Toripalimab Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 13, 2024.

Applies to toripalimab: intravenous solution.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, skin sores, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Toripalimab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have:

• intestinal problems--severe stomach pain, diarrhea, bloody or tarry stools;

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• immune system problems--confusion, problems with thinking or memory, balance problems, trouble breathing, weakness, muscle cramps, irregular heart rhythm or swelling of ankles;

• signs of organ transplant rejection--feeling sick or uneasy, with pain or swelling near your transplanted organ;

• signs of a hormonal disorder--unusual headaches, vision problems, feeling light-headed, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss;

• lung problems--cough, shortness of breath, chest pain;

• kidney problems--swelling, urinating less, feeling tired or short of breath; or

• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed, cold hands and feet.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• fever, cough, cold symptoms such as stuffy nose, sneezing, sore throat;

• dizziness;

• feeling very weak or tired;

• low levels of thyroid hormone;

• rash;

• numbness or tingling in your feet;

• muscle or bone pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to toripalimab: intravenous solution.

General

The most common adverse reactions of 20% or greater frequency were nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, fatigue, dizziness, and malaise.

Cardiovascular

Common (1% to 10%): Hypertension

Frequency Not Reported: Myocarditis, pericarditis, pericardial effusion, vasculitis^[Ref]

Hypertension included blood pressure increased, blood pressure systolic increased, hypertension, and hypertensive crisis.^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 36%), pruritus (up to 17%)

Rash included acneiform dermatitis, allergic dermatitis, catheter-site rash, dermatitis, drug eruption, eczema, erythema, macule, maculopapular rash, palmar-plantar erythrodysesthesia syndrome, papule, pruritic rash, rash, and urticaria.

Endocrine

Very common (10% or more): Hypothyroidism (up to 38%)

Frequency Not Reported: Hypoparathyroidism

Hypothyroidism included hypothyroidism, tri-iodothyronine decreased, tri-iodothyronine free decreased, and thyroiditis.

Gastrointestinal

Very common (10% or more): Nausea (up to 71%), vomiting (up to 68%), constipation (up to 39%), diarrhea (up to 31%), stomatitis (up to 12%)

Frequency Not Reported: Duodenitis, gastritis, pancreatitis

Stomatitis included mouth ulceration, stomatitis, and radiation stomatitis. Pancreatitis included increases in serum amylase and lipase levels.

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 94%), decreased neutrophils (up to 91%), decreased lymphocytes (up to 88%), decreased platelets (up to 71%)

Common (1% to 10%): Epistaxis

Frequency Not Reported: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection

Metabolic

Very common (10% or more): Decreased magnesium (up to 78%), decreased sodium (up to 63%), increased ALT (up to 58%), increased AST (up to 58%), decreased appetite (up to 55%), decreased albumin (up to 49%), decreased calcium (up to 45%), increased LDH (up to 42%), increased calcium (up to 39%), decreased potassium (up to 40%), increased creatinine (up to 39%), increased alkaline phosphatase (up to 27%), increased triglyceride (26%), decreased glucose (up to 23%), decreased weight (11%)

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (up to 25%)

Frequency Not Reported: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis, polymyalgia rheumatica, dermatomyositis

Musculoskeletal pain included back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, pain in extremity, pain in jaw.

Nervous system

Peripheral neuropathy includes hypoesthesia, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy.

Very common (10% or more): Peripheral neuropathy (up to 30%), dizziness (up to 21%), headache (up to 18%)

Frequency Not Reported: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy

Other

Fatigue included asthenia and fatigue.

Very common (10% or more): Pyrexia (up to 32%), malaise (up to 21%), fatigue (up to 19%; includes asthenia and fatigue)

Psychiatric

Very common (10% or more): Insomnia (up to 23%)

Respiratory

Very common (10% or more): Cough (up to 26%), upper respiratory infection (up to 23%), pneumonia (up to 18%)

Cough included cough and productive cough. Upper respiratory infection included acute sinusitis, bronchitis, laryngitis, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis, and upper respiratory tract infection. Pneumonia included aspiration pneumonia and pneumonia.

Frequently asked questions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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