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Promacta Side Effects

Generic Name: eltrombopag

Note: This document contains side effect information about eltrombopag. Some of the dosage forms listed on this page may not apply to the brand name Promacta.

In Summary

More frequent 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 (the active ingredient contained in Promacta) 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


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]


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]


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]


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]


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]


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]


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


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


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


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]


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]


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]


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


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]


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


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]


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]


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


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

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.