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 (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 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 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
|