Table 2.
Ranking of the most reported adverse drug reactions
| ADR (PTName) | Number of reports | ROR | Lower limit ROR | Upper limit ROR | Described in SmPC |
|---|---|---|---|---|---|
| Headache | 143 | 2.11 | 1.77 | 2.51 | Yes |
| Epistaxis | 124 | 23.76 | 19.59 | 28.82 | Yes |
| Anosmia | 57 | 49.14 | 36.75 | 65.71 | Yes |
| Dyspnoea | 53 | 1.55 | 1.18 | 2.05 | Yes |
| Palpitations | 52 | 1.97 | 1.49 | 2.60 | No |
| Therapeutic response unexpected | 38 | 1.53 | 1.11 | 2.12 | Not applicable |
| Dysgeusia | 30 | 3.65 | 2.53 | 5.26 | Yes |
| Ageusia | 28 | 6.30 | 4.31 | 9.20 | Yes |
| Parosmia | 27 | 21.55 | 14.47 | 32.09 | Yes |
| Nasal discomfort | 24 | 56.02 | 35.76 | 87.77 | Yes |
| Vision blurred | 23 | 2.74 | 1.81 | 4.14 | Yes |
| Anxiety | 21 | 2.34 | 1.51 | 3.60 | No |
| Nasal congestion | 20 | 12.11 | 7.70 | 19.04 | Yes |
| Visual impairment | 20 | 2.13 | 1.37 | 3.32 | Yes |
| Tinnitus | 19 | 2.41 | 1.53 | 3.81 | No |
| Throat irritation | 16 | 7.61 | 4.61 | 12.56 | Yes |
| Nasal septum perforation | 14 | 463.23 | 186.65 | 1149.67 | Yes |
| Migraine | 14 | 2.37 | 1.40 | 4.03 | No |
| Rhinorrhea | 13 | 6.23 | 3.58 | 10.84 | Yes |
| Dysphonia | 13 | 3.30 | 1.90 | 5.72 | Yes |
ADR adverse drug reaction, PTname Preferred Term name of Medical Dictionary for Regulatory Activities [12], ROR reporting odds ratio, SmPC summary of product characteristics