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Lung problems:
Problems with your lungs such as breathing difficulties, shortness of breath, or cough.
These may be signs of inflammation of the lungs (pneumonitis or interstitial lung
disease)
Stomach and Intestinal problems:
Inflammation of the intestines (colitis, enterocolitis, coeliac disease, pancreatic
exocrine insufficiency), stomach (gastritis) and duodenum (duodenitis) which can worsen
to bleeding or bowel perforation
Symptoms may include diarrhoea (watery, loose or soft stools), an increased number
of bowel movements (an increase by two or more per day), constipation, vomiting, nausea,
mucus and blood in your stools, or darker-coloured stools, stomach pain or tenderness
in your stomach area
Liver problems:
Inflammation of the liver (hepatitis) and Inflammation of the bile duct system (cholangitis).
Symptoms may include yellowing of the eyes or skin (jaundice), pain on the right side
of your stomach area, tiredness, nausea or vomiting, fever or chills
Kidney problems:
Inflammation in the kidney (nephritis)
Signs and symptoms may include abnormal kidney function tests, decreased volume of
urine and kidney failure (including abrupt loss of kidney function)
Hormone gland problems:
Underactive thyroid gland, which can cause tiredness or weight gain
Overactive thyroid gland, which can cause rapid heart rate, sweating and weight loss
Decreased secretion of hormones produced by adrenal glands (glands situated above
the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis)
of the pituitary gland situated at the base of the brain, swelling of the thyroid
gland
Decrease in parathyroid hormone
Acid in the blood produced by diabetes (diabetic ketoacidosis)
Excessive thirst, the passing of a greatly increased amount of urine, increase in
appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable
and generally unwell (diabetes)
Skin problems:
Inflammation of the skin that can lead to rash and itching
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson
syndrome)
Severe condition of the skin that causes red, often itchy spots, similar to rash of
measles, which starts on the limbs and sometimes on the face and the rest of the body
(erythema multiforme), skin disease with thickened patches of red skin, often silvery
scales (psoriasis), hives (itchy, bumpy rash)
Brain and nervous system problems:
Damage to nerves causing numbness and weakness, including in the extremities like
hands or feet (polyneuropathy, peripheral neuropathy)
Inflammation of the brain (encephalitis)
A condition in which the muscles become weak and tire easily (myasthenic syndrome)
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs, headaches, dizziness (autoimmune neuropathy)
Loss of the covering around the nerves (demyelination) pain
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome)
Sensations like numbness and tingling (paraesthesia), dizziness
Inflammation of the spinal cord (myelitis) causing back and neck pain, weakness in
the arms or legs, loss of bladder or bowel control
Inflammation of the tissue around the brain and spinal cord (aseptic meningitis) causing
headache, neck stiffness (with or without fever), light sensitivity, muscle pain and
altered levels of consciousness
Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT):
Complications of stem cell transplant that uses donor cells (allogeneic) may occur
after treatment with OPDIVO.
These complications can be severe and can lead to death. Your healthcare provider
will monitor you for signs of complications if you have an allogeneic stem cell transplant.
Problems in other organs:
Inflammation of the heart (myocarditis). Symptoms may include shortness of breath,
fatigue, palpitations or chest pain
Changes in the rhythm or rate of the heart, abnormal heart rhythm
Inflammation of muscles (myositis). Symptoms may include muscle pain, stiffness, weakness,
chest pain or severe fatigue
Muscle breakdown/injury (rhabdomyolysis). Symptoms may include muscle pain, weakness,
nausea or vomiting.
Inflammation of the eye, which causes pain and redness, blurred vision
Solid organ transplant rejection
A condition where the immune system mistakenly destroys red blood cells (oxygen carrying
cells) and results in decreased number of red blood cells (autoimmune haemolytic anaemia)
A condition where the bone marrow fails to produce enough new blood cells (aplastic
anaemia) which can result in anaemia (decreased red blood cells), and susceptibility
to infection or bruising
A condition where the immune system makes too many infection-fighting cells called
histiocytes and lymphocytes that may cause various symptoms (called haemophagocytic
lymphohistiocytosis). Symptoms may include enlarged liver and/or spleen, skin rash,
lymph node enlargement, breathing problems, easy bruising, kidney abnormalities, and
heart problems.
Inflammation throughout the body (systemic inflammatory response syndrome) leading
to redness and swelling (oedema) in the affected parts, intense pain, fatigue, fast
heart rate, abnormal breathing, fever or chills
A group of metabolic complications occurring after cancer treatment characterised
by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour
lysis syndrome).
Infusion reactions:
Allergic reaction, reaction related to the infusion of the medicine
Life threatening allergic reaction
Hypovolaemic shock, causing rapid heart rate, shallow breathing, cool, clammy skin,
confusion or dizziness
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