TABLE 4.
Tofacitinib‐related adverse events.
| Tofacitinib: 109 years | |
|---|---|
| Mild infections | 24 (22.0 per 100 patient‐years) |
| Flu‐like symptoms | 4 |
| Upper respiratory tract | 4 |
| Herpes simplex | 3 |
| Herpes zoster | 3 |
| Covid‐19 | 2 |
| Fever of unknown origin | 2 |
| Dental | 1 |
| Ear | 1 |
| Gynaecologic | 1 |
| Lower respiratory tract | 1 |
| Skin | 1 |
| Urinary tract | 1 |
| Moderate infections | 15 (13.8 per 100 patient‐years) |
| Urinary tract | 6 |
| Herpes zoster | 4 |
| CMV | 3 |
| Herpes simplex | 3 |
| Flu‐like symptoms | 2 |
| Fever of unknown origin | 1 |
| Gastrointestinal | 1 |
| Gynaecologic | 1 |
| Lower respiratory tract | 1 |
| Skin | 1 |
| Throat | 1 |
| Upper respiratory tract | 1 |
| Severe infections | 2 (1.8 per 100 patient‐years) |
| Flu‐like symptoms | 1 |
| Lower respiratory tract | 1 |
| Possibly related | 37 (33.9 per 100 patient‐years) |
| Skin | 10 |
| Headache | 6 |
| Gastrointestinal | 3 |
| Respiratory | 3 |
| Cardiac | 2 |
| Musculoskeletal | 2 |
| Glaucoma | 1 |
| Genital | 1 |
| Hepatobiliary | 1 |
| Kidney and urinary tract | 1 |
| Malaise | 1 |
| Mouth | 1 |
| Nerve system | 1 |
| Oedema | 1 |
| Psychiatric | 1 |
| Sleep disturbance | 1 |
| Vascular | 1 |
| Probably related | 8 (7.3 per 100 patient‐years) |
| Musculoskeletal | 3 |
| Skin | 3 |
| Cardiac | 1 |
| Headache | 1 |
| Serious adverse events | 10 (9.2 per 100 patient‐years) |
| Severe headache | 2 |
| Dizziness | 1 |
| Gastrointestinal | 1 |
| Hepatocellular hepatitis | 1 |
| Malaise | 1 |
| Musculoskeletal | 1 |
| Nausea | 1 |
| Skin | 1 |
| Throat | 1 |
Note: Number of adverse events during treatment of ulcerative colitis patients with tofacitinib. Infections were classified as: mild infections: no antibiotics or antiviral medication; moderate infections: oral antibiotics or antiviral medication; severe infections: hospitalisation or intravenously administrated antibiotic or antiviral medication.