Opdivo Side Effects

Generic name: nivolumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 27, 2024.

Note: This document provides detailed information about Opdivo.

Applies to nivolumab: intravenous solution Side Effects associated with nivolumab. Some dosage forms listed on this page may not apply specifically to the brand name Opdivo.

Applies to nivolumab: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 5 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem (eg, pneumonitis).

Colitis (inflammation of the colon) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious problems with adrenal, pituitary, or thyroid gland may occur while you are receiving this medicine. Tell your doctor if you have changes in mood or behavior (eg, being irritable or forgetful), constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, unusual or continuing headaches, or weight changes.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Tell your doctor right away if you have bloody or cloudy urine, decrease in the amount of urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain. These may be symptoms of a serious kidney problem.

Check with your doctor if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.

Serious skin reactions, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), and toxic epidermal necrolysis can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sores or ulcers on the skin, mouth or lips, or swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.

This medicine may increase your risk for transplant complications (eg, graft-versus-host-disease [GVHD]) in patients who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), which can be severe and life-threatening. Check with your doctor right away if you have skin rash, stomach pain, diarrhea, yellow skin or eyes, swelling in the legs or ankles, dark urine, pale stools, nausea, or vomiting.

Serious side effects of Opdivo

Along with its needed effects, nivolumab (the active ingredient contained in Opdivo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking nivolumab:

Other side effects of Opdivo

Some side effects of nivolumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to nivolumab: intravenous solution.

General adverse events

The most commonly reported adverse reaction in clinical trials was rash; a composite term including the following rashes maculopapular, erythematous, pruritic, follicular, macular, papular, pustular, vesicular, and dermatitis acneiform.^[Ref]

Hepatic

• Very common (10% or more): Elevated AST (28%), elevated alkaline phosphatase (22%), elevated ALT (16%)
• Common (1% to 10%): Elevated total bilirubin, immune-mediated hepatitis
• Frequency not reported: Increased amylase, increased lipase^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea or colitis (21%)
• Common (1% to 10%): Immune-mediated colitis, nausea, vomiting
• Frequency not reported: Immune-mediated pancreatitis^[Ref]

Respiratory

• Very common (10% or more): Cough (17%), upper respiratory tract infection (17%)
• Common (1% to 10%): Pneumonitis, immune-mediated pneumonitis, dyspnea^[Ref]

Renal

• Very common (10% or more): Increased serum creatinine (13%)
• Uncommon (0.1% to 1%): Immune-mediated nephritis, immune-mediated renal dysfunction^[Ref]

Cardiovascular

• Very common (10% or more): Peripheral edema (10%)
• Frequency not reported: Ventricular arrhythmia^[Ref]

Dermatologic

• Very common (10% or more): Rash (21%), pruritus (19%), vitiligo (11%), erythema (10%)
• Frequency not reported: Exfoliative dermatitis, erythema multiforme, vitiligo, psoriasis, immune-mediated rash^[Ref]

Endocrine

• Common (1% to 10%): Hypothyroidism, hyperthyroidism
• Frequency not reported: Immune-mediated hypopituitarism, immune-mediated hypophysitis^[Ref]

Nervous system

• Frequency not reported: Dizziness, peripheral and sensory neuropathy, immune-mediated demyelination, immune-mediated facial and abducens nerve paresis, immune-mediated myasthenic syndrome, immune-mediated encephalitis^[Ref]

Local

• Frequency not reported: Infusion-related reactions^[Ref]

Ocular

• Frequency not reported: Iridocyclitis^[Ref]

Metabolic

• Very common (10% or more): Anorexia (28%)
• Frequency not reported: Immune-mediated adrenal insufficiency, immune-mediated diabetic ketoacidosis^[Ref]

Immunologic

• Frequency not reported: Immune-mediated uveitis, immune-mediated autoimmune neuropathy, immune-mediated Guillain-Barre Syndrome^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (32%), back pain (21%), arthralgia (20%)
• Frequency not reported: Pain in extremity^[Ref]

Other

• Very common (10% or more): Fatigue (49%)
• Common (1% to 10%): Pyrexia^[Ref]

See also:

Frequently asked questions

• What are monoclonal antibodies?
• How long does it prolong life and what’s the success rate?
• How long does Opdivo take to work and how do you know if it's working?
• What is the difference between Opdivo and Keytruda?
• Pembrolizumab vs. nivolumab: How do they compare?
• How long does Opdivo stay in your system?
• What happens when you stop taking Opdivo for melanoma?
• How effective are Opdivo and Yervoy when taken together?
• Opdivo vs Opdivo Qvantig: What is the Difference?

Further information

Opdivo side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer