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Eltrombopag Side Effects

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Common Eltrombopag Side Effects


The most commonly reported Eltrombopag side effects (click to view or check a box to report):

Asthenia (25)
Dyspnoea (22)
Ascites (19)
Pyrexia (16)
Oedema Peripheral (16)
Febrile Neutropenia (16)
Abdominal Pain (14)
Cataract (13)
Chest Pain (13)
Portal Vein Thrombosis (13)
Abdominal Distension (13)
Thrombocytopenia (12)
Platelet Count Decreased (11)
Pain In Extremity (10)
Vomiting (10)
Nausea (10)
Pancytopenia (10)
Visual Acuity Reduced (10)
Deep Vein Thrombosis (10)
Dehydration (8)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Eltrombopag Side Effects Reported to FDA



Eltrombopag Side Effect Report#9915969
Intracardiac Thrombus, Thrombocytopenia, Dyspnoea, Pulmonary Artery Thrombosis
This is a report of a 26-year-old female patient (weight: NA) from TR, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura,menorrhagia, who was treated with Eltrombopag (dosage: NA, start time: NS), combined with:
  • Oral Contraceptive Nos
  • Danazol
  • Vincristine
and developed a serious reaction and side effect(s): Intracardiac Thrombus, Thrombocytopenia, Dyspnoea, Pulmonary Artery Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Eltrombopag treatment in female patients, resulting in Intracardiac Thrombus side effect. The patient was hospitalized.
Eltrombopag Side Effect Report#9882354
Colitis
This report suggests a potential Eltrombopag Colitis side effect(s) that can have serious consequences. A 36-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: aplastic anaemia and used Eltrombopag (dosage: NA) starting
Jul 09, 2013. After starting Eltrombopag the patient began experiencing various side effects, including: ColitisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Eltrombopag demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Colitis, may still occur.
Eltrombopag Side Effect Report#9800276
Syncope
This Syncope problem was reported by a physician from IT. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome,neuropathy peripheral. On
Jun 04, 2013 this consumer started treatment with Eltrombopag (dosage: 300mg Per Day). The following drugs were being taken at the same time:
  • Gabapentin
When using Eltrombopag, the patient experienced the following unwanted symptoms/side effects: SyncopeThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Syncope, may become evident only after a product is in use by the general population.
Eltrombopag Side Effect Report#9758360
Atrial Fibrillation, Weight Increased
This Atrial Fibrillation side effect was reported by a physician from US. A 42-year-old male patient (weight:NA) experienced the following symptoms/conditions: aplastic anaemia.The patient was prescribed Eltrombopag (drug dosage: NA), which was initiated on
Nov 08, 2013. Concurrently used drugs: NA..After starting to take Eltrombopag the consumer reported adverse symptoms, such as: Atrial Fibrillation, Weight IncreasedThese side effects may potentially be related to Eltrombopag. The patient was hospitalized.
Eltrombopag Side Effect Report#9756096
Haemoglobin Decreased
This is a report of a 79-year-old male patient (weight: NA) from IL, suffering from the following health symptoms/conditions: thrombocytopenia, who was treated with Eltrombopag (dosage: NA, start time:
Oct 13, 2013), combined with: NA. and developed a serious reaction and side effect(s): Haemoglobin Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Eltrombopag treatment in male patients, resulting in Haemoglobin Decreased side effect. The patient was hospitalized.
Eltrombopag Side Effect Report#9744059
Dyspnoea, Pulmonary Embolism
This report suggests a potential Eltrombopag Dyspnoea side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from IL was diagnosed with the following symptoms/conditions: thrombocytopenia and used Eltrombopag (dosage: NA) starting
May 10, 2013. After starting Eltrombopag the patient began experiencing various side effects, including: Dyspnoea, Pulmonary EmbolismAdditional drugs used concurrently:
  • Prednison
  • Telfast
  • Zovirax
  • Cardiloc
  • Losec
  • Magnesium
  • Resprin
The patient was hospitalized. Although Eltrombopag demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dyspnoea, may still occur.
Eltrombopag Side Effect Report#9722887
Acute Coronary Syndrome, Troponin Increased, Atrial Fibrillation
This Acute Coronary Syndrome problem was reported by a health professional from US. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: aplastic anaemia. On
Nov 18, 2013 this consumer started treatment with Eltrombopag (dosage: NA). The following drugs were being taken at the same time: NA. When using Eltrombopag, the patient experienced the following unwanted symptoms/side effects: Acute Coronary Syndrome, Troponin Increased, Atrial FibrillationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Acute Coronary Syndrome, may become evident only after a product is in use by the general population.
Eltrombopag Side Effect Report#9698587
Rash, Lip Swelling, Mouth Ulceration, Purpura, Rash Erythematous, Platelet Count Decreased, Withdrawal Syndrome
This Rash side effect was reported by a physician from GB. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura.The patient was prescribed Eltrombopag (drug dosage: NA), which was initiated on
Oct 18, 2013. Concurrently used drugs:
  • Prednisolone Acetate
  • Romiplostim
  • Ferrous Fumarate
  • Thyroxine
  • Omeprazole
  • Tranexamic Acid
  • Calcium + Vitamin D3
  • Nystatin
.After starting to take Eltrombopag the consumer reported adverse symptoms, such as: Rash, Lip Swelling, Mouth Ulceration, Purpura, Rash Erythematous, Platelet Count Decreased, Withdrawal SyndromeThese side effects may potentially be related to Eltrombopag.
Eltrombopag Side Effect Report#9688982
Blood Hiv Rna Increased
This is a report of a 18-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Eltrombopag (dosage: 50mg Per Day, start time: NS), combined with:
  • Prednisolone
  • Ivig
and developed a serious reaction and side effect(s): Blood Hiv Rna Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Eltrombopag treatment in male patients, resulting in Blood Hiv Rna Increased side effect.
Eltrombopag Side Effect Report#9686565
Abdominal Discomfort, Asthenia, Nausea, Malaise, Decreased Appetite, Pyrexia
This report suggests a potential Eltrombopag Abdominal Discomfort side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: aplastic anaemia and used Eltrombopag (dosage: NA) starting
Feb 19, 2010. After starting Eltrombopag the patient began experiencing various side effects, including: Abdominal Discomfort, Asthenia, Nausea, Malaise, Decreased Appetite, PyrexiaAdditional drugs used concurrently:
  • Exjade
  • Reglan
The patient was hospitalized. Although Eltrombopag demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Discomfort, may still occur.
Eltrombopag Side Effect Report#9649290
Bone Pain
This Bone Pain problem was reported by a physician from IE. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: thrombocytopenia. On
May 28, 2013 this consumer started treatment with Eltrombopag (dosage: NA). The following drugs were being taken at the same time: NA. When using Eltrombopag, the patient experienced the following unwanted symptoms/side effects: Bone PainThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bone Pain, may become evident only after a product is in use by the general population.
Eltrombopag Side Effect Report#9614622
Fall, Upper Limb Fracture
This Fall side effect was reported by a health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura.The patient was prescribed Eltrombopag (drug dosage: NA), which was initiated on
Apr 18, 2013. Concurrently used drugs:
  • Prednisone 15 Mg
  • Prednisone 10 Mg
.After starting to take Eltrombopag the consumer reported adverse symptoms, such as: Fall, Upper Limb FractureThese side effects may potentially be related to Eltrombopag. The patient was hospitalized.
Eltrombopag Side Effect Report#9611033
Pneumonitis, Haemorrhage Intracranial
This is a report of a 75-year-old male patient (weight: NA) from IL, suffering from the following health symptoms/conditions: thrombocytopenia, who was treated with Eltrombopag (dosage: NA, start time:
Jun 27, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pneumonitis, Haemorrhage Intracranial after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Eltrombopag treatment in male patients, resulting in Pneumonitis side effect. The patient was hospitalized.
Eltrombopag Side Effect Report#9575266
Lower Respiratory Tract Infection, Sepsis
This report suggests a potential Eltrombopag Lower Respiratory Tract Infection side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from IE was diagnosed with the following symptoms/conditions: thrombocytopenia and used Eltrombopag (dosage: NA) starting
Dec 17, 2012. After starting Eltrombopag the patient began experiencing various side effects, including: Lower Respiratory Tract Infection, SepsisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Eltrombopag demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lower Respiratory Tract Infection, may still occur.
Eltrombopag Side Effect Report#9565820
Febrile Neutropenia
This Febrile Neutropenia problem was reported by a physician from KR. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: thrombocytopenia,acute myeloid leukaemia. On
Sep 07, 2013 this consumer started treatment with Eltrombopag (dosage: 100g Per Day). The following drugs were being taken at the same time:
  • Cytarabine (100mgm2 Cyclic)
  • Daunorubicin (60mgm2 Cyclic)
When using Eltrombopag, the patient experienced the following unwanted symptoms/side effects: Febrile NeutropeniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Febrile Neutropenia, may become evident only after a product is in use by the general population.
Eltrombopag Side Effect Report#9501472
Dyspnoea, Troponin Increased, Oxygen Saturation Decreased, Streptococcal Infection, Pneumonitis
This Dyspnoea side effect was reported by a physician from IT. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: thrombocytopenia.The patient was prescribed Eltrombopag (drug dosage: 50mg Per Day), which was initiated on
Aug 07, 2013. Concurrently used drugs: NA..After starting to take Eltrombopag the consumer reported adverse symptoms, such as: Dyspnoea, Troponin Increased, Oxygen Saturation Decreased, Streptococcal Infection, PneumonitisThese side effects may potentially be related to Eltrombopag. The patient was hospitalized.
Eltrombopag Side Effect Report#9458909
Haematuria
This is a report of a 23-year-old female patient (weight: NA) from TW, suffering from the following health symptoms/conditions: NA, who was treated with Eltrombopag (dosage: 25mg Per Day, start time:
Jun 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Haematuria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Eltrombopag treatment in female patients, resulting in Haematuria side effect. The patient was hospitalized.
Eltrombopag Side Effect Report#9454538
Dermatitis Contact
This report suggests a potential Eltrombopag Dermatitis Contact side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from TW was diagnosed with the following symptoms/conditions: NA and used Eltrombopag (dosage: 25mg Per Day) starting
Jun 20, 2013. After starting Eltrombopag the patient began experiencing various side effects, including: Dermatitis ContactAdditional drugs used concurrently: NA.The patient was hospitalized. Although Eltrombopag demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dermatitis Contact, may still occur.
Eltrombopag Side Effect Report#9454504
Upper Gastrointestinal Haemorrhage, Faeces Discoloured, Asthenia, Off Label Use, Gastritis Erosive
This Upper Gastrointestinal Haemorrhage problem was reported by a consumer or non-health professional from PE. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome. On
Jul 15, 2013 this consumer started treatment with Eltrombopag (dosage: 25mg Per Day). The following drugs were being taken at the same time: NA. When using Eltrombopag, the patient experienced the following unwanted symptoms/side effects: Upper Gastrointestinal Haemorrhage, Faeces Discoloured, Asthenia, Off Label Use, Gastritis ErosiveAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Upper Gastrointestinal Haemorrhage, may become evident only after a product is in use by the general population.
Eltrombopag Side Effect Report#9435478
Renal Failure Acute
This Renal Failure Acute side effect was reported by a physician from IL. A 85-year-old male patient (weight:NA) experienced the following symptoms/conditions: thrombocytopenia.The patient was prescribed Eltrombopag (drug dosage: NA), which was initiated on
Jun 11, 2013. Concurrently used drugs: NA..After starting to take Eltrombopag the consumer reported adverse symptoms, such as: Renal Failure AcuteThese side effects may potentially be related to Eltrombopag. The patient was hospitalized.
Eltrombopag Side Effect Report#9422187
Portal Vein Thrombosis, Renal Vein Thrombosis, Deep Vein Thrombosis, Gastrointestinal Disorder
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Eltrombopag (dosage: NA, start time:
Aug 24, 2011), combined with:
  • Prednisone
and developed a serious reaction and side effect(s): Portal Vein Thrombosis, Renal Vein Thrombosis, Deep Vein Thrombosis, Gastrointestinal Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Eltrombopag treatment in male patients, resulting in Portal Vein Thrombosis side effect. The patient was hospitalized.
Eltrombopag Side Effect Report#9410392
Mesenteric Vein Thrombosis, Portal Vein Thrombosis, Splenic Vein Thrombosis, Splenomegaly, Pancytopenia
This report suggests a potential Eltrombopag Mesenteric Vein Thrombosis side effect(s) that can have serious consequences. A 45-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hepatitis c and used Eltrombopag (dosage: 25mg Per Day) starting
Nov 05, 2012. After starting Eltrombopag the patient began experiencing various side effects, including: Mesenteric Vein Thrombosis, Portal Vein Thrombosis, Splenic Vein Thrombosis, Splenomegaly, PancytopeniaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Eltrombopag demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mesenteric Vein Thrombosis, may still occur.
Eltrombopag Side Effect Report#9401008
Febrile Neutropenia
This Febrile Neutropenia problem was reported by a physician from AU. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome. On
Apr 25, 2013 this consumer started treatment with Eltrombopag (dosage: 100mg Per Day). The following drugs were being taken at the same time:
  • Azacitidine (75mgm2 Cyclic)
  • Teicoplanin (800mg Per Day)
When using Eltrombopag, the patient experienced the following unwanted symptoms/side effects: Febrile NeutropeniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Febrile Neutropenia, may become evident only after a product is in use by the general population.
Eltrombopag Side Effect Report#9395886
Cerebral Haemorrhage, Neutropenic Sepsis, Aphasia, Petechiae
This Cerebral Haemorrhage side effect was reported by a consumer or non-health professional from GB. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura,diabetes mellitus.The patient was prescribed Eltrombopag (drug dosage: NA), which was initiated on
Apr 02, 2013. Concurrently used drugs:
  • Metformin (1g Twice Per Day)
  • Glicazide (80mg Twice Per Day)
  • Novomix (36u Per Day)
  • Filgrastim (300mcg Weekly)
.After starting to take Eltrombopag the consumer reported adverse symptoms, such as: Cerebral Haemorrhage, Neutropenic Sepsis, Aphasia, PetechiaeThese side effects may potentially be related to Eltrombopag. The patient was hospitalized.
Eltrombopag Side Effect Report#9308359
Haemorrhage, Platelet Count Decreased, Cushingoid, Petechiae
This is a report of a 48-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: idiopathic thrombocytopenic purpura, who was treated with Eltrombopag (dosage: NA, start time: 201011), combined with:
  • Prednisolone
  • Hydrocortisone
  • Ivig
  • Tranexamic Acid
  • Rituximab
and developed a serious reaction and side effect(s): Haemorrhage, Platelet Count Decreased, Cushingoid, Petechiae after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Eltrombopag treatment in male patients, resulting in Haemorrhage side effect.


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The appearance of Eltrombopag on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Eltrombopag Side Effects for Women?

Women Side EffectsReports
Asthenia 13
Ascites 12
Dyspnoea 12
Oedema Peripheral 10
Pyrexia 10
Abdominal Distension 9
Abdominal Pain 9
Cataract 8
Chest Pain 7
Febrile Neutropenia 7

What are common Eltrombopag Side Effects for Men?

Men Side EffectsReports
Asthenia 12
Portal Vein Thrombosis 11
Dyspnoea 10
Febrile Neutropenia 9
Coma 8
Pain In Extremity 8
Thrombocytopenia 8
Ascites 7
Chest Pain 6
Deep Vein Thrombosis 6

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Why Your Notes are Important

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  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Eltrombopag reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Eltrombopag Safety Alerts, Active Ingredients, Usage Information

    More About Eltrombopag

    Side Effects reported to FDA: 320

    Eltrombopag safety alerts: 2010

    Reported deaths: 40

    Reported hospitalizations: 225

    Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease

    Audience: Hematology healthcare professionals

    [Posted 05/12/2010] GlaxoSmithKline and FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated with eltrombopag, a thrombopoietin receptor agonist approved for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura. The ELEVATE study, a randomized, double-blind, placebo-controlled, multinational study was terminated following the identification of an imbalance of thrombosis of the portal venous system in the patients treated with eltrombopag versus matching placebo. Six patients (4%) in the eltrombopag group and one (1%) in the placebo group experienced a thrombotic event of the portal venous system. Five of the six patients treated with eltrombopag experienced the portal venous thrombosis at platelet counts above 200,000/μL. GSK has communicated this safety finding to clinical trial investigators and regulatory agencies. GSK is working with regulatory agencies to include this safety information in the label.

    Action required by Health Care Professionals:

    • Health Care Professionals are reminded that Promacta is indicated for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease.
    • Treatment with Promacta should be aimed at increasing the platelet count to a level that reduces the risk of bleeding; Promacta should not be used in an attempt to normalize the platelet count.
    • Use caution when administering Promacta to patients with known risk factors for thromboembolism.
    • Exercise caution when administering Promacta to patients with hepatic disease. Use a lower starting dose (25mg once daily) of Promacta in patients with moderate to severe hepatic disease and monitor closely.

    [05/04/2010 - Dear Healthcare Professional Letter - GSK] 

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