Table 3.

Incidence of specifically important adverse drug reactions in patients participating in postmarketing surveillance of etanercept in Japan.

Adverse Drug ReactionsEtanercept n (%)
Total pneumonia*102 (1.4)
Pneumocystis jiroveci pneumonia16 (0.2)
Tuberculosis10 (0.1)
  Pulmonary8 (0.1)
  Extrapulmonary††2 (0.03)
Interstitial lung disease44 (0.6)
Malignancy14 (0.2)
Demyelinating disease0 (0)
Congestive heart failure2 (0.03)
Lupus-like syndrome1 (0.01)
  • * Total pneumonia = pneumonia (n = 80), bacterial pneumonia (9), bronchopneumonia (6), chlamydia pneumonia (4), staphylococcal pneumonia (1), candida pneumonia (1), fungal pneumonia (1). One case developed both pneumonia and bronchopneumonia. 2 indefinite cases.††Tuberculous abscess (thigh) + gastrointestinal tuberculosis.