Table 5. Most frequently reported drug-ADR combinations (Primary and secondary suspected drugs only).
≤27 days | N = 3,274 (%) | 28 days—23 months | N = 21,356 (%) | 2–11 years | N = 146,094 (%) | 12–17 years | N = 129,699 (%) | Total | N = 548,640 (%) |
---|---|---|---|---|---|---|---|---|---|
Buprenorphine–Drug withdrawal syndrome neonatal | 32 (1.0%) | Valproate—Drug exposure during pregnancy | 84 (0.4%) | Atomoxetine–Prescribed overdose | 473 (0.3%) | Isotretinoin—Depression | 472 (0.4%) | Isotretinoin—Depression | 669 (0.1%) |
Heparin—Maternal drugs affecting foetus | 29 (0.9%) | Fluoxetine- Drug exposure during pregnancy | 49 (0.2%) | Atomoxetine–Drug Ineffective | 462 (0.3%) | Isotretinoin-Inflammatory bowel disease | 337 (0.3%) | Atomoxetine–Drug Ineffective | 664 (0.1%) |
Heparin—Premature baby | 21 (0.6%) | Valproate–Foetal anticonvulsant syndrome | 40 (0.2%) | Atomoxetine–Abnormal behaviour | 396 (0.3%) | Isotretinoin-Colitis Ulcerosa | 257 (0.2%) | Atomoxetine–Prescribed overdose | 654 (0.1%) |
Levetiracetam—Maternal drugs affecting foetus | 17 (0.5%) | Olanzapine—Drug exposure during pregnancy | 39 (0.2%) | Methylphenidate–Product quality issue | 393 (0.3%) | Isotretinoin-Crohn's disease | 234 (0.2%) | Atomoxetine–Abnormal behaviour | 579 (0.1%) |
Heparin-Caesarean section | 14 (0.4%) | Fentanyl–Accidental drug intake by child | 38 (0.2%) | Atomoxetine–Somnolence | 356 (0.2%) | Isotretinoin-Suicidal ideation | 225 (0.2%) | Methylphenidate–Product quality issue | 573 (0.1%) |
Presented proportion are based on the total number of “primary suspect” and secondary suspect” reported drugs. The number of unique drug-event combinations was 180,100 and within the age groups: 2,606 (0–27 days); 14,800 (28 days-23 months); 62,788 (2–11 years); 59,101 (12–17 years).