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Hepsera (Adefovir Dipivoxil) - Osteomalacia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Osteomalacia (43)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Hepsera (Adefovir Dipivoxil) where reactions include osteomalacia. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 43   Next >>

Possible Hepsera side effects in 71 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 71 year old female

Reactions: Osteomalacia

Drug(s) suspected as cause:
Hepsera
    Administration route: Oral
    Indication: Hepatic Cirrhosis
    Start date: 2008-03-01

Lamivudine (Epivir Hbv)
    Administration route: Oral
    Indication: Hepatic Cirrhosis

Other drugs received by patient: Lipitor; Famotidine



Possible Hepsera side effects in 71 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 71 year old female

Reactions: Osteomalacia

Drug(s) suspected as cause:
Hepsera
    Administration route: Oral
    Indication: Hepatic Cirrhosis
    Start date: 2008-03-01

Lamivudine
    Administration route: Oral
    Indication: Hepatic Cirrhosis

Other drugs received by patient: Gaster / 00706001 /; Lipitor



Possible Hepsera side effects in 63 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 63 year old male

Reactions: Osteomalacia

Drug(s) suspected as cause:
Hepsera

Other drugs received by patient: Lamivudine



Possible Hepsera side effects in male

Reported by a pharmacist from Japan on 2012-06-27

Patient: male

Reactions: Hypophosphataemia, Pain in Extremity, Muscular Weakness, Osteomalacia, Gait Disturbance, Asthenia, Blood Creatinine Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Hepsera
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-10-24

Lamivudine
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 1996-08-03
    End date: 2011-08-18

Hepsera
    Dosage: 10mg alternate days
    Administration route: Oral
    Start date: 2011-08-19

Lamivudine
    Dosage: 200 mg, qod
    Administration route: Oral
    Start date: 2011-08-19

Other drugs received by patient: Candesartan Cilexetil; Flivastatin Sodium; Vitamin B12; Alinamin-F / 00257802 /; Cernilton / 00521401 /; Candesartan Cilexetil; Candesartan Cilexetil; Vitamin B12; Alinamin-F / 06868601 /; Vitamin B12



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-06-26

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Hypophosphataemia, Pain in Extremity, Muscular Weakness, Osteomalacia, Gait Disturbance, Blood Creatinine Increased, Asthenia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 1996-08-03
    End date: 2011-08-18

Lamivudine (Epivir Hbv)
    Dosage: 100mg twice per day
    Administration route: Oral
    Start date: 2011-08-19

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-10-24
    End date: 2011-08-18

Hepsera
    Dosage: 10mg twice per day
    Administration route: Oral
    Start date: 2011-08-19

Other drugs received by patient: Candesartan Cilexetil; Alinamin-F; Flivastatin Sodium; Vitamin B12; Cernilton



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-06-15

Patient: male

Reactions: Urine Phosphorus Increased, Pain, Blood Uric Acid Decreased, Aminoaciduria, Urine Uric Acid Increased, Fibula Fracture, Blood Creatinine Increased, RIB Fracture, Metabolic Acidosis, Fanconi Syndrome, Glucose Urine Present, Osteomalacia, Nephrosclerosis, Urine Calcium Increased, Limb Discomfort, Renal Impairment, Blood Phosphorus Decreased, Arthralgia, Tibia Fracture

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2001-10-01
    End date: 2011-11-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-09-01
    End date: 2011-11-01

Other drugs received by patient: Losartan Potassium; Etodolac; Antagostin



Possible Hepsera side effects in male

Reported by a pharmacist from Japan on 2012-06-11

Patient: male

Reactions: Hypophosphataemia, Pain in Extremity, Muscular Weakness, Gait Disturbance, Osteomalacia, Asthenia, Blood Creatinine Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Lamivudine
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1996-08-03
    End date: 2011-08-18

Lamivudine
    Dosage: unk
    Administration route: Oral
    Start date: 2011-08-19

Hepsera
    Dosage: 10mg alternate days
    Administration route: Oral
    Start date: 2004-10-24

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2004-10-24
    End date: 2011-08-18

Other drugs received by patient: Candesartan Cilexetil; Vitamin B12; Alinamin-F / 06868601 /; Candesartan Cilexetil; Vitamin B12



Possible Hepsera side effects in male

Reported by a pharmacist from Japan on 2012-06-07

Patient: male

Reactions: Hypophosphataemia, Pain in Extremity, Muscular Weakness, Osteomalacia, Gait Disturbance, Asthenia, Blood Creatinine Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg alternate days
    Administration route: Oral
    Start date: 2011-08-19

Lamivudine (Epivir Hbv)
    Administration route: Oral
    Start date: 2011-08-19

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2004-10-24
    End date: 2011-08-18

Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1996-08-03
    End date: 2011-08-18

Other drugs received by patient: Alinamin-F; Vitamin B12; Candesartan Cilexetil



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-05-29

Patient: male

Reactions: Urine Phosphorus Increased, Pain, Blood Uric Acid Decreased, Aminoaciduria, Urine Uric Acid Increased, Fibula Fracture, Blood Creatinine Increased, RIB Fracture, Blood Alkaline Phosphatase Increased, Metabolic Acidosis, Fanconi Syndrome, Fanconi Syndrome Acquired, Multiple Fractures, Glucose Urine Present, Osteomalacia, Nephrosclerosis, Urine Calcium Increased, Renal Impairment, Limb Discomfort, Blood Phosphorus Decreased, Arthralgia, Tibia Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-09-01
    End date: 2011-11-01

Lamivudine
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2001-10-01
    End date: 2011-11-01

Lamivudine
    Dosage: 100mg per day
    Administration route: Oral

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Start date: 2004-09-01
    End date: 2011-11-01

Lamivudine
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2001-10-01
    End date: 2011-11-01

Other drugs received by patient: Etodolac; Etodolac; Antagostin; Etodolac; Losartan Potassium; Antagostin; Losartan Potassium; Losartan Potassium; Antagostin



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-05-22

Patient: male

Reactions: Urine Phosphorus Increased, Pain, Anti-SS-A Antibody Negative, Bence Jones Protein Urine Present, Blood Uric Acid Decreased, Aminoaciduria, Urine Uric Acid Increased, Fibula Fracture, Blood Creatinine Increased, RIB Fracture, Blood Alkaline Phosphatase Increased, Metabolic Acidosis, Anti-SS-B Antibody Negative, Fanconi Syndrome, Multiple Fractures, Glucose Urine Present, Osteomalacia, Nephrosclerosis, Urine Calcium Increased, Limb Discomfort, Renal Impairment, Blood Phosphorus Decreased, Arthralgia, Tibia Fracture

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-09-01
    End date: 2011-11-01

Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2001-10-01
    End date: 2011-11-01

Other drugs received by patient: Antagostin; Losartan Potassium; Etodolac



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-05-21

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Renal Disorder, Arthralgia, Fanconi Syndrome Acquired, Renal Tubular Acidosis, Osteomalacia, Blood Creatinine Increased

Drug(s) suspected as cause:
Hepsera
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2005-01-19
    End date: 2011-08-01

Hepsera
    Dosage: 10 mg, qod
    Administration route: Oral
    Start date: 2011-08-01

Lamivudine (Epivir Hbv)
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2000-12-22



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-05-17

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Renal Disorder, Fanconi Syndrome, Arthralgia, Osteomalacia, Renal Tubular Acidosis, Blood Creatinine Increased

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2005-01-19
    End date: 2011-08-01

Hepsera
    Dosage: 10mg alternate days
    Administration route: Oral
    Start date: 2011-08-01

Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2000-12-22



Possible Hepsera side effects in 74 year old male

Reported by a pharmacist from Japan on 2012-05-16

Patient: 74 year old male

Reactions: Hypophosphataemia, Osteomalacia, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg alternate days
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01

Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01

Other drugs received by patient: Candesartan Cilexetil; Vitamin B12; Alinamin-F / 06868601 /



Possible Hepsera side effects in 74 year old male

Reported by a pharmacist from Japan on 2012-05-15

Patient: 74 year old male

Reactions: Hypophosphataemia, Gait Disturbance, Osteomalacia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01

Hepsera
    Dosage: 10mg alternate days
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01

Other drugs received by patient: Vitamin B12; Candesartan Cilexetil; Alinamin-F



Possible Hepsera side effects in 46 year old female

Reported by a physician from China on 2012-05-10

Patient: 46 year old female

Reactions: Back Pain, Pain in Extremity, Osteoporosis, Fanconi Syndrome, Musculoskeletal Pain, Osteomalacia, Ulcer, Myalgia, Arthralgia, Ecchymosis

Drug(s) suspected as cause:
Hepsera



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-05-08

Patient: male

Reactions: Pain, Blood Uric Acid Decreased, Intervertebral Disc Degeneration, Vertebral Foraminal Stenosis, Bone Density Decreased, Blood Creatinine Increased, Intervertebral Disc Protrusion, Protein Urine Present, Fanconi Syndrome, Alanine Aminotransferase Increased, Glucose Urine Present, Osteomalacia, Hyperplasia, Blood Phosphorus Decreased, RED Blood Cells Urine Positive, Spinal Osteoarthritis, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera

Other drugs received by patient: Lamivudine (Epivir Hbv); Candesartan Cilexetil; Rabeprazole Sodium



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-05-03

Patient: male

Reactions: Renal Impairment, Fanconi Syndrome Acquired, Electrolyte Imbalance, Osteomalacia, Multiple Fractures

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg alternate days
    Administration route: Oral
    Start date: 2010-09-30
    End date: 2011-07-09

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-10-27
    End date: 2010-09-29

Other drugs received by patient: Vitamin B12; Promacta; Neurotropin; Lamivudine (Epivir Hbv); Rabeprazole Sodium; Depas; Magnesium Oxide; Aldactone; Lactitol; Furosemide; Livact; Aminoleban EN; Actonel



Possible Hepsera side effects in 42 year old male

Reported by a physician from Japan on 2012-05-03

Patient: 42 year old male

Reactions: Blood Alkaline Phosphatase Increased, Renal Tubular Disorder, Back Pain, Fanconi Syndrome, Spinal Fracture, Pain, Osteomalacia, Hypophosphataemia, Blood Phosphorus Decreased, Renal Impairment, Arthralgia, Bone Density Decreased, Bone Metabolism Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera

Other drugs received by patient: Antiinflammatory Agents, NON-Steroids



Possible Hepsera side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-03

Patient: 54 year old male

Reactions: Back Pain, Hypophosphataemia, Osteomalacia, Bone Disorder, Abdominal Pain Upper

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

Hepsera
    Administration route: Oral
    Indication: Hepatitis B

Hepsera
    Administration route: Oral

Other drugs received by patient: Lamivudine



Possible Hepsera side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-03

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Fanconi Syndrome, Urine Phosphorus Increased, Muscular Weakness, Osteomalacia, Multiple Fractures, Chest Pain, Aminoaciduria, Gait Disturbance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-01-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2005-05-30

Other drugs received by patient: Lexin / 00052501 /; Amlodipine; Lioresal; Gaster / 00706001 /; Loxoprofen; Lioresal; Rilutek; Lioresal; Gaster / 00706001 /; Gaster / 00706001 /; ATP / 00090104 /; Loxoprofen; Loxoprofen; Lioresal; Amlodipine; Amlodipine



Possible Hepsera side effects in 54 year old male

Reported by a physician from Japan on 2012-04-05

Patient: 54 year old male

Reactions: Back Pain, Hypophosphataemia, Bone Disorder, Osteomalacia, Abdominal Pain Upper

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

Hepsera
    Administration route: Oral

Hepsera
    Administration route: Oral
    Indication: Hepatitis B

Other drugs received by patient: Lamivudine



Possible Hepsera side effects in male

Reported by a consumer/non-health professional from Japan on 2012-03-21

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Urine Phosphorus Increased, Fanconi Syndrome, Muscular Weakness, Multiple Fractures, Osteomalacia, Chest Pain, Aminoaciduria, Gait Disturbance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lamivudine (Epivir Hbv)
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-01-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2005-05-30

Other drugs received by patient: Lexin / 00052501 /; Lioresal; Gaster / 00706001 /; Gaster / 00706001 /; Gaster / 00706001 /; ATP / 00090104 /; Amlodipine; Lioresal; Lioresal; Loxoprofen; Loxoprofen; Amlodipine; Rilutek; Loxoprofen; Lioresal; Amlodipine



Possible Hepsera side effects in 47 year old male

Reported by a physician from Japan on 2012-03-06

Patient: 47 year old male

Reactions: Body Height Decreased, Gait Disturbance, Osteomalacia

Drug(s) suspected as cause:
Hepsera



Possible Hepsera side effects in male

Reported by a consumer/non-health professional from Japan on 2012-02-13

Patient: male

Reactions: Deformity Thorax, Weight Decreased, Blood Calcium Increased, Body Height Decreased, Renal Tubular Acidosis, Blood Creatinine Increased, Spinal Deformity, Blood Alkaline Phosphatase Increased, Pain in Extremity, Fanconi Syndrome, Blood Chloride Increased, Osteomalacia, Renal Impairment, Blood Phosphorus Decreased, Arthralgia, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera

Other drugs received by patient: Lyrica; Lamivudine; Urso / 00465701 /; Alfarol



Possible Hepsera side effects in 62 year old male

Reported by a physician from Japan on 2012-02-03

Patient: 62 year old male

Reactions: Fanconi Syndrome, Urine Phosphorus Increased, Pain in Extremity, Osteomalacia, Glucose Urine Present, Urine Calcium Increased, Hypophosphataemia, Hypouricaemia, Arthralgia, Aminoaciduria, Femoral Neck Fracture, Hyperphosphatasaemia, Urine Uric Acid Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-01-20

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Fanconi Syndrome Acquired, Osteomalacia, Multiple Fractures, Blood Phosphorus Decreased, Blood Uric Acid Decreased, Arthralgia, Tibia Fracture, Fibula Fracture, Blood Creatinine Increased, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamivudine
    Dosage: 100mg per day
    Administration route: Oral

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-09-01
    End date: 2011-11-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Start date: 2004-09-01
    End date: 2011-11-01

Lamivudine
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2001-10-01
    End date: 2011-11-01

Other drugs received by patient: Antagostin; Losartan Potassium; Etodolac; Antagostin; Losartan Potassium; Etodolac



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-01-18

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Fanconi Syndrome, Osteomalacia, Multiple Fractures, Blood Phosphorus Decreased, Arthralgia, Blood Uric Acid Decreased, Tibia Fracture, Fibula Fracture, Blood Creatinine Increased, RIB Fracture

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-09-01
    End date: 2011-11-01

Lamivudine, Stavudine, and Nevirapine
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2001-10-01
    End date: 2011-11-01

Other drugs received by patient: Losartan Potassium; Etodolac; Antagostin



Possible Hepsera side effects in male

Reported by a consumer/non-health professional from Japan on 2012-01-18

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Chest Pain, Osteomalacia, Multiple Fractures

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zefix
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-01-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2005-05-30

Other drugs received by patient: Gaster / 00706001 /; Gaster / 00706001 /; Lexin / 00052501 /; Rilutek; Lioresal; Gaster / 00706001 /; ATP / 00090104 /; Loxoprofen; Amlodipine; Loxoprofen; Lioresal; Amlodipine; Lioresal



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-01-16

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Fanconi Syndrome, Urine Phosphorus Increased, Muscular Weakness, Multiple Fractures, Osteomalacia, Aminoaciduria, Chest Pain, Gait Disturbance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lamivudine, Stavudine, and Nevirapine
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-01-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2005-05-30

Other drugs received by patient: Famotidine; Lexin; Loxoprofen; Lioresal; ATP; Amlodipine; Rilutek



Possible Hepsera side effects in male

Reported by a consumer/non-health professional from Japan on 2012-01-11

Patient: male

Reactions: Weight Decreased, Deformity Thorax, Blood Calcium Increased, Body Height Decreased, Renal Tubular Acidosis, Spinal Deformity, Blood Creatinine Increased, Blood Alkaline Phosphatase Increased, Fanconi Syndrome, Pain in Extremity, Blood Chloride Increased, Osteomalacia, Renal Impairment, Blood Phosphorus Decreased, Arthralgia, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera

Other drugs received by patient: Lamivudine; Alfarol; Urso / 00465701 /; Lyrica



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