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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