Table 6 Expression of rare adverse reactions in instructions in FAERs

Respiratory, thoracic and mediastinal disorders

nasal septum perforation

47.502

Musculoskeletal and connective tissue disorders

osteonecrosis of jaw

3.999

Nervous system disorders

posterior reversible encephalopathy syndrome

9.279

hypertensive encephalopathy

18.288

Infections and infestations

necrotising fasciitis

20.261

Hepatobiliary disorders

gallbladder rupture

14.438

gastric ulcer

2.21

Gastrointestinal disorders

duodenal ulcer

3.706