Ipilimumab Side Effects

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

For the Consumer

Applies to ipilimumab: intravenous solution

Along with its needed effects, ipilimumab 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 ipilimumab:

More common
  • Bloody, black, or tarry stools
  • diarrhea
  • fever
  • heartburn
  • indigestion
  • itching skin
  • nausea
  • rash
  • severe stomach pain, cramping, or burning
  • unusual tiredness or weakness
  • vomiting
  • vomiting of material that looks like coffee grounds, severe and continuing
  • watery or bloody diarrhea
Less common
  • Abdominal or stomach tenderness
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody or cloudy urine
  • blurred vision or other changes in vision
  • burning, dry, or itching eyes
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • chest pain
  • chills
  • clay-colored stools
  • cough
  • cracked, dry, or scaly skin
  • dark urine
  • darkening of the skin
  • decreased appetite
  • decreased frequency or amount of urine
  • difficulty with breathing, chewing, swallowing, or talking
  • dizziness
  • double vision
  • drooping eyelids
  • drowsiness
  • eye discharge or excessive tearing
  • eye pain or sensitivity to light
  • fainting
  • headache, possibly severe
  • hives or welts
  • loss of appetite
  • mental depression
  • muscle weakness
  • pain, itching, burning, swelling, bleeding, or a lump under the skin where the needle was placed
  • painful or difficult urination
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sensation of pins and needles
  • severe tiredness
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain
  • swelling of the face, feet, or lower legs
  • swollen glands
  • trouble breathing
  • unusual bleeding or bruising
  • unusual weight gain
  • yellow eyes or skin
  • Anxiety
  • bloating
  • blue or pale skin
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • confusion
  • constipation
  • difficulty with moving
  • fast heartbeat
  • general feeling of discomfort or illness
  • increased blood pressure
  • increased thirst
  • lower back or side pain
  • muscle pain or stiffness
  • muscle weakness
  • pain or burning in the throat
  • pain, swelling, or redness in the joints
  • pains in the stomach or side, possibly radiating to the back
  • skin irritation or rash, including rash that looks like psoriasis
  • sores, welting, or blisters on the skin
  • stiff neck or back
Incidence not known
  • Back, leg, or stomach pains
  • bleeding gums
  • general body swelling
  • inability to move the arms and legs
  • nosebleeds
  • throbbing pain

For Healthcare Professionals

Applies to ipilimumab: intravenous solution


In general, the most commonly reported adverse effects occurring in 5% or more of patients included fatigue, diarrhea, pruritus, rash, and colitis. Approximately 10% of patients discontinued ipilimumab because of adverse reactions.


Cardiovascular side effects occurring in less than 1% of patients have included immune-mediated pericarditis, myocarditis, angiopathy, temporal arteritis, and vasculitis.


Dermatologic side effects have included pruritus (31%), rash (29%), urticaria (2%), and immune-mediated dermatitis (2%; including Stevens-Johnson syndrome and toxic epidermal necrolysis). Dermatologic side effects occurring in less than 1% of patients have included immune-mediated erythema multiforme and psoriasis.


Endocrine side effects have included immune-mediated endocrinopathy (4%), hypopituitarism (4%), hypothyroidism, and in less than 1% of patients, autoimmune thyroiditis, adrenal insufficiency, and hypogonadism.


Gastrointestinal side effects have included diarrhea (32%), colitis (8%), and immune-mediated enterocolitis (7%; including intestinal perforation). Gastrointestinal side effects occurring in less than 1% of patients have included large intestinal ulcer, esophagitis, and immune-mediated pancreatitis.

The incidence and severity of enterocolitis appears to be dose dependent.


Hematologic side effects have included immune-mediated eosinophilia (1%) and in less than 1% of patients, hemolytic anemia and leukocytoclastic vasculitis.


Hepatic side effects have included immune-mediated hepatitis (1%; including fatal hepatic failure and elevated transaminase and bilirubin levels).

The incidence and severity of hepatitis appears to be dose dependent.


Immunologic side effects have included severe and fatal immune-mediated reactions involving any organ system; most commonly enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Anti-ipilimumab antibodies have been detected in patients receiving ipilimumab.

Nervous system

Nervous system side effects have included immune-mediated neuropathy (1%) and in less than 1% of patients, meningitis.


Ocular side effects occurring in less than 1% of patients have included immune-mediated uveitis, iritis, conjunctivitis, blepharitis, episcleritis, and scleritis.


Other side effects have included fatigue (41%).


Renal side effects have included immune-mediated nephritis (1%). Renal side effects occurring in less than 1% of patients have included renal failure.


Respiratory side effects occurring in less than 1% of patients have included acute respiratory distress syndrome and immune-mediated pneumonitis.

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