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Opdivo Side Effects

Generic name: nivolumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 27, 2023.

Note: This document contains side effect information about nivolumab. Some dosage forms listed on this page may not apply to the brand name Opdivo.

Applies to nivolumab: intravenous solution.

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:

More common

  • Back pain
  • blistering, peeling, or loosening of the skin
  • blurred vision
  • bone, joint, or muscle pain
  • burning, numbness, tingling, or painful sensations
  • change or loss of taste
  • chest tightness
  • chills
  • constipation
  • cough
  • depressed mood
  • diarrhea
  • difficulty in moving
  • dizziness
  • dry skin and hair
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • feeling cold
  • feeling of warmth
  • fever
  • hair loss
  • headache
  • hoarseness or husky voice
  • itching
  • loss of appetite
  • muscle cramps and stiffness
  • nausea
  • nervousness
  • palpitations
  • red, irritated eyes
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness, swelling, pain of the skin
  • scaling of the skin on the hands and feet
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • tingling of the hands and feet
  • trouble breathing
  • ulceration of the skin
  • unsteadiness or awkwardness
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • weakness in the arms, hands, legs, or feet

Less common

  • Chest pain
  • dark urine
  • general feeling of discomfort or illness
  • light-colored stools
  • pain
  • sensitivity to heat
  • stomach cramps
  • sweating
  • tenderness
  • thickening of bronchial secretions
  • trouble sleeping
  • upper right abdominal or stomach pain
  • watery or bloody diarrhea
  • weight loss
  • yellow eyes and skin

Rare

  • Bloating
  • bloody or cloudy urine
  • change in vision
  • darkening of the skin
  • drowsiness
  • eye pain
  • fruity breath odor
  • increased hunger, thirst, and urination
  • indigestion
  • mental depression
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • redness of the eye
  • sensitivity of the eyes to light
  • skin rash
  • swelling of the face, feet, or lower legs
  • tearing

Incidence not known

  • Feeling of constant movement of self or surroundings
  • lightheadedness
  • sensation of spinning
  • very deep pain in the eyes

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:

More common

  • Stuffy or runny nose
  • swelling or inflammation of the mouth

Incidence not known

  • Increase in blood flow to the whites of the eyes
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes or a veil or curtain appearing across a part of vision

For Healthcare Professionals

Applies to nivolumab: intravenous solution.

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]

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]

General

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]

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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Opdivo (nivolumab). Bristol-Myers Squibb. 2014.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer