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Promacta (Eltrombopag) - Side Effect Reports to FDA

 
 



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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