| ADR Term |
ADReCS ID |
ADR Frequency (FAERS)
|
ADR Severity Grade (FAERS)
|
ADR Severity Grade (CTCAE)
|
| Aggression | 19.05.01.001 | 0.000062% | | Not Available |
| Agitation | 19.06.02.001; 17.02.05.012 | - | - | |
| Cardiac arrest | 02.03.04.001 | 0.000156% | | |
| Cardio-respiratory arrest | 22.02.06.007; 02.03.04.002 | 0.000387% | | Not Available |
| Chest pain | 02.02.02.011; 22.12.02.003; 08.01.08.002 | 0.000062% | | Not Available |
| Choreoathetosis | 17.01.01.003 | 0.000156% | | Not Available |
| Completed suicide | 19.12.01.001; 08.04.01.010 | 0.000125% | | Not Available |
| Constipation | 07.02.02.001 | - | - | |
| Crying | 12.02.11.001; 08.01.03.005; 19.04.02.002; 17.02.05.013 | 0.000094% | | Not Available |
| Death | 08.04.01.001 | 0.000375% | | |
| Developmental delay | 19.07.05.003; 08.01.03.037 | 0.000094% | | Not Available |
| Diarrhoea | 07.02.01.001 | - | - | |
| Dizziness | 24.06.02.007; 17.02.05.003; 02.11.04.006 | - | - | |
| Drug abuse | 19.07.06.010 | 0.000512% | | Not Available |
| Drug withdrawal syndrome neonatal | 19.07.06.014; 18.04.13.001; 08.06.02.008 | 0.000094% | | Not Available |
| Dyspepsia | 07.01.02.001 | - | - | |
| Dysphoria | 19.04.02.004 | - | - | Not Available |
| Encephalopathy | 17.13.02.001 | 0.000094% | | |
| Euphoric mood | 19.04.02.006 | - | - | |
| Gastrointestinal disorder | 07.11.01.001 | - | - | Not Available |
| Headache | 17.14.01.001 | 0.000137% | | |
| Hyperammonaemia | 14.10.01.001; 09.01.02.002 | 0.000094% | | Not Available |
| Hypersensitivity | 10.01.03.003 | - | - | |
| Insomnia | 19.02.01.002; 17.15.03.002 | - | - | |
| Irritability | 08.01.03.011; 19.04.02.013 | 0.000094% | | |
| Metabolic acidosis | 14.01.01.003 | 0.000062% | | Not Available |
| Palpitations | 02.11.04.012 | - | - | |
| Premature baby | 18.04.02.001 | 0.000062% | | Not Available |
| Pulmonary oedema | 22.01.03.003; 02.05.02.003 | 0.000062% | | |
| Respiratory arrest | 22.02.01.009 | 0.000062% | | Not Available |