Drug information for HEPSERA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 10MG Prescription  (Reference Drug) ADEFOVIR DIPIVOXIL adefovir dipivoxil GILEAD 21449
2012-03-02 Letter

2012-03-01 Label

2009-11-25 Letter

2009-10-21 Label

2008-01-09 Letter

2007-12-27 Label

2006-10-23 Label

2006-10-23 Letter

2006-09-25 Letter

2006-09-21 Label

2006-05-02 Letter

2006-05-02 Label

2004-08-25 Letter

2004-08-25 Label

2004-06-07 Review

2002-09-20 Letter

2002-09-20 Label

Drug Adverse Effects information for HEPSERA

Role code Indications Reaction # Reports
PS AMYOTROPHIC LATERAL SCLEROSIS BLOOD ALKALINE PHOSPHATASE INCREASED 9
PS AMYOTROPHIC LATERAL SCLEROSIS CHEST PAIN 9
PS AMYOTROPHIC LATERAL SCLEROSIS HYPERPHOSPHATASAEMIA 3
PS AMYOTROPHIC LATERAL SCLEROSIS MULTIPLE FRACTURES 9
PS AMYOTROPHIC LATERAL SCLEROSIS OSTEOMALACIA 9
PS EPILEPSY HYPOPHOSPHATAEMIA 1
PS EPILEPSY OSTEOMALACIA 1
PS GASTROOESOPHAGEAL REFLUX DISEASE HYPOPHOSPHATAEMIA 2
PS GASTROOESOPHAGEAL REFLUX DISEASE OSTEOMALACIA 2
PS HEPATIC CIRRHOSIS ANAEMIA 2
PS HEPATIC CIRRHOSIS ANGIODYSPLASIA 2
PS HEPATIC CIRRHOSIS BLOOD CREATININE INCREASED 2
PS HEPATIC CIRRHOSIS GLOMERULAR FILTRATION RATE DECREASED 2
PS HEPATIC CIRRHOSIS LARGE INTESTINAL HAEMORRHAGE 2
PS HEPATIC CIRRHOSIS PANCYTOPENIA 2
PS HEPATIC CIRRHOSIS RENAL IMPAIRMENT 2
PS HEPATIC CIRRHOSIS SPLENOMEGALY 2
PS HEPATIC CIRRHOSIS VARICES OESOPHAGEAL 2
PS HEPATITIS B ABDOMINAL PAIN UPPER 4
PS HEPATITIS B ALANINE AMINOTRANSFERASE INCREASED 1
PS HEPATITIS B AMINOACIDURIA 3
PS HEPATITIS B ARTHRALGIA 1
PS HEPATITIS B ASTHENIA 1
PS HEPATITIS B BACK PAIN 5
PS HEPATITIS B BLOOD ALKALINE PHOSPHATASE INCREASED 7
PS HEPATITIS B BLOOD BILIRUBIN ABNORMAL 2
PS HEPATITIS B BLOOD CREATININE INCREASED 1
PS HEPATITIS B BLOOD PHOSPHORUS DECREASED 2
PS HEPATITIS B BONE DENSITY DECREASED 2
PS HEPATITIS B BONE DISORDER 4
PS HEPATITIS B BONE METABOLISM DISORDER 1
PS HEPATITIS B BONE PAIN 1
PS HEPATITIS B CHEST PAIN 6
PS HEPATITIS B DIZZINESS 2
PS HEPATITIS B DRUG RESISTANCE 2
PS HEPATITIS B EXPOSURE DURING BREAST FEEDING 2
PS HEPATITIS B FANCONI SYNDROME 2
PS HEPATITIS B FANCONI SYNDROME ACQUIRED 3
PS HEPATITIS B GAIT DISTURBANCE 3
PS HEPATITIS B HEPATIC PAIN 1
PS HEPATITIS B HYPERPHOSPHATASAEMIA 2
PS HEPATITIS B HYPOPHOSPHATAEMIA 6
PS HEPATITIS B JAUNDICE 2
PS HEPATITIS B MATERNAL EXPOSURE DURING PREGNANCY 2
PS HEPATITIS B METABOLIC ACIDOSIS 3
PS HEPATITIS B MULTIPLE FRACTURES 6
PS HEPATITIS B NAUSEA 2
PS HEPATITIS B OSTEOMALACIA 11
PS HEPATITIS B OSTEONECROSIS 3
PS HEPATITIS B OSTEOPOROSIS 3
PS HEPATITIS B PAIN 1
PS HEPATITIS B PAIN IN EXTREMITY 3
PS HEPATITIS B PELVIC FRACTURE 3
PS HEPATITIS B PRODUCT QUALITY ISSUE 2
PS HEPATITIS B PROTEIN URINE PRESENT 3
PS HEPATITIS B RENAL FAILURE 3
PS HEPATITIS B RENAL IMPAIRMENT 7
PS HEPATITIS B RENAL TUBULAR DISORDER 4
PS HEPATITIS B RIB FRACTURE 3
PS HEPATITIS B SPINAL COMPRESSION FRACTURE 3
PS HEPATITIS B SPINAL FRACTURE 1
PS HEPATITIS B TRANSAMINASES INCREASED 2
PS HEPATITIS B URINE PHOSPHORUS DECREASED 3
PS HYPERTENSION BLOOD ALKALINE PHOSPHATASE INCREASED 3
PS HYPERTENSION CHEST PAIN 3
PS HYPERTENSION HYPERPHOSPHATASAEMIA 1
PS HYPERTENSION MULTIPLE FRACTURES 3
PS HYPERTENSION OSTEOMALACIA 3
PS INSOMNIA HYPOPHOSPHATAEMIA 1
PS INSOMNIA OSTEOMALACIA 1
PS MYOCARDIAL ISCHAEMIA HYPOPHOSPHATAEMIA 1
PS MYOCARDIAL ISCHAEMIA OSTEOMALACIA 1
PS PAIN BLOOD ALKALINE PHOSPHATASE INCREASED 3
PS PAIN CHEST PAIN 3
PS PAIN HYPERPHOSPHATASAEMIA 1
PS PAIN MULTIPLE FRACTURES 3
PS PAIN OSTEOMALACIA 3
PS PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN UPPER 2
PS PRODUCT USED FOR UNKNOWN INDICATION AMINOACIDURIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION ARTHRALGIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 3
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD ALKALINE PHOSPHATASE INCREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD PHOSPHORUS DECREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION BONE DENSITY DECREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION BONE DISORDER 2
PS PRODUCT USED FOR UNKNOWN INDICATION BONE METABOLISM DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION ELECTROLYTE IMBALANCE 1
PS PRODUCT USED FOR UNKNOWN INDICATION FANCONI SYNDROME 1
PS PRODUCT USED FOR UNKNOWN INDICATION FANCONI SYNDROME ACQUIRED 2
PS PRODUCT USED FOR UNKNOWN INDICATION GAIT DISTURBANCE 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPOPHOSPHATAEMIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION METABOLIC ACIDOSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION MULTIPLE FRACTURES 1
PS PRODUCT USED FOR UNKNOWN INDICATION OSTEOMALACIA 4
PS PRODUCT USED FOR UNKNOWN INDICATION OSTEONECROSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION OSTEOPOROSIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION PAIN IN EXTREMITY 1
PS PRODUCT USED FOR UNKNOWN INDICATION PELVIC FRACTURE 1
PS PRODUCT USED FOR UNKNOWN INDICATION PROTEIN URINE PRESENT 1
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL IMPAIRMENT 3
PS PRODUCT USED FOR UNKNOWN INDICATION RENAL TUBULAR DISORDER 2
PS PRODUCT USED FOR UNKNOWN INDICATION RIB FRACTURE 1
PS PRODUCT USED FOR UNKNOWN INDICATION SPINAL COMPRESSION FRACTURE 1
PS PRODUCT USED FOR UNKNOWN INDICATION SPINAL FRACTURE 1
PS PRODUCT USED FOR UNKNOWN INDICATION URINE PHOSPHORUS DECREASED 1
PS URINARY INCONTINENCE HYPOPHOSPHATAEMIA 1
PS URINARY INCONTINENCE OSTEOMALACIA 1
SS AMYOTROPHIC LATERAL SCLEROSIS BLOOD ALKALINE PHOSPHATASE INCREASED 12
SS AMYOTROPHIC LATERAL SCLEROSIS CHEST PAIN 15
SS AMYOTROPHIC LATERAL SCLEROSIS HYPERPHOSPHATASAEMIA 3
SS AMYOTROPHIC LATERAL SCLEROSIS MULTIPLE FRACTURES 15
SS AMYOTROPHIC LATERAL SCLEROSIS OSTEOMALACIA 12
SS HEPATIC CIRRHOSIS ANAEMIA 2
SS HEPATIC CIRRHOSIS ANGIODYSPLASIA 2
SS HEPATIC CIRRHOSIS BLOOD CREATININE INCREASED 2
SS HEPATIC CIRRHOSIS GLOMERULAR FILTRATION RATE DECREASED 2
SS HEPATIC CIRRHOSIS LARGE INTESTINAL HAEMORRHAGE 2
SS HEPATIC CIRRHOSIS PANCYTOPENIA 2
SS HEPATIC CIRRHOSIS RENAL IMPAIRMENT 2
SS HEPATIC CIRRHOSIS SPLENOMEGALY 2
SS HEPATIC CIRRHOSIS VARICES OESOPHAGEAL 2
SS HEPATITIS FANCONI SYNDROME ACQUIRED 1
SS HEPATITIS FOOT FRACTURE 1
SS HEPATITIS HYPOPHOSPHATAEMIA 1
SS HEPATITIS PAIN 1
SS HEPATITIS PROTEINURIA 1
SS HEPATITIS SWELLING 1
SS HEPATITIS B ABDOMINAL PAIN UPPER 2
SS HEPATITIS B AGITATED DEPRESSION 1
SS HEPATITIS B AMINOACIDURIA 3
SS HEPATITIS B BACK PAIN 2
SS HEPATITIS B BLOOD ALKALINE PHOSPHATASE INCREASED 8
SS HEPATITIS B BONE DISORDER 2
SS HEPATITIS B CHEST PAIN 10
SS HEPATITIS B DELUSION 1
SS HEPATITIS B DEPRESSED MOOD 1
SS HEPATITIS B DRUG INTOLERANCE 1
SS HEPATITIS B FANCONI SYNDROME 6
SS HEPATITIS B FANCONI SYNDROME ACQUIRED 4
SS HEPATITIS B FOOT FRACTURE 1
SS HEPATITIS B GAIT DISTURBANCE 3
SS HEPATITIS B HYPERPHOSPHATASAEMIA 2
SS HEPATITIS B HYPOPHOSPHATAEMIA 6
SS HEPATITIS B METABOLIC ACIDOSIS 3
SS HEPATITIS B MULTIPLE FRACTURES 11
SS HEPATITIS B OSTEOMALACIA 10
SS HEPATITIS B OSTEONECROSIS 3
SS HEPATITIS B OSTEOPOROSIS 3
SS HEPATITIS B PAIN 1
SS HEPATITIS B PAIN IN EXTREMITY 3
SS HEPATITIS B PELVIC FRACTURE 3
SS HEPATITIS B PROTEIN URINE PRESENT 3
SS HEPATITIS B PROTEINURIA 1
SS HEPATITIS B RENAL FAILURE 2
SS HEPATITIS B RENAL IMPAIRMENT 3
SS HEPATITIS B RENAL TUBULAR DISORDER 3
SS HEPATITIS B RIB FRACTURE 3
SS HEPATITIS B SPINAL COMPRESSION FRACTURE 3
SS HEPATITIS B SWELLING 1
SS HEPATITIS B URINE PHOSPHORUS DECREASED 3
SS HYPERTENSION BLOOD ALKALINE PHOSPHATASE INCREASED 4
SS HYPERTENSION CHEST PAIN 5
SS HYPERTENSION HYPERPHOSPHATASAEMIA 1
SS HYPERTENSION MULTIPLE FRACTURES 5
SS HYPERTENSION OSTEOMALACIA 4
SS PAIN BLOOD ALKALINE PHOSPHATASE INCREASED 4
SS PAIN CHEST PAIN 5
SS PAIN HYPERPHOSPHATASAEMIA 1
SS PAIN MULTIPLE FRACTURES 5
SS PAIN OSTEOMALACIA 4
SS PRODUCT USED FOR UNKNOWN INDICATION AMINOACIDURIA 1
SS PRODUCT USED FOR UNKNOWN INDICATION ELECTROLYTE IMBALANCE 1
SS PRODUCT USED FOR UNKNOWN INDICATION FANCONI SYNDROME 5
SS PRODUCT USED FOR UNKNOWN INDICATION FANCONI SYNDROME ACQUIRED 2
SS PRODUCT USED FOR UNKNOWN INDICATION GAIT DISTURBANCE 1
SS PRODUCT USED FOR UNKNOWN INDICATION HYPOPHOSPHATAEMIA 1
SS PRODUCT USED FOR UNKNOWN INDICATION METABOLIC ACIDOSIS 1
SS PRODUCT USED FOR UNKNOWN INDICATION MULTIPLE FRACTURES 1
SS PRODUCT USED FOR UNKNOWN INDICATION OSTEOMALACIA 1
SS PRODUCT USED FOR UNKNOWN INDICATION OSTEONECROSIS 1
SS PRODUCT USED FOR UNKNOWN INDICATION OSTEOPOROSIS 1
SS PRODUCT USED FOR UNKNOWN INDICATION PAIN IN EXTREMITY 1
SS PRODUCT USED FOR UNKNOWN INDICATION PELVIC FRACTURE 1
SS PRODUCT USED FOR UNKNOWN INDICATION PROTEIN URINE PRESENT 1
SS PRODUCT USED FOR UNKNOWN INDICATION RENAL IMPAIRMENT 2
SS PRODUCT USED FOR UNKNOWN INDICATION RENAL TUBULAR DISORDER 1
SS PRODUCT USED FOR UNKNOWN INDICATION RIB FRACTURE 1
SS PRODUCT USED FOR UNKNOWN INDICATION SPINAL COMPRESSION FRACTURE 1
SS PRODUCT USED FOR UNKNOWN INDICATION URINE PHOSPHORUS DECREASED 1
C EMPHYSEMA CALCIUM DEFICIENCY 2
C EMPHYSEMA MUSCLE ATROPHY 2
C EMPHYSEMA PRURITUS 2
C EMPHYSEMA RASH 2
C EMPHYSEMA SKIN EXFOLIATION 2
C EMPHYSEMA WEIGHT DECREASED 2
C PRODUCT USED FOR UNKNOWN INDICATION DEAFNESS 1
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 1
C PRODUCT USED FOR UNKNOWN INDICATION MALAISE 1
C PRODUCT USED FOR UNKNOWN INDICATION PANCYTOPENIA 8
C PRODUCT USED FOR UNKNOWN INDICATION PHARYNGITIS 1
C PULMONARY MYCOSIS PANCYTOPENIA 1
C ZYGOMYCOSIS PANCYTOPENIA 1
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