Voltaren (Diclofenac) - Adverse Event Reports - All Cases - Aspartate Aminotransferase Increased

Adverse event in 77 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Finland on 2007-10-22

Patient: 77 year old female

Adverse reactions / side effects: Blood Alkaline Phosphatase Increased, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Cholestasis, Hepatic Enzyme Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Optinate; Calcichew; Magnesium Sulfate

Adverse event in 75 year old female receiving Voltaren (Diclofenac)

Reported by a health professional (non-physician/pharmacist) from Japan on 2007-10-16

Patient: 75 year old female, weighing 49.0 kg (107.8 pounds)

Adverse reactions / side effects: Hypoventilation, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Anaphylactic Shock, Hypoaesthesia, Hypoxic Encephalopathy, Heart Rate Decreased, Gamma-Glutamyltransferase Increased, Blood Potassium Decreased, Aspartate Aminotransferase Increased, Nuclear Magnetic Resonance Imaging Abnormal, Blood Sodium Increased, Blood Pressure Immeasurable, Altered State of Consciousness

Adverse event resulted in: life threatening event

Suspect drug(s):
Voltaren (Diclofenac)

Adverse event in 23 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-07-20

Patient: 23 year old female, weighing 47.0 kg (103.4 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Hepatitis C Antibody Positive, Nausea, Hepatitis C, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Biopsy Liver Abnormal, Liver Disorder, Discomfort, Malaise, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Flank Pain
    Start date: 2007-05-31
    End date: 2007-05-31

Strocain
    Dosage: unk, unk
    Administration route: Oral
    Indication: Flank Pain
    Start date: 2007-06-01
    End date: 2007-06-01

Marzulene
    Dosage: unk, unk
    Administration route: Oral
    Indication: Nausea
    Start date: 2007-06-01
    End date: 2007-06-01

Adverse event in 23 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-07-20

Patient: 23 year old female, weighing 47.0 kg (103.4 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Hepatitis C Antibody Positive, Nausea, Hepatitis C, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Biopsy Liver Abnormal, Liver Disorder, Discomfort, Malaise, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Flank Pain
    Start date: 2007-05-31
    End date: 2007-05-31

Strocain
    Dosage: unk, unk
    Administration route: Oral
    Indication: Flank Pain
    Start date: 2007-06-01
    End date: 2007-06-01

Marzulene
    Dosage: unk, unk
    Administration route: Oral
    Indication: Nausea
    Start date: 2007-06-01
    End date: 2007-06-01

Adverse event in 20 year old male receiving Voltaren (Diclofenac)

Reported by a health professional (non-physician/pharmacist) from Japan on 2007-07-16

Patient: 20 year old male, weighing 55.0 kg (121.0 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Drug Eruption, Disseminated Intravascular Coagulation, Pyrexia, Haematocrit Decreased, RED Blood Cell Count Decreased, Gamma-Glutamyltransferase Increased, Dermatitis Bullous, Blood Creatinine Increased, Melaena, Blister, Stevens-Johnson Syndrome, White Blood Cell Count Increased, Blood Pressure Increased, Pneumonia, Histiocytosis Haematophagic, Blood Urea Increased, Alanine Aminotransferase Increased, Life Support, Pulmonary Haemorrhage, Mucosal Erosion, Haemoglobin Decreased, Aspartate Aminotransferase Increased, Platelet Count Decreased, Skin Erosion

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Voltaren
    Dosage: unk, unk
    Administration route: Oral
    Indication: Pyrexia

Voltaren
    Dosage: 25 mg/day
    Start date: 2007-03-22
    End date: 2007-03-29

Loxoprofen
    Dosage: 60 mg/day
    Administration route: Oral
    Indication: Headache
    Start date: 2007-03-28
    End date: 2007-04-03

Meropen
    Dosage: 1.5 g/day
    Indication: Infection
    Start date: 2007-03-23
    End date: 2007-03-28

Other drugs received by patient: Minocycline HCL; Rocephin; Zyvox; Amikacin; Funguard

Adverse event in 61 year old female receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Japan on 2007-07-16

Patient: 61 year old female, weighing 59.0 kg (129.8 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Drug Eruption, Thoracic Cavity Drainage, Disseminated Intravascular Coagulation, Pyrexia, Erythema, Laboratory Test Abnormal, Gamma-Glutamyltransferase Increased, C-Reactive Protein Increased, Pleural Effusion, Blood Creatinine Increased, Lymphocyte Count Decreased, Oxygen Saturation Decreased, White Blood Cell Count Increased, Blood Urea Increased, Dyspnoea, Neutrophil Count Increased, Monocyte Count Decreased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Urine Output Decreased, Lymphocyte Stimulation Test Positive, Rash Macular, Haemoglobin Decreased, Renal Failure, Aspartate Aminotransferase Increased, Oliguria, Platelet Count Decreased, Lung Infiltration

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Voltaren
    Dosage: 37.5 mg/day
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2005-11-09
    End date: 2005-11-10

Loxonin
    Dosage: 60 mg, tid
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2005-11-10
    End date: 2005-11-13

Dacarbazine
    Dosage: 180 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-12

Nidran
    Dosage: 100 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-08

Oncovin
    Dosage: 1 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-08

Feron
    Dosage: 3000000 iu/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-12

Other drugs received by patient: Norvasc; Towamin; Lipitor; Voglibose

Adverse event in 20 year old male receiving Voltaren (Diclofenac)

Reported by a health professional (non-physician/pharmacist) from Japan on 2007-07-16

Patient: 20 year old male, weighing 55.0 kg (121.0 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Drug Eruption, Disseminated Intravascular Coagulation, Pyrexia, Haematocrit Decreased, RED Blood Cell Count Decreased, Gamma-Glutamyltransferase Increased, Dermatitis Bullous, Blood Creatinine Increased, Melaena, Blister, Stevens-Johnson Syndrome, White Blood Cell Count Increased, Blood Pressure Increased, Pneumonia, Histiocytosis Haematophagic, Blood Urea Increased, Alanine Aminotransferase Increased, Life Support, Pulmonary Haemorrhage, Mucosal Erosion, Haemoglobin Decreased, Aspartate Aminotransferase Increased, Platelet Count Decreased, Skin Erosion

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Voltaren
    Dosage: unk, unk
    Administration route: Oral
    Indication: Pyrexia

Voltaren
    Dosage: 25 mg/day
    Start date: 2007-03-22
    End date: 2007-03-29

Loxoprofen
    Dosage: 60 mg/day
    Administration route: Oral
    Indication: Headache
    Start date: 2007-03-28
    End date: 2007-04-03

Meropen
    Dosage: 1.5 g/day
    Indication: Infection
    Start date: 2007-03-23
    End date: 2007-03-28

Other drugs received by patient: Minocycline HCL; Rocephin; Zyvox; Amikacin; Funguard

Adverse event in 70 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-07-13

Patient: 70 year old female, weighing 36.0 kg (79.2 pounds)

Adverse reactions / side effects: Hyperhidrosis, Cardiac Massage, Blood Creatinine Increased, White Blood Cell Count Increased, Metabolic Acidosis, Urine Output Decreased, Blood Lactate Dehydrogenase Increased, Hypotension, Haemodialysis, Respiratory Rate Decreased, Heart Rate Decreased, Aspartate Aminotransferase Increased, Depressed Level of Consciousness, Intubation, Anaphylactic Shock, Pallor, Haematocrit Decreased, RED Blood Cell Count Decreased, Tachypnoea, Oxygen Supplementation, Hepatitis Fulminant, Oxygen Saturation Decreased, Blood Urea Increased, Mydriasis, Alanine Aminotransferase Increased, Drug Hypersensitivity, Life Support, Hepatic Enzyme Increased, Haemoglobin Decreased, Blood Glucose Decreased, Catheterisation Cardiac, Feeling Abnormal, Electrocardiogram ST Segment Elevation

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Loxonin; Pentagin; Aspirin; Ticlopidine HCL; Sigmart; Lansoprazole; Artist; Ferromia

Adverse event in 70 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-07-13

Patient: 70 year old female, weighing 36.0 kg (79.2 pounds)

Adverse reactions / side effects: Hyperhidrosis, Cardiac Massage, Blood Creatinine Increased, White Blood Cell Count Increased, Metabolic Acidosis, Blood Lactate Dehydrogenase Increased, Hypotension, Urine Output Decreased, Haemodialysis, Respiratory Rate Decreased, Heart Rate Decreased, Aspartate Aminotransferase Increased, Depressed Level of Consciousness, Anaphylactic Shock, Pallor, Haematocrit Decreased, RED Blood Cell Count Decreased, Tachypnoea, Oxygen Supplementation, Hepatitis Fulminant, Oxygen Saturation Decreased, Blood Urea Increased, Mydriasis, Drug Hypersensitivity, Alanine Aminotransferase Increased, Life Support, Hepatic Enzyme Increased, Haemoglobin Decreased, Blood Glucose Decreased, Catheterisation Cardiac, Feeling Abnormal, Electrocardiogram ST Segment Elevation

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Loxonin; Pentagin; Aspirin; Ticlopidine HCL; Sigmart; Lansoprazole; Artist; Ferromia

Adverse event in 23 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-07-06

Patient: 23 year old female, weighing 47.0 kg (103.4 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Hepatitis C Antibody Positive, Nausea, Hepatitis C, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Biopsy Liver Abnormal, Liver Disorder, Discomfort, Malaise, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Flank Pain
    Start date: 2007-05-31
    End date: 2007-05-31

Strocain
    Dosage: unk, unk
    Administration route: Oral
    Indication: Flank Pain
    Start date: 2007-06-01
    End date: 2007-06-01

Marzulene
    Dosage: unk, unk
    Administration route: Oral
    Indication: Nausea
    Start date: 2007-06-01
    End date: 2007-06-01

Adverse event in 70 year old male receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Japan on 2007-07-02

Patient: 70 year old male, weighing 60.0 kg (132.0 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Productive Cough, Pruritus, Erythema Annulare, Pyrexia, Dermatitis, C-Reactive Protein Increased, White Blood Cell Count Increased, Pleurisy, Blood Lactate Dehydrogenase Increased, LIP Ulceration, Staphylococcal Infection, Cerebral Infarction, Aspartate Aminotransferase Increased, Insomnia, Depressed Level of Consciousness, Platelet Count Decreased, Hemiplegia, Drug Eruption, Oculomucocutaneous Syndrome, Post Procedural Complication, Culture Urine Positive, Liver Disorder, Lung Neoplasm Malignant, Pleural Effusion, White Blood Cell Count Decreased, Intercostal Neuralgia, Alanine Aminotransferase Increased, Haemorrhoids, Muscular Weakness, Rash, LIP Pain, Haematochezia, Agranulocytosis, Sepsis, Sputum Retention, Cardiac Arrest, Shock, Infection

Adverse event resulted in: death

Suspect drug(s):
Voltaren
    Dosage: 25 mg/day
    Indication: Wound Complication
    Start date: 2006-08-24
    End date: 2006-08-24

Voltaren
    Dosage: 25 mg/day
    Start date: 2006-09-04
    End date: 2006-09-23

Voltaren
    Dosage: 50 mg/day
    Start date: 2006-09-17
    End date: 2006-09-17

Voltaren
    Dosage: 50 mg/day
    Start date: 2006-09-20
    End date: 2006-09-20

Voltaren
    Dosage: 50 mg/day
    Start date: 2006-09-21
    End date: 2006-09-21

Voltaren
    Dosage: 50 mg/day
    Start date: 2006-09-22
    End date: 2006-09-22

Tegretol
    Dosage: 100 mg/day
    Administration route: Oral
    Indication: Wound Complication
    Start date: 2006-09-22
    End date: 2006-09-23

Other drugs received by patient: Amoban; Zolpidem; Rohypnol; Ubretid; Spelear; Selbex; Sennoside; Takepron; Naproxen; Aspirin; Polaramine; Aminofluid; Omepral; Cataclot; Solu-Medrol; Soldem 3A; Multivitamin Additive; Heparin Sodium; Pacil; Pansporin; Finibax; Flumarin; Perdipine; Potacol-R; Radicut; NEO-Minophagen C; LOW Molecular Dextran L; Bisolvon; Magmitt Kenei; Cercine; Phenobarbital TAB; Mobic; Loxonin; Distilled Water; Ketoprofen; Laxoberon; Rinderon-VG; Wakobital; Serum Albumin Human; Humulin 70 / 30; Ropivacaine; Aminotripa 1; Aminotripa 2

Adverse event in 2 year old male receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Japan on 2007-07-02

Patient: 2 year old male, weighing 13.0 kg (28.6 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Myoglobinuria, Blood Creatine Phosphokinase Increased, Hepatic Necrosis, Rhabdomyolysis, Hepatic Failure, Resuscitation, Hypoxia, Myoglobin Blood Increased, Blood Creatinine Increased, Blood Urea Increased, Metabolic Acidosis, Alanine Aminotransferase Increased, Haemodialysis, Hepatic Steatosis, Renal Failure, Aspartate Aminotransferase Increased, Depressed Level of Consciousness, Prothrombin Time Shortened, Retroperitoneal Neoplasm, Bradycardia, Obstructive Airways Disorder, Venous Occlusion

Adverse event resulted in: death, life threatening event

Suspect drug(s):
Voltaren

Nitrous Oxide W / Oxygen

Vecuronium Bromide

Fentanyl

Adverse event in 61 year old female receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Japan on 2007-06-29

Patient: 61 year old female, weighing 59.0 kg (129.8 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Thoracic Cavity Drainage, Disseminated Intravascular Coagulation, Pyrexia, Erythema, Laboratory Test Abnormal, Gamma-Glutamyltransferase Increased, C-Reactive Protein Increased, Pleural Effusion, Blood Creatinine Increased, Lymphocyte Count Decreased, Oxygen Saturation Decreased, White Blood Cell Count Increased, Monocyte Count Decreased, Neutrophil Count Increased, Blood Urea Increased, Dyspnoea, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Urine Output Decreased, Lymphocyte Stimulation Test Positive, Rash Macular, Haemoglobin Decreased, Renal Failure, Aspartate Aminotransferase Increased, Oliguria, Platelet Count Decreased, Lung Infiltration

Adverse event resulted in: life threatening event

Suspect drug(s):
Voltaren
    Dosage: 37.5 mg/day
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2005-11-09
    End date: 2005-11-10

Loxonin
    Dosage: 60 mg, tid
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2005-11-10
    End date: 2005-11-13

Dacarbazine
    Dosage: 180 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-12

Nidran
    Dosage: 100 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-08

Oncovin
    Dosage: 1 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-08

Feron
    Dosage: 3000000 iu/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-12

Other drugs received by patient: Norvasc; Towamin; Lipitor; Voglibose

Adverse event in 23 year old female receiving Voltaren (Diclofenac)

Reported by a pharmacist from Japan on 2007-06-28

Patient: 23 year old female

Adverse reactions / side effects: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Hepatitis, Hepatitis C Positive, Discomfort

Suspect drug(s):
Voltaren
    Administration route: Oral
    Indication: Flank Pain
    Start date: 2007-05-31
    End date: 2007-06-02

Strocain
    Indication: Flank Pain
    Start date: 2007-06-01

Marzulene
    Indication: Flank Pain
    Start date: 2007-06-01

Adverse event in 82 year old male receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Italy on 2007-06-25

Patient: 82 year old male

Adverse reactions / side effects: Blood Bilirubin Increased, Jaundice, Hepatic Neoplasm Malignant, Antibody Test Abnormal, Hepatic Failure, Neoplasm, Hepatomegaly, Pulmonary Oedema, Small Intestinal Haemorrhage, Thrombocytopenia, Endoscopy Abnormal, Hepatitis Fulminant, Alanine Aminotransferase Increased, Duodenal Ulcer, Coagulation Time Shortened, Gastric Haemorrhage, Renal Failure, Aspartate Aminotransferase Increased

Adverse event resulted in: death

Suspect drug(s):
Glibomet
    Dosage: 400 glibe - 2.5 metf mg/day
    Administration route: Oral
    Indication: Diabetes Mellitus non-Insulin-Dependent
    Start date: 2006-12-03
    End date: 2007-05-03

Voltaren
    Dosage: 75 mg/day
    Indication: Bone Pain
    Start date: 2007-04-30
    End date: 2007-05-02

Adverse event in 61 year old female receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Japan on 2007-06-19

Patient: 61 year old female, weighing 59.0 kg (129.8 pounds)

Adverse reactions / side effects: Blood Bilirubin Increased, Thoracic Cavity Drainage, Disseminated Intravascular Coagulation, Pyrexia, Laboratory Test Abnormal, Gamma-Glutamyltransferase Increased, C-Reactive Protein Increased, Pleural Effusion, Blood Creatinine Increased, Oxygen Saturation Decreased, Lymphocyte Count Decreased, White Blood Cell Count Increased, Neutrophil Count Increased, Blood Urea Increased, Dyspnoea, Monocyte Count Decreased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Urine Output Decreased, Lymphocyte Stimulation Test Positive, Rash Macular, Haemoglobin Decreased, Renal Failure, Aspartate Aminotransferase Increased, Oliguria, Platelet Count Decreased, Lung Infiltration

Adverse event resulted in: life threatening event

Suspect drug(s):
Voltaren
    Dosage: 37.5 mg/day
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2005-11-09
    End date: 2005-11-10

Loxonin
    Dosage: 60 mg, tid
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2005-11-10
    End date: 2005-11-13

Dacarbazine
    Dosage: 180 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-12

Nidran
    Dosage: 100 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-08

Oncovin
    Dosage: 1 mg/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-08

Feron
    Dosage: 3000000 iu/day
    Indication: Malignant Melanoma
    Start date: 2005-11-08
    End date: 2005-11-12

Other drugs received by patient: Norvasc; Towamin; Lipitor; Voglibose

Adverse event in 69 year old male receiving Voltaren (Diclofenac)

Reported by a pharmacist from Japan on 2007-06-07

Patient: 69 year old male, weighing 69.0 kg (151.8 pounds)

Adverse reactions / side effects: Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Rash, Erythema Multiforme

Suspect drug(s):
Tegretol
    Administration route: Oral

Voltaren
    Administration route: Oral

Other drugs received by patient: Depas; Maalox Fast Blocker; Ranitac; Kakkon-TO; Bisopollon; Resplen; Rikaverin; Selbex; Ranitac

Adverse event in 11 year old male receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Japan on 2007-06-07

Patient: 11 year old male, weighing 32.0 kg (70.4 pounds)

Adverse reactions / side effects: Blood PH Increased, Disseminated Intravascular Coagulation, Blood Albumin Decreased, Petechiae, Pyrexia, Erythema, Blood Fibrinogen Decreased, Interstitial Lung Disease, C-Reactive Protein Increased, Acute Respiratory Distress Syndrome, Blood Creatinine Increased, White Blood Cell Count Increased, Cough, Renal Failure Acute, Hypertensive Encephalopathy, Dyspnoea, Blood Urea Increased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Pancytopenia, Life Support, Rash, Protein Total Decreased, Lymphocyte Stimulation Test Positive, Aspartate Aminotransferase Increased, Platelet Count Decreased, PO2 Increased, Lung Infiltration, Calculus Ureteric

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Predonine; Bufferin; Sulpyrine; Kashilon; Cefazolin Sodium; Methylprednisolone 16mg TAB

Adverse event in 11 year old male receiving Voltaren (Diclofenac)

Reported by a individual with unspecified qualification from Japan on 2007-06-04

Patient: 11 year old male, weighing 32.0 kg (70.4 pounds)

Adverse reactions / side effects: Blood PH Increased, Disseminated Intravascular Coagulation, Petechiae, Blood Albumin Decreased, Blood Fibrinogen Decreased, C-Reactive Protein Increased, Acute Respiratory Distress Syndrome, Blood Creatinine Increased, White Blood Cell Count Increased, Renal Failure Acute, Cough, Dyspnoea, Blood Urea Increased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Pancytopenia, Protein Total Decreased, Lymphocyte Stimulation Test Positive, Rash, Aspartate Aminotransferase Increased, Platelet Count Decreased, PO2 Increased, Lung Infiltration, Calculus Ureteric

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Predonine; Bufferin; Sulpyrine; Kashilon; Cefazolin Sodium

Adverse event in 51 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-05-29

Patient: 51 year old female, weighing 62.0 kg (136.4 pounds)

Adverse reactions / side effects: Blood Alkaline Phosphatase Increased, Blood Creatine Phosphokinase Increased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Paralysis, Lymphocyte Stimulation Test Positive, Pallor, Tremor, Haemoglobin Decreased, Gamma-Glutamyltransferase Increased, Palpitations, C-Reactive Protein Increased, Aspartate Aminotransferase Increased

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Allegra; Aspirin; Ferromia

Adverse event in 71 year old male receiving Voltaren (Diclofenac)

Reported by a pharmacist from Japan on 2007-05-25

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

Adverse reactions / side effects: Dyspnoea, Bronchoalveolar Lavage Abnormal, Cryptogenic Organising Pneumonia, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Lymphocyte Stimulation Test Positive

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Lipovas; Norvasc; Fluitran; Inhibace

Adverse event in 71 year old male receiving Voltaren (Diclofenac)

Reported by a pharmacist from Japan on 2007-05-23

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

Adverse reactions / side effects: Cryptogenic Organising Pneumonia, Bronchoalveolar Lavage Abnormal, Dyspnoea, Gamma-Glutamyltransferase Increased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Lipovas; Norvasc; Fluitran; Inhibace

Adverse event in 16 year old male receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-05-22

Patient: 16 year old male

Adverse reactions / side effects: Glucose-6-Phosphate Dehydrogenase Deficiency, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Protein Urine Present, Haematuria, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Pyrexia, Haemoglobin Decreased, Haematocrit Decreased, C-Reactive Protein Increased, Aspartate Aminotransferase Increased, Platelet Count Decreased, Haemolytic Anaemia, Influenza

Adverse event resulted in: hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Onon; Clarithromycin; Selbex; PL Gran.; Pansporin; Relenza; Calonal; Alpinyl; Miltax

Adverse event in 28 year old female receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-05-21

Patient: 28 year old female, weighing 58.0 kg (127.6 pounds)

Adverse reactions / side effects: Malaise, Hepatic Function Abnormal, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pyrexia, Prothrombin Time Prolonged

Adverse event resulted in: hospitalization

Suspect drug(s):
PEG-Intron
    Dosage: 80 mcg; qw; sc
    Indication: Hepatitis C
    Start date: 2007-03-02
    End date: 2007-03-02

Rebetol
    Dosage: 600 mg; qd; po
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2007-03-02
    End date: 2007-03-03

Voltaren
    Dosage: 25 mg; prn; po
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2007-03-02
    End date: 2007-03-02

Adverse event in 41 year old male receiving Voltaren (Diclofenac)

Reported by a physician from Japan on 2007-05-11

Patient: 41 year old male, weighing 60.0 kg (132.0 pounds)

Adverse reactions / side effects: Brain Death, Rhabdomyolysis, Blood Creatine Phosphokinase Increased, Blood Calcium Increased, Pyrexia, C-Reactive Protein Increased, Brain Oedema, Blood Creatinine Increased, White Blood Cell Count Increased, Mydriasis, Brain Stem Haemorrhage, Blood Urea Increased, Dyspnoea, Urine Output Decreased, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Dependence ON Respirator, Haemodialysis, Brain Stem Syndrome, Dehydration, Aspartate Aminotransferase Increased, Platelet Count Decreased, Blood Pressure Decreased

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Voltaren (Diclofenac)

Other drugs received by patient: Adona; Transamin; Primperan INJ; Gaster; Glyceol