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Targretin (Bexarotene) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Targretin (Bexarotene) 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 (28)
Death (8)
Disability (2)

Reports by Reaction Type

Dehydration (7)Lung Infection (3)Anaemia (3)Febrile Neutropenia (3)Haematochezia (3)Abdominal Pain (2)Tinnitus (2)Coagulopathy (2)Deafness (2)Renal Failure Acute (2)Cardiac Failure Congestive (2)General Physical Health Deterioration (2)

Possible Targretin side effects in 69 year old male

Reported by a physician from Switzerland on 2012-08-27

Patient: 69 year old male

Reactions: Mucosal Inflammation, Agranulocytosis, Glomerular Filtration Rate Decreased, Skin Lesion, Toxic Epidermal Necrolysis, Pancytopenia, Melaena, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mefenamic Acid
    Dosage: as necessary
    Administration route: Oral
    Indication: Pain
    Start date: 2012-07-05
    End date: 2012-07-22

Methotrexate
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-18

Doxorubicin HCL
    Dosage: total cumulates dose 880mg
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-05

Mefenamic Acid
    Dosage: as necessary
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2012-07-05
    End date: 2012-07-22

Targretin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Aspirin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-22

Novalgine
    Dosage: as necessary
    Administration route: Oral
    Indication: Pain
    Start date: 2012-07-05
    End date: 2012-07-22

Methotrexate
    Start date: 2012-07-11

Novalgine
    Dosage: as necessary
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2012-07-05
    End date: 2012-07-22

Other drugs received by patient: Hydrocortisone; Acetaminophen; Fenofibrate; Levothyroxine Sodium; Metformin HCL; Carvedilol



Possible Targretin side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-22

Patient: 65 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Vomiting, Psychomotor Retardation, Flatulence, General Physical Health Deterioration, Blood Chloride Increased, Disorientation, Hypernatraemia, Haemoconcentration, Hypercalcaemia, Cachexia, Dehydration, Protein Total Increased, Haemoglobin Increased, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Targretin
    Indication: Mycosis Fungoides
    Start date: 2009-11-01
    End date: 2011-12-05

Emend
    Administration route: Oral
    Indication: Vomiting
    Start date: 2011-09-01

Roferon-A
    Dosage: miu
    Indication: Mycosis Fungoides
    Start date: 2010-11-01

Other drugs received by patient: Nutritional Supplements; Levothyroxine Sodium; Xerial 50; Amitriptyline Hydrochloride; Lexomil



Possible Targretin side effects in male

Reported by a physician from France on 2012-05-25

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Aphthous Stomatitis, Tinnitus, Deafness, Vertigo

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Targretin

Other drugs received by patient: Levothyroxine Sodium; Valsartan; Fenofibrate



Possible Targretin side effects in female

Reported by a pharmacist from United States on 2012-05-23

Patient: female

Reactions: Abdominal Pain Lower, Blood Urine Present, Decreased Appetite

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in male

Reported by a physician from Italy on 2012-04-24

Patient: male

Reactions: Skin Exfoliation, Fibrin D Dimer Increased, Pain, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in 66 year old female

Reported by a physician from France on 2012-04-12

Patient: 66 year old female

Reactions: Pneumonia Cryptococcal

Drug(s) suspected as cause:
Alemtuzumab
    Dosage: unknown
    Start date: 2010-07-01
    End date: 2010-07-01

Targretin
    Dosage: unknown
    Administration route: Oral
    Start date: 2006-01-01

Chlorambucil
    Dosage: unknown
    Start date: 2006-01-01

Methotrexate
    Dosage: unknown
    Start date: 2006-01-01

Alemtuzumab
    Dosage: unknown
    Start date: 2011-04-01
    End date: 2011-04-01

Interferon
    Dosage: unknown
    Start date: 2006-01-01

Alemtuzumab
    Dosage: unknown
    Start date: 2009-03-01
    End date: 2009-03-01



Possible Targretin side effects in 67 year old male

Reported by a physician from France on 2012-03-21

Patient: 67 year old male

Reactions: Tinnitus, Vertigo, Deafness

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in male

Reported by a physician from France on 2012-03-12

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Apathy, Dyspepsia, Acne, Hypothyroidism, Depression, Asthenia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Targretin
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2011-09-10
    End date: 2012-01-23

Targretin
    Administration route: Oral
    Start date: 2012-01-24



Possible Targretin side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in male

Reported by a physician from United States on 2012-01-31

Patient: male, weighing 67.0 kg (147.4 pounds)

Reactions: Neoplasm Malignant, Anaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Targretin

Other drugs received by patient: Simvastatin; Fish OIL; Tricor; Iron



Possible Targretin side effects in 83 year old female

Reported by a physician from Germany on 2012-01-30

Patient: 83 year old female

Reactions: Cardiac Failure

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-27

Patient: 65 year old male

Reactions: Dehydration

Adverse event resulted in: death

Drug(s) suspected as cause:
Targretin
    Indication: Mycosis Fungoides
    Start date: 2009-11-01
    End date: 2011-12-05

Interferon Alfa
    Dosage: miu
    Indication: Mycosis Fungoides
    Start date: 2010-11-01

Emend
    Indication: Vomiting
    Start date: 2011-09-01

Other drugs received by patient: Levothyroxine Sodium; Amitriptyline HCL; Lexomil; Xerial 50



Possible Targretin side effects in 83 year old female

Reported by a individual with unspecified qualification from Germany on 2012-01-25

Patient: 83 year old female

Reactions: Cardiac Failure

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in male

Reported by a physician from Germany on 2012-01-09

Patient: male

Reactions: Delirium

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin
    Administration route: Oral

Targretin
    Administration route: Oral
    Start date: 2008-01-01

Targretin
    Administration route: Oral
    Start date: 2005-02-01
    End date: 2008-01-01

Other drugs received by patient: Amlodipine; Ramipril; Pantoprazole; Maprotiline; Metoclopramide



Possible Targretin side effects in male

Reported by a physician from France on 2012-01-06

Patient: male, weighing 43.0 kg (94.6 pounds)

Reactions: Dehydration

Adverse event resulted in: death

Drug(s) suspected as cause:
Targretin
    Administration route: Oral
    Start date: 2011-11-01
    End date: 2011-12-05

Roferon-A
    Dosage: 300 mui
    Start date: 2011-11-01

Emend
    Indication: Vomiting
    Start date: 2011-09-01

Other drugs received by patient: Dexeryl; Amitriptyline HCL; Lexomil; Levothyroxine Sodium; Xerial 50



Possible Targretin side effects in male

Reported by a physician from France on 2012-01-06

Patient: male, weighing 43.0 kg (94.6 pounds)

Reactions: Dehydration

Adverse event resulted in: death

Drug(s) suspected as cause:
Interferon Alfa
    Indication: Mycosis Fungoides
    Start date: 2010-11-01
    End date: 2011-12-05

Emend
    Indication: Vomiting
    Start date: 2011-09-01
    End date: 2011-11-18

Targretin
    Indication: Mycosis Fungoides
    Start date: 2009-11-01
    End date: 2011-12-05

Other drugs received by patient: Levothyroxine Sodium; Amitriptyline HCL; Dexeryl (France); Lexomil; Xerial (France)



Possible Targretin side effects in male

Reported by a physician from France on 2012-01-05

Patient: male, weighing 43.0 kg (94.6 pounds)

Reactions: Dehydration

Adverse event resulted in: death

Drug(s) suspected as cause:
Interferon Alfa
    Indication: Mycosis Fungoides

Emend
    Indication: Vomiting

Targretin
    Indication: Mycosis Fungoides
    End date: 2011-12-05

Other drugs received by patient: Lexomil; Dexeryl (France); Levothyroxine Sodium; Amitriptyline HCL; Xerial (France)



Possible Targretin side effects in 79 year old male

Reported by a physician from United States on 2011-12-20

Patient: 79 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Lung Infection, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin
    Administration route: Oral
    Start date: 2011-11-12

Decitabine
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-11-14
    End date: 2011-11-18

Other drugs received by patient: Coreg; Multi-Vitamin; Allopurinol; Lovaza; Lisinopril; Zocor



Possible Targretin side effects in female

Reported by a physician from France on 2011-12-05

Patient: female

Reactions: Anaemia, Coagulopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicnu
    Dosage: unknown
    Indication: Mycosis Fungoides
    Start date: 2011-03-01
    End date: 2011-06-01

Targretin
    Dosage: unknown
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2011-01-01
    End date: 2011-01-01

Other drugs received by patient: Fluticasone Propionate; Tiotropium; Clopidogrel; Folic Acid; Albuterol Sulfate Autohaler; FER; Betamethasone Cream; Dexeryl; Almitrine; Atorvastatin; Levothyroxine Sodium; Lyrica; Zolpidem; Trimeprazine TAB; Gluconate DE Zinc; Acetaminophen



Possible Targretin side effects in male

Reported by a physician from United States on 2011-12-02

Patient: male, weighing 105.0 kg (231.0 pounds)

Reactions: Haematochezia, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin
    Administration route: Oral
    Start date: 2011-08-10
    End date: 2011-09-06

Targretin
    Administration route: Oral
    Start date: 2011-10-05

Targretin
    Administration route: Oral
    Start date: 2011-09-22
    End date: 2011-10-04



Possible Targretin side effects in 69 year old female

Reported by a physician from France on 2011-12-02

Patient: 69 year old female

Reactions: Haematochezia, Dermatitis Atopic, Neoplasm Malignant, Anaemia, Coagulopathy, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carmustine
    Dosage: september to october 2007 stopped for atopic eczema march to june 2011,diluted at 10%
    Indication: Mycosis Fungoides
    Start date: 2011-03-01
    End date: 2011-06-01

Targretin
    Dosage: september 2008 for 3 months (also stopped due to inefficiency and dyslipidemia)
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2011-01-01
    End date: 2011-07-27

Other drugs received by patient: Trimeprazine Tartrate; Vectarion; Speciafoldine; Ferrous Sulfate TAB; Diprosone; Zolpidem; Atorvastatin Calcium; Acetaminophen; Dexeryl; Plavix; Fluticasone Propionate / Salmeterol; Spiriva; Rubozinc; Anafranil; Levothyroxine Sodium; Lyrica; Ventolin; Fenofibrate



Possible Targretin side effects in 78 year old male

Reported by a physician from United States on 2011-11-14

Patient: 78 year old male, weighing 99.0 kg (217.8 pounds)

Reactions: Lung Infection, Sepsis, Febrile Neutropenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Decitabine
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-08-17
    End date: 2011-10-14

Targretin
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-08-15
    End date: 2011-10-14

Other drugs received by patient: Amitriptyline HCL; Amoxicillin; Fenofibrate; Prilosec; Furosemide; Valaciclovir; Fluconazole; Lipitor; Atenolol; Levothyroxine Sodium; Celebrex; Cipro; Hydromorphone HCL; Hydrochlorothiazide



Possible Targretin side effects in 71 year old male

Reported by a individual with unspecified qualification on 2011-11-07

Patient: 71 year old male

Reactions: Exostosis

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in male

Reported by a physician from United States on 2011-11-04

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Abdominal Pain, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in 78 year old male

Reported by a physician from United States on 2011-11-01

Patient: 78 year old male, weighing 97.0 kg (213.4 pounds)

Reactions: Lung Infection, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-08-15
    End date: 2011-10-14

Decitabine
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-08-17
    End date: 2011-10-14

Other drugs received by patient: Fluconazole; Atenolol; Celebrex; Prilosec; Hydromorphone HCL; Fenofibrate; Levothyroxine Sodium; Ciprofloxacin; Valaciclovir; Lipitor; Amoxicillin; Amitriptyline HCL; Furosemide; Hydrochlorothiazide



Possible Targretin side effects in male

Reported by a physician from United States on 2011-10-24

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Abdominal Pain, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin



Possible Targretin side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-14

Patient: female, weighing 81.0 kg (178.2 pounds)

Reactions: Drug Ineffective, Oedema Peripheral, Erythema, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin
    Administration route: Oral

Targretin
    Administration route: Oral
    Indication: Mycosis Fungoides

Targretin
    Administration route: Oral
    Start date: 2011-01-28

Other drugs received by patient: Xerial 10; Lipanthyl 160



Possible Targretin side effects in male

Reported by a physician from United States on 2011-10-10

Patient: male, weighing 105.0 kg (231.0 pounds)

Reactions: Haematochezia, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Targretin
    Administration route: Oral
    Start date: 2011-09-22

Targretin
    Administration route: Oral
    Start date: 2011-08-10
    End date: 2011-09-06

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