POSSIBLE SIDE EFFECTS
Like all medicines, OPDIVO can cause side effects, although not everybody gets them.
Your doctor will discuss these with you and will explain the risks and benefits of
your treatment.
Do not try to treat your symptoms with other medicines.
Do not be alarmed by possible side effects.
You may not experience any of them.
Ask your doctor to answer any questions you may have.
The following side effects have been reported in clinical trials when OPDIVO has been
given alone:
Very common (may affect more than 1 in 10 people)
Diarrhoea (watery, loose or soft stools), nausea
Skin rash sometimes with blisters, itching
Feeling tired or weak
Common (may affect up to 1 in 10 people)
Infections of the upper respiratory tract
Serious lung infection (pneumonia)
Underactive thyroid gland, which can cause tiredness or weight gain, overactive thyroid
gland, which can cause rapid heart rate, sweating and weight loss
Decreased appetite
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs, headaches, dizziness
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty
breathing
Coughing, shortness of breath (dyspnoea)
Inflammation of the intestines (colitis)
Stomach pain, constipation
Mouth ulcers and cold sores (stomatitis), vomiting, dry mouth
Skin colour changes in patches (vitiligo), dry skin, redness of the skin, hair loss
or thinning
Pain in the muscles, bones and joints
Fever, oedema (swelling)
Allergic reaction, reaction related to the infusion of the medicine
High blood pressure (hypertension)
Decrease in some white blood cells
Uncommon (may affect up to 1 in 100 people)
Bronchitis
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, diabetes
Inflammation of the pancreas, inflammation of the stomach (gastritis)
Dehydration
Increased acid level in the blood
Increase in some white blood cells
Inflammation of the eye, which causes pain and redness, blurred vision, dry eyes
Inflammation in the kidney, kidney failure
Fast heart rate, abnormal heart rhythm Arthritis
Damage to nerves causing numbness and weakness (polyneuropathy), inflammation of the
nerves caused by the body attacking itself, causing numbness, weakness, tingling and
burning pain
Inflammation of the liver (hepatitis)
Fluid around the lungs
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)
Pain, chest pain
Rare (may affect up to 1 in 1000 people)
Life threatening allergic reaction
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson
syndrome), , skin condition of the face where the nose and cheeks are unusually red
(rosacea)
Loss of the covering around the nerves (demyelination) pain
A condition in which the muscles become weak and tire easily (myasthenic syndrome)
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome)
Inflammation of the brain
Ulcer of the small intestine
Blockage of the bile ducts
Fluid in lungs
Acid in the blood produced from diabetes (diabetic ketoacidosis)
A disease causing inflammation or enlargement of a lymph node (Kikuchi lymphadenitis)
Changes in the rhythm or rate of the heart, abnormal heart rhythm
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue,
palpitations or chest pain
Inflammation of muscles causing pain or stiffness
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea
or vomiting.
Myopathy (aching muscles, muscle tenderness or weakness, not caused by exercise)
Inflammatory disease of blood vessels
Disease in which the
immune system attacks the glands that make moisture for the body, such as tears and
saliva (Sjogren's syndrome)
decrease in parathyroid hormone
blood disorder caused by overactive immune cells
Changes in test results
OPDIVO may cause changes in the results of tests carried out by your doctor. These
include:
Abnormal liver function tests
Abnormal kidney function tests
A decreased number of red blood cells (which carry oxygen), white blood cells (which
are important in fighting infection) or platelets (cells which help the blood clot)
Abnormal levels of calcium, potassium, magnesium or sodium in your blood
Decrease in body weight
Higher levels of sugar in your blood (hyperglycaemia)
The following side effects have been reported in clinical trials when OPDIVO has been
given in combination with ipilimumab:
Very common (may affect more than 1 in 10 people)
Overactive thyroid gland, which can cause rapid heart rate, sweating and weight loss
Underactive thyroid gland, which can cause tiredness or weight gain
Decreased appetite
Headache
Shortness of breath (dyspnoea)
Inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools),
vomiting, nausea, stomach pain
Skin rash sometimes with blisters, itching
Pain in the joints, muscles and bones
Feeling tired or weak
Fever
Common (may affect up to 1 in 10 people)
Serious lung infection (pneumonia), infections of the upper respiratory tract
Increase in some white blood cells
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; inflammation of the thyroid
gland (hyperthyroidism); swelling of the thyroid gland
Dehydration
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs; dizziness
Inflammation of the eye, which causes pain and redness, blurred vision
Fast heart rate
High blood pressure (hypertension)
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty
breathing, blood clots, cough
Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis),
constipation, dry mouth
Inflammation of the liver
Skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair
loss or thinning, hives (itchy rash)
Pain in the muscles and bones
Kidney failure (including abrupt loss of kidney function)
Oedema (swelling), pain
Allergic reaction, reactions related to the infusion of the medicine
Uncommon (may affect up to 1 in 100 people)
Inflammation of the brain
Bronchitis
Chronic diseases associated with a build-up of inflammatory cells in various organs
and tissues, most commonly the lungs (sarcoidosis)
Acid in the blood produced from diabetes (diabetic ketoacidosis), diabetes
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome); damage to nerves causing numbness and weakness
(polyneuropathy); inflammation of the nerves; foot drop (peroneal nerve palsy); inflammation
of the nerves caused by the body attacking itself, causing numbness, weakness, tingling
or burning pain (autoimmune neuropathy)
Changes in the rhythm or rate of the heart beat, abnormal heart rhythm
Fluid around the lungs
Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the
duodenum (duodenitis)
Skin disease with thickened patches of red skin, often with silvery scales (psoriasis)
Chronic disease of joints (spondyloarthropathy)
Disease in which the
immune system attacks the glands that make moisture for the body, such as tears and
saliva (Sjogren's syndrome)
Inflammation of the joints (arthritis)
Inflammation of muscles (myositis) causing pain or stiffness
Inflammation of the kidney (nephritis)
Chest pain
Inflammation of the heart (myocarditis) characterised by shortness of breath, fatigue,
palpitations or chest pain.
Muscle breakdown/injury (rhabdomyolysis) characterised by muscle pain, weakness, nausea
or vomiting.
Rare (may affect up to 1 in 1000 people)
Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis, Steven-Johnson
syndrome)
decrease in parathyroid hormone
blood disorder caused by overactive immune cells
Changes in test results
OPDIVO in combination with ipilimumab may cause changes in the results of tests carried
out by your doctor. These include:
Abnormal liver function tests
Abnormal kidney function tests
A decreased number of red blood cells (which carry oxygen), white blood cells (which
are important in fighting infection) or platelets (cells which help the blood to clot)
An increased level of the enzyme that breaks down fats and of the enzyme that breaks
down starch.
Abnormal levels of calcium, potassium, magnesium or sodium in your blood
Higher blood levels of bilirubin
Decrease in body weight
Higher (hyperglycaemia) or lower (hypoglycaemia) levels of sugar in your blood
The following side effects have been reported in clinical trials when OPDIVO has been
given in combination with ipilimumab and chemotherapy:
Very common (may affect more than 1 in 10 people)
Underactive thyroid gland, which can cause tiredness or weight gain
Decreased appetite
diarrhoea (watery, loose or soft stools), vomiting, nausea
Skin rash sometimes with blisters, itching
Feeling tired or weak
Common (may affect up to 1 in 10 people)
Conjunctivitis
Serious lung infection (pneumonia), infections of the upper respiratory tract
Increase in some white blood cells
Allergic reaction, reactions related to the infusion of the medicine
Decreased secretion of hormones produced by adrenal glands (glands situated above
the kidneys), inflammation (hypophysitis) of the pituitary gland situated at the base
of the brain, overactive thyroid gland, which can cause rapid heart rate, sweating
and weight loss, swelling of the thyroid gland
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs; dizziness
dry eyes
headache
Shortness of breath (dyspnoea)
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty
breathing, blood clots, cough
Inflammation of the intestines (colitis)
Mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis),
constipation, dry mouth
Inflammation of the liver
dry skin, redness of the skin, unusual hair loss or thinning
Pain in the joints, muscles and bones, inflammation of the joints
Kidney failure (including abrupt loss of kidney function)
Fever
Oedema (swelling)
Uncommon (may affect up to 1 in 100 people)
underactive function (hypopituitarism) of the pituitary gland situated at the base
of the brain, decrease in parathyroid hormone
damage to nerves causing numbness and weakness (polyneuropathy); inflammation of the
nerves caused by the body attacking itself, causing numbness, weakness, tingling or
burning pain (autoimmune neuropathy), inflammation of the brain
blurred vision
Changes in the rhythm or rate of the heart beat, abnormal heart rhythm
High blood pressure (hypertension), low blood pressure (hypotension)
Fluid around the lungs, bronchitis
Skin disease with thickened patches of red skin, often with silvery scales (psoriasis)
Severe and possibly fatal peeling of the skin (Steven-Johnson syndrome)
Inflammation of muscles (myositis) causing pain or stiffness
Inflammation of the kidney (nephritis)
Chest pain
Changes in test results
OPDIVO in combination with ipilimumab and chemotherapy may cause changes in the results
of tests carried out by your doctor. These include:
Abnormal liver function tests
Abnormal kidney function tests
A decreased number of red blood cells (which carry oxygen), white blood cells (which
are important in fighting infection) or platelets (cells which help the blood to clot)
An increased level of the enzyme that breaks down fats and of the enzyme that breaks
down starch.
Abnormal levels of calcium, potassium, magnesium or sodium in your blood
Higher levels of sugar in your blood (hyperglycaemia)
Higher blood levels of bilirubin
The following side effects have been reported in clinical trials when OPDIVO has been
given in combination with cabozantinib:
Very common (may affect more than 1 in 10 people)
Underactive thyroid gland, which can cause tiredness or weight gain
Decreased appetite, altered sense of taste
High blood pressure (hypertension)
Hoarseness
Diarrhoea, nausea, mouth ulcers and cold sores (stomatitism), vomiting, abdominal
pain, indigestion
Blisters, pain of the hands or soles of the feet, rash or redness of the skin, rash,
itching
Feeling tired or weak
Common (may affect up to 1 in 10 people)
Infections of the upper respiratory tract
Allergic reaction, reactions related to the infusion of the medicine
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)
Dehydration
Headache, dizziness, inflammation of the nerves causing numbness or burning pain of
the arms and legs
Dry eye
Blood clots
Inflammation of the lungs (pneumonitis) characterised by coughing and difficulty breathing,
cough, shortness of breath (dyspnoea), nose bleeds
Dry mouth, constipation, inflammation of the stomach (gastritis), oral pain
Inflammation of the liver (hepatitis)
Dry skin, unusual hair loss or thinning, redness of the skin, hair colour change
Pain in the joints, muscle spasm, pain in the muscles or bones, pains, inflammation
in the joints
Protein in the urine (seen in tests), Kidney failure including abrupt loss of kidney
function
oedema (swelling), fever, pain
Uncommon (may affect up to 1 in 100 people)
Serious lung infection (pneumonia)
Increase in some white blood cells
Allergic reaction, reactions related to the infusion of the medicine
Inflammation (hypophysitis) of the pituitary gland situated at the base of the brain,
swelling of the thyroid gland
Inflammation of the brain, autoimmune, a temporary inflammation of the nerves that
causes pain, weakness and paralysis in the extremities (Guillain- Barré syndrome),
a condition in which the muscles become weak and tire easily (myasthenic syndrome)
Ringing in ears
Inflammation of the eye, which causes pain and redness, blurred vision
Changes in the rhythm or rate of the heart, fast heart rate, inflammation of the heart
(myocarditis) characterised by shortness of breath, fatigue, palpitations or chest
pain
Fluid around the lungs
Inflammation of the intestines (colitis), inflammation of the pancreas (pancreatitis),
intestinal perforation, a burning or stinging sensation on the tongue, haemorrhoids
Skin disease with thickened patches of red skin, often with silvery scales (psoriasis),
severe itching of skin
Myopathy (aching muscles, muscle tenderness or weakness, not caused by exercise),
bone damage in the jaw, a painful tear or abnormal connection of the tissues in your
body
Inflammation of the kidney (nephritis)
chest pain
Changes in test results
OPDIVO in combination with cabozantinib may cause changes in the results of tests
carried out by your doctor. These include:
Abnormal liver function tests
Abnormal kidney function tests
A decreased number of red blood cells (which carry oxygen), white blood cells (which
are important in fighting infection) or platelets (cells which help the blood to clot)
An increased level of the enzyme that breaks down fats and of the enzyme that breaks
down starch.
Abnormal levels of calcium, potassium, magnesium, sodium or phosphate in your blood.
Higher (hyperglycaemia) or lower (hypoglycaemia) levels of sugar in your blood
The following side effects have been reported in clinical trials when OPDIVO has been
given in combination with chemotherapy:
Very common (may affect more than 1 in 10 people)
Decreased appetite
Inflammation of the nerves causing numbness, weakness, tingling or burning pain of
the arms and legs; dizziness
diarrhoea (watery, loose or soft stools), vomiting, nausea
Mouth ulcers and cold sores (stomatitis)
Feeling tired or weak
Skin rash sometimes with blisters, itching, tingling and tenderness developing to
symmetrical redness, swelling and pain primarily on the palm of the hand and sole
of the foot (palmar-plantar erythrodysaesthaesia syndrome)
Common (may affect up to 1 in 10 people)
Serious lung infection (pneumonia)
Increase in some white blood cells
Allergic reaction, reactions related to the infusion of the medicine
Underactive thyroid gland, which can cause tiredness or weight gain. overactive thyroid
gland, which can cause rapid heart rate, sweating and weight loss, swelling of the
thyroid gland
Sensations like numbness and tingling (paraesthesia), dizziness
headache
dry eyes
blurred vision
Shortness of breath (dyspnoea)
Blood clots, low blood pressure (hypotension)
Inflammation of the lungs (pneumonitis), characterised by coughing and difficulty
breathing, blood clots, cough
Inflammation of the intestines (colitis)
Constipation, dry mouth
Abdominal pain
Dry skin, redness of the skin, unusual hair loss or thinning, skin colour change in
patches, hives (itchy rash)
Pain in the joints, muscles and bones, inflammation of the joints, muscle weakness
Fever
Oedema (swelling)
Uncommon (may affect up to 1 in 100 people)
Infections of the upper respiratory tract
Underactive function (hypopituitarism) of the pituitary gland situated at the base
of the brain, decreased secretion of hormones produced by adrenal glands (glands situated
above the kidneys), inflammation (hypophysitis) of the pituitary gland situated at
the base of the brain
Diabetes
A temporary inflammation of the nerves that causes pain, weakness and paralysis in
the extremities (Guillain-Barré syndrome)
Inflammation of the eye, which causes pain and redness, blurred vision
Rapid heart rate, inflammation of the heart (myocarditis) characterised by shortness
of breath, fatigue, palpitations or chest pain
Inflammation of the pancreas (pancreatitis)
Inflammation of the liver
Kidney failure (including abrupt loss of kidney function), inflammation of the kidney
(nephritis)
Changes in test results
OPDIVO in combination with chemotherapy may cause changes in the results of tests
carried out by your doctor. These include:
Abnormal liver function tests
Abnormal kidney function tests
A decreased number of red blood cells (which carry oxygen), white blood cells (which
are important in fighting infection) or platelets (cells which help the blood to clot)
An increased level of the enzyme that breaks down fats and of the enzyme that breaks
down starch.
Abnormal levels of calcium, potassium or sodium in your blood
Higher (hyperglycaemia) or lower (hypoglycaemia) levels of sugar in your blood
Higher blood levels of bilirubin