Table 3.
The Top 30 Adverse Drug Events Associated with TNF-Alfa Inhibitors
| PT | SOC | All TNF-Alfa Inhibitors |
||
|---|---|---|---|---|
| n | ROR | 95% CI | ||
| Pneumonia | Infections and infestations | 2517 | 5.36 | 5.14–5.6* |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 1760 | 2.04 | 1.95–2.15* |
| Pneumocystis jirovecii pneumonia | Infections and infestations | 1357 | 11.8 | 11.1–12.5* |
| Herpes zoster | Infections and infestations | 729 | 6.4 | 5.92–6.91* |
| Infusion-related reaction | Injury, poisoning and procedural complications | 679 | 29.2 | 26.6–32* |
| Sepsis | Infections and infestations | 660 | 3.16 | 2.92–3.41* |
| Pneumonia bacterial | Infections and infestations | 636 | 11.5 | 10.5–12.5* |
| Pyrexia | General disorders and administration site conditions | 622 | 1.35 | 1.25–1.47* |
| Pulmonary tuberculosis | Infections and infestations | 573 | 27.9 | 25.3–30.9* |
| Cellulitis | Infections and infestations | 524 | 6.73 | 6.15–7.38* |
| Lymphoma | Neoplasms benign, malignant and unspecified | 454 | 14.9 | 13.5–16.5* |
| Pyelonephritis | Infections and infestations | 309 | 10.4 | 9.19–11.7* |
| Pancytopenia | Blood and lymphatic system disorders | 296 | 1.42 | 1.27–1.6* |
| Disseminated tuberculosis | Infections and infestations | 292 | 31.9 | 27.6–36.7* |
| Organising pneumonia | Infections and infestations | 261 | 13.6 | 11.9–15.5* |
| Hepatic function abnormal | Hepatobiliary disorders | 248 | 0.41 | 0.36–0.46 |
| Anaphylactoid reaction | Immune system disorders | 246 | 2.7 | 2.37–3.07* |
| Breast cancer | Neoplasms benign, malignant and unspecified | 241 | 12.5 | 10.9–14.3* |
| Urinary tract infection | Infections and infestations | 226 | 3.61 | 3.15–4.13* |
| White blood cell count decreased | Investigations | 219 | 0.26 | 0.23–0.3 |
| Tuberculosis | Infections and infestations | 218 | 32.7 | 27.7–38.6* |
| Tuberculous pleurisy | Infections and infestations | 216 | 47.4 | 39.6–56.7* |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | 214 | 10.8 | 9.34–12.5* |
| Platelet count decreased | Investigations | 211 | 0.23 | 0.2–0.27 |
| Arthritis bacterial | Infections and infestations | 205 | 13.7 | 11.8–16* |
| Bronchitis | Infections and infestations | 199 | 4.65 | 4.02–5.37* |
| Intestinal obstruction | Gastrointestinal disorders | 182 | 4.71 | 4.05–5.48* |
| Blood pressure decreased | Investigations | 173 | 1.05 | 0.9–1.22 |
| Rash | Skin and subcutaneous tissue disorders | 172 | 0.68 | 0.59–0.79 |
| Gastric cancer | Neoplasms benign, malignant and unspecified | 164 | 6.07 | 5.17–7.13* |
Note: *Signal detected.
Abbreviations: CI, confidence interval; PT, preferred terms; ROR, reporting odds ratio; SOC, system organ class; TNF, tumor necrosis factor.