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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