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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 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 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 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 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 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 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 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 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 29 year old male

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

Patient: 29 year old male

Reactions: Drug Intolerance

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: Malaise

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 67 year old male

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

Patient: 67 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Abdominal Pain, Pruritus, Nausea, Pain, Headache, Fatigue, Diarrhoea, Decreased Appetite

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 52 year old male

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

Patient: 52 year old male

Reactions: Back Pain, Nausea, Dizziness, 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 84.0 kg (184.8 pounds)

Reactions: Confusional State, Fatigue, Headache, Tremor

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Metformin Hydrochloride; Glipizide



Possible Sprycel side effects in male

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

Patient: male

Reactions: Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 70 year old female

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

Patient: 70 year old female

Reactions: Adverse Event

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 40 year old male

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

Patient: 40 year old male

Reactions: Musculoskeletal Pain

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in female

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

Patient: female

Reactions: Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 74 year old male

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

Patient: 74 year old male

Reactions: Anaemia, Bone Marrow Failure, Rash

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 85 year old female

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

Patient: 85 year old female

Reactions: Nausea, Feeling Hot, Feeling Cold, Decreased Appetite

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 50 year old female

Reactions: Fibromyalgia, Bone Pain

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: Gastrointestinal Haemorrhage

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 85 year old female

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

Patient: 85 year old female, weighing 74.0 kg (162.8 pounds)

Reactions: Vomiting, Diarrhoea, Nausea, Hypophagia, Chills, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: 01-mar-2012 interrupted for 3 days and finally taken off.
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-01-25
    End date: 2012-03-01

Sprycel
    Dosage: 26-feb-2012:dose reduced to 70mg; from 01mar12, interpt for 3 days; restart from 08mar12 50mg od.
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-01-25



Possible Sprycel side effects in 64 year old male

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

Patient: 64 year old male

Reactions: Myalgia, Pruritus, Joint Swelling, Rash

Drug(s) suspected as cause:
Sprycel

Other drugs received by patient: Simvastatin



Possible Sprycel side effects in 82 year old male

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

Patient: 82 year old male

Reactions: Cardiac Disorder, Fluid Retention

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: Pancytopenia

Drug(s) suspected as cause:
Sprycel



Possible Sprycel side effects in 49 year old male

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

Patient: 49 year old male

Reactions: Dyspnoea, Pancytopenia

Drug(s) suspected as cause:
Sprycel
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-02-08

Sprycel
    Administration route: Oral
    Indication: Chromosome Analysis Abnormal
    Start date: 2011-02-08

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