Table 4.
Adverse events manifestation by most commonly reported suspected drug classes.
| ED Visits for ADEs Resulting in Hospitalization | |||
|---|---|---|---|
| Women | Men | p-Value | |
| No. of Preferred Terms | No. of Preferred Terms | ||
| N = 47,937 (%) | N = 36,231 (%) | ||
| Anticoagulants and Antiplatelets (B01A) | |||
| Haemorrhage | 4431 (43.65) | 5719 (51.45) | <0.001 |
| Epistaxis | 1476 (14.52) | 2083 (18.83) | |
| Gastrointestinal | 858 (8.46) | 1009 (9.13) | |
| Genitourinary | 394 (3.88) | 805 (7.28) | |
| Central Nervous System | 554 (5.46) | 601 (5.44) | |
| Dermatologic | 54 (0.53) | 59 (0.54) | |
| Pulmonary | 78 (0.77) | 151 (1.37) | |
| Ophthalmic | 183 (1.8) | 195 (1.76) | |
| Altered International Normalized Ratio | 822 (8.10) | 661 (5.97) | <0.001 |
| Anaemia | 514 (5.06) | 574 (5.19) | 0.658 |
| Unintentional or Intentional Overdose | 167 (1.65) | 145 (1.31) | 0.045 |
| Antibacterials (J01) | |||
| Dermatologic Reactions | 6413 (47.74) | 4441 (47.73) | <0.001 |
| Urticaria | 1893 (14.10) | 1315 (14.14) | |
| Localized or General Pruritus | 1661 (12.38) | 1038 (11.16) | |
| Erythema | 1197 (8.91) | 853 (9.17) | |
| Rash | 249 (1.85) | 238 (2.55) | |
| Localized or Peripheral Edema | 1049 (7.82) | 746 (8.03) | 0.571 |
| Gastrointestinal Disturbances | 1532 (11.43) | 913 (9.83) | <0.001 |
| Nausea or Vomiting | 700 (5.22) | 380 (4.09) | |
| Abdominal Pain | 397 (2.96) | 247 (2.66) | |
| Diarrhoea | 351 (2.62) | 237 (2.55) | |
| Unspecified Hypersensitivity | 636 (4.74) | 414 (4.46) | 0.311 |
| Neurological Effects | 778 (5.67) | 468 (5.03) | 0.013 |
| Respiratory Reactions | 728 (5.43) | 486 (5.22) | 0.514 |
| Dyspnoea | 405 (3.02) | 279 (3.0) | |
| Throat Tightness | 127 (0.95) | 64 (0.69) | |
| Anaphylaxis | 117 (0.87) | 118 (1.27) | 0.004 |
| Nonsteroidal Anti-Inflammatory Drugs (M01A) | |||
| Dermatologic Reactions | 2220 (32.11) | 1571 (30.01) | 0.012 |
| Urticaria | 768 (11.11) | 579 (11.06) | |
| Localized or General Pruritus | 572 (8.28) | 385 (7.35) | |
| Erythema | 376 (5.44) | 278 (5.31) | |
| Rash | 378 (5.47) | 244 (4.66) | |
| Gastrointestinal Disturbances | 1256 (18.18) | 862 (16.51) | 0.014 |
| Abdominal Pain | 497 (7.2) | 316 (6.04) | |
| Nausea or Vomiting | 351 (5.08) | 149 (2.85) | |
| Melena | 83 (1.2) | 98 (1.87) | |
| Gastritis | 91 (1.32) | 65 (1.24) | |
| Hematemesis | 58 (0.84) | 65 (1.24) | |
| Localized or Peripheral Edema | 949 (13.73) | 844 (16.14) | <0.001 |
| Unspecified Hypersensitivity | 235 (3.4) | 198 (3.79) | 0.262 |
| Respiratory Reactions | 243 (3.51) | 216 (4.13) | 0.081 |
| Abuse or Self-Harm | 100 (1.45) | 52 (0.99) | 0.026 |
| Sedative or Hypnotic Agents (N05B, N05C) | |||
| Neurological Effects | 3721 (57.44) | 2049 (56.63) | 0.292 |
| Drowsiness | 1226 (18.93) | 607 (16.7) | |
| Altered Mental Status or Bradyphrenia | 504 (7.78) | 270 (7.43) | |
| Loss of Consciousness | 179 (2.76) | 103 (3.04) | |
| Bradykinesia | 196 (3.03) | 119 (3.28) | |
| Muscular Weakness | 116 (2.56) | 101 (2.78) | |
| Presyncope or Syncope | 127 (1.96) | 74 (2.04) | |
| Opioid and Nonopioid Analgesics (N02A, N02B) | |||
| Neurological Effects | 2124 (28.29) | 866 (23.21) | <0.001 |
| Muscular Weakness | 167 (2.22) | 85 (2.28) | |
| Dizziness | 411 (5.47) | 147 (3.94) | |
| Presyncope or Syncope | 258 (3.44) | 97 (2.6) | |
| Drowsiness | 204 (2.71) | 99 (2.65) | |
| Hyperhidrosis | 115 (1.53) | 84 (2.25) | |
| Altered Mental Status | 246 (3.28) | 117 (3.14) | |
| Headache | 107 (1.43) | 32 (0.86) | |
| Gastrointestinal Disturbances | 2076 (27.65) | 725 (19.43) | <0.001 |
| Nausea or Vomiting | 1370 (18.25) | 409 (10.96) | |
| Abdominal Pain | 508 (6.77) | 199 (5.33) | |
| Constipation | 65 (0.86) | 34 (0.91) | |
| Dermatologic Reactions | 1011 (13.47) | 686 (18.39) | <0.001 |
| Urticaria | 343 (4.57) | 249 (6.68) | |
| Localized or General Pruritus | 286 (3.81) | 193 (5.17) | |
| Erythema | 214 (2.85) | 125 (3.35) | |
| Rash | 168 (2.24) | 119 (3.19) | |
| Localized or Peripheral Edema | 380 (5.07) | 248 (6.64) | 0.001 |
| Abuse or Self-Harm | 173 (2.31) | 89 (2.38) | 0.787 |
| Respiratory Distress | 152 (2.03) | 97 (2.60) | 0.051 |
| Unspecified Hypersensitivity | 106 (1.41) | 91 (2.44) | <0.001 |
| Insulin and Oral Antidiabetic Agents (A10) | |||
| Hypoglycaemia (from Mild to Severe) | 1476 (42.73) | 1530 (46.8) | 0.001 |
| Hypoglycaemia-Related Symptoms | 620 (26.41) | 575 (17.62) | 0.699 |
| Shock, Loss of Consciousness or Seizures | 260 (7.52) | 276 (8.45) | |
| Altered Mental Status | 139 (4.03) | 129 (3.96) | |
| Presyncope or Syncope | 72 (2.09) | 80 (2.45) | |
| Acidosis | 89 (2.58) | 46 (1.41) | |
| Neurological Effects | 432 (12.51) | 413 (12.63) | 0.876 |
| Drowsiness | 114 (3.3) | 117 (3.58) | |
| Hyperhidrosis | 88 (2.55) | 85 (2.60) | |
| Muscular Weakness | 61 (1.77) | 41 (1.25) | |
| Aphasia, Dizziness or Tremor | 63 (1.82) | 71 (2.17) | |
| Therapeutic Errors | 152 (4.4) | 164 (5.02) | 0.233 |
| Gastrointestinal Disturbances | 151 (4.37) | 98 (3.01) | 0.003 |
ADE: adverse drug event; ED: emergency department.