Promacta

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

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
• 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

• 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

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 cramps or stiffness
• swollen joints

Less common

• Back pain
• belching
• bone pain
• dry mouth
• heartburn
• indigestion
• rash
• stomach discomfort, upset, or pain

Incidence not known

• Darkening of the skin

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