Ipilimumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 27, 2025.

Applies to ipilimumab: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Colitis (inflammation of the colon) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while you are receiving this medicine.

Check with your doctor right away if you are having unusual weakness of the arms or legs, or a burning, numbness, tingling, or painful sensation in the arms, hands, legs, or feet. These could be symptoms of a serious nerve problem that can lead to paralysis.

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may increase the risk for other problems caused by the immune system, including pneumonitis (inflammation of the lungs), nephritis (kidney problem), or encephalitis (inflammation of the brain). Check with your doctor if you have chest pain, thickening of bronchial secretions, trouble breathing, bloody or cloudy urine, unusual tiredness or weakness, nausea, vomiting, unusual weight gain, swelling of the face, feet, or lower legs, confusion, irritability, headache, seizures, or stiff neck.

This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

Serious side effects of ipilimumab

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:

Other side effects of ipilimumab

Some side effects of ipilimumab 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:

For healthcare professionals

Applies to ipilimumab: intravenous solution.

General adverse events

The most common adverse reactions reported with this drug as a single agent were fatigue, diarrhea, pruritus, rash, decreased appetite, nausea, vomiting, abdominal pain, cough, headache, pyrexia, insomnia, weight loss, and colitis.

The most common adverse reactions reported with this drug in combination with nivolumab were fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia, headache, increased transaminases, hypothyroidism, constipation, decreased weight, and dizziness.

The most common adverse reactions with this drug in combination with nivolumab and platinum-doublet chemotherapy were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension (includes hypertension, increased blood pressure), hypotension, flushing, hematoma, venous thrombosis, thrombosis, hemorrhage, lymphedema, arrhythmia (including ventricular arrhythmia), atrial fibrillation, cardiac failure, hot flush, tachycardia
• Uncommon (0.1% to 1%): Myocarditis, bradycardia, vasculitis, angiopathy, peripheral ischemia, orthostatic hypotension
• Rare (0.01% to 0.1%): Cardiomyopathy, pericardial effusion (pericarditis), temporal arteritis, Raynaud's phenomenon
• Frequency not reported: Pericarditis, acute heart failure, shock, pericardial disorders (includes pericarditis, pericardial effusion, cardiac tamponade, Dressler's syndrome)

Dermatologic

• Very common (10% or more): Rash (includes pustular rash, dermatitis, acneiform dermatitis, allergic dermatitis, atopic dermatitis, bullous dermatitis, exfoliative dermatitis, psoriasiform dermatitis, drug eruption, exfoliative rash, erythematous rash, follicular rash, generalized rash, macular rash, maculopapular rash, morbilliform rash, papular rash, papulosquamous rash, pruritic rash, fixed-drug eruption, autoimmune dermatitis, contact dermatitis, granulomatous dermatitis, dyshidrotic eczema, eczema, nodular rash, rash, toxic skin eruption, acne, generalized exfoliative rash, keratoderma blenorrhagica, skin exfoliation, skin reaction, skin toxicity, Stevens-Johnson syndrome, urticaria, pemphigoid; up to 53%), pruritus (includes pruritus, generalized pruritus, allergic pruritus; up to 53%), immune-related skin adverse reactions (up to 42%), immune-mediated rash (up to 28%), dry skin (up to 11%), alopecia (up to 11%)
• Common (1% to 10%): Vitiligo, urticaria, erythema, night sweats, dermatitis, eczema, skin hypopigmentation, cellulitis, contusion, excoriation
• Uncommon (0.1% to 1%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, psoriasis, erythema multiforme, leukocytoclastic vasculitis, skin exfoliation, hair color changes
• Frequency not reported: Hypersensitivity vasculitis, palmar-plantar erythrodysesthesia syndrome, pemphigoid, erythema nodosum
• Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Endocrine

• Very common (10% or more): Increased thyroid stimulating hormone (TSH; up to 31%), immune-mediated endocrinopathies (up to 28%), hypothyroidism (includes autoimmune thyroiditis, increased blood TSH, hypothyroidism, primary hypothyroidism, thyroiditis, decreased free triiodothyronine [T3], autoimmune hypothyroidism; up to 20%), adrenal insufficiency (up to 18%), hyperthyroidism (includes decreased blood TSH, hyperthyroidism, increased free T3; up to 12%)
• Common (1% to 10%): Hypophysitis, thyroiditis, decreased blood corticotrophin, hypopituitarism (including hypophysitis), immune-related endocrine adverse reactions
• Uncommon (0.1% to 1%): Hypoparathyroidism, secondary adrenocortical insufficiency, hypogonadism, decreased blood cortisol, decreased blood testosterone
• Rare (0.01% to 0.1%): Hyperpituitarism, autoimmune thyroiditis, decreased blood TSH, decreased thyroxine, abnormal blood prolactin
• Frequency not reported: Decreased blood gonadotrophin, thyroid dysfunction

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 54%), nausea (up to 44%), increased lipase (up to 51%), increased amylase (up to 39%), vomiting (up to 31%), diarrhea/colitis (includes colitis, microscopic colitis, ulcerative colitis, diarrhea, enteritis, infectious enteritis, enterocolitis, infectious enterocolitis, viral enterocolitis; up to 31%), immune-mediated colitis (up to 31%), abdominal pain (includes upper abdominal pain, lower abdominal pain, abdominal discomfort, abdominal pain, abdominal tenderness, gastrointestinal pain; up to 30%), immune-related gastrointestinal adverse reactions (up to 28%), constipation (up to 21%), colitis (up to 16%), ascites (up to 14%), dry mouth (up to 12%), dyspepsia (up to 12%), dysphagia (up to 12%), stomatitis (including aphthous ulcer, mouth ulceration, mucosal inflammation; up to 11%)
• Common (1% to 10%): Pancreatitis, esophageal varices hemorrhage, gastrointestinal hemorrhage, retching, gastroenteritis, oral candidiasis, large intestine perforation, gastroesophageal reflux disease, mucosal inflammation, gastritis
• Uncommon (0.1% to 1%): Intestinal perforation, enterocolitis, autoimmune pancreatitis, infectious peritonitis, duodenitis, gastrointestinal perforation, peritonitis, diverticulitis, gastric ulcer, large intestinal ulcer, esophagitis, ileus
• Rare (0.01% to 0.1%): Proctitis

Genitourinary

• Common (1% to 10%): Urinary tract infection, hematuria
• Uncommon (0.1% to 1%): Amenorrhea, noninfective cystitis
• Rare (0.01% to 0.1%): Proteinuria

Hematologic

• Very common (10% or more): Anemia (includes hemolytic anemia, autoimmune anemia, iron-deficiency anemia, decreased hemoglobin; up to 70%), lymphopenia (up to 53%), neutropenia (up to 43%), leukopenia (up to 40%), thrombocytopenia (up to 34%), decreased hemoglobin (up to 25%)
• Common (1% to 10%): Cytopenias, eosinophilia, febrile neutropenia, lymphadenopathy
• Uncommon (0.1% to 1%): Hemolytic anemia
• Rare (0.01% to 0.1%): Polycythemia
• Frequency not reported: Aplastic anemia, lymphocytosis

Hepatic

• Very common (10% or more): Increased ALT (up to 66%), increased AST (up to 66%), increased bilirubin (up to 55%), hepatitis C virus (HCV) virologic breakthrough (up to 50%), hepatitis (includes increased ALT, increased AST, autoimmune hepatitis, increased blood bilirubin, increased hepatic enzyme, hepatic failure, abnormal hepatic function, hepatitis, hepatitis E, hepatocellular injury, hepatotoxicity, hyperbilirubinemia, immune-mediated hepatitis, abnormal liver function test, increased liver function test, increased transaminases; up to 21%), immune-mediated hepatitis (up to 15%), hepatitis B virus (HBV) virologic breakthrough (up to 14%)
• Common (1% to 10%): Abnormal hepatic function, hepatic events, infectious hepatitis, hepatic failure, hepatomegaly, jaundice, immune-related hepatic adverse reactions
• Uncommon (0.1% to 1%): Autoimmune hepatitis, increased GGT
• Frequency not reported: Hepatic toxicity, abnormal liver function test

In patients who received this drug with nivolumab for hepatocellular carcinoma, virologic breakthrough occurred in 4 of 28 (14%) patients and 2 of 4 (50%) patients with active HBV or HCV at baseline, respectively.

Hypersensitivity

• Very common (10% or more): Hypersensitivity/infusion reactions (up to 12%)
• Common (1% to 10%): Hypersensitivity, contrast media allergy, seasonal allergy
• Very rare (less than 0.01%): Anaphylactic reaction (shock)

Immunologic

• Very common (10% or more): Any immune-related adverse reactions (up to 60%)
• Common (1% to 10%): Positive for treatment-emergent binding antibodies against this drug, anti-drug antibodies, neutralizing antibodies against this drug
• Uncommon (0.1% to 1%): Sarcoidosis, positive antinuclear antibody
• Frequency not reported: Immune-related adverse reactions with fatal outcomes (includes gastrointestinal perforation, colitis, hepatic failure, toxic epidermal necrolysis, Guillain-Barre syndrome, multi-organ failure), cytokine release syndrome
• Postmarketing reports: Hemophagocytic lymphohistiocytosis, graft-versus-host disease, solid organ transplant rejection

This drug was most commonly associated with immune-related adverse reactions (i.e., adverse reactions resulting from increased/excessive immune activity). Most of these adverse reactions (including severe reactions) resolved after appropriate medical therapy was started or this drug was withdrawn; some immune-related adverse reactions were permanent (e.g., thyroid dysfunction, diabetes mellitus). Life-threatening or fatal immune-related adverse reactions that occurred with this drug (as monotherapy or in combination with nivolumab) have included colitis, intestinal perforation, hepatitis, pneumonitis, hypophysitis, adrenal insufficiency, toxic epidermal necrolysis, myocarditis, encephalitis, myasthenia gravis, and neuropathy.

Local

• Very common (10% or more): Injection site reaction (up to 50%)
• Common (1% to 10%): Vaccination site reaction

Metabolic

• Very common (10% or more): Hyperglycemia (up to 53%), hyponatremia (up to 49%), hypocalcemia (up to 47%), decreased appetite (up to 35%), hyperkalemia (up to 30%), hypomagnesemia (up to 29%), hypokalemia (up to 26%), hypercalcemia (up to 15%), hypoglycemia (up to 15.2%)
• Common (1% to 10%): Diabetes mellitus, dehydration, hypoalbuminemia, hypermagnesemia, hypernatremia, hypophosphatemia
• Uncommon (0.1% to 1%): Diabetic ketoacidosis, metabolic acidosis, tumor lysis syndrome
• Rare (0.01% to 0.1%): Alkalosis, type 1 diabetes mellitus (including diabetic ketoacidosis)

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, pain in extremity, spinal pain, flank pain, muscle spasms, musculoskeletal disorder, osteitis, musculoskeletal stiffness, noncardiac chest pain, arthralgia, arthritis, arthropathy, joint effusion, psoriatic arthropathy, synovitis, involuntary muscle contractions, muscle twitching, polymyalgia rheumatica; up to 41%), arthralgia (up to 23%)
• Common (1% to 10%): Increased blood creatine phosphokinase, myalgia, muscle spasms, arthritis, muscular weakness
• Uncommon (0.1% to 1%): Myopathy, Sjogren's syndrome, spondyloarthropathy, myositis (including polymyositis), necrotizing myositis, rhabdomyolysis, polymyalgia rheumatica
• Rare (0.01% to 0.1%): Polymyositis

Nervous system

• Very common (10% or more): Headache (up to 33%), dizziness (includes dizziness, vertigo, positional vertigo; up to 20%)
• Common (1% to 10%): Autoimmune neuropathy (including facial nerve paresis, abducens nerve paresis), lethargy, tremor, brain edema, cranial neuropathy, peripheral neuropathy, aphasia, immune-related neurological adverse reactions, peripheral sensory neuropathy
• Uncommon (0.1% to 1%): Guillain-Barre syndrome, polyneuropathy, neuritis, peroneal nerve palsy, encephalitis, ataxia, dysarthria, aseptic meningitis, myasthenia gravis, autoimmune central neuropathy (encephalitis), syncope, myoclonus
• Rare (0.01% to 0.1%): Meningism, neurosensory hypoacusis, myelitis
• Frequency not reported: Meningitis, demyelination, myasthenic syndrome/myasthenia gravis, nerve paresis, motor dysfunction, autoimmune encephalitis, myasthenia gravis-like syndrome

Ocular

• Common (1% to 10%): Blurred vision, conjunctivitis, uveitis, eye pain, dry eye
• Uncommon (0.1% to 1%): Episcleritis, vitreous hemorrhage, iritis, eye edema, blepharitis, reduced visual acuity, foreign body sensation in eyes
• Rare (0.01% to 0.1%): Scleritis, ocular myositis
• Frequency not reported: Vogt-Koyanagi-Harada-like syndrome, orbital myositis, retinal detachment
• Postmarketing reports: Serous retinal detachment, Vogt-Koyanagi-Harada syndrome

Oncologic

• Common (1% to 10%): Tumor pain, cancer pain
• Uncommon (0.1% to 1%): Paraneoplastic syndrome
• Frequency not reported: Histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis)

Other

• Very common (10% or more): Fatigue (includes asthenia, fatigue, malaise; up to 62%), increased alkaline phosphatase (up to 41%), pyrexia (includes pyrexia, tumor-associated fever; up to 40%), decreased weight (up to 32%), malaise (up to 18%), edema (includes peripheral edema, peripheral swelling, eyelid edema, face edema, generalized edema, localized edema, edema, periorbital edema; up to 17%), influenza-like illness (up to 14%), infusion-related reactions (up to 12%)
• Common (1% to 10%): Chills, chest pain, sepsis, asthenia, pain
• Uncommon (0.1% to 1%): Septic shock, multi-organ failure, systemic inflammatory response syndrome
• Frequency not reported: Infusion reaction

Psychiatric

• Very common (10% or more): Insomnia (up to 18%)
• Common (1% to 10%): Depression, anxiety, decreased libido, confusional state
• Uncommon (0.1% to 1%): Mental status change

Renal

• Very common (10% or more): Increased creatinine (up to 42.7%)
• Common (1% to 10%): Immune-mediated nephritis with renal dysfunction, acute kidney injury, renal failure, glomerulonephritis
• Uncommon (0.1% to 1%): Tubulointerstitial nephritis, autoimmune nephritis, renal tubular acidosis, nephritis
• Frequency not reported: Acute renal failure

Respiratory

• Very common (10% or more): Cough (includes cough, productive cough, upper-airway cough syndrome; up to 37%), dyspnea (includes dyspnea, exertional dyspnea, dyspnea at rest; up to 27%), upper respiratory tract infection (includes upper respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis; up to 23%), pneumonia (includes lower respiratory tract infection, bacterial lower respiratory tract infection, lung infection, pneumonia, adenoviral pneumonia, aspiration pneumonia, bacterial pneumonia, Klebsiella pneumonia, influenzal pneumonia, viral pneumonia, atypical pneumonia, organizing pneumonia, Pneumocystis jirovecii pneumonia, pseudomonal pneumonia; up to 14%)
• Common (1% to 10%): Immune-mediated pneumonitis, pneumonitis, aspiration pneumonia, pleural effusion, pulmonary embolism, respiratory failure, influenza, lower respiratory tract infection, oropharyngeal pain, wheezing, nasal disorder, sinus congestion, respiratory tract infection, bronchitis
• Uncommon (0.1% to 1%): Lung infiltration, acute respiratory distress syndrome, pulmonary edema, allergic rhinitis
• Frequency not reported: Massive hemoptysis (in the setting of thrombocytopenia), interstitial lung disease

See also:

Further information

Ipilimumab 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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