Drug information for DIDANOSINE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, DELAYED REL PELLETS; ORAL 200MG Prescription AB  DIDANOSINE Didanosine BARR 77167
2004-12-06 Letter
CAPSULE, DELAYED REL PELLETS; ORAL 250MG Prescription AB  DIDANOSINE Didanosine BARR   "
CAPSULE, DELAYED REL PELLETS; ORAL 400MG Prescription AB  DIDANOSINE Didanosine BARR   "
CAPSULE, DELAYED REL PELLETS; ORAL 125MG Prescription AB  DIDANOSINE Didanosine AUROBINDO PHARMA 90094
2008-11-13 Other Important Information from FDA

2008-09-26 Letter
CAPSULE, DELAYED REL PELLETS; ORAL 200MG Prescription AB  DIDANOSINE Didanosine AUROBINDO PHARMA   "
CAPSULE, DELAYED REL PELLETS; ORAL 250MG Prescription AB  DIDANOSINE Didanosine AUROBINDO PHARMA   "
CAPSULE, DELAYED REL PELLETS; ORAL 400MG Prescription AB  DIDANOSINE Didanosine AUROBINDO PHARMA   "
CAPSULE, DELAYED REL PELLETS; ORAL 125MG Prescription AB  DIDANOSINE Didanosine MATRIX LABS LTD 90788
2010-04-13 Letter
CAPSULE, DELAYED REL PELLETS; ORAL 200MG Prescription AB  DIDANOSINE Didanosine MATRIX LABS LTD   "
CAPSULE, DELAYED REL PELLETS; ORAL 250MG Prescription AB  DIDANOSINE Didanosine MATRIX LABS LTD   "
CAPSULE, DELAYED REL PELLETS; ORAL 400MG Prescription AB  DIDANOSINE Didanosine MATRIX LABS LTD   "
FOR SOLUTION; ORAL 10MG/ML Prescription AA  DIDANOSINE Didanosine AUROBINDO PHARMA 78112
2007-03-15 Letter
TABLET, CHEWABLE; ORAL 100MG Tentative Approval   DIDANOSINE Didanosine AUROBINDO PHARMA LTD 77275
TABLET, CHEWABLE; ORAL 150MG Tentative Approval   DIDANOSINE Didanosine AUROBINDO PHARMA LTD   "
TABLET, CHEWABLE; ORAL 200MG Tentative Approval   DIDANOSINE Didanosine AUROBINDO PHARMA LTD   "

Drug Adverse Effects information for DIDANOSINE

Role code Indications Reaction # Reports
SS ANTIRETROVIRAL THERAPY ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS 3
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 GLUCOSE TOLERANCE IMPAIRED 6
SS ANTIRETROVIRAL THERAPY HIGH DENSITY LIPOPROTEIN DECREASED 6
SS ANTIRETROVIRAL THERAPY HYPERTRIGLYCERIDAEMIA 6
SS ANTIRETROVIRAL THERAPY HYPOAESTHESIA 8
SS ANTIRETROVIRAL THERAPY LIPOATROPHY 6
SS ANTIRETROVIRAL THERAPY LIPODYSTROPHY ACQUIRED 8
SS ANTIRETROVIRAL THERAPY TYPE 2 DIABETES MELLITUS 9
SS ANTIRETROVIRAL THERAPY VASODILATATION 8
SS ANTIVIRAL TREATMENT ASCITES 11
SS ANTIVIRAL TREATMENT CHOLESTASIS 11
SS ANTIVIRAL TREATMENT HAEMATOTOXICITY 11
SS ANTIVIRAL TREATMENT HYPOPHOSPHATAEMIA 11
SS ANTIVIRAL TREATMENT IRON DEFICIENCY ANAEMIA 11
SS ANTIVIRAL TREATMENT LIPOATROPHY 11
SS ANTIVIRAL TREATMENT LIVER DISORDER 11
SS ANTIVIRAL TREATMENT OESOPHAGEAL VARICES HAEMORRHAGE 11
SS ANTIVIRAL TREATMENT PORTAL HYPERTENSION 11
SS ANTIVIRAL TREATMENT PORTAL VEIN THROMBOSIS 11
SS ANTIVIRAL TREATMENT PROTEINURIA 11
SS ANTIVIRAL TREATMENT SPLENOMEGALY 11
SS ANTIVIRAL TREATMENT TRANSAMINASES INCREASED 11
SS ANTIVIRAL TREATMENT VIROLOGIC FAILURE 11
SS CD4 LYMPHOCYTES DECREASED BLOOD TRIGLYCERIDES INCREASED 3
SS CD4 LYMPHOCYTES DECREASED CHYLOTHORAX 3
SS CD4 LYMPHOCYTES DECREASED DYSPNOEA 3
SS CD4 LYMPHOCYTES DECREASED IMMUNE RECONSTITUTION SYNDROME 3
SS CD4 LYMPHOCYTES DECREASED LYMPHADENOPATHY 3
SS CD4 LYMPHOCYTES DECREASED OSTEOLYSIS 3
SS CD4 LYMPHOCYTES DECREASED PLEURAL EFFUSION 3
SS CD4 LYMPHOCYTES DECREASED PYREXIA 3
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 ANAEMIA 4
SS HIV INFECTION ASCITES 4
SS HIV INFECTION BLOOD TRIGLYCERIDES INCREASED 8
SS HIV INFECTION CD4 LYMPHOCYTES INCREASED 17
SS HIV INFECTION CEREBRAL TOXOPLASMOSIS 17
SS HIV INFECTION DIARRHOEA 17
SS HIV INFECTION DIZZINESS 28
SS HIV INFECTION DRUG RESISTANCE 17
SS HIV INFECTION EAR INFECTION 17
SS HIV INFECTION ECONOMIC PROBLEM 8
SS HIV INFECTION EPILEPSY 17
SS HIV INFECTION FEBRILE CONVULSION 3
SS HIV INFECTION FIBRIN DEGRADATION PRODUCTS INCREASED 28
SS HIV INFECTION GASTROINTESTINAL DISORDER 27
SS HIV INFECTION HAEMOGLOBIN DECREASED 8
SS HIV INFECTION HEPATIC FUNCTION ABNORMAL 28
SS HIV INFECTION HEPATOTOXICITY 17
SS HIV INFECTION IMMUNE RECONSTITUTION SYNDROME 17
SS HIV INFECTION INFLUENZA LIKE ILLNESS 28
SS HIV INFECTION LARGE INTESTINAL HAEMORRHAGE 4
SS HIV INFECTION LIPOATROPHY 4
SS HIV INFECTION LIPODYSTROPHY ACQUIRED 10
SS HIV INFECTION MATERNAL EXPOSURE DURING PREGNANCY 4
SS HIV INFECTION MELAENA 4
SS HIV INFECTION MENINGITIS 17
SS HIV INFECTION MITOCHONDRIAL TOXICITY 4
SS HIV INFECTION MOBILITY DECREASED 8
SS HIV INFECTION MONOPLEGIA 17
SS HIV INFECTION NAUSEA 45
SS HIV INFECTION NERVOUS SYSTEM DISORDER 28
SS HIV INFECTION NEUROPATHY PERIPHERAL 4
SS HIV INFECTION OESOPHAGEAL CANDIDIASIS 17
SS HIV INFECTION OSTEONECROSIS 28
SS HIV INFECTION PALPITATIONS 28
SS HIV INFECTION PNEUMONIA STREPTOCOCCAL 17
SS HIV INFECTION POLYNEUROPATHY 17
SS HIV INFECTION PORTAL HYPERTENSION 56
SS HIV INFECTION PREGNANCY 4
SS HIV INFECTION PULMONARY ARTERIAL HYPERTENSION 8
SS HIV INFECTION PULMONARY HYPERTENSION 28
SS HIV INFECTION PULMONARY TUBERCULOSIS 10
SS HIV INFECTION QUADRIPARESIS 17
SS HIV INFECTION SEPSIS 17
SS HIV INFECTION TREATMENT FAILURE 27
SS HIV INFECTION TREATMENT NONCOMPLIANCE 17
SS HIV INFECTION TREMOR 28
SS HIV INFECTION VARICES OESOPHAGEAL 4
SS HIV INFECTION VIITH NERVE PARALYSIS 17
SS HIV INFECTION VIRAL LOAD INCREASED 17
SS HIV INFECTION VIRAL UPPER RESPIRATORY TRACT INFECTION 3
SS HIV INFECTION VISUAL IMPAIRMENT 28
SS HIV INFECTION VOMITING 17
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
SS PNEUMONIA STREPTOCOCCAL CD4 LYMPHOCYTES INCREASED 1
SS PNEUMONIA STREPTOCOCCAL CEREBRAL TOXOPLASMOSIS 1
SS PNEUMONIA STREPTOCOCCAL DIARRHOEA 1
SS PNEUMONIA STREPTOCOCCAL DRUG RESISTANCE 1
SS PNEUMONIA STREPTOCOCCAL EAR INFECTION 1
SS PNEUMONIA STREPTOCOCCAL EPILEPSY 1
SS PNEUMONIA STREPTOCOCCAL GASTROINTESTINAL DISORDER 1
SS PNEUMONIA STREPTOCOCCAL HEPATOTOXICITY 1
SS PNEUMONIA STREPTOCOCCAL IMMUNE RECONSTITUTION SYNDROME 1
SS PNEUMONIA STREPTOCOCCAL MENINGITIS 1
SS PNEUMONIA STREPTOCOCCAL MONOPLEGIA 1
SS PNEUMONIA STREPTOCOCCAL NAUSEA 1
SS PNEUMONIA STREPTOCOCCAL OESOPHAGEAL CANDIDIASIS 1
SS PNEUMONIA STREPTOCOCCAL PNEUMONIA STREPTOCOCCAL 1
SS PNEUMONIA STREPTOCOCCAL POLYNEUROPATHY 1
SS PNEUMONIA STREPTOCOCCAL QUADRIPARESIS 1
SS PNEUMONIA STREPTOCOCCAL SEPSIS 1
SS PNEUMONIA STREPTOCOCCAL TREATMENT FAILURE 1
SS PNEUMONIA STREPTOCOCCAL TREATMENT NONCOMPLIANCE 1
SS PNEUMONIA STREPTOCOCCAL VIITH NERVE PARALYSIS 1
SS PNEUMONIA STREPTOCOCCAL VIRAL LOAD INCREASED 1
SS PNEUMONIA STREPTOCOCCAL VOMITING 1
C BLOOD TRIGLYCERIDES INCREASED ABNORMAL SENSATION IN EYE 1
C BLOOD TRIGLYCERIDES INCREASED EYELID OEDEMA 1
C BLOOD TRIGLYCERIDES INCREASED LOCAL SWELLING 1
C BLOOD TRIGLYCERIDES INCREASED SWELLING FACE 1
C CONSTIPATION ABDOMINAL PAIN 1
C CONSTIPATION DIARRHOEA 1
C CONSTIPATION HAEMOGLOBIN DECREASED 1
C CONSTIPATION HEPATOSPLENOMEGALY 1
C CONSTIPATION PAIN 1
C CONSTIPATION SICKLE CELL ANAEMIA WITH CRISIS 1
C CONSTIPATION SPLENOMEGALY 1
C CONSTIPATION VOMITING 1
C DEPRESSION ABDOMINAL PAIN 1
C DEPRESSION DIARRHOEA 1
C DEPRESSION HAEMOGLOBIN DECREASED 1
C DEPRESSION HEPATOSPLENOMEGALY 1
C DEPRESSION PAIN 1
C DEPRESSION SICKLE CELL ANAEMIA WITH CRISIS 1
C DEPRESSION SPLENOMEGALY 1
C DEPRESSION VOMITING 1
C HIV INFECTION ABDOMINAL PAIN 3
C HIV INFECTION ASCITES 1
C HIV INFECTION DIARRHOEA 4
C HIV INFECTION GASTROENTERITIS 1
C HIV INFECTION HAEMOGLOBIN DECREASED 3
C HIV INFECTION HEPATIC CIRRHOSIS 1
C HIV INFECTION HEPATOSPLENOMEGALY 3
C HIV INFECTION PAIN 3
C HIV INFECTION SICKLE CELL ANAEMIA WITH CRISIS 3
C HIV INFECTION SPLENOMEGALY 3
C HIV INFECTION TUBERCULOSIS 1
C HIV INFECTION VOMITING 4
C PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 3
C PRODUCT USED FOR UNKNOWN INDICATION GASTROENTERITIS 3
C PRODUCT USED FOR UNKNOWN INDICATION TUBERCULOSIS 3
C PRODUCT USED FOR UNKNOWN INDICATION VOMITING 3
C SICKLE CELL ANAEMIA ABDOMINAL PAIN 1
C SICKLE CELL ANAEMIA DIARRHOEA 1
C SICKLE CELL ANAEMIA HAEMOGLOBIN DECREASED 1
C SICKLE CELL ANAEMIA HEPATOSPLENOMEGALY 1
C SICKLE CELL ANAEMIA PAIN 1
C SICKLE CELL ANAEMIA SICKLE CELL ANAEMIA WITH CRISIS 1
C SICKLE CELL ANAEMIA SPLENOMEGALY 1
C SICKLE CELL ANAEMIA VOMITING 1
C TUBERCULOSIS DIARRHOEA 1
C TUBERCULOSIS GASTROENTERITIS 1
C TUBERCULOSIS TUBERCULOSIS 1
C TUBERCULOSIS VOMITING 1
C URINARY TRACT INFECTION GRAND MAL CONVULSION 1
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