pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Signal detection of metoclopramide
| Adverse events | Number of reports | PRR | ROR | IC 95% LCI | Drug label / information | ||
|---|---|---|---|---|---|---|---|
| MFDS | FDA | Micromedex® | |||||
| Extrapyramidal disorder | 833 | 53.98 | 56.01 | 5.10 | Y | Y | Y |
| Chest pain | 609 | 2.34 | 2.37 | 1.09 | Y | N | Y |
| Anxiety | 479 | 9.15 | 9.33 | 2.96 | Y | Y | Y |
| Agitation | 292 | 25.58 | 25.90 | 4.22 | Y | Y | Y |
| Sweating increased | 289 | 2.13 | 2.15 | 0.91 | Y | Y | Y |
| Nervousness | 228 | 8.49 | 8.57 | 2.81 | Y | Y | Y |
| Agranulocytosis | 159 | 2.23 | 2.24 | 0.92 | Y | Y | Y |
| Mucositis nos | 113 | 2.54 | 2.55 | 1.07 | N | N | N |
| Hiccup | 108 | 2.22 | 2.22 | 0.87 | N | N | N |
| Hyperkinesia | 93 | 4.57 | 4.59 | 1.86 | Y | N | N |
| Neuropathy | 92 | 2.38 | 2.38 | 0.95 | N | N | N |
| Dyskinesia | 47 | 5.26 | 5.27 | 1.95 | Y | Y | Y |
| Convulsions | 41 | 2.55 | 2.55 | 0.91 | Y | Y | Y |
| Hypoproteinemia | 36 | 2.07 | 2.07 | 0.59 | N | N | N |
| Dysesthesia | 29 | 2.08 | 2.09 | 0.56 | Y | N | Y |
| Paralysis | 24 | 2.04 | 2.05 | 0.49 | Y | N | N |
| Hypertonia | 22 | 2.04 | 2.05 | 0.47 | Y | Y | Y |
| Hypomagnesaemia | 22 | 2.22 | 2.22 | 0.59 | N | N | N |
| Hypophosphatasemia | 19 | 2.15 | 2.15 | 0.51 | N | N | N |
| Dystonia | 18 | 2.48 | 2.49 | 0.70 | Y | Y | Y |
| Tenesmus | 17 | 2.30 | 2.30 | 0.58 | N | N | N |
| Thrombophlebitis deep | 17 | 4.10 | 4.10 | 1.39 | N | N | N |
| Thinking abnormal | 16 | 2.60 | 2.60 | 0.74 | N | Y | Y |
| Hyperpyrexia | 16 | 2.89 | 2.90 | 0.89 | Y | Y | Y |
| Lymphoedema | 13 | 3.24 | 3.25 | 0.99 | N | N | N |
| Torticollis | 12 | 2.97 | 2.97 | 0.85 | Y | Y | Y |
| Aphasia | 11 | 2.49 | 2.50 | 0.58 | Y | Y | N |
| Tongue paralysis | 11 | 3.05 | 3.05 | 0.86 | N | N | N |
| Muscle contractions involuntary | 9 | 2.65 | 2.65 | 0.61 | Y | Y | Y |
| Herpes nos | 9 | 2.83 | 2.83 | 0.70 | N | N | N |
| Oculogyric crisis | 8 | 4.24 | 4.24 | 1.23 | Y | Y | Y |
| LDH increased | 8 | 2.04 | 2.04 | 0.21 | N | N | N |
| Thrombocythemia | 7 | 2.17 | 2.17 | 0.26 | N | N | N |
| Procedural site reaction | 7 | 2.41 | 2.41 | 0.41 | Y | N | N |
| Fluid overload | 6 | 2.44 | 2.44 | 0.38 | Y | Y | Y |
| Depersonalization | 5 | 3.29 | 3.29 | 0.75 | N | N | N |
| Dyskinesia tardive | 5 | 8.87 | 8.87 | 2.07 | Y | Y | Y |
| Concentration impaired | 5 | 2.58 | 2.58 | 0.41 | N | Y | Y |
| Malnutrition | 5 | 3.61 | 3.61 | 0.88 | N | N | N |
| Colitis ulcerative aggravated | 4 | 2.72 | 2.72 | 0.43 | N | N | N |
| Onycholysis | 3 | 3.05 | 3.05 | 0.52 | N | N | N |
| Bradykinesia | 3 | 7.80 | 7.80 | 1.77 | Y | Y | Y |
PRR; Proportional reporting ratio, ROR; Reporting odds ratio; IC; Information component, LCI; Lower confidence intervals, MFDS; Ministry Food and Drug Safety