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Eltrombopag Side Effects

In Summary

More frequently reported side effects include: cataract. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to eltrombopag: oral powder for suspension, oral tablet

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

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chills or fever
  • cough
  • difficulty with breathing
  • headache
  • loss of voice
  • pale skin
  • rapid weight gain
  • runny nose
  • sore throat
  • 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

  • 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

Incidence Not Known

  • Chest pain
  • pain, redness, or swelling in the legs or arms

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

  • Decreased appetite
  • difficulty with moving
  • hair loss or thinning of the hair
  • itching skin
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • swollen joints

Less Common

For Healthcare Professionals

Applies to eltrombopag: oral powder for reconstitution, oral tablet

General

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, peripheral edema, 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

Common (1% to 10%): Abnormal hepatic function, ascites, hepatic failure, hyperbilirubinemia, increased ALT or AST, increased blood alkaline phosphatase, increased blood bilirubin levels, jaundice, portal vein thrombosis, drug-induced liver injury

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[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): Alopecia, pruritus

Common (1% to 10%): Dry skin, eczema, erythema, generalized pruritus, hyperhidrosis, night sweats, pruritic rash, rash, skin lesion

Uncommon (0.1% to 1%): Cold sweat, contusion, dermatosis, ecchymosis, inflammation of wound, melanosis, petechia, pigmentation disorder, skin discoloration, 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): Myalgia

Common (1% to 10%): Arthralgia, back pain, bone pain, muscle spasm, musculoskeletal pain, pain in extremity

Uncommon (0.1% to 1%): Muscular weakness, sensation of heaviness[Ref]

Nervous system

Very common (10% or more): Headache

Common (1% to 10%): Dizziness, 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

Common (1% to 10%): Chest discomfort, irritability, malaise, non-cardiac chest pain, pain

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[Ref]

Local

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

References

1. "Product Information. Promacta (eltrombopag)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

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.

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