Tislelizumab Side Effects

Applies to tislelizumab: parenteral injection for iv infusion.

Side effects include:

Most common adverse reactions (≥20%) as a single agent in patients with esophageal cancer: anemia, fatigue, musculoskeletal pain, decreased weight, cough.

Most common (≥20%) adverse reactions in combination with chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma: nausea, fatigue, decreased appetite, anemia, peripheral sensory neuropathy, vomiting, decreased platelet count, decreased neutrophil count, increased aspartate aminotransferase, diarrhea, abdominal pain, increased alanine aminotransferase, decreased white blood cell count, decreased weight, pyrexia.

For healthcare professionals

Applies to tislelizumab: intravenous solution.

General adverse events

The most common (20% or greater) adverse reactions, including laboratory abnormalities, were increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT, and cough. The most frequent serious adverse reactions (2% or greater) were pneumonia, dysphagia, hemorrhage, pneumonitis (including pneumonitis and immune-mediated pneumonitis), and esophageal obstruction.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Myocarditis
• Rare (less than 0.1%): Pericarditis^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (15%), nausea (14%), diarrhea (up to 13%), dysphagia (11%), abdominal pain (11%), vomiting (11%)
• Common (1% to 10%): Stomatitis
• Uncommon (0.1% to 1%): Pancreatitis, colitis
• Frequency not reported: Esophageal obstruction^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 16%), pruritus (10.6%)
• Uncommon (0.1% to 1%): Severe skin reactions
• Postmarketing reports: Steven-Johnson syndrome, toxic epidermal necrolysis (including fatal cases)^[Ref]

Endocrine

• Very common (10% or more): Hypothyroidism (13%)
• Common (1% to 10%): Hyperthyroidism, thyroiditis
• Uncommon (0.1% to 1%): Adrenal insufficiency, hypophysitis^[Ref]

Hematologic

• Very common (10% or more): Decreased hemoglobin (45%), decreased lymphocytes (43%), decreased albumin (33%), anemia (31%), decreased platelets (11%), hemorrhage (12%), decreased leukocytes (10%)^[Ref]

Hepatic

• Very common (10% or more): Increased AST (up to 27%), increased ALT (up to 23%), increased bilirubin (up to 11%)
• Common (1% to 10%): Hepatitis^[Ref]

Hypersensitivity

• Common (1% to 10%): Infusion-related reactions^[Ref]

Metabolic

• Very common (10% or more): Increased glucose (up to 46%), decreased sodium (34%), increased alkaline phosphatase (up to 32%), decreased phosphate (15%), decreased potassium (13%), diabetes mellitus (13%), decreased glucose (10%)^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (24%)
• Common (1% to 10%): Myalgia, arthralgia
• Uncommon (0.1% to 1%): Myositis, arthritis^[Ref]

Ocular

• Uncommon (0.1% to 1%): Uveitis^[Ref]

Other

• Very common (10% or more): Fatigue (up to 28%), decreased weight (23%), pyrexia (16%), decreased appetite (16%)^[Ref]

Renal

• Very common (10% or more): Increased creatinine kinase (13%)
• Common (1% to 10%): Nephritis^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 22%), pneumonia (16%)
• Common (1% to 10%): Pneumonitis, dyspnea^[Ref]

See also:

Further information

Tislelizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer