Eltrombopag Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 19, 2024.

Applies to eltrombopag: oral powder for suspension, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (powder for suspension; tablet)

Risk For Hepatic Decompensation In Patients With Chronic Hepatitis CRisk of Hepatotoxicity. In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation.

Eltrombopag may increase the risk of severe and potentially life-threatening hepatotoxicity.

Monitor hepatic function and discontinue dosing as recommended.

Serious side effects of eltrombopag

Along with its needed effects, eltrombopag 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 immediately if any of the following side effects occur while taking eltrombopag:

More common side effects

• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• chills
• cough
• difficulty with breathing
• fever
• headache
• loss of voice
• pain in the chest, groin, or legs, especially the calves
• pale skin
• rapid weight gain
• runny nose
• severe, sudden headache
• slurred speech
• sore throat
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• tingling of the hands or feet
• troubled breathing with exertion
• unusual tiredness or weakness
• unusual weight gain or loss
• yellow eyes or skin

Less common side effects

• bladder pain
• blindness
• blurred or decreased vision
• bruising
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• diarrhea
• general feeling of discomfort or illness
• hoarseness
• joint pain
• lower back or side pain
• muscle aches and pains
• nausea
• pinpoint red spots on the skin
• redness of the eye
• shivering
• sweating
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• voice changes
• vomiting

Other side effects of eltrombopag

Some side effects of eltrombopag 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

• decreased appetite
• difficulty with moving
• hair loss or thinning of the hair
• itching skin
• lack or loss of strength
• muscle cramps or stiffness
• swollen joints

Less common side effects

• back pain
• belching
• bone pain
• darkening of the skin
• dry mouth
• heartburn
• indigestion
• rash
• stomach discomfort, upset, or pain

For healthcare professionals

Applies to eltrombopag: oral powder for reconstitution, oral tablet.

General adverse events

The most common side effects reported in ITP patients have included nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia, urinary tract infection, oropharyngeal pain, increased AST, pharyngitis, back pain, influenza, paresthesia, and rash.

The most common side effects reported in thrombocytopenic patients with chronic hepatitis C have included anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia, and peripheral edema.^[Ref]

Cardiovascular

• Common (1% to 10%): Deep vein thrombosis, edema, palpitations, prolonged QT interval on ECG, thrombotic/thromboembolic events
• Uncommon (0.1% to 1%): Acute myocardial infarction, cardiovascular disorder, chest pain, cyanosis, embolism, flushing, hematoma, hot flush, hypertension, sinus tachycardia, superficial thrombophlebitis, tachycardia^[Ref]

Hepatic

• Very common (10% or more): Total bilirubin greater than or equal to 1.5 times the upper limit of normal (ULN) (76%), ALT or AST greater than 3 x ULN with total bilirubin greater than 1.5 x ULN (44%), ALT or AST greater than 3 x ULN with total bilirubin greater than 2 x ULN (33%), ALT increased (32%), ALT common terminology criteria for adverse events (CTCAE) grade 3 increase (26%), AST increased (20%), blood bilirubin increased (20%), AST CTCAE grade 3 increase (15%), bilirubin CTCAE grade 3 increase (12%)
• Common (1% to 10%): Abnormal hepatic function, ascites, hepatic failure, hyperbilirubinemia, increased blood alkaline phosphatase, jaundice, portal vein thrombosis, drug-induced liver injury, CTCAE grade 4 increase, AST CTCAE grade 4 increase, bilirubin CTCAE grade 4 increase
• Uncommon (0.1% to 1%): Cholestasis, hepatic lesion, hepatitis^[Ref]

In clinical trials, hepatic decompensation (ascites, hepatic encephalopathy, variceal hemorrhage, spontaneous bacterial peritonitis) was reported more commonly in chronic HCV patients with cirrhosis treated with eltrombopag compared to placebo.^[Ref]

Hematologic

• Very common (10% or more): Anemia
• Common (1% to 10%): Decreased hemoglobin, decreased neutrophil count, decreased white blood cell count, hemolytic anemia, increased INR, lymphopenia, prolonged activated partial thromboplastin time
• Uncommon (0.1% to 1%): Anisocytosis, eosinophilia, increased hemoglobin, increased band neutrophil count, increased platelet cell counts, leukocytosis, myelocytosis, presence of myelocytes, thrombocytopenia
• Frequency not reported: Thrombotic microangiopathy^[Ref]

In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea, nausea
• Common (1% to 10%): Abdominal discomfort, abdominal distension, abdominal pain, aphthous stomatitis, constipation, dry mouth, dyspepsia, dysgeusia, esophageal varices hemorrhage, esophageal varices, gastritis, gastroenteritis,stomatitis, gastroesophageal reflux disease, hemorrhoids, toothache, upper abdominal pain, vomiting
• Uncommon (0.1% to 1%): Abdominal tenderness, discolored feces, flatulence, food poisoning, frequent bowel movements, gingival bleeding, glossodynia, hematemesis, hemorrhoids, mouth hemorrhage, oral discomfort^[Ref]

Dermatologic

• Very common (10% or more): Pruritus, rash, alopecia
• Common (1% to 10%): Dry skin, eczema, erythema, generalized pruritus, hyperhidrosis, night sweats, pruritic rash, skin lesion, skin discoloration including hyperpigmentation
• Uncommon (0.1% to 1%): Cold sweat, contusion, dermatosis, ecchymosis, inflammation of wound, melanosis, petechia, pigmentation disorder, skin exfoliation, swelling face, sunburn, urticaria^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Uncommon (0.1% to 1%): Dysuria, leukocyturia, nocturia, proteinuria^[Ref]

Hypersensitivity

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

Immunologic

• Very common (10% or more): Influenza-like illness
• Common (1% to 10%): Influenza, oral herpes^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite
• Common (1% to 10%): Abnormal loss of weight, decreased blood albumin, hyperglycemia, increased blood glucose
• Uncommon (0.1% to 10%): Gout, hypocalcemia, hypokalemia, increased appetite, increased blood albumin, increased blood uric acid, increased total protein, increased weight^[Ref]

Musculoskeletal

• Very common (10% or more): Pain in extremity, myalgia, muscle spasm, arthralgia
• Common (1% to 10%): Back pain, bone pain, musculoskeletal pain
• Uncommon (0.1% to 1%): Muscular weakness, sensation of heaviness^[Ref]

Nervous system

• Very common (10% or more): Headache, dizziness
• Common (1% to 10%): Hepatic encephalopathy, lethargy, memory impairment, paresthesia
• Uncommon (0.1% to 1%): Balance disorder, cerebral infarction, dysesthesia, hemiparesis, hypoesthesia, migraine, migraine with aura, peripheral neuropathy, peripheral sensory neuropathy, somnolence, speech disorder, toxic neuropathy, tremor, vascular headache^[Ref]

Ocular

• Very common (10% or more): Cataract developed or worsened (up to 11%)
• Common (1% to 10%): Dry eye, ocular icterus, retinal exudates, retinal hemorrhage
• Uncommon (0.1% to 1%): Abnormal visual acuity tests, astigmatism, blepharitis, blurred vision, conjunctival hemorrhage, cortical cataract, eye pain, increased lacrimation, keratoconjunctivitis sicca, lenticular opacities, retinal hemorrhage, retinal pigment epitheliopathy, reduced visual acuity, visual impairment,^[Ref]

Oncologic

• Common (1% to 10%): Malignant hepatic neoplasm
• Uncommon (0.1% to 1%): Rectosigmoid cancer^[Ref]

Psychiatric

• Very common (10% or more): Insomnia
• Common (1% to 10%): Agitation, anxiety, confusional state, depression, disturbance in attention, sleep disorder
• Uncommon (0.1% to 1%): Altered mood, apathy, tearfulness^[Ref]

Renal

• Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, increased urine pH, increased urine protein/creatinine ratio, lupus nephritis, renal failure^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 23%), upper respiratory tract infection (up to 17%), nasopharyngitis (up to 12%), rhinorrhea (up to 12%)
• Common (1% to 10%): Bronchitis, dyspnea, exertional dyspnea, oropharyngeal pain, pharyngitis, productive cough, pulmonary embolism, upper respiratory tract infection, rhinitis, oropharyngeal pain
• Uncommon (0.1% to 1%): Epistaxis, nasal discomfort, oropharyngeal blistering, pneumonia, pulmonary infarction, sinusitis, sinus disorder, sleep apnea syndrome, tonsillitis^[Ref]

Other

• Very common (10% or more): Asthenia, chills, fatigue, pyrexia, peripheral edema, clonal cytogenetic evolution, new cytogenetic abnormality, complex changes in chromosome 7
• Common (1% to 10%): Chest discomfort, irritability, malaise, non-cardiac chest pain, pain, loss of chromosome 7, chromosomal aberrations, deletion of chromosome 13
• Uncommon (0.1% to 1%): Ear pain, feeling hot, feeling jittery, ill-defined disorder, mucosal inflammation, pyrexia, sensation of foreign body, vertigo, vessel puncture site hemorrhage, features of dysplasia with hypercellularity concerning for potential development of myelodysplastic syndrome^[Ref]

Local

• Common (1% to 10%): Injection site rash/pruritus, injection site reaction^[Ref]

Further information

Eltrombopag 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.

Medical Disclaimer