Promacta Side Effects

Generic Name: eltrombopag

Note: This page contains side effects data for the generic drug eltrombopag. It is possible that some of the dosage forms included below may not apply to the brand name Promacta.

It is possible that some side effects of Promacta may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to eltrombopag: oral tablet

As well as its needed effects, eltrombopag (the active ingredient contained in Promacta) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking eltrombopag, check with your doctor immediately:

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 with sleeping
  • trouble with swallowing
  • voice changes
  • vomiting
Incidence not known
  • chest pain
  • pain, redness, or swelling in the legs or arms
  • shortness of breath

Some eltrombopag side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • Acid or sour stomach
  • back pain
  • belching
  • bone pain
  • dry mouth
  • heartburn
  • indigestion
  • rash
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to eltrombopag: 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%): Thrombotic/thromboembolic events, palpitations, edema, prolonged QT interval on ECG, deep vein thrombosis, peripheral edema
Uncommon (0.1% to 1%): Tachycardia, acute myocardial infarction, cardiovascular disorder, cyanosis, sinus tachycardia, hypertension, embolism, hot flush, superficial thrombophlebitis, flushing, hematoma, chest pain.[Ref]


Common (1% to 10%): Increased ALT or AST, hyperbilirubinemia, ascites, increased blood bilirubin levels, increased blood alkaline phosphatase, abnormal hepatic function, jaundice, portal vein thrombosis, hepatic failure
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 white blood cell count, decreased hemoglobin, decreased neutrophil count, increased INR, prolonged activated partial thromboplastin time, lymphopenia, hemolytic anemia
Uncommon (0.1% to 1%): Anisocytosis, eosinophilia, leukocytosis, myelocytosis, thrombocytopenia, increased hemoglobin, increased band neutrophil count, presence of myelocytes, increased platelet cell counts[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): Nausea, diarrhea
Common (1% to 10%): Vomiting, dry mouth, constipation, dysgeusia, upper abdominal pain, abdominal pain, dyspepsia, abdominal distension, toothache, stomatitis, gastroesophageal reflux disease, hemorrhoids, abdominal discomfort, gastritis, esophageal varices, aphthous stomatitis, esophageal varices hemorrhage, gastroenteritis
Uncommon (0.1% to 1%): Gingival bleeding, glossodynia, hemorrhoids, mouth hemorrhage, abdominal tenderness, discolored feces, flatulence, food poisoning, frequent bowel movements, hematemesis, oral discomfort[Ref]


Very common (10% or more): Alopecia, pruritus
Common (1% to 10%): Rash, generalized pruritus, night sweats, dry skin, eczema, pruritic rash, erythema, hyperhidrosis, skin lesion
Uncommon (0.1% to 1%): Ecchymosis, urticaria, dermatosis, petechia, cold sweat, melanosis, pigmentation disorder, skin discoloration, skin exfoliation, swelling face, inflammation of wound, contusion, sunburn[Ref]


Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Leukocyturia, nocturia, proteinuria, dysuria[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%): Hyperglycemia, increased blood glucose, abnormal loss of weight, decreased blood albumin
Uncommon (0.1% to 10%): Hypokalemia, increased appetite, gout, hypocalcemia, increased blood uric acid, increased blood albumin, increased total protein, increased weight[Ref]


Very common (10% or more): Myalgia
Common (1% to 10%): Back pain, musculoskeletal pain, arthralgia, muscle spasm, bone 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%): Paresthesia, hepatic encephalopathy, dizziness, lethargy, memory impairment
Uncommon (0.1% to 1%): Hypoesthesia, somnolence, migraine, migraine with aura, vascular headache, tremor, balance disorder, dysesthesia, hemiparesis, peripheral neuropathy, peripheral sensory neuropathy, speech disorder, toxic neuropathy, vertigo, cerebral infarction[Ref]


Common (1% to 10%): Cataract, dry eye, retinal exudates, ocular icterus, retinal hemorrhage
Uncommon (0.1% to 1%): Blurred vision, lenticular opacities, astigmatism, cortical cataract, conjunctival hemorrhage, eye pain, increased lacrimation, retinal hemorrhage, retinal pigment epitheliopathy, reduced visual acuity, visual impairment, abnormal visual acuity tests, blepharitis, keratoconjunctivitis sicca[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%): Depression, anxiety, sleep disorder, confusional state, agitation, disturbance in attention
Uncommon (0.1% to 1%): Apathy, altered mood, tearfulness[Ref]


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


Very common (10% or more): Cough
Common (1% to 10%): Upper respiratory tract infection, oropharyngeal pain, pharyngitis, bronchitis, nasopharyngitis, dyspnea, oropharyngeal pain, exertional dyspnea, productive cough, pulmonary embolism
Uncommon (0.1% to 1%): Pneumonia, sinusitis, tonsillitis, epistaxis, pulmonary infarction, nasal discomfort, oropharyngeal blistering, sinus disorder, sleep apnea syndrome[Ref]


Very common (10% or more): Fatigue, pyrexia, asthenia, chills
Common (1% to 10%): Irritability, pain, malaise, non-cardiac chest pain, chest discomfort
Uncommon (0.1% to 1%): Ear pain, feeling hot, vessel puncture site hemorrhage, feeling jittery, ill-defined disorder, pyrexia, sensation of foreign body, mucosal inflammation[Ref]


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


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

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