Drug information for LEXIVA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SUSPENSION; ORAL
EQ 50MG BASE/ML
Prescription
(Reference Drug)
FOSAMPRENAVIR CALCIUM
fosamprenavir
VIIV HLTHCARE
22116
2012-05-02 Letter
2012-05-01 Label
2012-02-27 Letter
2012-02-22 Label
2011-05-16 Letter
2011-05-16 Label
2010-05-03 Label
2010-04-29 Letter
2009-11-10 Review
2009-10-26 Letter
2009-09-18 Label
2009-04-20 Letter
2008-05-05 Letter
2008-03-07 Letter
2008-03-07 Label
2007-07-05 Letter
2007-06-18 Label
TABLET; ORAL
EQ 700MG BASE
Prescription
(Reference Drug)
FOSAMPRENAVIR CALCIUM
fosamprenavir
VIIV HLTHCARE
21548
2012-05-02 Letter
2012-05-01 Label
2012-02-27 Letter
2012-02-22 Label
2011-05-16 Label
2011-05-16 Letter
2010-05-03 Label
2010-04-29 Letter
2009-10-26 Letter
2009-09-18 Label
2009-04-20 Letter
2008-05-05 Letter
2008-03-07 Label
2008-03-07 Letter
2008-02-25 Label
2008-02-22 Letter
2008-01-09 Letter
2008-01-09 Letter
2007-12-27 Label
2007-12-14 Label
2007-10-22 Letter
2007-10-15 Label
2007-02-21 Label
2007-02-12 Letter
2006-11-22 Letter
2006-11-16 Label
2006-08-09 Letter
2006-08-09 Label
2006-05-16 Letter
2006-05-16 Label
2006-03-23 Letter
2006-03-14 Label
2005-11-18 Letter
2005-11-17 Label
2005-06-14 Label
2005-06-14 Letter
2004-12-03 Label
2004-12-02 Letter
2004-10-26 Review
2003-10-27 Label
2003-10-27 Letter
Drug Adverse Effects information for LEXIVA
Role code
Indications
Reaction
# Reports
PS
ACQUIRED IMMUNODEFICIENCY SYNDROME
DISSEMINATED TUBERCULOSIS
8
PS
ACQUIRED IMMUNODEFICIENCY SYNDROME
IMMUNE RECONSTITUTION SYNDROME
8
PS
ACQUIRED IMMUNODEFICIENCY SYNDROME
LUNG INFECTION
8
PS
FACTOR VIII DEFICIENCY
MUSCLE HAEMORRHAGE
1
PS
HIV INFECTION
ABDOMINAL DISCOMFORT
8
PS
HIV INFECTION
ABNORMAL DREAMS
2
PS
HIV INFECTION
ANXIETY
2
PS
HIV INFECTION
BLOOD PRESSURE INCREASED
2
PS
HIV INFECTION
CONFUSIONAL STATE
2
PS
HIV INFECTION
DIABETIC KETOACIDOSIS
1
PS
HIV INFECTION
DIARRHOEA
1
PS
HIV INFECTION
DIZZINESS
2
PS
HIV INFECTION
HEADACHE
2
PS
HIV INFECTION
HEPATIC FUNCTION ABNORMAL
2
PS
HIV INFECTION
HYPOTENSION
2
PS
HIV INFECTION
JOINT STIFFNESS
2
PS
HIV INFECTION
MUSCLE HAEMORRHAGE
3
PS
HIV INFECTION
MYALGIA
2
PS
HIV INFECTION
NAUSEA
2
PS
HIV INFECTION
RASH
2
PS
HIV INFECTION
RASH MACULAR
2
PS
HIV INFECTION
SOMNOLENCE
1
PS
HIV INFECTION
VISION BLURRED
2
SS
ABDOMINAL DISCOMFORT
GASTROINTESTINAL DISORDER
4
SS
ABDOMINAL DISCOMFORT
HERPES ZOSTER
4
SS
DIARRHOEA
GASTROINTESTINAL DISORDER
2
SS
DIARRHOEA
HERPES ZOSTER
2
SS
HERPES ZOSTER
GASTROINTESTINAL DISORDER
4
SS
HERPES ZOSTER
HERPES ZOSTER
4
SS
HIV INFECTION
ABDOMINAL DISCOMFORT
8
SS
HIV INFECTION
ANAL FISTULA
5
SS
HIV INFECTION
CALCULUS URINARY
5
SS
HIV INFECTION
GASTROINTESTINAL DISORDER
8
SS
HIV INFECTION
HERPES ZOSTER
8
SS
HIV INFECTION
RENAL FAILURE ACUTE
5
SS
POSTOPERATIVE CARE
ANAL FISTULA
1
SS
POSTOPERATIVE CARE
CALCULUS URINARY
1
SS
POSTOPERATIVE CARE
RENAL FAILURE ACUTE
1
SS
PROCEDURAL PAIN
ANAL FISTULA
1
SS
PROCEDURAL PAIN
CALCULUS URINARY
1
SS
PROCEDURAL PAIN
RENAL FAILURE ACUTE
1
SS
SCHIZOPHRENIA
ANAL FISTULA
1
SS
SCHIZOPHRENIA
CALCULUS URINARY
1
SS
SCHIZOPHRENIA
RENAL FAILURE ACUTE
1
C
BACK PAIN
AGITATION
2
C
BACK PAIN
DRUG DOSE OMISSION
2
C
BACK PAIN
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
BACK PAIN
HYPERHIDROSIS
2
C
BACK PAIN
MOOD ALTERED
2
C
BACK PAIN
NERVOUSNESS
2
C
BACK PAIN
PAIN
2
C
BACK PAIN
PRODUCT QUALITY ISSUE
2
C
BACK PAIN
WITHDRAWAL SYNDROME
2
C
DEPRESSION
AGITATION
1
C
DEPRESSION
DRUG DOSE OMISSION
1
C
DEPRESSION
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
DEPRESSION
HYPERHIDROSIS
1
C
DEPRESSION
MOOD ALTERED
1
C
DEPRESSION
NERVOUSNESS
1
C
DEPRESSION
PAIN
1
C
DEPRESSION
PRODUCT QUALITY ISSUE
1
C
DEPRESSION
WITHDRAWAL SYNDROME
1
C
EXOSTOSIS
AGITATION
2
C
EXOSTOSIS
DRUG DOSE OMISSION
2
C
EXOSTOSIS
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
EXOSTOSIS
HYPERHIDROSIS
2
C
EXOSTOSIS
MOOD ALTERED
2
C
EXOSTOSIS
NERVOUSNESS
2
C
EXOSTOSIS
PAIN
2
C
EXOSTOSIS
PRODUCT QUALITY ISSUE
2
C
EXOSTOSIS
WITHDRAWAL SYNDROME
2
C
HAEMORRHAGE
DIZZINESS
1
C
HAEMORRHAGE
FIBRIN DEGRADATION PRODUCTS INCREASED
1
C
HAEMORRHAGE
HEPATIC FUNCTION ABNORMAL
1
C
HAEMORRHAGE
INFLUENZA LIKE ILLNESS
1
C
HAEMORRHAGE
NAUSEA
1
C
HAEMORRHAGE
NERVOUS SYSTEM DISORDER
1
C
HAEMORRHAGE
PALPITATIONS
1
C
HAEMORRHAGE
PULMONARY HYPERTENSION
1
C
HAEMORRHAGE
TREMOR
1
C
HAEMORRHAGE
VISUAL IMPAIRMENT
1
C
HEPATITIS C
DIZZINESS
2
C
HEPATITIS C
FIBRIN DEGRADATION PRODUCTS INCREASED
2
C
HEPATITIS C
HEPATIC FUNCTION ABNORMAL
2
C
HEPATITIS C
INFLUENZA LIKE ILLNESS
2
C
HEPATITIS C
NAUSEA
2
C
HEPATITIS C
NERVOUS SYSTEM DISORDER
2
C
HEPATITIS C
PALPITATIONS
2
C
HEPATITIS C
PULMONARY HYPERTENSION
2
C
HEPATITIS C
TREMOR
2
C
HEPATITIS C
VISUAL IMPAIRMENT
2
C
HIV INFECTION
ABDOMINAL DISCOMFORT
3
C
HIV INFECTION
ABDOMINAL DISTENSION
1
C
HIV INFECTION
BACK PAIN
3
C
HIV INFECTION
DIZZINESS
14
C
HIV INFECTION
ERECTILE DYSFUNCTION
3
C
HIV INFECTION
FIBRIN DEGRADATION PRODUCTS INCREASED
14
C
HIV INFECTION
HEPATIC FUNCTION ABNORMAL
14
C
HIV INFECTION
HYPOKINESIA
3
C
HIV INFECTION
INCORRECT DOSE ADMINISTERED
1
C
HIV INFECTION
INFLUENZA LIKE ILLNESS
14
C
HIV INFECTION
INSOMNIA
3
C
HIV INFECTION
NASAL CONGESTION
3
C
HIV INFECTION
NAUSEA
15
C
HIV INFECTION
NERVOUS SYSTEM DISORDER
14
C
HIV INFECTION
NEUROPATHY PERIPHERAL
3
C
HIV INFECTION
PALPITATIONS
14
C
HIV INFECTION
PRURITUS
3
C
HIV INFECTION
PULMONARY HYPERTENSION
14
C
HIV INFECTION
TREMOR
14
C
HIV INFECTION
VISUAL IMPAIRMENT
14
C
HIV TEST POSITIVE
AGITATION
3
C
HIV TEST POSITIVE
DRUG DOSE OMISSION
3
C
HIV TEST POSITIVE
GENERAL PHYSICAL HEALTH DETERIORATION
3
C
HIV TEST POSITIVE
HYPERHIDROSIS
3
C
HIV TEST POSITIVE
MOOD ALTERED
3
C
HIV TEST POSITIVE
NERVOUSNESS
3
C
HIV TEST POSITIVE
PAIN
3
C
HIV TEST POSITIVE
PRODUCT QUALITY ISSUE
3
C
HIV TEST POSITIVE
WITHDRAWAL SYNDROME
3
C
HYPERTENSION
DIZZINESS
2
C
HYPERTENSION
FIBRIN DEGRADATION PRODUCTS INCREASED
2
C
HYPERTENSION
HEPATIC FUNCTION ABNORMAL
2
C
HYPERTENSION
INFLUENZA LIKE ILLNESS
2
C
HYPERTENSION
NAUSEA
2
C
HYPERTENSION
NERVOUS SYSTEM DISORDER
2
C
HYPERTENSION
PALPITATIONS
2
C
HYPERTENSION
PULMONARY HYPERTENSION
2
C
HYPERTENSION
TREMOR
2
C
HYPERTENSION
VISUAL IMPAIRMENT
2
C
IRON METABOLISM DISORDER
ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE
1
C
IRON METABOLISM DISORDER
HIV INFECTION
1
C
IRON METABOLISM DISORDER
PLEURAL EFFUSION
1
C
IRON METABOLISM DISORDER
STAPHYLOCOCCAL BACTERAEMIA
1
C
MUSCLE SPASMS
AGITATION
2
C
MUSCLE SPASMS
DRUG DOSE OMISSION
2
C
MUSCLE SPASMS
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
MUSCLE SPASMS
HYPERHIDROSIS
2
C
MUSCLE SPASMS
MOOD ALTERED
2
C
MUSCLE SPASMS
NERVOUSNESS
2
C
MUSCLE SPASMS
PAIN
2
C
MUSCLE SPASMS
PRODUCT QUALITY ISSUE
2
C
MUSCLE SPASMS
WITHDRAWAL SYNDROME
2
C
OSTEOARTHRITIS
ABDOMINAL DISCOMFORT
1
C
OSTEOARTHRITIS
BACK PAIN
1
C
OSTEOARTHRITIS
ERECTILE DYSFUNCTION
1
C
OSTEOARTHRITIS
HYPOKINESIA
1
C
OSTEOARTHRITIS
INSOMNIA
1
C
OSTEOARTHRITIS
NASAL CONGESTION
1
C
OSTEOARTHRITIS
NEUROPATHY PERIPHERAL
1
C
OSTEOARTHRITIS
PRURITUS
1
C
PAIN
AGITATION
1
C
PAIN
DRUG DOSE OMISSION
1
C
PAIN
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
PAIN
HYPERHIDROSIS
1
C
PAIN
MOOD ALTERED
1
C
PAIN
NERVOUSNESS
1
C
PAIN
PAIN
1
C
PAIN
PRODUCT QUALITY ISSUE
1
C
PAIN
WITHDRAWAL SYNDROME
1
C
PAIN IN EXTREMITY
AGITATION
2
C
PAIN IN EXTREMITY
DRUG DOSE OMISSION
2
C
PAIN IN EXTREMITY
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
PAIN IN EXTREMITY
HYPERHIDROSIS
2
C
PAIN IN EXTREMITY
MOOD ALTERED
2
C
PAIN IN EXTREMITY
NERVOUSNESS
2
C
PAIN IN EXTREMITY
PAIN
2
C
PAIN IN EXTREMITY
PRODUCT QUALITY ISSUE
2
C
PAIN IN EXTREMITY
WITHDRAWAL SYNDROME
2
C
POLLAKIURIA
ABDOMINAL DISCOMFORT
2
C
POLLAKIURIA
BACK PAIN
2
C
POLLAKIURIA
ERECTILE DYSFUNCTION
2
C
POLLAKIURIA
HYPOKINESIA
2
C
POLLAKIURIA
INSOMNIA
2
C
POLLAKIURIA
NASAL CONGESTION
2
C
POLLAKIURIA
NEUROPATHY PERIPHERAL
2
C
POLLAKIURIA
PRURITUS
2
C
PULMONARY ARTERIAL HYPERTENSION
NAUSEA
2
C
PULMONARY ARTERIAL HYPERTENSION
PNEUMONIA
2
C
PULMONARY ARTERIAL HYPERTENSION
STOMATITIS
2
C
PULMONARY ARTERIAL HYPERTENSION
TREATMENT NONCOMPLIANCE
2
C
ROAD TRAFFIC ACCIDENT
AGITATION
2
C
ROAD TRAFFIC ACCIDENT
DRUG DOSE OMISSION
2
C
ROAD TRAFFIC ACCIDENT
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
ROAD TRAFFIC ACCIDENT
HYPERHIDROSIS
2
C
ROAD TRAFFIC ACCIDENT
MOOD ALTERED
2
C
ROAD TRAFFIC ACCIDENT
NERVOUSNESS
2
C
ROAD TRAFFIC ACCIDENT
PAIN
2
C
ROAD TRAFFIC ACCIDENT
PRODUCT QUALITY ISSUE
2
C
ROAD TRAFFIC ACCIDENT
WITHDRAWAL SYNDROME
2
C
SPINAL OSTEOARTHRITIS
AGITATION
2
C
SPINAL OSTEOARTHRITIS
DRUG DOSE OMISSION
2
C
SPINAL OSTEOARTHRITIS
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
SPINAL OSTEOARTHRITIS
HYPERHIDROSIS
2
C
SPINAL OSTEOARTHRITIS
MOOD ALTERED
2
C
SPINAL OSTEOARTHRITIS
NERVOUSNESS
2
C
SPINAL OSTEOARTHRITIS
PAIN
2
C
SPINAL OSTEOARTHRITIS
PRODUCT QUALITY ISSUE
2
C
SPINAL OSTEOARTHRITIS
WITHDRAWAL SYNDROME
2
C
SUPPLEMENTATION THERAPY
ABDOMINAL DISCOMFORT
1
C
SUPPLEMENTATION THERAPY
BACK PAIN
1
C
SUPPLEMENTATION THERAPY
ERECTILE DYSFUNCTION
1
C
SUPPLEMENTATION THERAPY
HYPOKINESIA
1
C
SUPPLEMENTATION THERAPY
INSOMNIA
1
C
SUPPLEMENTATION THERAPY
NASAL CONGESTION
1
C
SUPPLEMENTATION THERAPY
NEUROPATHY PERIPHERAL
1
C
SUPPLEMENTATION THERAPY
PRURITUS
1
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