 | 3.1 | 3.1 | signal |
| 149 | Dysphagia | 64 | 3.0 | 3.1 | signal |
| 150 | Hernia | 13 | 3.0 | 3.0 | signal |
| 151 | Cellulitis | 34 | 3.0 | 3.0 | signal |
| 152 | Insurance Issue | 10 | 3.0 | 3.0 | signal |
| 153 | Colon Cancer | 10 | 3.0 | 3.0 | signal |
| 154 | Product Taste Abnormal | 9 | 3.0 | 3.0 | signal |
| 155 | Throat Tightness | 18 | 3.0 | 3.0 | signal |
| 156 | Toothache | 12 | 3.0 | 3.0 | signal |
| 157 | Hot Flush | 50 | 3.0 | 3.0 | signal |
| 158 | Bursitis | 8 | 3.0 | 3.0 | signal |
| 159 | Neuropathy Peripheral | 62 | 2.9 | 3.0 | signal |
| 160 | Hypoxia | 23 | 2.9 | 3.0 | signal |
| 161 | Joint Injury | 14 | 2.9 | 2.9 | signal |
| 162 | Brain Neoplasm | 6 | 2.9 | 2.9 | signal |
| 163 | Haemoglobin Decreased | 67 | 2.9 | 2.9 | signal |
| 164 | Skin Laceration | 7 | 2.9 | 2.9 | signal |
| 165 | Oral Discomfort | 9 | 2.9 | 2.9 | signal |
| 166 | Delusion | 10 | 2.9 | 2.9 | signal |
| 167 | Product Use Complaint | 10 | 2.9 | 2.9 | signal |
| 168 | Bronchitis | 48 | 2.9 | 2.9 | signal |
| 169 | Middle Insomnia | 12 | 2.9 | 2.9 | signal |
| 170 | Stomatitis | 39 | 2.9 | 2.9 | signal |
| 171 | Epistaxis | 48 | 2.9 | 2.9 | signal |
| 172 | Injury | 45 | 2.9 | 2.9 | signal |
| 173 | Hair Colour Changes | 8 | 2.9 | 2.9 | signal |
| 174 | Paranoia | 11 | 2.8 | 2.9 | signal |
| 175 | Tooth Fracture | 7 | 2.8 | 2.9 | signal |
| 176 | Arthritis | 50 | 2.8 | 2.9 | signal |
| 177 | Osteoporosis | 26 | 2.8 | 2.8 | signal |
| 178 | Urinary Retention | 21 | 2.8 | 2.8 | signal |
| 179 | Gastric Ulcer | 12 | 2.8 | 2.8 | signal |
| 180 | Blood Urine Present | 12 | 2.8 | 2.8 | signal |
| 181 | Oedema Peripheral | 77 | 2.8 | 2.9 | signal |
| 182 | Haematemesis | 16 | 2.8 | 2.8 | signal |
| 183 | Hepatic Failure | 19 | 2.8 | 2.8 | signal |
| 184 | Deep Vein Thrombosis | 41 | 2.8 | 2.8 | signal |
| 185 | Nausea | 494 | 2.8 | 3.0 | signal |
| 186 | Glossodynia | 14 | 2.8 | 2.8 | signal |
| 187 | Musculoskeletal Pain | 33 | 2.8 | 2.8 | signal |
| 188 | Post Procedural Complication | 12 | 2.8 | 2.8 | signal |
| 189 | Respiratory Distress | 17 | 2.8 | 2.8 | signal |
| 190 | Atrial Fibrillation | 60 | 2.8 | 2.8 | signal |
| 191 | Impaired Driving Ability | 7 | 2.8 | 2.8 | signal |
| 192 | Contusion | 59 | 2.8 | 2.8 | signal |
| 193 | Back Disorder | 10 | 2.7 | 2.8 | signal |
| 194 | Internal Haemorrhage | 7 | 2.7 | 2.7 | signal |
| 195 | Bedridden | 8 | 2.7 | 2.7 | signal |
| 196 | Ligament Sprain | 6 | 2.7 | 2.7 | signal |
| 197 | Osteomyelitis | 11 | 2.7 | 2.7 | signal |
| 198 | Anaemia | 116 | 2.7 | 2.8 | signal |
| 199 | Neck Pain | 34 | 2.7 | 2.7 | signal |
| 200 | Blood Pressure Abnormal | 12 | 2.7 | 2.7 | signal |
| 201 | Restless Legs Syndrome | 11 | 2.7 | 2.7 | signal |
| 202 | Dysgeusia | 45 | 2.7 | 2.7 | signal |
| 203 | Muscle Spasms | 110 | 2.7 | 2.7 | signal |
| 204 | White Blood Cell Count Decreased | 65 | 2.7 | 2.7 | signal |
| 205 | Taste Disorder | 12 | 2.7 | 2.7 | signal |
| 206 | Neoplasm Progression | 21 | 2.7 | 2.7 | signal |
| 207 | Vaginal Discharge | 6 | 2.7 | 2.7 | signal |
| 208 | Hunger | 8 | 2.7 | 2.7 | signal |
| 209 | Oropharyngeal Pain | 55 | 2.7 | 2.7 | signal |
| 210 | Sluggishness | 6 | 2.7 | 2.7 | signal |
| 211 | Nervousness | 31 | 2.6 | 2.7 | signal |
| 212 | Nephrolithiasis | 27 | 2.6 | 2.7 | signal |
| 213 | Night Sweats | 19 | 2.6 | 2.7 | signal |
| 214 | Hepatic Cirrhosis | 11 | 2.6 | 2.6 | signal |
| 215 | Blood Count Abnormal | 9 | 2.6 | 2.6 | signal |
| 216 | Blood Sodium Decreased | 11 | 2.6 | 2.6 | signal |
| 217 | Wrist Fracture | 7 | 2.6 | 2.6 | signal |
| 218 | Unresponsive To Stimuli | 15 | 2.6 | 2.6 | signal |
| 219 | Hyperbilirubinaemia | 6 | 2.6 | 2.6 | signal |
| 220 | Sneezing | 13 | 2.6 | 2.6 | signal |
| 221 | Fatigue | 451 | 2.6 | 2.8 | signal |
| 222 | Bone Pain | 34 | 2.6 | 2.6 | signal |
| 223 | Ejection Fraction Decreased | 9 | 2.6 | 2.6 | signal |
| 224 | Pulmonary Embolism | 55 | 2.6 | 2.6 | signal |
| 225 | Asthenia | 215 | 2.6 | 2.6 | signal |
| 226 | Lacrimation Increased | 17 | 2.6 | 2.6 | signal |
| 227 | Pneumothorax | 9 | 2.5 | 2.6 | signal |
| 228 | Vomiting | 266 | 2.5 | 2.6 | signal |
| 229 | Ulcer | 9 | 2.5 | 2.5 | signal |
| 230 | Muscle Spasticity | 7 | 2.5 | 2.5 | signal |
| 231 | Blood Triglycerides Increased | 10 | 2.5 | 2.5 | signal |
| 232 | Type 2 Diabetes Mellitus | 19 | 2.5 | 2.5 | signal |
| 233 | Chills | 66 | 2.5 | 2.5 | signal |
| 234 | Kidney Infection | 11 | 2.5 | 2.5 | signal |
| 235 | Pulmonary Oedema | 25 | 2.5 | 2.5 | signal |
| 236 | Colitis | 21 | 2.5 | 2.5 | signal |
| 237 | Paraesthesia Oral | 8 | 2.5 | 2.5 | signal |
| 238 | Muscle Tightness | 9 | 2.5 | 2.5 | signal |
| 239 | Heart Rate Increased | 55 | 2.5 | 2.5 | signal |
| 240 | Clostridium Difficile Infection | 12 | 2.5 | 2.5 | signal |
| 241 | Hyperglycaemia | 20 | 2.5 | 2.5 | signal |
| 242 | Metastases To Bone | 9 | 2.5 | 2.5 | signal |
| 243 | Pulmonary Thrombosis | 6 | 2.5 | 2.5 | no signal |
| 244 | Bipolar Disorder | 6 | 2.5 | 2.5 | no signal |
| 245 | Nightmare | 19 | 2.5 | 2.5 | signal |
| 246 | Back Pain | 127 | 2.5 | 2.5 | signal |
| 247 | Haematochezia | 30 | 2.4 | 2.5 | signal |
| 248 | Immunodeficiency | 8 | 2.4 | 2.4 | signal |
| 249 | Dental Caries | 6 | 2.4 | 2.4 | no signal |
| 250 | Nerve Compression | 5 | 2.4 | 2.4 | no signal |
| 251 | Skin Ulcer | 14 | 2.4 | 2.4 | signal |
| 252 | Product Prescribing Issue | 11 | 2.4 | 2.4 | signal |
| 253 | Psychomotor Hyperactivity | 9 | 2.4 | 2.4 | signal |
| 254 | Haemoptysis | 15 | 2.4 | 2.4 | signal |
| 255 | Amnesia | 35 | 2.4 | 2.4 | signal |
| 256 | Hepatic Encephalopathy | 5 | 2.4 | 2.4 | no signal |
| 257 | Fibromyalgia | 13 | 2.4 | 2.4 | signal |
| 258 | Blood Pressure Increased | 82 | 2.4 | 2.4 | signal |
| 259 | Peripheral Swelling | 82 | 2.4 | 2.4 | signal |
| 260 | Diarrhoea Haemorrhagic | 5 | 2.4 | 2.4 | no signal |
| 261 | Dermatitis | 11 | 2.4 | 2.4 | signal |
| 262 | Cardiac Failure Congestive | 43 | 2.4 | 2.4 | signal |
| 263 | Sputum Discoloured | 5 | 2.4 | 2.4 | no signal |
| 264 | Anhedonia | 14 | 2.4 | 2.4 | signal |
| 265 | Swelling | 49 | 2.4 | 2.4 | signal |
| 266 | Joint Range Of Motion Decreased | 7 | 2.3 | 2.4 | signal |
| 267 | Musculoskeletal Discomfort | 9 | 2.3 | 2.3 | signal |
| 268 | Pharyngeal Swelling | 5 | 2.3 | 2.3 | no signal |
| 269 | Product Dose Omission In Error | 14 | 2.3 | 2.3 | signal |
| 270 | Thyroid Disorder | 8 | 2.3 | 2.3 | signal |
| 271 | Prescribed Overdose | 10 | 2.3 | 2.3 | signal |
| 272 | Platelet Count Decreased | 55 | 2.3 | 2.3 | signal |
| 273 | Speech Disorder | 27 | 2.3 | 2.3 | signal |
| 274 | Cough | 144 | 2.3 | 2.4 | signal |
| 275 | Drug Effective For Unapproved Indication | 15 | 2.3 | 2.3 | signal |
| 276 | Pharyngeal Oedema | 8 | 2.3 | 2.3 | signal |
| 277 | Vision Blurred | 70 | 2.3 | 2.3 | signal |
| 278 | Fluid Retention | 26 | 2.3 | 2.3 | signal |
| 279 | Skin Cancer | 11 | 2.3 | 2.3 | signal |
| 280 | Insomnia | 136 | 2.3 | 2.3 | signal |
| 281 | Chronic Kidney Disease | 39 | 2.3 | 2.3 | signal |
| 282 | Local Swelling | 9 | 2.3 | 2.3 | signal |
| 283 | Fall | 169 | 2.3 | 2.3 | signal |
| 284 | Diabetes Mellitus Inadequate Control | 9 | 2.3 | 2.3 | signal |
| 285 | Lymphadenopathy | 18 | 2.3 | 2.3 | signal |
| 286 | Peripheral Coldness | 7 | 2.3 | 2.3 | no signal |
| 287 | Cyanosis | 8 | 2.3 | 2.3 | signal |
| 288 | Pollakiuria | 21 | 2.3 | 2.3 | signal |
| 289 | Ataxia | 6 | 2.3 | 2.3 | no signal |
| 290 | Agitation | 37 | 2.3 | 2.3 | signal |
| 291 | Unevaluable Event | 38 | 2.3 | 2.3 | signal |
| 292 | Muscle Rigidity | 6 | 2.3 | 2.3 | no signal |
| 293 | Spinal Fracture | 10 | 2.3 | 2.3 | signal |
| 294 | Sensory Disturbance | 8 | 2.2 | 2.2 | signal |
| 295 | Presyncope | 12 | 2.2 | 2.2 | signal |
| 296 | Pelvic Pain | 9 | 2.2 | 2.2 | signal |
| 297 | Emphysema | 5 | 2.2 | 2.2 | no signal |
| 298 | Dyskinesia | 20 | 2.2 | 2.2 | signal |
| 299 | Tooth Disorder | 11 | 2.2 | 2.2 | signal |
| 300 | Coronary Artery Disease | 15 | 2.2 | 2.2 | signal |
| 301 | Initial Insomnia | 5 | 2.2 | 2.2 | no signal |
| 302 | Hypersomnia | 14 | 2.2 | 2.2 | signal |
| 303 | Angina Pectoris | 14 | 2.2 | 2.2 | signal |
| 304 | Migraine | 46 | 2.2 | 2.2 | signal |
| 305 | Folliculitis | 5 | 2.2 | 2.2 | no signal |
| 306 | Anxiety | 138 | 2.2 | 2.2 | signal |
| 307 | Surgery | 28 | 2.2 | 2.2 | signal |
| 308 | Myalgia | 82 | 2.2 | 2.2 | signal |
| 309 | Hypokinesia | 7 | 2.2 | 2.2 | no signal |
| 310 | Skin Disorder | 16 | 2.2 | 2.2 | signal |
| 311 | Muscle Atrophy | 6 | 2.1 | 2.1 | no signal |
| 312 | Hallucination, Visual | 10 | 2.1 | 2.1 | signal |
| 313 | Intentional Dose Omission | 13 | 2.1 | 2.1 | signal |
| 314 | Diabetes Mellitus | 36 | 2.1 | 2.1 | signal |
| 315 | Procedural Pain | 13 | 2.1 | 2.1 | signal |
| 316 | Throat Irritation | 21 | 2.1 | 2.1 | signal |
| 317 | Restlessness | 17 | 2.1 | 2.1 | signal |
| 318 | Paraesthesia | 73 | 2.1 | 2.1 | signal |
| 319 | Pharyngitis Streptococcal | 5 | 2.1 | 2.1 | no signal |
| 320 | Haematoma | 12 | 2.1 | 2.1 | signal |
| 321 | Mucosal Inflammation | 12 | 2.1 | 2.1 | signal |
| 322 | Plasma Cell Myeloma | 18 | 2.1 | 2.1 | signal |
| 323 | Ocular Discomfort | 5 | 2.1 | 2.1 | no signal |
| 324 | Nodule | 6 | 2.1 | 2.1 | no signal |
| 325 | Anorexia | 6 | 2.1 | 2.1 | no signal |
| 326 | Thrombosis | 37 | 2.1 | 2.1 | signal |
| 327 | Rash Generalised | 12 | 2.0 | 2.1 | signal |
| 328 | Tardive Dyskinesia | 13 | 2.0 | 2.1 | signal |
| 329 | Pruritus Generalised | 10 | 2.0 | 2.0 | signal |
| 330 | Tooth Infection | 6 | 2.0 | 2.0 | no signal |
| 331 | Localised Infection | 11 | 2.0 | 2.0 | signal |
| 332 | Road Traffic Accident | 19 | 2.0 | 2.0 | signal |
| 333 | Pancreatitis | 24 | 2.0 | 2.0 | signal |
| 334 | Gastrointestinal Haemorrhage | 38 | 2.0 | 2.0 | signal |
| 335 | Disease Progression | 53 | 2.0 | 2.0 | signal |
| 336 | Feeling Abnormal | 108 | 2.0 | 2.0 | signal |
| 337 | Basal Cell Carcinoma | 7 | 2.0 | 2.0 | no signal |
| 338 | Swollen Tongue | 14 | 2.0 | 2.0 | signal |
| 339 | Influenza | 50 | 2.0 | 2.0 | signal |
| 340 | Discomfort | 27 | 2.0 | 2.0 | no signal |
| 341 | Pain | 274 | 2.0 | 2.1 | no signal |
| 342 | Intestinal Perforation | 5 | 2.0 | 2.0 | no signal |
| 343 | Rash Pruritic | 24 | 2.0 | 2.0 | no signal |
| 344 | Weight Increased | 99 | 2.0 | 2.0 | no signal |
| 345 | Neutrophil Count Decreased | 18 | 2.0 | 2.0 | no signal |
| 346 | Fear | 12 | 2.0 | 2.0 | no signal |
| 347 | Transient Ischaemic Attack | 15 | 2.0 | 2.0 | no signal |
| 348 | Chronic Obstructive Pulmonary Disease | 23 | 2.0 | 2.0 | no signal |
| 349 | Tremor | 73 | 2.0 | 2.0 | no signal |
| 350 | Balance Disorder | 38 | 2.0 | 2.0 | no signal |
| 351 | Gingival Bleeding | 6 | 2.0 | 2.0 | no signal |
| 352 | Mental Disorder | 19 | 2.0 | 2.0 | no signal |
| 353 | Myocardial Ischaemia | 5 | 2.0 | 2.0 | no signal |
| 354 | Coronary Artery Occlusion | 6 | 2.0 | 2.0 | no signal |
| 355 | Drug Toxicity | 6 | 1.9 | 1.9 | no signal |
| 356 | Blood Thyroid Stimulating Hormone Increased | 4 | 1.9 | 1.9 | no signal |
| 357 | Metastases To Lung | 5 | 1.9 | 1.9 | no signal |
| 358 | Product Packaging Issue | 4 | 1.9 | 1.9 | no signal |
| 359 | Rash Macular | 15 | 1.9 | 1.9 | no signal |
| 360 | Aphonia | 6 | 1.9 | 1.9 | no signal |
| 361 | Blood Test Abnormal | 6 | 1.9 | 1.9 | no signal |
| 362 | Impaired Healing | 14 | 1.9 | 1.9 | no signal |
| 363 | Drug Effect Less Than Expected | 6 | 1.9 | 1.9 | no signal |
| 364 | Underdose | 31 | 1.9 | 1.9 | no signal |
| 365 | Skin Fissures | 8 | 1.9 | 1.9 | no signal |
| 366 | Febrile Neutropenia | 28 | 1.9 | 1.9 | no signal |
| 367 | Laceration | 4 | 1.9 | 1.9 | no signal |
| 368 | Nervous System Disorder | 13 | 1.9 | 1.9 | no signal |
| 369 | Convulsion | 24 | 1.9 | 1.9 | no signal |
| 370 | Skin Discolouration | 19 | 1.9 | 1.9 | no signal |
| 371 | Anger | 14 | 1.8 | 1.9 | no signal |
| 372 | Crying | 15 | 1.8 | 1.8 | no signal |
| 373 | Inflammatory Bowel Disease | 4 | 1.8 | 1.8 | no signal |
| 374 | Hip Fracture | 13 | 1.8 | 1.8 | no signal |
| 375 | Tooth Extraction | 5 | 1.8 | 1.8 | no signal |
| 376 | Flushing | 41 | 1.8 | 1.8 | no signal |
| 377 | Prescribed Underdose | 8 | 1.8 | 1.8 | no signal |
| 378 | Hallucination | 30 | 1.8 | 1.8 | no signal |
| 379 | Peritonitis Bacterial | 4 | 1.8 | 1.8 | no signal |
| 380 | Poisoning | 5 | 1.8 | 1.8 | no signal |
| 381 | Device Failure | 6 | 1.8 | 1.8 | no signal |
| 382 | Cardiac Disorder | 37 | 1.8 | 1.8 | no signal |
| 383 | Drug Level Decreased | 4 | 1.8 | 1.8 | no signal |
| 384 | Arthralgia | 162 | 1.8 | 1.8 | no signal |
| 385 | Emotional Disorder | 12 | 1.7 | 1.7 | no signal |
| 386 | Panic Attack | 14 | 1.7 | 1.7 | no signal |
| 387 | Knee Arthroplasty | 8 | 1.7 | 1.7 | no signal |
| 388 | Asthma | 43 | 1.7 | 1.7 | no signal |
| 389 | Dysmenorrhoea | 5 | 1.7 | 1.7 | no signal |
| 390 | Illness | 38 | 1.7 | 1.7 | no signal |
| 391 | Complication Associated With Device | 5 | 1.7 | 1.7 | no signal |
| 392 | Arthropathy | 21 | 1.7 | 1.7 | no signal |
| 393 | Breast Pain | 4 | 1.7 | 1.7 | no signal |
| 394 | Mood Altered | 10 | 1.7 | 1.7 | no signal |
| 395 | Feeling Jittery | 7 | 1.6 | 1.6 | no signal |
| 396 | Irritability | 22 | 1.6 | 1.6 | no signal |
| 397 | Therapy Interrupted | 25 | 1.6 | 1.6 | no signal |
| 398 | Multiple Fractures | 6 | 1.6 | 1.6 | no signal |
| 399 | Osteonecrosis Of Jaw | 9 | 1.6 | 1.6 | no signal |
| 400 | Ageusia | 9 | 1.6 | 1.6 | no signal |
| 401 | Abnormal Dreams | 10 | 1.6 | 1.6 | no signal |
| 402 | Extrapyramidal Disorder | 9 | 1.6 | 1.6 | no signal |
| 403 | Status Epilepticus | 4 | 1.6 | 1.6 | no signal |
| 404 | Dialysis | 5 | 1.6 | 1.6 | no signal |
| 405 | Hypoacusis | 15 | 1.6 | 1.6 | no signal |
| 406 | Hospitalisation | 53 | 1.6 | 1.6 | no signal |
| 407 | Intentional Self-injury | 7 | 1.6 | 1.6 | no signal |
| 408 | Myelodysplastic Syndrome | 5 | 1.5 | 1.6 | no signal |
| 409 | Malignant Neoplasm Progression | 35 | 1.5 | 1.5 | no signal |
| 410 | Metastases To Liver | 6 | 1.5 | 1.5 | no signal |
| 411 | Madarosis | 4 | 1.5 | 1.5 | no signal |
| 412 | Cerebrovascular Accident | 58 | 1.5 | 1.5 | no signal |
| 413 | Caesarean Section | 4 | 1.5 | 1.5 | no signal |
| 414 | Colitis Ulcerative | 15 | 1.5 | 1.5 | no signal |
| 415 | Tooth Loss | 7 | 1.5 | 1.5 | no signal |
| 416 | Spinal Operation | 4 | 1.5 | 1.5 | no signal |
| 417 | Dry Skin | 43 | 1.5 | 1.5 | no signal |
| 418 | Respiratory Depression | 4 | 1.5 | 1.5 | no signal |
| 419 | Ovarian Cancer | 3 | 1.5 | 1.5 | no signal |
| 420 | Libido Decreased | 4 | 1.4 | 1.4 | no signal |
| 421 | Product Dose Omission Issue | 91 | 1.4 | 1.4 | no signal |
| 422 | Haemorrhage | 33 | 1.4 | 1.4 | no signal |
| 423 | Needle Issue | 9 | 1.4 | 1.4 | no signal |
| 424 | Hallucination, Auditory | 5 | 1.4 | 1.4 | no signal |
| 425 | Product Quality Issue | 42 | 1.4 | 1.4 | no signal |
| 426 | Affect Lability | 3 | 1.4 | 1.4 | no signal |
| 427 | Knee Operation | 3 | 1.4 | 1.4 | no signal |
| 428 | Drug Prescribing Error | 6 | 1.4 | 1.4 | no signal |
| 429 | Parkinsonism | 3 | 1.4 | 1.4 | no signal |
| 430 | Psychotic Disorder | 9 | 1.4 | 1.4 | no signal |
| 431 | Expired Product Administered | 10 | 1.4 | 1.4 | no signal |
| 432 | Product Physical Issue | 6 | 1.4 | 1.4 | no signal |
| 433 | Cytomegalovirus Infection | 5 | 1.3 | 1.3 | no signal |
| 434 | Malignant Melanoma | 4 | 1.3 | 1.3 | no signal |
| 435 | Hair Texture Abnormal | 4 | 1.3 | 1.3 | no signal |
| 436 | Pain Of Skin | 8 | 1.3 | 1.3 | no signal |
| 437 | Therapy Cessation | 15 | 1.3 | 1.3 | no signal |
| 438 | Diabetic Ketoacidosis | 7 | 1.3 | 1.3 | no signal |
| 439 | Femur Fracture | 9 | 1.3 | 1.3 | no signal |
| 440 | Peritonitis | 6 | 1.3 | 1.3 | no signal |
| 441 | Central Nervous System Lesion | 4 | 1.3 | 1.3 | no signal |
| 442 | Drug Administration Error | 9 | 1.3 | 1.3 | no signal |
| 443 | Prostatic Specific Antigen Increased | 4 | 1.3 | 1.3 | no signal |
| 444 | Abasia | 7 | 1.3 | 1.3 | no signal |
| 445 | Inappropriate Schedule Of Drug Administration | 20 | 1.2 | 1.2 | no signal |
| 446 | Extra Dose Administered | 11 | 1.2 | 1.2 | no signal |
| 447 | Product Packaging Quantity Issue | 3 | 1.2 | 1.2 | no signal |
| 448 | Injection Site Nodule | 3 | 1.2 | 1.2 | no signal |
| 449 | Eye Pruritus | 9 | 1.2 | 1.2 | no signal |
| 450 | Blood Glucose Fluctuation | 3 | 1.2 | 1.2 | no signal |
| 451 | Wrong Technique In Drug Usage Process | 10 | 1.2 | 1.2 | no signal |
| 452 | Vaginal Haemorrhage | 11 | 1.2 | 1.2 | no signal |
| 453 | Sexual Dysfunction | 3 | 1.2 | 1.2 | no signal |
| 454 | Palmar-plantar Erythrodysaesthesia Syndrome | 6 | 1.2 | 1.2 | no signal |
| 455 | Neoplasm Malignant | 17 | 1.1 | 1.1 | no signal |
| 456 | Device Dislocation | 11 | 1.1 | 1.1 | no signal |
| 457 | Injury Associated With Device | 5 | 1.1 | 1.1 | no signal |
| 458 | Thyroid Cancer | 3 | 1.1 | 1.1 | no signal |
| 459 | Hepatitis C | 3 | 1.1 | 1.1 | no signal |
| 460 | Injection Site Discolouration | 3 | 1.1 | 1.1 | no signal |
| 461 | Device Issue | 21 | 1.1 | 1.1 | no signal |
| 462 | Amenorrhoea | 4 | 1.1 | 1.1 | no signal |
| 463 | Withdrawal Syndrome | 10 | 1.1 | 1.1 | no signal |
| 464 | Genital Haemorrhage | 3 | 1.0 | 1.0 | no signal |
| 465 | Multiple Sclerosis Relapse | 16 | 1.0 | 1.0 | no signal |
| 466 | Injection Site Bruising | 18 | 1.0 | 1.0 | no signal |
| 467 | Blood Glucose Decreased | 11 | 1.0 | 1.0 | no signal |
| 468 | Blood Glucose Increased | 43 | 1.0 | 1.0 | no signal |
| 469 | Drug Dose Omission | 38 | 1.0 | 1.0 | no signal |
| 470 | Product Substitution Issue | 13 | 1.0 | 1.0 | no signal |
| 471 | Wrong Technique In Product Usage Process | 45 | 1.0 | 1.0 | no signal |
| 472 | Emotional Distress | 27 | 1.0 | 1.0 | no signal |
| 473 | Application Site Pruritus | 5 | 1.0 | 1.0 | no signal |
| 474 | Akathisia | 3 | 1.0 | 1.0 | no signal |
| 475 | Drug Effect Incomplete | 8 | 1.0 | 1.0 | no signal |
| 476 | Pancreatic Carcinoma | 6 | 0.9 | 0.9 | no signal |
| 477 | Injection Site Haematoma | 3 | 0.9 | 0.9 | no signal |
| 478 | Drug Effect Decreased | 11 | 0.9 | 0.9 | no signal |
| 479 | Incorrect Dose Administered | 45 | 0.9 | 0.9 | no signal |
| 480 | Device Adhesion Issue | 3 | 0.9 | 0.9 | no signal |
| 481 | Injection Site Pruritus | 13 | 0.9 | 0.9 | no signal |
| 482 | Injection Site Pain | 59 | 0.9 | 0.9 | no signal |
| 483 | Pharmaceutical Product Complaint | 5 | 0.9 | 0.9 | no signal |
| 484 | Intentional Drug Misuse | 4 | 0.8 | 0.8 | no signal |
| 485 | Device Defective | 3 | 0.8 | 0.8 | no signal |
| 486 | Circumstance Or Information Capable Of Leading To Medication Error | 6 | 0.8 | 0.8 | no signal |
| 487 | Device Malfunction | 12 | 0.8 | 0.8 | no signal |
| 488 | Injection Site Reaction | 12 | 0.8 | 0.8 | no signal |
| 489 | Injection Site Swelling | 13 | 0.8 | 0.8 | no signal |
| 490 | Product Adhesion Issue | 6 | 0.8 | 0.8 | no signal |
| 491 | Injection Site Mass | 6 | 0.7 | 0.7 | no signal |
| 492 | Product Complaint | 4 | 0.7 | 0.7 | no signal |
| 493 | Therapeutic Response Shortened | 5 | 0.7 | 0.7 | no signal |
| 494 | Skin Irritation | 7 | 0.7 | 0.7 | no signal |
| 495 | Injection Site Haemorrhage | 12 | 0.7 | 0.7 | no signal |
| 496 | Menstruation Irregular | 4 | 0.7 | 0.7 | no signal |
| 497 | Injection Site Erythema | 18 | 0.7 | 0.7 | no signal |
| 498 | Injection Site Warmth | 3 | 0.7 | 0.7 | no signal |
| 499 | Drug Exposure During Pregnancy | 5 | 0.7 | 0.6 | no signal |
| 500 | Injection Site Rash | 4 | 0.6 | 0.6 | no signal |
| 501 | Breast Cancer | 12 | 0.6 | 0.6 | no signal |
| 502 | Hepatic Cancer | 3 | 0.6 | 0.6 | no signal |
| 503 | Device Difficult To Use | 8 | 0.5 | 0.5 | no signal |
| 504 | Incorrect Dose Administered By Device | 3 | 0.5 | 0.5 | no signal |
| 505 | Device Use Error | 4 | 0.5 | 0.5 | no signal |
| 506 | Prostate Cancer | 9 | 0.5 | 0.5 | no signal |
| 507 | Drug Abuse | 9 | 0.5 | 0.5 | no signal |
| 508 | Completed Suicide | 8 | 0.4 | 0.4 | no signal |
| 509 | Device Leakage | 4 | 0.4 | 0.4 | no signal |
| 510 | Device Breakage | 3 | 0.3 | 0.3 | no signal |
| 511 | Drug Dependence | 10 | 0.3 | 0.3 | no signal |