Table 3.

List of serious and other adverse events reported by the combination category.

Combinations	Serious adverse events	Other adverse events
Vedolizumab + ustekinumab	Abscesses (abdominal wall, pelvic abscesses, perianal), PICC line infection, sepsis, malnutrition, arthralgia, rotavirus infection/high output ostomy, Acinetobacter bacteremia	Clostridioides difficile infection (3), viral enteritis, rotavirus infection, recurrent basal cell skin cancer, sinopulmonary infection (5), viral warts
Vedolizumab + anti-TNF	Peristomal cellulitis, bacterial enteric infection, Clostridioides difficile infection, Salmonella infection, elevated transaminases, eczema (face, scalp, and body), rash, pneumonia	Bacterial enteric infection, perianal abscess, pneumonia, drug-induced lupus, rash, sinopulmonary infection (4), influenza virus infection, hand–foot–mouth disease
Ustekinumab + anti-TNF	—	Perianal abscess, skin infection, otitis externa, tubo-ovarian abscess
Tofacitinib + ustekinumab	—	Urinary tract infection, sinopulmonary infection, headache, exacerbation of Crohn’s disease, urinary frequency, worsened GERD, rash (2)
Tofacitinib + vedolizumab	Septic arthritis, deep venous thrombosis, Clostridioides difficile infection, paresthesia	Clostridioides difficile infection (2), pneumonia, high LDL, bacterial enteric infection (Escherichia coli),sinopulmonary infection, gluteal abscess, hand injury, basal cell carcinoma, seborrheic dermatitis, rash (2)
Tofacitinib + anti-TNF	Clostridioides difficile infection	Candida esophagitis, sinopulmonary infection
Natalizumab + anti-TNF	—	Headache (12), fatigue (7), exacerbation of Crohn’s disease (5), dizziness (5), nausea (5), DNA or ANA antibody positive (7), dyspexia (4), abdominal pain (3), arthralgia (3), backpain (3), insomnia (3), pyrexia (3), sinopulmonary infections (8)

Abbreviations: GERD, gastroesophageal reflux disease; LDL, low-density lipoprotein; PICC, peripherally inserted central catheter; TNF, tumor necrosis factor.