This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Promacta (Eltrombopag) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (598)
Death (185)
Life Threatening Events (38)
Disability (41)
Reports by Reaction Type
Death (78),
Drug Ineffective (59),
Platelet Count Decreased (41),
Thrombocytopenia (38),
Myelodysplastic Syndrome (28),
Platelet Count Increased (28),
Liver Disorder (23),
Fatigue (23),
Anaemia (22),
Pulmonary Embolism (19),
Nausea (18),
Headache (17)
Below are a few examples of reports where side effects / adverse reactions may be related to Promacta (Eltrombopag). For a complete list or a specific selection of reports, please use the links above.
Possible Promacta side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: male
Reactions: Myelofibrosis
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: Corticosteroid
Possible Promacta side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 79 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: male
Reactions: Pharyngeal Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in 79 year old female
Reported by a physician from United States on 2012-08-06
Patient: 79 year old female
Reactions: Cellulitis, Pain in Extremity, Oedema Peripheral, Gait Disturbance, Erythema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: Carvedilol; Prednisone; Levothyroxine Sodium; Hydrochlorothiazde TAB
Possible Promacta side effects in 80 year old male
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 80 year old male, weighing 73.6 kg (161.9 pounds)
Reactions: Contusion, Renal Impairment, Oedema Peripheral, Creatinine Renal Clearance Increased, Renal Cyst, Rash, Renal Failure Chronic
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: Foradil; Iron; Simvastatin; Doxazosin Mesylate; Avodart; Proventil; Omeprazole
Possible Promacta side effects in 77 year old male
Reported by a physician from United States on 2012-08-01
Patient: 77 year old male
Reactions: Death, Condition Aggravated, Autoimmune Thrombocytopenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in female
Reported by a health professional (non-physician/pharmacist) from Greece on 2012-08-01
Patient: female
Reactions: Pulmonary Embolism, Venous Thrombosis
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in 42 year old male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: 42 year old male
Reactions: Pancreatitis Acute, Haematemesis
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: Unspecified Medications
Possible Promacta side effects in
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-07-25
Patient:
Reactions: Haemorrhage Intracranial
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in 77 year old male
Reported by a consumer/non-health professional from United States on 2012-07-25
Patient: 77 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: NO Concurrent Medication
Possible Promacta side effects in male
Reported by a physician from Japan on 2012-07-25
Patient: male, weighing 53.0 kg (116.6 pounds)
Reactions: Anaemia, Cerebral Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Start date: 2011-07-28
End date: 2011-08-10
Promacta
Dosage: 25mg per day
Administration route: Oral
Start date: 2011-07-06
End date: 2011-07-27
Promacta
Dosage: 25mg per day
Administration route: Oral
Start date: 2011-08-11
End date: 2012-05-31
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-06-14
End date: 2011-07-05
Other drugs received by patient: Warfarin Sodium; Aspirin; Allopurinol; Amlodipine; Olmesartan Medoxomil; Almarl; Lansoprazole; Prednisolone; Furosemide; Zetia
Possible Promacta side effects in female
Reported by a pharmacist from Japan on 2012-07-24
Patient: female
Reactions: Cerebral Infarction, Altered State of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: Digoxin; Isosorbide Dinitrate (Isopit); Depakene; Cimetidine; Isosorbide Mononitrate
Possible Promacta side effects in female
Reported by a consumer/non-health professional from Canada on 2012-07-24
Patient: female, weighing 65.9 kg (145.0 pounds)
Reactions: Confusional State, Nasopharyngitis, Nausea, Headache, Amnesia, Tremor, Visual Impairment, Withdrawal Syndrome, Toothache
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in female
Reported by a pharmacist from Ireland on 2012-07-18
Patient: female
Reactions: Oesophageal Candidiasis, Chest Pain
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in female
Reported by a physician from Japan on 2012-07-17
Patient: female
Reactions: Platelet Aggregation, non-Hodgkin's Lymphoma Recurrent
Drug(s) suspected as cause:
Promacta
Dosage: 25mg per day
Administration route: Oral
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Possible Promacta side effects in male
Reported by a physician from Japan on 2012-07-17
Patient: male, weighing 11.0 kg (24.2 pounds)
Reactions: Neuroblastoma
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Start date: 2011-08-02
Promacta
Dosage: 6.25mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-05-31
End date: 2011-08-01
Other drugs received by patient: Prednisolone; Prednisolone; Prednisolone; Prednisolone; Prednisolone; Cyclophosphamide; Oncovin; Cisplatin; Mesna; Prednisolone; Prednisolone; Normal Human Immunoglobulin; Normal Human Immunoglobulin; Cyclophosphamide; Oncovin; Oncovin; Cisplatin; Cisplatin; Alkeran; Prednisolone; Prednisolone; Normal Human Immunoglobulin; Acyclovir; Mesna; Therarubicin; Therarubicin; Carboplatin; Cyclophosphamide; Cyclophosphamide; Mesna; Prednisolone; Prednisolone; Prednisolone; Firstcin; Omeprazole; Cisplatin; Sandostatin; Oncovin; Prednisolone; Prednisolone; Buprenorphine HCL; Sulfamethoxazole and Trimethoprim; Therarubicin; Prednisolone; Prednisolone; Midazolam HCL; Mesna; Therarubicin; Etoposide
Possible Promacta side effects in male
Reported by a physician from Japan on 2012-07-16
Patient: male
Reactions: Haemoglobin Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Promacta
Dosage: 50mg per day
Administration route: Oral
Start date: 2012-01-23
Promacta
Dosage: 37.5mg per day
Administration route: Oral
Start date: 2011-12-05
End date: 2012-01-22
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-10-17
End date: 2011-10-27
Promacta
Dosage: 25mg per day
Administration route: Oral
Start date: 2011-10-28
End date: 2011-12-04
Other drugs received by patient: Urso 250; Furosemide; Allopurinol
Possible Promacta side effects in female
Reported by a physician from Japan on 2012-07-16
Patient: female, weighing 61.0 kg (134.2 pounds)
Reactions: Haemolytic Anaemia
Drug(s) suspected as cause:
Promacta
Dosage: 37.5mg per day
Administration route: Oral
Start date: 2012-02-10
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-06-17
End date: 2011-10-30
Promacta
Dosage: 25mg per day
Administration route: Oral
Start date: 2011-10-31
End date: 2012-02-09
Other drugs received by patient: D-Alfa; Prednisolone; Cefotax; Mucosta; Prednisolone; Lorfenamin; Protecadin
Possible Promacta side effects in male
Reported by a physician from Japan on 2012-07-12
Patient: male
Reactions: Myelofibrosis
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in 90 year old male
Reported by a physician from Mexico on 2012-07-12
Patient: 90 year old male
Reactions: Splenomegaly
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in 54 year old female
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: 54 year old female
Reactions: Death, Haematemesis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in female
Reported by a physician from Japan on 2012-07-10
Patient: female
Reactions: Pneumocystis Jiroveci Pneumonia, Hypoxia, Blood Beta-D-Glucan Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2010-07-14
End date: 2010-09-08
Prednisolone
Indication: Product Used FOR Unknown Indication
Promacta
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Methotrexate; Prednisolone; Methotrexate; Prednisolone
Possible Promacta side effects in male
Reported by a physician from Japan on 2012-07-10
Patient: male, weighing 67.0 kg (147.4 pounds)
Reactions: Lymphoma
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Imuran
Dosage: 50mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 1998-11-27
End date: 2011-11-19
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-10-24
End date: 2011-11-26
Other drugs received by patient: Heavy Magnesium Oxide; Alendronate Sodium; Ketoprofen; Selbex; Digoxin; Prednisolone; Isodine Gargle
Possible Promacta side effects in female
Reported by a health professional (non-physician/pharmacist) from Romania on 2012-07-10
Patient: female
Reactions: Bone Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in 68 year old female
Reported by a physician from Belgium on 2012-07-10
Patient: 68 year old female
Reactions: Renal Failure, Blood Creatinine Increased
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-09
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Aphagia, Abdominal Pain, Hepatic Pain, Fatigue, Platelet Count Decreased, Loss of Consciousness
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: Furosemide; Fentanyl; Spironolactone; Morphine Sulfate; Doculase; Lactulose; Fluoxetine; Propranolol; Pancrease; Promethazine
Possible Promacta side effects in female
Reported by a pharmacist from Ireland on 2012-07-06
Patient: female
Reactions: Myocardial Infarction
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-05
Patient: 67 year old female
Reactions: Bone Marrow Reticulin Fibrosis, Anaemia
Drug(s) suspected as cause:
Promacta
Possible Promacta side effects in female
Reported by a physician from Japan on 2012-07-05
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Renal Impairment
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Promacta
Dosage: 25mg per day
Administration route: Oral
Start date: 2011-10-27
End date: 2011-12-15
Promacta
Dosage: 12.5mg per day
Administration route: Oral
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-09-25
End date: 2011-10-26
Other drugs received by patient: Ciprofloxacin HCL; Lansoprazole; Zosyn
Possible Promacta side effects in female
Reported by a physician from Brazil on 2012-07-05
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: Thrombosis, Platelet Count Increased, Vaginal Haemorrhage, Thrombocytosis, Platelet Count Decreased, Anal Haemorrhage, Blindness Transient, Thrombocytopenia, Rebound Effect, Epistaxis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Promacta
Other drugs received by patient: Corticosteroid; Cortisone Acetate
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