Table I.
Distribution of rash frequencies among medicinal products (per active substance) administered by oral or injectable route.
| Frequency | Number | % |
|---|---|---|
| Very common (≥1/10) | 114 | 10.89 |
| Common (≥1/100 to <1/10) | 267 | 25.50 |
| Uncommon (≥1/1,000 to <1/100) | 218 | 20.82 |
| Rare (≥1/10,000 to <1/1,000) | 98 | 9.36 |
| Very rare (<1/10,000) | 33 | 3.15 |
| Not knowna | 235 | 22.45 |
| Noneb | 82 | 7.83 |
| Total | 1,047 | 100.00 |
a
In the up-to-date SmPC, the ‘not known’ frequency label is used when the frequency cannot be estimated from the current data. In our study, however, the same label has also been used for the older SmPC, in which the CIOMS classification has not been applied (e.g., when the SmPC mentioned rash as an example of adverse reaction occurring in ‘isolated cases’, or ‘rarely’, the ‘not known’ label was used).
b
The ‘none’ label was used for those product/active substances for which rash or an alternative term suggesting rash as a possible adverse reaction (e.g., hypersensitivity, allergy, urticaria) was found in SmPCs.