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Avelumab Side Effects

For the Consumer

Applies to avelumab: intravenous solution

Along with its needed effects, avelumab 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 avelumab:

More common
  • Abdominal or stomach pain
  • back pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chills
  • confusion
  • cough
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of warmth
  • fever
  • headache
  • hives or welts, itching, or skin rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • nervousness
  • pounding in the ears
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • slow or fast heartbeat
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing or swallowing
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common
  • Chest pain
  • constipation
  • depressed mood
  • dry skin and hair
  • feeling cold
  • general feeling of discomfort or illness
  • hair loss
  • muscle cramps and stiffness
  • stomach cramps
  • thickening of bronchial secretions
  • watery or bloody diarrhea
  • weight gain
  • Blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • chest discomfort
  • dark urine
  • darkening of the skin
  • diarrhea
  • drowsiness
  • dry mouth
  • fainting
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • muscle pain
  • nausea or vomiting
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sensitivity to heat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomachache
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • weight loss
  • yellow eyes and skin

Some side effects of avelumab 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
  • Decreased appetite

For Healthcare Professionals

Applies to avelumab: intravenous solution


Very common (10% or more): Hypotension (25%), hypertension (13%)
Uncommon (0.1% to 1%): Myocarditis[Ref]


Very common (10% or more): Urticaria (25%), rash (e.g., maculopapular, erythema, dermatitis bullous) (22%), pruritus (10%)
Uncommon (0.1% to 1%): Psoriasis, arthritis, exfoliative dermatitis, pemphigoid, Stevens Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), histiocytic necrotizing lymphadenitis, vasculitis, hypophysitis[Ref]


Common (1% to 10%): Immune-mediated thyroid disorders (hypothyroidism/hyperthyroidism)
Uncommon (0.1% to 1%): Adrenal insufficiency, hypopituitarism, hypophysitis[Ref]


Very common (10% or more): Abdominal pain (25%), diarrhea (23%), nausea (22%), constipation (17%)
Common (1% to 10%): Immune-mediated colitis
Uncommon (0.1% to 1%): Pancreatitis[Ref]


Very common (10% or more): Lymphopenia (49%), anemia (35%), thrombocytopenia (27%)
Common (1% to 10%): Neutropenia
Rare (0.01% to 0.1%): Hemolytic anemia[Ref]


Very common (10% or more): Increased aspartate aminotransferase (AST) (34%), increased alanine aminotransferase (ALT) (20%)
Common (1% to 10%): Increased bilirubin
Uncommon (0.1% to 1%): Immune-mediated hepatitis[Ref]


Common (1% to 10%): Immunogenicity[Ref]


Very common (10% or more): Anorexia (20%), weight loss (15%), increased lipase (14%)
Common (1% to 10%): Increased amylase[Ref]


Very common (10% or more): Anorexia (20%), weight loss (15%), increased lipase (14%)
Common (1% to 10%): Increased amylase[Ref]


Very common (10% or more): Musculoskeletal pain (32%), back pain (25%), arthralgia (16%)
Common (1% to 10%):
Uncommon (0.1% to 1%): Myositis, rhabdomyolysis, myasthenia gravis[Ref]

Nervous system

Very common (10% or more): Dizziness (14%), headache (10%)
Uncommon (0.1% to 1%): Guillain-Barre syndrome, demyelination, encephalitis[Ref]


Very common (10% or more): Couth (18%), dyspnea (11%)
Common (1% to 10%): Immune-mediated pneumonitis, wheezing[Ref]


Rare (less than 0.1%): Immune-mediated nephritis[Ref]


Very common (10% or more): Fatigue (50%), pyrexia (25%), chills (25%), flushing (25%), peripheral edema (20%)[Ref]


Uncommon (0.1% to 1%): Uveitis, iritis[Ref]


1. "Product Information. Bavencio (avelumab)." EMD Serono Inc, Rockland, MA.

Some side effects of avelumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.