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Nivolumab Side Effects

For the Consumer

Applies to nivolumab: intravenous solution

Along with its needed effects, nivolumab 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
  • chest tightness
  • chills
  • constipation
  • cough
  • depressed mood
  • diarrhea
  • dry skin and hair
  • feeling cold
  • feeling of warmth
  • fever
  • hair loss
  • headache
  • hoarseness or husky voice
  • itching
  • joint or muscle pain
  • loss of appetite
  • muscle cramps and stiffness
  • nausea
  • red, irritated eyes
  • redness of the face, neck, arms and occasionally, upper chest
  • slowed heartbeat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Less Common

  • Chest pain
  • dark urine
  • general feeling of discomfort or illness
  • light-colored stools
  • nervousness
  • 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
  • blurred vision or other change in vision
  • darkening of the skin
  • dizziness
  • drowsiness
  • eye pain
  • fainting
  • fast heartbeat
  • 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

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

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]

References

1. "Product Information. Opdivo (nivolumab)." Bristol-Myers Squibb, Princeton, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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.

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