Drug information for ZIAGEN
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SOLUTION; ORAL
EQ 20MG BASE/ML
Prescription
(Reference Drug)
ABACAVIR SULFATE
abacavir
VIIV HLTHCARE
20978
2012-03-19 Letter
2012-03-16 Label
2011-11-22 Label
2011-11-22 Letter
2011-05-17 Letter
2010-09-01 Other
2010-08-10 Letter
2010-08-10 Medication Guide
2009-12-18 Other
2009-08-25 Letter
2009-08-25 Letter
2009-01-02 Label
2008-12-29 Letter
2008-07-23 Letter
2008-07-22 Label
2007-09-26 Review
2007-09-26 Review
2007-09-26 Review
2007-05-09 Label
2007-05-09 Letter
2007-02-28 Medication Guide
2006-08-21 Letter
2006-08-14 Label
2004-08-05 Label
2004-08-05 Letter
2004-07-28 Letter
2004-07-28 Label
2004-05-03 Label
2004-04-20 Letter
2004-04-14 Review
2003-12-17 Medication Guide
2003-12-12 Other Important Information from FDA
2003-09-25 Label
2003-07-28 Letter
2002-10-02 Label
2002-10-02 Letter
2002-08-14 Label
2002-08-14 Letter
2002-01-28 Letter
1998-12-17 Review
1998-12-17 Letter
1998-12-17 Label
TABLET; ORAL
EQ 300MG BASE
Prescription
(Reference Drug)
ABACAVIR SULFATE
abacavir
VIIV HLTHCARE
20977
2012-03-19 Letter
2012-03-16 Label
2011-11-22 Label
2011-11-22 Letter
2011-05-17 Letter
2010-09-01 Other
2010-08-10 Letter
2010-08-10 Medication Guide
2009-12-18 Other
2009-08-25 Letter
2009-08-25 Letter
2009-01-02 Label
2008-12-29 Letter
2008-07-23 Letter
2008-07-22 Label
2007-09-26 Review
2007-09-26 Review
2007-05-09 Label
2007-05-09 Letter
2007-02-28 Medication Guide
2006-08-21 Letter
2006-08-14 Label
2004-08-05 Label
2004-08-05 Letter
2004-07-28 Label
2004-07-28 Letter
2004-05-03 Label
2004-04-20 Letter
2004-04-14 Review
2003-12-12 Other Important Information from FDA
2003-09-25 Label
2003-07-28 Letter
2002-10-02 Label
2002-10-02 Letter
2002-08-14 Label
2002-08-14 Letter
2002-01-28 Letter
1998-12-17 Letter
1998-12-17 Review
1998-12-17 Label
Drug Adverse Effects information for ZIAGEN
Role code
Indications
Reaction
# Reports
PS
ANTIRETROVIRAL THERAPY
ABORTION SPONTANEOUS
6
PS
ANTIRETROVIRAL THERAPY
CERVIX OPERATION
6
PS
ANTIRETROVIRAL THERAPY
MATERNAL EXPOSURE DURING PREGNANCY
6
PS
ANTIRETROVIRAL THERAPY
NORMAL LABOUR
6
PS
ANTIRETROVIRAL THERAPY
PYREXIA
6
PS
ANTIRETROVIRAL THERAPY
RASH
6
PS
ANTIRETROVIRAL THERAPY
VAGINAL HAEMORRHAGE
6
PS
ANTIVIRAL TREATMENT
ABORTION SPONTANEOUS
3
PS
ANTIVIRAL TREATMENT
MATERNAL EXPOSURE DURING PREGNANCY
3
PS
HIV INFECTION
CARDIAC FAILURE
3
SS
ANTIRETROVIRAL THERAPY
ABORTION SPONTANEOUS
6
SS
ANTIRETROVIRAL THERAPY
MATERNAL EXPOSURE DURING PREGNANCY
6
SS
ANTIRETROVIRAL THERAPY
PREGNANCY
6
SS
DEPRESSION
GOUT
1
SS
DIARRHOEA
GOUT
3
SS
DRUG ABUSE
ABORTION SPONTANEOUS
1
SS
DRUG ABUSE
MATERNAL EXPOSURE DURING PREGNANCY
1
SS
DRUG ABUSE
PYREXIA
1
SS
DRUG ABUSE
RASH
1
SS
FOETAL EXPOSURE DURING PREGNANCY
ABORTION SPONTANEOUS
8
SS
FOETAL EXPOSURE DURING PREGNANCY
CELL DEATH
8
SS
FOETAL EXPOSURE DURING PREGNANCY
EXOMPHALOS
8
SS
FOETAL EXPOSURE DURING PREGNANCY
MATERNAL DRUGS AFFECTING FOETUS
8
SS
FOETAL EXPOSURE DURING PREGNANCY
MATERNAL EXPOSURE DURING PREGNANCY
8
SS
HAEMARTHROSIS
ALANINE AMINOTRANSFERASE INCREASED
1
SS
HAEMARTHROSIS
ASPARTATE AMINOTRANSFERASE INCREASED
1
SS
HAEMARTHROSIS
DIZZINESS
1
SS
HAEMARTHROSIS
PALPITATIONS
1
SS
HAEMARTHROSIS
PULMONARY HYPERTENSION
1
SS
HIV INFECTION
ABORTION SPONTANEOUS
6
SS
HIV INFECTION
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS
3
SS
HIV INFECTION
ALANINE AMINOTRANSFERASE INCREASED
8
SS
HIV INFECTION
ANAL FISTULA
10
SS
HIV INFECTION
APHASIA
3
SS
HIV INFECTION
APPARENT LIFE THREATENING EVENT
10
SS
HIV INFECTION
ASPARTATE AMINOTRANSFERASE INCREASED
8
SS
HIV INFECTION
ASTHENIA
3
SS
HIV INFECTION
BODY TEMPERATURE INCREASED
12
SS
HIV INFECTION
CALCULUS URINARY
10
SS
HIV INFECTION
CYTOLYTIC HEPATITIS
3
SS
HIV INFECTION
DIZZINESS
18
SS
HIV INFECTION
ENDOLYMPHATIC HYDROPS
10
SS
HIV INFECTION
EOSINOPHILIA
3
SS
HIV INFECTION
GOUT
3
SS
HIV INFECTION
GYNAECOMASTIA
10
SS
HIV INFECTION
HYPERAEMIA
12
SS
HIV INFECTION
HYPERSENSITIVITY
12
SS
HIV INFECTION
INFLAMMATION
3
SS
HIV INFECTION
LEUKOCYTOSIS
3
SS
HIV INFECTION
LYMPHADENOPATHY
3
SS
HIV INFECTION
MATERNAL EXPOSURE DURING PREGNANCY
18
SS
HIV INFECTION
MENIERE'S DISEASE
10
SS
HIV INFECTION
NEUTROPENIA
2
SS
HIV INFECTION
ODYNOPHAGIA
3
SS
HIV INFECTION
ORAL MUCOSA EROSION
3
SS
HIV INFECTION
PALPITATIONS
18
SS
HIV INFECTION
PANCREATITIS
10
SS
HIV INFECTION
PERICARDITIS
3
SS
HIV INFECTION
PULMONARY HYPERTENSION
18
SS
HIV INFECTION
PYREXIA
9
SS
HIV INFECTION
RASH
9
SS
HIV INFECTION
RASH GENERALISED
15
SS
HIV INFECTION
RASH MACULAR
3
SS
HIV INFECTION
RASH MORBILLIFORM
3
SS
HIV INFECTION
RASH PRURITIC
3
SS
HIV INFECTION
RASH PUSTULAR
3
SS
HIV INFECTION
RENAL FAILURE ACUTE
13
SS
HIV INFECTION
SEBORRHOEIC DERMATITIS
3
SS
HIV INFECTION
STOMATITIS
3
SS
HIV INFECTION
THROMBOCYTOPENIA
3
SS
HYPERLIPIDAEMIA
GOUT
2
SS
INSOMNIA
GOUT
3
SS
MATERNAL EXPOSURE TIMING UNSPECIFIED
ABORTION SPONTANEOUS
6
SS
MATERNAL EXPOSURE TIMING UNSPECIFIED
DEATH
6
SS
MATERNAL EXPOSURE TIMING UNSPECIFIED
EXOMPHALOS
6
SS
MATERNAL EXPOSURE TIMING UNSPECIFIED
FOETAL EXPOSURE DURING PREGNANCY
6
SS
MATERNAL EXPOSURE TIMING UNSPECIFIED
PREMATURE RUPTURE OF MEMBRANES
6
SS
MYCOBACTERIUM TEST
GOUT
1
SS
POSTOPERATIVE CARE
ANAL FISTULA
2
SS
POSTOPERATIVE CARE
CALCULUS URINARY
2
SS
POSTOPERATIVE CARE
RENAL FAILURE ACUTE
2
SS
PROCEDURAL PAIN
ANAL FISTULA
2
SS
PROCEDURAL PAIN
CALCULUS URINARY
2
SS
PROCEDURAL PAIN
RENAL FAILURE ACUTE
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
ABORTION SPONTANEOUS
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
APHASIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
ASTHENIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
CYTOLYTIC HEPATITIS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
EOSINOPHILIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
INFLAMMATION
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
LEUKOCYTOSIS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
LYMPHADENOPATHY
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
MATERNAL EXPOSURE DURING PREGNANCY
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
NEUTROPENIA
3
SS
PRODUCT USED FOR UNKNOWN INDICATION
ODYNOPHAGIA
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
ORAL MUCOSA EROSION
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
PERICARDITIS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
PREGNANCY
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
PYREXIA
5
SS
PRODUCT USED FOR UNKNOWN INDICATION
RASH
5
SS
PRODUCT USED FOR UNKNOWN INDICATION
RASH GENERALISED
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
RASH MACULAR
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
RASH MORBILLIFORM
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
RASH PRURITIC
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
RASH PUSTULAR
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE ACUTE
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
SEBORRHOEIC DERMATITIS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
STOMATITIS
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
THROMBOCYTOPENIA
4
SS
SCHIZOPHRENIA
ANAL FISTULA
2
SS
SCHIZOPHRENIA
CALCULUS URINARY
2
SS
SCHIZOPHRENIA
RENAL FAILURE ACUTE
2
C
ANTIBIOTIC PROPHYLAXIS
CONVULSION
1
C
ANTIVIRAL TREATMENT
ABORTION SPONTANEOUS
3
C
CORONARY ARTERY BYPASS
ANHEDONIA
2
C
CORONARY ARTERY BYPASS
ANXIETY
2
C
CORONARY ARTERY BYPASS
CARDIAC DISORDER
2
C
CORONARY ARTERY BYPASS
CEREBROVASCULAR ACCIDENT
2
C
CORONARY ARTERY BYPASS
DEATH
2
C
CORONARY ARTERY BYPASS
DEPRESSION
2
C
CORONARY ARTERY BYPASS
FEAR
2
C
CORONARY ARTERY BYPASS
INJURY
2
C
CORONARY ARTERY BYPASS
ORGAN FAILURE
2
C
CORONARY ARTERY BYPASS
PAIN
2
C
CORONARY ARTERY BYPASS
RENAL FAILURE
2
C
CORONARY ARTERY BYPASS
RENAL IMPAIRMENT
2
C
CORONARY ARTERY BYPASS
RENAL INJURY
2
C
CORONARY ARTERY BYPASS
UNEVALUABLE EVENT
2
C
CYTOMEGALOVIRUS CHORIORETINITIS
BLOOD ALKALINE PHOSPHATASE INCREASED
2
C
CYTOMEGALOVIRUS CHORIORETINITIS
BRONCHOPULMONARY ASPERGILLOSIS
2
C
CYTOMEGALOVIRUS CHORIORETINITIS
CYTOMEGALOVIRUS CHORIORETINITIS
2
C
CYTOMEGALOVIRUS CHORIORETINITIS
GAMMA-GLUTAMYLTRANSFERASE INCREASED
2
C
CYTOMEGALOVIRUS CHORIORETINITIS
LYMPHOMA
2
C
CYTOMEGALOVIRUS CHORIORETINITIS
PLATELET COUNT DECREASED
2
C
EPILEPSY
CONVULSION
1
C
HIV INFECTION
ABORTION INDUCED
5
C
HIV INFECTION
ABORTION SPONTANEOUS
6
C
HIV INFECTION
BLOOD ALKALINE PHOSPHATASE INCREASED
12
C
HIV INFECTION
BRONCHOPULMONARY ASPERGILLOSIS
12
C
HIV INFECTION
CONVULSION
3
C
HIV INFECTION
CYTOMEGALOVIRUS CHORIORETINITIS
12
C
HIV INFECTION
DEPRESSION
2
C
HIV INFECTION
ECZEMA
2
C
HIV INFECTION
FANCONI SYNDROME
5
C
HIV INFECTION
GAMMA-GLUTAMYLTRANSFERASE INCREASED
12
C
HIV INFECTION
GENERAL PHYSICAL HEALTH DETERIORATION
5
C
HIV INFECTION
HIDRADENITIS
1
C
HIV INFECTION
LIPODYSTROPHY ACQUIRED
2
C
HIV INFECTION
LIPOHYPERTROPHY
2
C
HIV INFECTION
LYMPHOMA
12
C
HIV INFECTION
PHARYNGOTONSILLITIS
2
C
HIV INFECTION
PLATELET COUNT DECREASED
12
C
HIV INFECTION
RASH
5
C
HIV INFECTION
RENAL FAILURE ACUTE
5
C
HIV INFECTION
RENAL TUBULAR DISORDER
5
C
HIV INFECTION
SINUSITIS
2
C
HIV INFECTION
SQUAMOUS CELL CARCINOMA
4
C
HIV INFECTION
SUICIDE ATTEMPT
2
C
MITRAL VALVE REPAIR
ANHEDONIA
1
C
MITRAL VALVE REPAIR
ANXIETY
1
C
MITRAL VALVE REPAIR
CARDIAC DISORDER
1
C
MITRAL VALVE REPAIR
CEREBROVASCULAR ACCIDENT
1
C
MITRAL VALVE REPAIR
DEATH
1
C
MITRAL VALVE REPAIR
DEPRESSION
1
C
MITRAL VALVE REPAIR
FEAR
1
C
MITRAL VALVE REPAIR
INJURY
1
C
MITRAL VALVE REPAIR
ORGAN FAILURE
1
C
MITRAL VALVE REPAIR
PAIN
1
C
MITRAL VALVE REPAIR
RENAL FAILURE
1
C
MITRAL VALVE REPAIR
RENAL IMPAIRMENT
1
C
MITRAL VALVE REPAIR
RENAL INJURY
1
C
MITRAL VALVE REPAIR
UNEVALUABLE EVENT
1
C
NEUROPATHY PERIPHERAL
CONVULSION
1
C
OPPORTUNISTIC INFECTION PROPHYLAXIS
BLOOD ALKALINE PHOSPHATASE INCREASED
2
C
OPPORTUNISTIC INFECTION PROPHYLAXIS
BRONCHOPULMONARY ASPERGILLOSIS
2
C
OPPORTUNISTIC INFECTION PROPHYLAXIS
CYTOMEGALOVIRUS CHORIORETINITIS
2
C
OPPORTUNISTIC INFECTION PROPHYLAXIS
GAMMA-GLUTAMYLTRANSFERASE INCREASED
2
C
OPPORTUNISTIC INFECTION PROPHYLAXIS
LYMPHOMA
2
C
OPPORTUNISTIC INFECTION PROPHYLAXIS
PLATELET COUNT DECREASED
2
C
PRODUCT USED FOR UNKNOWN INDICATION
ABORTION INDUCED
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ABORTION SPONTANEOUS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
FANCONI SYNDROME
3
C
PRODUCT USED FOR UNKNOWN INDICATION
GENERAL PHYSICAL HEALTH DETERIORATION
3
C
PRODUCT USED FOR UNKNOWN INDICATION
RASH
1
C
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE ACUTE
3
C
PRODUCT USED FOR UNKNOWN INDICATION
RENAL TUBULAR DISORDER
3
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