Drug information for VIDEX

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
FOR SOLUTION; ORAL 100MG/PACKET Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB 20155
2010-08-09 Other Important Information from FDA

2007-11-19 Review

2007-08-06 Review

2007-08-06 Review

2006-12-28 Letter

2006-12-04 Label

2006-09-18 Letter

2006-08-21 Label

2005-04-27 Review

2005-04-27 Review

2005-04-19 Review

2005-04-19 Review

2005-01-06 Review

2004-08-09 Review

2004-06-30 Letter

2004-06-30 Label

2004-01-22 Label

2004-01-22 Letter

2003-04-21 Label

2003-04-21 Label

2003-03-10 Letter

2003-03-07 Label

2002-09-25 Letter

2002-09-25 Label

2002-04-01 Label

2002-04-01 Letter

1999-10-29 Letter

1999-10-29 Label
FOR SOLUTION; ORAL 167MG/PACKET Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB   "
FOR SOLUTION; ORAL 250MG/PACKET Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB   "
FOR SOLUTION; ORAL 375MG/PACKET Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB   "
FOR SOLUTION; ORAL 10MG/ML Prescription AA (Reference Drug) DIDANOSINE Didanosine BRISTOL MYERS SQUIBB 20156
2011-11-22 Label

2011-11-22 Letter

2011-11-22 Medication Guide

2011-05-12 Letter

2010-08-09 Other Important Information from FDA

2010-07-20 Other

2010-02-01 Letter

2010-01-29 Medication Guide

2010-01-29 Label

2009-06-22 Label

2009-06-17 Letter

2007-11-19 Review

2007-08-06 Review

2007-08-06 Review

2006-12-28 Letter

2006-12-04 Label

2006-09-18 Letter

2006-08-21 Label

2005-04-27 Review

2005-04-27 Review

2005-04-19 Review

2005-04-19 Review

2005-01-06 Review

2004-08-09 Review

2004-01-22 Label

2004-01-22 Letter

2003-04-21 Label

2003-04-21 Label

2003-03-10 Letter

2003-03-07 Label

2002-09-25 Label

2002-09-25 Letter

2002-09-25 Label

2002-09-25 Letter

2002-04-01 Label

2002-04-01 Letter

1999-10-29 Letter

1999-10-21 Label
TABLET, CHEWABLE; ORAL 100MG Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB 20154
2010-08-09 Other Important Information from FDA

2007-11-19 Review

2007-08-06 Review

2007-08-06 Review

2007-08-06 Review

2006-12-28 Letter

2006-12-04 Label

2006-09-18 Letter

2006-08-21 Label

2005-04-27 Review

2005-04-27 Review

2005-04-19 Review

2005-04-19 Review

2005-01-06 Review

2004-08-09 Review

2004-08-09 Review

2004-01-22 Letter

2004-01-22 Label

2003-04-21 Label

2003-04-21 Label

2003-03-10 Letter

2003-03-06 Label

2002-09-25 Label

2002-09-25 Letter

2002-09-25 Label

2002-09-25 Letter

2002-04-01 Label

2002-04-01 Letter

1999-10-29 Letter

1999-10-29 Label

1999-10-29 Letter

1999-10-29 Label
TABLET, CHEWABLE; ORAL 150MG Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB   "
TABLET, CHEWABLE; ORAL 200MG Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB   "
TABLET, CHEWABLE; ORAL 25MG Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB   "
TABLET, CHEWABLE; ORAL 50MG Discontinued   DIDANOSINE Didanosine BRISTOL MYERS SQUIBB   "

Drug Adverse Effects information for VIDEX

Role code Indications Reaction # Reports
PS HAEMARTHROSIS ALANINE AMINOTRANSFERASE INCREASED 1
PS HAEMARTHROSIS ASPARTATE AMINOTRANSFERASE INCREASED 1
PS HAEMARTHROSIS DIZZINESS 1
PS HAEMARTHROSIS PALPITATIONS 1
PS HAEMARTHROSIS PULMONARY HYPERTENSION 1
PS HIV INFECTION ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS 5
PS HIV INFECTION ALANINE AMINOTRANSFERASE INCREASED 8
PS HIV INFECTION ASPARTATE AMINOTRANSFERASE INCREASED 8
PS HIV INFECTION ASTHENIA 5
PS HIV INFECTION CASTLEMAN'S DISEASE 5
PS HIV INFECTION DIZZINESS 8
PS HIV INFECTION DRUG RESISTANCE 5
PS HIV INFECTION PALPITATIONS 8
PS HIV INFECTION PANCYTOPENIA 5
PS HIV INFECTION PORTAL HYPERTENSION 9
PS HIV INFECTION PORTAL VEIN THROMBOSIS 1
PS HIV INFECTION PREGNANCY 8
PS HIV INFECTION PULMONARY HYPERTENSION 8
PS HIV INFECTION SPLENIC VEIN THROMBOSIS 1
PS HIV INFECTION VARICES OESOPHAGEAL 1
PS HIV INFECTION WEIGHT DECREASED 5
SS ANTIRETROVIRAL THERAPY DRUG RESISTANCE 15
SS ANTIRETROVIRAL THERAPY PSYCHIATRIC SYMPTOM 15
SS ANTIVIRAL TREATMENT ABORTION SPONTANEOUS 5
SS ANTIVIRAL TREATMENT MATERNAL EXPOSURE DURING PREGNANCY 5
SS HIV INFECTION ABORTION INDUCED 3
SS HIV INFECTION ABORTION SPONTANEOUS 3
SS HIV INFECTION ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS 10
SS HIV INFECTION AGGRESSION 4
SS HIV INFECTION ANAPHYLACTIC SHOCK 10
SS HIV INFECTION APPARENT LIFE THREATENING EVENT 20
SS HIV INFECTION ASCITES 4
SS HIV INFECTION ASTHENIA 10
SS HIV INFECTION CASTLEMAN'S DISEASE 10
SS HIV INFECTION DIZZINESS 20
SS HIV INFECTION DRUG INTERACTION 3
SS HIV INFECTION DRUG RESISTANCE 10
SS HIV INFECTION ENDOLYMPHATIC HYDROPS 10
SS HIV INFECTION GENERALISED ERYTHEMA 10
SS HIV INFECTION GYNAECOMASTIA 10
SS HIV INFECTION HEPATIC NECROSIS 4
SS HIV INFECTION HEPATITIS A 4
SS HIV INFECTION INSOMNIA 3
SS HIV INFECTION JAUNDICE 4
SS HIV INFECTION MENIERE'S DISEASE 10
SS HIV INFECTION PALPITATIONS 20
SS HIV INFECTION PANCREATITIS 10
SS HIV INFECTION PANCREATITIS ACUTE 6
SS HIV INFECTION PANCYTOPENIA 10
SS HIV INFECTION PERITONEAL HAEMATOMA 4
SS HIV INFECTION PREGNANCY 6
SS HIV INFECTION PULMONARY HYPERTENSION 20
SS HIV INFECTION SOMNOLENCE 4
SS HIV INFECTION VERTIGO 3
SS HIV INFECTION VOMITING 4
SS HIV INFECTION WEIGHT DECREASED 10
SS HYPERPHOSPHATAEMIA DRUG INTERACTION 1
SS HYPERPHOSPHATAEMIA PANCREATITIS ACUTE 3
SS HYPERTENSION DRUG INTERACTION 2
SS HYPERTENSION PANCREATITIS ACUTE 4
SS PRODUCT USED FOR UNKNOWN INDICATION ABORTION SPONTANEOUS 5
SS RENAL FAILURE DRUG INTERACTION 1
SS RENAL FAILURE PANCREATITIS ACUTE 1
C ASYMPTOMATIC HIV INFECTION CONVULSION 3
C ASYMPTOMATIC HIV INFECTION LOSS OF CONSCIOUSNESS 3
C ASYMPTOMATIC HIV INFECTION MASKED FACIES 3
C ASYMPTOMATIC HIV INFECTION MUSCULOSKELETAL STIFFNESS 3
C HIV INFECTION ABDOMINAL PAIN UPPER 8
C HIV INFECTION ASTHENIA 16
C HIV INFECTION DEPRESSION 2
C HIV INFECTION DIZZINESS 8
C HIV INFECTION DRY SKIN 4
C HIV INFECTION ECZEMA 2
C HIV INFECTION FACE OEDEMA 8
C HIV INFECTION HEADACHE 8
C HIV INFECTION HIDRADENITIS 1
C HIV INFECTION HYPERSENSITIVITY 16
C HIV INFECTION LIP OEDEMA 8
C HIV INFECTION LIPODYSTROPHY ACQUIRED 2
C HIV INFECTION LIPOHYPERTROPHY 2
C HIV INFECTION NAUSEA 8
C HIV INFECTION OSTEONECROSIS 4
C HIV INFECTION PHARYNGOTONSILLITIS 2
C HIV INFECTION PREGNANCY 4
C HIV INFECTION PYREXIA 16
C HIV INFECTION RASH 8
C HIV INFECTION SINUSITIS 2
C HIV INFECTION SUICIDE ATTEMPT 2
C HIV INFECTION THROAT IRRITATION 4
C HIV INFECTION VOMITING 12
C PRODUCT USED FOR UNKNOWN INDICATION CONVULSION 6
C PRODUCT USED FOR UNKNOWN INDICATION LOSS OF CONSCIOUSNESS 6
C PRODUCT USED FOR UNKNOWN INDICATION MASKED FACIES 6
C PRODUCT USED FOR UNKNOWN INDICATION MUSCULOSKELETAL STIFFNESS 6
C URINARY TRACT INFECTION CONVULSION 1
C URINARY TRACT INFECTION LOSS OF CONSCIOUSNESS 1
C URINARY TRACT INFECTION MASKED FACIES 1
C URINARY TRACT INFECTION MUSCULOSKELETAL STIFFNESS 1
I HIV INFECTION DRUG INTERACTION 12
I HIV INFECTION PANCREATITIS ACUTE 12
I HYPERPHOSPHATAEMIA DRUG INTERACTION 6
I HYPERPHOSPHATAEMIA PANCREATITIS ACUTE 6
I HYPERTENSION DRUG INTERACTION 8
I HYPERTENSION PANCREATITIS ACUTE 8
I RENAL FAILURE DRUG INTERACTION 2
I RENAL FAILURE PANCREATITIS ACUTE 2
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