Promacta Side Effects

Generic name: eltrombopag

Medically reviewed by Drugs.com. Last updated on Jan 21, 2024.

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

Applies to eltrombopag: oral powder for suspension, oral tablet.

Warning

Oral route (Powder for Suspension; Tablet)

Risk For Hepatic Decompensation In Patients With Chronic Hepatitis CRisk of HepatotoxicityIn 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. Monitor hepatic function and discontinue dosing as recommended.

Serious side effects of Promacta

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

Other side effects of Promacta

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
darkening of the skin
dry mouth
heartburn
indigestion
rash
stomach discomfort, upset, or pain

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, 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

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 (the active ingredient contained in Promacta) compared to placebo.^[Ref]

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^[Ref]

Hematologic

In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag (the active ingredient contained in Promacta) ^[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

Frequency not reported: Thrombotic microangiopathy^[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): 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^[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): 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^[Ref]

Nervous system

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^[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, 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^[Ref]