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

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 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 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 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

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.

Cardiovascular

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.

Hepatic

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

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.

Hematologic

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

In clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag.

Gastrointestinal

Very common (10% or more): Nausea, diarrhea
Common (1% to 10%): Vomiting, dry mouth, constipation, 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

Dermatologic

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

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Leukocyturia, nocturia, proteinuria, dysuria

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Immunologic

Very common (10% or more): Influenza-like illness
Common (1% to 10%): Influenza, oral herpes

Metabolic

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

Musculoskeletal

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

Nervous system

Very common (10% or more): Headache
Common (1% to 10%): Paresthesia, hepatic encephalopathy, dizziness, dysgeusia, disturbance in attention, 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.

Ocular

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

Oncologic

Common (1% to 10%): Malignant hepatic neoplasm
Uncommon (0.1% to 1%): Rectosigmoid cancer

Psychiatric

Very common (10% or more): Insomnia
Common (1% to 10%): Depression, anxiety, sleep disorder, confusional state, agitation
Uncommon (0.1% to 1%): Apathy, altered mood, tearfulness

Renal

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

Respiratory

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

Other

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

Local

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

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