Ipilimumab Side Effects

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:

• 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

• 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
• 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
• 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 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

• Back, leg, or stomach pains
• bleeding gums
• general body swelling
• inability to move the arms and legs
• nosebleeds
• throbbing pain

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:

• Headache
• trouble sleeping
• weight loss

For Healthcare Professionals

Applies to ipilimumab: intravenous solution

General

The most common side effects were diarrhea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite, abdominal pain, and colitis.^[Ref]

Immunologic

Common (1% to 10%): Sepsis, oral candidiasis, cellulitis, contrast media allergy, seasonal allergy
Uncommon (0.1% to 1%): Septic shock, cytokine release syndrome, positive antinuclear antibody
Rare (less than 0.1%): Sarcoidosis^[Ref]

Hepatic

Common (1% to 10%): Infectious hepatitis, increased blood bilirubin, increased alanine aminotransferase, increased aspartate aminotransferase, abnormal hepatic function, hepatic failure, hepatomegaly, jaundice
Uncommon (0.1% to 1%): Autoimmune hepatitis, increased gamma-glutamyltransferase^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, flushing, hypertension, hematoma, venous thrombosis, hemorrhage, lymphedema, hot flush
Uncommon (0.1% to 1%): Orthostatic hypotension, pericardial effusion
Rare (less than 0.1%): Myocarditis, cardiomyopathy, angiopathy, peripheral ischemia, vasculitis, temporal arteritis, Raynaud's phenomenon^[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 33%), rash (up to 30%)
Common (1% to 10%): Erythema, vitiligo, alopecia, dry skin, night sweats, dermatitis, urticaria, eczema, skin hypopigmentation, contusion, excoriation
Uncommon (0.1% to 1%): Toxic epidermal necrolysis, leukocytoclastic vasculitis, skin exfoliation, erythema multiforme, psoriasis, palmar-plantar erythrodysesthesia syndrome, erythema nodosum, hair color changes^[Ref]

Endocrine

Common (1% to 10%): Decreased blood corticotrophin, hypopituitarism (including hypophysitis), hypothyroidism, adrenal insufficiency, hyperthyroidism
Uncommon (0.1% to 1%): Increased blood thyroid stimulating hormone, decreased blood cortisol, decreased blood testosterone, hypogonadism, thyroiditis, hypoparathyroidism, decreased blood thyroid stimulating hormone, decreased blood gonadotrophin, decreased thyroxin, abnormal blood prolactin, hypocalcemia
Rare (less than 0.1%): Secondary adrenocortical insufficiency, hyperpituitarism, autoimmune thyroiditis^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 38%), vomiting (up to 24%), abdominal pain (up to 23%), nausea
Common (1% to 10%): Colitis, gastrointestinal hemorrhage, constipation, gastroesophageal reflux disease, stomatitis, dysphagia, retching, gastroenteritis, increased lipase, large intestine perforation, proctitis
Uncommon (0.1% to 1%): Increased blood amylase, gastrointestinal perforation, large intestinal ulcer, esophagitis, ileus, diverticulitis, gastric ulcer, enterocolitis, pancreatitis, peritonitis^[Ref]

Hematologic

Common (1% to 10%): Lymphoadenopathy, eosinophilia, neutropenia, thrombocytopenia, anemia, lymphopenia
Uncommon (0.1% to 1%): Hemolytic anemia, leucopenia, lymphocytosis
Rare (less than 0.1%): Polycythemia^[Ref]

Nervous system

Very common (10% or more): Headache (up to 15%)
Common (1% to 10%): Lethargy, tremor, brain edema, cranial neuropathy, peripheral sensory neuropathy, aphasia, dizziness
Uncommon (0.1% to 1%): Guillain-Barré syndrome, meningitis (aseptic), syncope, ataxia, tremor, myoclonus, dysarthria, myasthenia gravis-like syndrome
Rare (less than 0.1%): Meninginism, autoimmune central neuropathy (encephalitis), neurosensory hypoacusis^[Ref]

Ocular

Common (1% to 10%): Blurred vision, conjunctivitis, uveitis, eye pain, dry eye
Uncommon (0.1% to 1%): Vitreous hemorrhage, iritis, reduced visual acuity, foreign body sensation in eyes, blepharitis
Rare (less than 0.1%): Episcleritis, scleritis, eye edema, ocular myositis^[Ref]

Other

Very common (10% or more): Fatigue (up to 42%), pyrexia (up to 13%)
Common (1% to 10%): Chest pain, chills, asthenia, edema, pain, influenza-like illness
Uncommon (0.1% to 1%): Multi-organ failure, infusion related reaction, systemic inflammatory response syndrome, mucosal inflammation^[Ref]

Renal

Common (1% to 10%): Renal failure, hematuria, increased blood creatinine
Uncommon (0.1% to 1%): Glomerulonephritis, renal tubular acidosis, urinary tract infection
Rare (less than 0.1%) Autoimmune nephritis, proteinuria^[Ref]

Respiratory

Very common (10% or more): Cough (up to 17%)
Common (1% to 10%): Upper respiratory tract infection, lower respiratory tract infection, oropharyngeal pain, wheezing, nasal disorder, sinus, congestion, dyspnea
Uncommon (0.1% to 1%): Respiratory failure, acute respiratory distress syndrome, lung infiltration, pulmonary edema, pneumonitis, allergic rhinitis^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Amenorrhea^[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity^[Ref]

Local

Very common (10% or more): Injection site reaction (up to 50%)
Common (1% to 10%): Vaccination site reaction^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 27%)
Common (1% to 10%): Hypokalemia, hypoglycemia, hypoalbuminemia, hyponatremia, decreased weight, dehydration
Uncommon (0.1% to 1%): Alkalosis, hypophosphatemia, tumor lysis syndrome
Rare (less than 0.1%): Tumor lysis syndrome^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, muscle spasms.
Uncommon (0.1% to 1%): Arthralgia, musculoskeletal pain, arthritis.
Rare (less than 0.1%): Polymyalgia rheumatica, myositis, polymyositis.^[Ref]

Oncologic

Common (1% to 10%): Tumor pain, cancer pain
Frequency not reported: Paraneoplastic syndrome^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 12%)
Common (1% to 10%): Depression, anxiety, decreased libido, confusional state
Uncommon (0.1% to 1%): Mental status changes^[Ref]

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.

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