Drug information for ABACAVIR SULFATE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SOLUTION; ORAL
20MG
Tentative Approval
ABACAVIR SULFATE
abacavir
CIPLA LIMITED
78348
2011-02-18 Letter
TABLET; ORAL
60 MG
Tentative Approval
(Reference Drug)
ABACAVIR SULFATE
abacavir
MATRIX LABS LTD
200733
2010-12-03 Letter
TABLET; ORAL
60MG
Tentative Approval
ABACAVIR SULFATE
abacavir
AUROBINDO PHARMA
22293
2008-09-16 Letter
TABLET; ORAL
60MG
Tentative Approval
ABACAVIR SULFATE
abacavir
CIPLA LIMITED
22547
2011-03-08 Letter
TABLET; ORAL
300MG
Tentative Approval
ABACAVIR SULFATE
abacavir
CIPLA LIMITED
78119
2006-11-07 Letter
TABLET; ORAL
300MG
Tentative Approval
ABACAVIR SULFATE
abacavir
MATRIX LABS
78742
2007-04-20 Letter
TABLET; ORAL
300MG
Tentative Approval
ABACAVIR SULFATE
abacavir
STRIDES ARCOLAB LTD
91050
2010-05-17 Letter
TABLET; ORAL
300MG
Tentative Approval
ABACAVIR SULFATE
abacavir
MYLAN PHARMA
91294
TABLET; ORAL
300MG
Tentative Approval
ABACAVIR SULFATE
abacavir
INVAGEN PHARMS
91560
2010-10-04 Letter
Drug Adverse Effects information for ABACAVIR SULFATE
Role code
Indications
Reaction
# Reports
PS
PRODUCT USED FOR UNKNOWN INDICATION
MYOCARDIAL INFARCTION
1
SS
ANTIRETROVIRAL THERAPY
CACHEXIA
8
SS
ANTIRETROVIRAL THERAPY
CHRONIC FATIGUE SYNDROME
8
SS
ANTIRETROVIRAL THERAPY
DEPRESSION
8
SS
ANTIRETROVIRAL THERAPY
DYSLIPIDAEMIA
9
SS
ANTIRETROVIRAL THERAPY
FACIAL WASTING
8
SS
ANTIRETROVIRAL THERAPY
HYPOAESTHESIA
8
SS
ANTIRETROVIRAL THERAPY
LIPODYSTROPHY ACQUIRED
8
SS
ANTIRETROVIRAL THERAPY
TYPE 2 DIABETES MELLITUS
9
SS
ANTIRETROVIRAL THERAPY
VASODILATATION
8
SS
HAEMORRHAGE
DIZZINESS
2
SS
HAEMORRHAGE
FIBRIN DEGRADATION PRODUCTS INCREASED
2
SS
HAEMORRHAGE
HEPATIC FUNCTION ABNORMAL
2
SS
HAEMORRHAGE
INFLUENZA LIKE ILLNESS
2
SS
HAEMORRHAGE
NAUSEA
2
SS
HAEMORRHAGE
NERVOUS SYSTEM DISORDER
2
SS
HAEMORRHAGE
PALPITATIONS
2
SS
HAEMORRHAGE
PULMONARY HYPERTENSION
2
SS
HAEMORRHAGE
TREMOR
2
SS
HAEMORRHAGE
VISUAL IMPAIRMENT
2
SS
HEPATITIS C
DIZZINESS
4
SS
HEPATITIS C
FIBRIN DEGRADATION PRODUCTS INCREASED
4
SS
HEPATITIS C
HEPATIC FUNCTION ABNORMAL
4
SS
HEPATITIS C
INFLUENZA LIKE ILLNESS
4
SS
HEPATITIS C
NAUSEA
4
SS
HEPATITIS C
NERVOUS SYSTEM DISORDER
4
SS
HEPATITIS C
PALPITATIONS
4
SS
HEPATITIS C
PULMONARY HYPERTENSION
4
SS
HEPATITIS C
TREMOR
4
SS
HEPATITIS C
VISUAL IMPAIRMENT
4
SS
HIV INFECTION
DIZZINESS
28
SS
HIV INFECTION
FIBRIN DEGRADATION PRODUCTS INCREASED
28
SS
HIV INFECTION
HEPATIC FUNCTION ABNORMAL
28
SS
HIV INFECTION
INFLUENZA LIKE ILLNESS
28
SS
HIV INFECTION
NAUSEA
28
SS
HIV INFECTION
NERVOUS SYSTEM DISORDER
28
SS
HIV INFECTION
PALPITATIONS
28
SS
HIV INFECTION
PULMONARY HYPERTENSION
28
SS
HIV INFECTION
TREMOR
28
SS
HIV INFECTION
VISUAL IMPAIRMENT
28
SS
HYPERTENSION
DIZZINESS
4
SS
HYPERTENSION
FIBRIN DEGRADATION PRODUCTS INCREASED
4
SS
HYPERTENSION
HEPATIC FUNCTION ABNORMAL
4
SS
HYPERTENSION
INFLUENZA LIKE ILLNESS
4
SS
HYPERTENSION
NAUSEA
4
SS
HYPERTENSION
NERVOUS SYSTEM DISORDER
4
SS
HYPERTENSION
PALPITATIONS
4
SS
HYPERTENSION
PULMONARY HYPERTENSION
4
SS
HYPERTENSION
TREMOR
4
SS
HYPERTENSION
VISUAL IMPAIRMENT
4
C
ALCOHOLIC LIVER DISEASE
DIARRHOEA
4
C
ALCOHOLIC LIVER DISEASE
RENAL FAILURE ACUTE
4
C
ALCOHOLIC LIVER DISEASE
RHABDOMYOLYSIS
4
C
ASCITES
DIARRHOEA
3
C
ASCITES
RENAL FAILURE ACUTE
3
C
ASCITES
RHABDOMYOLYSIS
3
C
EPILEPSY
FALL
1
C
EPILEPSY
SOMNOLENCE
1
C
EPILEPSY
SUICIDAL IDEATION
1
C
HEPATITIS C
CHOLECYSTECTOMY
1
C
HEPATITIS C
CHOLELITHIASIS
1
C
HEPATITIS C
PANCREATITIS
1
C
HIV INFECTION
ASTHENIA
7
C
HIV INFECTION
CHOLECYSTECTOMY
1
C
HIV INFECTION
CHOLELITHIASIS
1
C
HIV INFECTION
CRANIOCEREBRAL INJURY
4
C
HIV INFECTION
DEEP VEIN THROMBOSIS
7
C
HIV INFECTION
DIARRHOEA
7
C
HIV INFECTION
ELECTROENCEPHALOGRAM ABNORMAL
4
C
HIV INFECTION
FALL
4
C
HIV INFECTION
FIBRIN D DIMER INCREASED
2
C
HIV INFECTION
HIV TEST POSITIVE
4
C
HIV INFECTION
HYPOKINESIA
4
C
HIV INFECTION
INJECTION SITE ERYTHEMA
2
C
HIV INFECTION
INTERNATIONAL NORMALISED RATIO INCREASED
2
C
HIV INFECTION
MAJOR DEPRESSION
4
C
HIV INFECTION
NAUSEA
7
C
HIV INFECTION
OEDEMA PERIPHERAL
7
C
HIV INFECTION
PAIN IN EXTREMITY
7
C
HIV INFECTION
PANCREATITIS
1
C
HIV INFECTION
PHLEBITIS
2
C
HIV INFECTION
PHLEBOTOMY
4
C
HIV INFECTION
PULMONARY EMBOLISM
2
C
HIV INFECTION
RENAL FAILURE ACUTE
7
C
HIV INFECTION
RHABDOMYOLYSIS
7
C
HIV INFECTION
SOMNOLENCE
4
C
HIV INFECTION
SUICIDAL IDEATION
4
C
HIV TEST POSITIVE
FALL
4
C
HIV TEST POSITIVE
SOMNOLENCE
4
C
HIV TEST POSITIVE
SUICIDAL IDEATION
4
C
PNEUMOCYSTIS JIROVECI PNEUMONIA
DIARRHOEA
1
C
PNEUMOCYSTIS JIROVECI PNEUMONIA
RENAL FAILURE ACUTE
1
C
PNEUMOCYSTIS JIROVECI PNEUMONIA
RHABDOMYOLYSIS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
CHOLECYSTECTOMY
2
C
PRODUCT USED FOR UNKNOWN INDICATION
CHOLELITHIASIS
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DIARRHOEA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
FALL
6
C
PRODUCT USED FOR UNKNOWN INDICATION
PANCREATITIS
2
C
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE ACUTE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
RHABDOMYOLYSIS
2
C
PRODUCT USED FOR UNKNOWN INDICATION
SOMNOLENCE
6
C
PRODUCT USED FOR UNKNOWN INDICATION
SUICIDAL IDEATION
6
C
PULMONARY ARTERIAL HYPERTENSION
ABDOMINAL PAIN
1
C
PULMONARY ARTERIAL HYPERTENSION
CONSTIPATION
1
C
SYPHILIS
DIARRHOEA
1
C
SYPHILIS
RENAL FAILURE ACUTE
1
C
SYPHILIS
RHABDOMYOLYSIS
1
C
TOXOPLASMOSIS PROPHYLAXIS
DIARRHOEA
1
C
TOXOPLASMOSIS PROPHYLAXIS
RENAL FAILURE ACUTE
1
C
TOXOPLASMOSIS PROPHYLAXIS
RHABDOMYOLYSIS
1
C
TYPE 1 DIABETES MELLITUS
FALL
2
C
TYPE 1 DIABETES MELLITUS
SOMNOLENCE
2
C
TYPE 1 DIABETES MELLITUS
SUICIDAL IDEATION
2
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