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Sprycel (Dasatinib) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sprycel (Dasatinib) 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 (1019)
Death (145)
Life Threatening Events (58)
Disability (16)

Reports by Reaction Type

Pleural Effusion (175)Headache (78)Death (77)Nausea (74)Diarrhoea (74)Neoplasm Malignant (71)Fatigue (64)Dyspnoea (51)Rash (51)Anaemia (47)Fluid Retention (36)Platelet Count Decreased (35)

Below are a few examples of reports where side effects / adverse reactions may be related to Sprycel (Dasatinib). For a complete list or a specific selection of reports, please use the links above.

Possible Sprycel side effects in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 43 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Everolimus

Sprycel
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2012-05-02

Tarceva

Votrient



Possible Sprycel side effects in 43 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 43 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Everolimus

Sprycel
    Administration route: Oral
    Indication: Neoplasm Malignant
    Start date: 2012-05-02

Tarceva

Votrient



Possible Sprycel side effects in 30 year old male

Reported by a consumer/non-health professional from India on 2012-08-24

Patient: 30 year old male

Reactions: Death, Drug Ineffective, Platelet Count Decreased, Nervous System Disorder, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Sprycel

Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-03-15
    End date: 2012-04-26



Possible Sprycel side effects in 75 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-24

Patient: 75 year old female

Reactions: Gastrointestinal Telangiectasia, Pleural Effusion, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Lasix



Possible Sprycel side effects in female

Reported by a pharmacist from United States on 2012-08-24

Patient: female

Reactions: Hypersensitivity

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 37 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient: 37 year old female

Reactions: Back Pain, Nasopharyngitis, Vomiting, Nausea, Splenomegaly

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Allopurinol



Possible Sprycel side effects in 85 year old female

Reported by a physician from United States on 2012-08-23

Patient: 85 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Dysgeusia, Hiatus Hernia, Atrial Fibrillation, Gastrointestinal Sounds Abnormal, Constipation, Cardiac Failure Congestive, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisone

Sprycel
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-14



Possible Sprycel side effects in 30 year old male

Reported by a consumer/non-health professional from India on 2012-08-22

Patient: 30 year old male

Reactions: Death, Drug Ineffective, Platelet Count Decreased, Nervous System Disorder, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Sprycel
    Dosage: unk

Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-03-15
    End date: 2012-04-26



Possible Sprycel side effects in 71 year old female

Reported by a consumer/non-health professional from Japan on 2012-08-22

Patient: 71 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Cardiac Failure, Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Predonine; Aldactone; Lasix; Famotidine



Possible Sprycel side effects in female

Reported by a pharmacist from United States on 2012-08-21

Patient: female

Reactions: Nausea, Bone Pain, Headache, Influenza Like Illness

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 51 year old female

Reactions: Nausea, Diarrhoea, Clostridium Difficile Colitis, Microangiopathic Haemolytic Anaemia, Muscular Weakness, Renal Failure Acute, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Campath
    Dosage: unk
    Start date: 2012-05-01

Campath
    Dosage: 100 mg, unknown/d
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23

Fludarabine Phosphate
    Dosage: 355 mg, total dose
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23

Fludarabine Phosphate
    Dosage: unk
    Start date: 2012-05-01

Melphalan Hydrochloride
    Dosage: 333 mg, total dose
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23

Melphalan Hydrochloride
    Dosage: unk
    Start date: 2012-05-02

Prograf
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Sprycel
    Dosage: unk
    Administration route: Oral
    Start date: 2012-04-26

Sprycel
    Dosage: unk
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-23



Possible Sprycel side effects in 69 year old male

Reported by a pharmacist from United States on 2012-08-20

Patient: 69 year old male, weighing 118.0 kg (259.6 pounds)

Reactions: Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 71 year old female, weighing 62.0 kg (136.4 pounds)

Reactions: Diarrhoea

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Hot Flush, Nausea, Pain in Extremity, Anaemia, Rash, Pyrexia

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 58 year old male

Reactions: Headache

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 78 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 78 year old male

Reactions: Pulmonary Hypertension, Joint Swelling, Diarrhoea, Depression

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Fluticasone Propionate; Allopurinol; Lasix



Possible Sprycel side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Headache

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 46 year old female, weighing 104.0 kg (228.8 pounds)

Reactions: Haemoglobin Decreased, Fluid Retention

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 38 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Menstrual Disorder, Haemoglobin Decreased, Nasopharyngitis, Haematocrit Decreased, Pain, Platelet Count Decreased

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Vitamin B-12



Possible Sprycel side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Memory Impairment

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Pleural Effusion

Drug(s) suspected as cause:
Nilotinib

Sprycel



Possible Sprycel side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 58 year old male

Reactions: Vomiting, Nausea, Constipation, Pericardial Effusion, Abdominal Discomfort, Weight Increased, Abdominal Distension, Pleural Effusion, Gastrooesophageal Reflux Disease, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Prevacid; Lasix; Potassium



Possible Sprycel side effects in

Reported by a physician from United States on 2012-08-17

Patient:

Reactions: Pulmonary Hypertension

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 67 year old female

Reactions: Dyspnoea, Malaise, Nausea, Pain, Chills, Chest Pain, Pyrexia

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 62 year old male, weighing 116.0 kg (255.2 pounds)

Reactions: Cough

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 69 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Depression

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Effexor; Ativan



Possible Sprycel side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Rash

Drug(s) suspected as cause:
Sprycel

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