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.
More frequent side effects include: cataract. See below for a comprehensive list of adverse effects.
Applies 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:
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:
Incidence not known
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.
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
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
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.
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
In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag.
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
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
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, leukocyturia, nocturia, proteinuria
Uncommon (0.1% to 1%): Hypersensitivity
Very common (10% or more): Influenza-like illness
Common (1% to 10%): Influenza, oral herpes
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
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
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
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,
Common (1% to 10%): Malignant hepatic neoplasm
Uncommon (0.1% to 1%): Rectosigmoid cancer
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
Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, increased urine pH, increased urine protein/creatinine ratio, lupus nephritis, renal failure
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
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
Common (1% to 10%): Injection site rash/pruritus, injection site reaction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Promacta (www.drugs.com/promacta.html).
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020