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Vesanoid (Tretinoin Oral) - Retinoic Acid Syndrome - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Retinoic Acid Syndrome (8)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vesanoid (Tretinoin Oral) where reactions include retinoic acid syndrome. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Vesanoid side effects in male

Reported by a physician from Japan on 2012-08-09

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Retinoic Acid Syndrome, Pulmonary Congestion, Acute Promyelocytic Leukaemia

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Vesanoid
    Administration route: Oral
    Indication: Myelodysplastic Syndrome
    Start date: 2008-10-09
    End date: 2008-10-11

Vesanoid
    Administration route: Oral
    Start date: 2008-10-14
    End date: 2008-11-10

Other drugs received by patient: Cytarabine; Fragmin; Heparin Calcium; Maxipime; Idamycin; Itraconazole



Possible Vesanoid side effects in 65 year old female

Reported by a physician from Japan on 2012-07-26

Patient: 65 year old female

Reactions: Retinoic Acid Syndrome, Muscle Abscess, Oesophageal Stenosis

Drug(s) suspected as cause:
Vesanoid

Other drugs received by patient: Idamycin



Possible Vesanoid side effects in 62 year old male

Reported by a individual with unspecified qualification from Spain on 2012-06-13

Patient: 62 year old male

Reactions: Retinoic Acid Syndrome, Acute Respiratory Distress Syndrome, Leukocytosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vesanoid



Possible Vesanoid side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-18

Patient:

Reactions: Acute Promyelocytic Leukaemia Differentiation Syndrome, Haemorrhage, Pyrexia, Death, Retinoic Acid Syndrome, Renal Failure, Benign Intracranial Hypertension, Embolism, Neutropenia, Myocardial Infarction, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: induction therapy: on days 2, 4, 6 and 8.
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: course 1: days 1-4.
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: course 3: days 1-5

Idarubicin HCL
    Dosage: consolidation course 1: on days 1, 2, 3 and 4

Vesanoid
    Dosage: induction: until complete remission or for maximum 45 days.
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: consolidation therapy: course 3: on day 1

Mitoxantrone Hydrochloride
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Thioguanine
    Dosage: consolidation: course 3: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Other drugs received by patient: Prednisone



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from Italy on 2012-03-13

Patient:

Reactions: Acute Promyelocytic Leukaemia Differentiation Syndrome, Haemorrhage, Pyrexia, Death, Retinoic Acid Syndrome, Benign Intracranial Hypertension, Renal Failure, Embolism, Neutropenia, Myocardial Infarction, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Idarubicin HCL
    Dosage: consolidation therapy: course 3: on day 1

Cytarabine
    Dosage: consolidation: course 3: days 1-5

Vesanoid
    Dosage: induction: until complete remission or for maximum 45 days.
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Mitoxantrone Hydrochloride
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: induction therapy: on days 2, 4, 6 and 8.
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: consolidation course 1: on days 1, 2, 3 and 4

Etoposide
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: course 1: days 1-4.
    Indication: Acute Promyelocytic Leukaemia

Thioguanine
    Dosage: consolidation: course 3: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Other drugs received by patient: Prednisone



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from United States on 2012-03-08

Patient:

Reactions: Retinoic Acid Syndrome, Myelodysplastic Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from India on 2011-10-31

Patient:

Reactions: Retinoic Acid Syndrome, Febrile Neutropenia

Drug(s) suspected as cause:
Vesanoid
    Indication: Acute Promyelocytic Leukaemia

Daunorubicin Hydrochloride
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Indication: Acute Promyelocytic Leukaemia



Possible Vesanoid side effects in 62 year old male

Reported by a physician from Japan on 2011-10-14

Patient: 62 year old male

Reactions: Pulmonary Haemorrhage, Retinoic Acid Syndrome, Disseminated Intravascular Coagulation, Gastric Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid

Other drugs received by patient: Daunorubicin HCL; Cytarabine

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