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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 SummaryMore frequent side effects include: cataract. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to eltrombopag: oral tablet
Oral route (Powder for Suspension; Tablet)
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; hepatic function should be monitored and therapy discontinued if necessary.
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
Less common
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
Less common
Incidence not known
For Healthcare Professionals
Applies to eltrombopag: oral powder for reconstitution, oral tablet
GeneralThe 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.
CardiovascularCommon (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
HepaticVery 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
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.
HematologicVery 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
In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag.
GastrointestinalVery 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
DermatologicVery 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
GenitourinaryCommon (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, leukocyturia, nocturia, proteinuria
HypersensitivityUncommon (0.1% to 1%): Hypersensitivity
ImmunologicVery common (10% or more): Influenza-like illness
Common (1% to 10%): Influenza, oral herpes
MetabolicVery 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
MusculoskeletalVery 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
Nervous systemVery 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
OcularVery 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,
OncologicCommon (1% to 10%): Malignant hepatic neoplasm
Uncommon (0.1% to 1%): Rectosigmoid cancer
PsychiatricVery 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
RenalUncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, increased urine pH, increased urine protein/creatinine ratio, lupus nephritis, renal failure
RespiratoryVery 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
OtherVery 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
LocalCommon (1% to 10%): Injection site rash/pruritus, injection site reaction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Promacta (www.drugs.com/promacta.html).
August 4, 2022
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