For Previously Treated Patients
With Advanced Bladder Cancer
(Urothelial Carcinoma) Side Effects
What Should I Know About Potential Side Effects?
Although they may not be experienced by every patient, OPDIVO® can cause serious
side effects. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.
Lung Problems (pneumonitis)
- new or worsening cough
- chest pain
- shortness of breath
Intestinal Problems (colitis) that can lead to tears or holes in your intestine
- diarrhea (loose stools) or more bowel movements than usual
- blood in your stools or dark, tarry, sticky stools
- severe stomach area (abdomen) pain or tenderness
Liver Problems (hepatitis)
- yellowing of your skin or the whites of your eyes
- severe nausea or vomiting
- pain on the right side of your stomach area (abdomen)
- drowsiness
- dark urine (tea colored)
- bleeding or bruising more easily than normal
- feeling less hungry than usual
- decreased energy
Hormone Gland Problems (especially the thyroid, pituitary, adrenal glands, and pancreas)
- headaches that will not go away or unusual headaches
- extreme tiredness
- weight gain or weight loss
- dizziness or fainting
- changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
- hair loss
- feeling cold
- constipation
- voice gets deeper
- excessive thirst or lots of urine
Kidney Problems,
including nephritis and kidney failure
- decrease in the amount of urine
- blood in your urine
- swelling in your ankles
- loss of appetite
Skin Problems
- rash
- itching
- skin blistering
- ulcers in mouth or other mucous membranes
Inflammation of the Brain (encephalitis)
- headache
- fever
- tiredness or weakness
- confusion
- memory problems
- sleepiness
- seeing or hearing things that are not really there (hallucinations)
- seizures
- stiff neck
Problems in Other Organs
- changes in eyesight
- severe or persistent muscle or joint pains
- severe muscle weakness
- chest pain
Severe Infusion Reactions
Tell your doctor or nurse right away if you get these symptoms during or after an infusion of OPDIVO:
- chills or shaking
- itching or rash
- flushing
- difficulty breathing
- dizziness
- fever
- feeling like passing out
- Getting medical treatment right away may keep the problem from becoming more serious.
- Do not treat symptoms yourself.
- Do not feel embarrassed or worry that you are bothering your oncologist.
What are the serious side effects of OPDIVO?
OPDIVO can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include: lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary,
adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions.
What are the most common side effects of OPDIVO?
The most common side effects of OPDIVO when used alone include:
- feeling tired
- rash
- pain in muscles, bones, and joints
- itchy skin
- diarrhea
- nausea
- weakness
- cough
- shortness of breath
- constipation
- decreased appetite
- back pain
- upper respiratory tract infection
- fever
- headache
- abdominal pain
See Clinical Trial Results
See how OPDIVO performed in a clinical trial in patients.
See the Results