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Indications

Prescribing Information

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Medication Guide

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An older woman reviewing a booklet of OPDIVO® (nivolumab) and OPDIVO® + YERVOY® (ipilimumab) side effects.
An older woman reviewing a booklet of OPDIVO® (nivolumab) and OPDIVO® + YERVOY® (ipilimumab) side effects.

What you should know
about side effects

Although not every person may experience them,
side effects are still possible with OPDIVO and OPDIVO-based combinations. Learn more about the most common side effects, potential side effects, and how to manage these side effects as well.

Actor portrayal.

OPDIVO or OPDIVO + YERVOY 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 anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.

Most common side effects

It’s important to remember that these are not all of the possible side effects of OPDIVO or OPDIVO-based combinations. That’s why you need to report any discomfort or change in the way you are feeling to your healthcare team, even if your symptoms are not listed below. Some of the side effects may be life-threatening and may need your doctor's immediate attention.

These are not all the possible side effects. Talk to your healthcare team or pharmacist for more information. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.

Complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic) may occur. These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications.

Potential side effects

It’s important to remember that these are not all of the possible side effects of OPDIVO or OPDIVO-based combinations. That’s why you need to report any discomfort or change in the way you are feeling to your healthcare team, even if your symptoms are not listed below. Some of the side effects may be life-threatening and may need your doctor's immediate attention.

Lung problems

  • New or worsening cough
  • Shortness of breath
  • Chest pain

Intestinal problems

  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky, or have blood or mucus
  • Severe stomach-area (abdominal) pain or tenderness

Liver problems

  • Yellowing of your skin or the whites of your eyes
  • Severe nausea or vomiting
  • Pain on the right side of your stomach area (abdomen)
  • Dark urine (tea colored)
  • Bleeding or bruising more easily than normal

Hormone gland problems

  • Headaches that will not go away or unusual headaches
  • Eye sensitivity to light
  • Eye problems
  • Rapid heartbeat
  • Increased sweating
  • Extreme tiredness
  • Weight gain or weight loss
  • Feeling more hungry or thirsty than usual
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • Your voice gets deeper
  • Dizziness or fainting
  • Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

  • Decrease in your amount of urine
  • Blood in your urine
  • Swelling in your ankles
  • Loss of appetite

Skin problems

  • Rash
  • Itching
  • Skin blistering or peeling
  • Painful sores or ulcers in the mouth or nose, throat, or genital area

Eye problems

  • Blurry vision, double vision, or other vision problems
  • Eye pain or redness

Problems in other organs

  • Chest pain, irregular heartbeat, shortness of breath, swelling of ankles
  • Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • Persistent or severe muscle pain or weakness, muscle cramps
  • Low red blood cells, bruising

Severe infusion reactions

Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO:

  • Chills or shaking
  • Itching or rash
  • Flushing
  • Shortness of breath or wheezing
  • Dizziness
  • Feel like passing out
  • Fever
  • Back or neck pain

These are not all the possible side effects. Talk to your healthcare team or pharmacist for more information. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.

Tracking potential side effects

When taking OPDIVO or an OPDIVO-based combination, it’s important to play an active role in talking with your healthcare team, as many signs and symptoms of side effects can only be noticed by you.

Make sure to pay attention to how you are feeling and be especially aware of any new discomfort that appears unexpectedly or any condition that suddenly gets worse.

If you notice a change in the way you are feeling—even if it seems small or irrelevant—contact your healthcare team immediately, and don’t try to treat possible side effects yourself.

Booklet to help patients track their side effects with OPDIVO® and OPDIVO®-based combinations.
Nurse monitoring a gentleman's infusion of OPDIVO® (nivolumab) immunotherapy treatment.

Getting an infusion

See your recommended treatment plan and what to expect from an infusion

Clinical trial results for OPDIVO® (nivolumab) and OPDIVO-based combinations.

Clinical trial results

Explore findings from clinical trials with OPDIVO and OPDIVO-based combinations

Hands perusing OPDIVO® (nivolumab) patient resources.

Helpful patient resources

Explore resources to help you along your treatment journey