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Hepsera (Adefovir Dipivoxil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Hepsera (Adefovir Dipivoxil) 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 (142)
Death (3)
Disability (30)

Reports by Reaction Type

Osteomalacia (43)Blood Creatinine Increased (34)Renal Impairment (33)Fanconi Syndrome (30)Blood Alkaline Phosphatase Increased (26)Multiple Fractures (25)Hypophosphataemia (24)Blood Phosphorus Decreased (22)Fanconi Syndrome Acquired (18)Arthralgia (18)Gait Disturbance (16)Pancytopenia (15)

Below are a few examples of reports where side effects / adverse reactions may be related to Hepsera (Adefovir Dipivoxil). For a complete list or a specific selection of reports, please use the links above.

Possible Hepsera side effects in 40 year old male

Reported by a consumer/non-health professional from China on 2012-08-24

Patient: 40 year old male

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Epivir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01



Possible Hepsera side effects in 40 year old male

Reported by a consumer/non-health professional from China on 2012-08-21

Patient: 40 year old male, weighing 55.0 kg (121.0 pounds)

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Epivir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01

Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01



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 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 60 year old male

Reported by a physician from Korea, Republic of on 2012-08-16

Patient: 60 year old male

Reactions: Therapeutic Response Decreased, Eyelid Oedema, Fatigue, Blood Creatine Phosphokinase Increased, Asthenia, Blood Creatinine Increased

Drug(s) suspected as cause:
Entecavir
    Dosage: 1 mg, unk
    Indication: Hepatitis B
    Start date: 2010-08-20
    End date: 2012-05-21

Hepsera
    Dosage: 10 mg, unk
    Indication: Hepatitis B
    Start date: 2010-08-20
    End date: 2012-05-21

Sebivo
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-05-21

Viread
    Dosage: 300 mg, qod
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-06-18

Viread
    Dosage: 300 mg, qd
    Administration route: Oral
    Start date: 2012-05-21
    End date: 2012-06-17



Possible Hepsera side effects in 40 year old male

Reported by a consumer/non-health professional from China on 2012-08-14

Patient: 40 year old male

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Epivir
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01

Hepsera
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01



Possible Hepsera side effects in 41 year old female

Reported by a physician from Japan on 2012-08-13

Patient: 41 year old female

Reactions: Renal Tubular Acidosis

Drug(s) suspected as cause:
Hepsera

Other drugs received by patient: Lamivudine; Baraclude



Possible Hepsera side effects in 40 year old male

Reported by a consumer/non-health professional from China on 2012-08-09

Patient: 40 year old male, weighing 55.0 kg (121.0 pounds)

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Hepsera
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01

Heptodin
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2009-01-01



Possible Hepsera side effects in male

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

Patient: male

Reactions: Tubulointerstitial Nephritis, Blood Alkaline Phosphatase Increased, Renal Disorder, Blood Phosphorus Decreased, Blood Potassium Decreased, Fanconi Syndrome, Blood Creatinine Increased

Drug(s) suspected as cause:
Hepsera
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis B
    End date: 2012-01-06

Hepsera
    Administration route: Oral
    End date: 2012-01-06

Other drugs received by patient: Mucosta; Magnesium Oxide; Alprazolam; Zolpidem; Zolpidem; Alprazolam; Warfarin Sodium; Baraclude / 03597801 /; Zolpidem; Alprazolam



Possible Hepsera side effects in 56 year old male

Reported by a physician from Japan on 2012-08-07

Patient: 56 year old male

Reactions: Renal Tubular Disorder, Protein Urine Present, Pelvic Fracture, Metabolic Acidosis, Osteoporosis, Pain in Extremity, Fanconi Syndrome Acquired, Multiple Fractures, Hypophosphataemia, Osteonecrosis, Renal Impairment, Spinal Compression Fracture, Aminoaciduria, Gait Disturbance, Urine Phosphorus Decreased, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Start date: 2006-03-28
    End date: 2010-03-18

Hepsera
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2006-03-28
    End date: 2010-03-18

Hepsera
    Administration route: Oral
    Start date: 2010-02-23
    End date: 2010-03-19

Lamivudine
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2004-10-17
    End date: 2010-02-23

Other drugs received by patient: Gaster / 00706001 /; Neurovitan / 00280501 /; Urso / 00465701 /



Possible Hepsera side effects in male

Reported by a individual with unspecified qualification from Turkey on 2012-08-06

Patient: male

Reactions: Hypophosphataemia, Osteopenia

Drug(s) suspected as cause:
Hepsera



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 physician from Japan on 2012-08-03

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Tubulointerstitial Nephritis, Renal Disorder, Fanconi Syndrome, Blood Creatinine Increased

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2007-10-02
    End date: 2012-02-21

Hepsera
    Dosage: 10 mg 3 times per day
    Administration route: Oral
    Start date: 2012-02-21

Other drugs received by patient: Lamivudine; Lamivudine



Possible Hepsera side effects in female

Reported by a physician from Japan on 2012-08-03

Patient: female

Reactions: Bone Pain, Renal Glycosuria, Blood Uric Acid Decreased, Aminoaciduria, Urine Uric Acid Increased, Blood Sodium Increased, Blood Creatinine Increased, Blood Glucose Increased, Blood Alkaline Phosphatase Increased, Back Pain, Metabolic Acidosis, Musculoskeletal Pain, Fanconi Syndrome Acquired, Blood Chloride Increased, Hypophosphataemia, Blood Phosphorus Decreased, Anion GAP Normal, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Hepatic Cirrhosis
    Start date: 2005-03-02
    End date: 2009-08-04

Lamivudine
    Administration route: Oral
    Indication: Hepatic Cirrhosis
    Start date: 2003-02-28
    End date: 2008-08-04

Prograf
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2003-03-01

Other drugs received by patient: Adalat; Ursodiol; Pursennid



Possible Hepsera side effects in male

Reported by a physician from Japan on 2012-08-02

Patient: male

Reactions: Tubulointerstitial Nephritis, Blood Alkaline Phosphatase Increased, Renal Disorder, Blood Phosphorus Decreased, Blood Potassium Decreased, Fanconi Syndrome, Glomerular Filtration Rate Abnormal, Blood Creatinine Increased

Drug(s) suspected as cause:
Hepsera
    Dosage: unk
    Administration route: Oral
    Indication: Hepatitis B
    End date: 2012-01-06

Hepsera
    Administration route: Oral
    End date: 2012-01-06

Other drugs received by patient: Zolpidem; Mucosta; Alprazolam; Zolpidem; Magnesium Oxide; Baraclude / 03597801 /; Alprazolam



Possible Hepsera side effects in 74 year old male

Reported by a physician from China on 2012-07-27

Patient: 74 year old male

Reactions: Platelet Count Decreased, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-04-01
    End date: 2012-05-01

Heptodin
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-05-01



Possible Hepsera side effects in male

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

Patient: male

Reactions: Renal Failure, Renal Impairment, Viral Load Increased, Fanconi Syndrome, Respiratory Failure, Hepatitis Fulminant

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Hepsera
    Indication: Hepatitis B

Viread
    Dosage: unk
    Indication: Hepatitis B
    Start date: 2010-11-01
    End date: 2011-11-01

Viread
    Dosage: 1 df, qod
    Start date: 2012-05-01

Other drugs received by patient: Amlodipina / 00972401 /; Aspirin; Bisoprolol Fumarate; Valsartan; Valproato DE Magnesio / 00017402 /



Possible Hepsera side effects in male

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

Patient: male

Reactions: Blood Phosphorus Decreased, Beta 2 Microglobulin Urine Increased, Arthralgia, Fanconi Syndrome Acquired

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg per day
    Administration route: Oral
    Start date: 2003-11-27
    End date: 2011-12-04

Hepsera
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2003-11-27
    End date: 2011-12-04

Other drugs received by patient: Alendronate Sodium; Lamivudine; Alendronate Sodium



Possible Hepsera side effects in

Reported by a pharmacist from United States on 2012-07-25

Patient:

Reactions: Tongue Neoplasm Malignant Stage Unspecified

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera



Possible Hepsera side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-24

Patient: 74 year old male

Reactions: Pancytopenia, Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-04-01
    End date: 2012-05-01

Lamivudine
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-05-01



Possible Hepsera side effects in

Reported by a pharmacist from United States on 2012-07-20

Patient:

Reactions: Tongue Neoplasm Malignant Stage Unspecified

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera



Possible Hepsera side effects in

Reported by a physician from Japan on 2012-07-19

Patient:

Reactions: Renal Disorder, Fanconi Syndrome

Drug(s) suspected as cause:
Hepsera
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lamivudine (Epivir Hbv)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



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

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

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

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 female

Reported by a physician from Canada on 2012-06-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hepsera



Possible Hepsera side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-27

Patient: female

Reactions: Abdominal Pain, Product Substitution Issue, Viral Infection, Abdominal Distension, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hepsera



Possible Hepsera side effects in male

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

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:
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

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

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:
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: 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:
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

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

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

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)
    Administration route: Oral
    Start date: 2011-08-19

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 68 year old male

Reported by a pharmacist from Japan on 2012-05-31

Patient: 68 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Renal Impairment

Drug(s) suspected as cause:
Hepsera
    Dosage: 10mg three times per day
    Administration route: Oral

Hepsera
    Administration route: Oral
    Indication: Hepatitis B

Lamivudine (Epivir Hbv)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Baraclude

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