Nivolumab Side Effects
Applies to nivolumab: intravenous solution.
Serious side effects of nivolumab
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 side effects
- 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 side effects
- 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 side effects
- 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 nivolumab
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 side effects
- 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.
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]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2014) "Product Information. Opdivo (nivolumab)." Bristol-Myers Squibb
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Further information
Nivolumab 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.
Some side effects may not be reported. You may report them to the FDA.
