Drug information for INTELENCE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 100MG Prescription   ETRAVIRINE etravirine JANSSEN R AND D 22187
2012-03-28 Letter
2012-03-26 Label
2011-10-12 Letter
2011-10-12 Label
2010-12-28 Letter
2010-12-26 Label
2010-12-22 Letter
2010-12-22 Label
2010-03-03 Letter
2010-03-03 Label
2009-12-02 Label
2009-11-10 Letter
2009-10-06 Label
2008-07-22 Summary Review
2008-03-17 Review
2008-01-23 Label
2008-01-23 Letter
TABLET; ORAL 200MG Prescription  (Reference Drug) ETRAVIRINE etravirine JANSSEN R AND D   "
TABLET; ORAL 25MG Prescription   ETRAVIRINE etravirine JANSSEN R AND D   "

Drug Adverse Effects information for INTELENCE

Role code Indications Reaction # Reports
PS ANTIVIRAL PROPHYLAXIS ASTHENIA 1
PS ANTIVIRAL PROPHYLAXIS CD4 LYMPHOCYTES DECREASED 1
PS ANTIVIRAL PROPHYLAXIS CD8 LYMPHOCYTES DECREASED 1
PS ANTIVIRAL PROPHYLAXIS DRUG INEFFECTIVE 1
PS ANTIVIRAL PROPHYLAXIS HEPATIC ENZYME INCREASED 1
PS ANTIVIRAL PROPHYLAXIS HEPATIC PAIN 1
PS ANTIVIRAL PROPHYLAXIS HYPERSOMNIA 1
PS ANTIVIRAL PROPHYLAXIS IMMUNE SYSTEM DISORDER 1
PS DRUG ABUSE ABORTION SPONTANEOUS 1
PS DRUG ABUSE MATERNAL EXPOSURE DURING PREGNANCY 1
PS DRUG ABUSE PYREXIA 1
PS DRUG ABUSE RASH 1
PS FOETAL EXPOSURE DURING PREGNANCY ABORTION SPONTANEOUS 8
PS FOETAL EXPOSURE DURING PREGNANCY CELL DEATH 8
PS FOETAL EXPOSURE DURING PREGNANCY EXOMPHALOS 8
PS FOETAL EXPOSURE DURING PREGNANCY MATERNAL DRUGS AFFECTING FOETUS 8
PS FOETAL EXPOSURE DURING PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY 8
PS HIV INFECTION ABORTION SPONTANEOUS 6
PS HIV INFECTION ANGIOEDEMA 3
PS HIV INFECTION ANXIETY 2
PS HIV INFECTION DEPRESSION 1
PS HIV INFECTION DRUG INTERACTION 3
PS HIV INFECTION DYSPHAGIA 3
PS HIV INFECTION DYSPNOEA 5
PS HIV INFECTION HEADACHE 2
PS HIV INFECTION INSOMNIA 1
PS HIV INFECTION MATERNAL EXPOSURE DURING PREGNANCY 6
PS HIV INFECTION NEUTROPENIA 1
PS HIV INFECTION OSTEOPOROSIS 1
PS HIV INFECTION PANCREATITIS ACUTE 3
PS HIV INFECTION PYREXIA 6
PS HIV INFECTION RASH 6
PS HIV INFECTION RASH PRURITIC 2
PS HIV INFECTION RESPIRATORY RATE INCREASED 2
PS HIV INFECTION TREMOR 2
PS HIV INFECTION URINARY INCONTINENCE 1
PS HIV INFECTION URTICARIA 2
PS HIV INFECTION VISION BLURRED 1
PS HIV INFECTION CDC CATEGORY B2 BALANCE DISORDER 2
PS HIV INFECTION CDC CATEGORY B2 MALAISE 2
PS HIV INFECTION CDC CATEGORY B2 NARCOLEPSY 2
PS HIV INFECTION CDC CATEGORY B2 PARAESTHESIA 2
PS HYPERPHOSPHATAEMIA DRUG INTERACTION 1
PS HYPERPHOSPHATAEMIA PANCREATITIS ACUTE 1
PS HYPERTENSION DRUG INTERACTION 2
PS HYPERTENSION PANCREATITIS ACUTE 2
PS INFLUENZA IMMUNISATION BALANCE DISORDER 1
PS INFLUENZA IMMUNISATION MALAISE 1
PS INFLUENZA IMMUNISATION NARCOLEPSY 1
PS INFLUENZA IMMUNISATION PARAESTHESIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION ABORTION SPONTANEOUS 4
PS PRODUCT USED FOR UNKNOWN INDICATION ANGIOEDEMA 6
PS PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 2
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPHAGIA 6
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 6
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 2
PS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE DURING PREGNANCY 4
PS PRODUCT USED FOR UNKNOWN INDICATION NEUTROPENIA 3
PS PRODUCT USED FOR UNKNOWN INDICATION OSTEOPOROSIS 3
PS PRODUCT USED FOR UNKNOWN INDICATION PYREXIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION RASH 1
PS PRODUCT USED FOR UNKNOWN INDICATION RASH PRURITIC 2
PS PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY RATE INCREASED 2
PS PRODUCT USED FOR UNKNOWN INDICATION TREMOR 2
PS RENAL FAILURE DRUG INTERACTION 1
PS RENAL FAILURE PANCREATITIS ACUTE 1
PS TOBACCO WITHDRAWAL SYMPTOMS BALANCE DISORDER 1
PS TOBACCO WITHDRAWAL SYMPTOMS MALAISE 1
PS TOBACCO WITHDRAWAL SYMPTOMS NARCOLEPSY 1
PS TOBACCO WITHDRAWAL SYMPTOMS PARAESTHESIA 1
SS ANTIRETROVIRAL THERAPY ABORTION SPONTANEOUS 12
SS ANTIRETROVIRAL THERAPY CERVIX OPERATION 6
SS ANTIRETROVIRAL THERAPY MATERNAL EXPOSURE DURING PREGNANCY 12
SS ANTIRETROVIRAL THERAPY NORMAL LABOUR 6
SS ANTIRETROVIRAL THERAPY PREGNANCY 6
SS ANTIRETROVIRAL THERAPY PYREXIA 6
SS ANTIRETROVIRAL THERAPY RASH 6
SS ANTIRETROVIRAL THERAPY VAGINAL HAEMORRHAGE 6
SS HIV INFECTION ABORTION SPONTANEOUS 3
SS HIV INFECTION CHOLANGITIS 6
SS HIV INFECTION CHOLECYSTITIS 6
SS HIV INFECTION CHOLELITHIASIS 6
SS HIV INFECTION DRUG INTERACTION 3
SS HIV INFECTION DYSPHAGIA 8
SS HIV INFECTION MATERNAL EXPOSURE DURING PREGNANCY 3
SS HIV INFECTION NARCOLEPSY 1
SS HIV INFECTION NECROSIS 8
SS HIV INFECTION NEOPLASM MALIGNANT 2
SS HIV INFECTION NEPHROLITHIASIS 6
SS HIV INFECTION OSTEOPOROSIS 1
SS HIV INFECTION PANCREATITIS ACUTE 6
SS HIV INFECTION SWELLING 4
SS HIV INFECTION THROMBOCYTOPENIA 2
SS HIV INFECTION TONSILLAR DISORDER 8
SS HIV INFECTION UVEITIS 6
SS HYPERPHOSPHATAEMIA DRUG INTERACTION 1
SS HYPERPHOSPHATAEMIA PANCREATITIS ACUTE 3
SS HYPERTENSION DRUG INTERACTION 2
SS HYPERTENSION PANCREATITIS ACUTE 4
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 PRODUCT USED FOR UNKNOWN INDICATION ABORTION SPONTANEOUS 6
SS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE DURING PREGNANCY 2
SS PRODUCT USED FOR UNKNOWN INDICATION NEOPLASM MALIGNANT 1
SS PRODUCT USED FOR UNKNOWN INDICATION PREGNANCY 2
SS PRODUCT USED FOR UNKNOWN INDICATION THROMBOCYTOPENIA 1
SS RENAL FAILURE DRUG INTERACTION 1
SS RENAL FAILURE PANCREATITIS ACUTE 1
SS SYPHILIS UVEITIS 1
SS TOBACCO USER NARCOLEPSY 1
C ATRIAL FIBRILLATION ABDOMINAL PAIN UPPER 6
C ATRIAL FIBRILLATION DYSPEPSIA 2
C ATRIAL FIBRILLATION ERUCTATION 6
C ATRIAL FIBRILLATION FATIGUE 6
C ATRIAL FIBRILLATION NAUSEA 6
C ATRIAL FIBRILLATION WHITE BLOOD CELL COUNT DECREASED 6
C B-CELL LYMPHOMA HEPATITIS B 6
C BLOOD CHOLESTEROL INCREASED ABDOMINAL PAIN UPPER 3
C BLOOD CHOLESTEROL INCREASED DYSPEPSIA 1
C BLOOD CHOLESTEROL INCREASED ERUCTATION 3
C BLOOD CHOLESTEROL INCREASED FATIGUE 3
C BLOOD CHOLESTEROL INCREASED NAUSEA 3
C BLOOD CHOLESTEROL INCREASED WHITE BLOOD CELL COUNT DECREASED 3
C DIABETES MELLITUS ABDOMINAL DISTENSION 2
C DIABETES MELLITUS ABDOMINAL PAIN UPPER 15
C DIABETES MELLITUS ACQUIRED IMMUNODEFICIENCY SYNDROME 2
C DIABETES MELLITUS ASCITES 2
C DIABETES MELLITUS ATRIOVENTRICULAR BLOCK SECOND DEGREE 2
C DIABETES MELLITUS ATRIOVENTRICULAR DISSOCIATION 2
C DIABETES MELLITUS BRADYCARDIA 2
C DIABETES MELLITUS DYSPEPSIA 5
C DIABETES MELLITUS ERUCTATION 15
C DIABETES MELLITUS FATIGUE 15
C DIABETES MELLITUS HEPATIC CIRRHOSIS 2
C DIABETES MELLITUS HYPOALBUMINAEMIA 2
C DIABETES MELLITUS HYPONATRAEMIA 2
C DIABETES MELLITUS HYPOTHYROIDISM 2
C DIABETES MELLITUS INGUINAL HERNIA 2
C DIABETES MELLITUS INTERNATIONAL NORMALISED RATIO INCREASED 2
C DIABETES MELLITUS LUNG INFILTRATION 2
C DIABETES MELLITUS NAUSEA 15
C DIABETES MELLITUS PAIN 2
C DIABETES MELLITUS PANCYTOPENIA 2
C DIABETES MELLITUS PLASMABLASTIC LYMPHOMA 2
C DIABETES MELLITUS RIGHT VENTRICULAR FAILURE 2
C DIABETES MELLITUS VENTRICULAR TACHYCARDIA 2
C DIABETES MELLITUS WHITE BLOOD CELL COUNT DECREASED 15
C ERECTILE DYSFUNCTION RECTAL CANCER 3
C FACE AND MOUTH X-RAY ABNORMAL ABDOMINAL PAIN UPPER 3
C FACE AND MOUTH X-RAY ABNORMAL DYSPEPSIA 1
C FACE AND MOUTH X-RAY ABNORMAL ERUCTATION 3
C FACE AND MOUTH X-RAY ABNORMAL FATIGUE 3
C FACE AND MOUTH X-RAY ABNORMAL NAUSEA 3
C FACE AND MOUTH X-RAY ABNORMAL WHITE BLOOD CELL COUNT DECREASED 3
C HERPES SIMPLEX ABDOMINAL PAIN UPPER 3
C HERPES SIMPLEX DYSPEPSIA 1
C HERPES SIMPLEX ERUCTATION 3
C HERPES SIMPLEX FATIGUE 3
C HERPES SIMPLEX NAUSEA 3
C HERPES SIMPLEX WHITE BLOOD CELL COUNT DECREASED 3
C HIV INFECTION ABDOMINAL DISTENSION 5
C HIV INFECTION ABORTION SPONTANEOUS 9
C HIV INFECTION ACQUIRED IMMUNODEFICIENCY SYNDROME 4
C HIV INFECTION ANGINA PECTORIS 8
C HIV INFECTION ASCITES 4
C HIV INFECTION ATRIOVENTRICULAR BLOCK SECOND DEGREE 4
C HIV INFECTION ATRIOVENTRICULAR DISSOCIATION 4
C HIV INFECTION BRADYCARDIA 4
C HIV INFECTION FANCONI SYNDROME ACQUIRED 8
C HIV INFECTION HEPATIC CIRRHOSIS 4
C HIV INFECTION HYPOALBUMINAEMIA 4
C HIV INFECTION HYPONATRAEMIA 4
C HIV INFECTION HYPOTHYROIDISM 4
C HIV INFECTION INCORRECT DOSE ADMINISTERED 1
C HIV INFECTION INGUINAL HERNIA 4
C HIV INFECTION INTERNATIONAL NORMALISED RATIO INCREASED 4
C HIV INFECTION LUNG INFILTRATION 4
C HIV INFECTION NAUSEA 1
C HIV INFECTION PAIN 4
C HIV INFECTION PANCYTOPENIA 4
C HIV INFECTION PLASMABLASTIC LYMPHOMA 4
C HIV INFECTION RECTAL CANCER 12
C HIV INFECTION RIGHT VENTRICULAR FAILURE 4
C HIV INFECTION VENTRICULAR TACHYCARDIA 4
C HIV TEST POSITIVE ABDOMINAL PAIN UPPER 12
C HIV TEST POSITIVE DYSPEPSIA 4
C HIV TEST POSITIVE ERUCTATION 12
C HIV TEST POSITIVE FATIGUE 12
C HIV TEST POSITIVE NAUSEA 12
C HIV TEST POSITIVE WHITE BLOOD CELL COUNT DECREASED 12
C HYPERCHOLESTEROLAEMIA RECTAL CANCER 3
C HYPERLIPIDAEMIA ABDOMINAL DISTENSION 1
C HYPERLIPIDAEMIA ACQUIRED IMMUNODEFICIENCY SYNDROME 1
C HYPERLIPIDAEMIA ASCITES 1
C HYPERLIPIDAEMIA ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
C HYPERLIPIDAEMIA ATRIOVENTRICULAR DISSOCIATION 1
C HYPERLIPIDAEMIA BRADYCARDIA 1
C HYPERLIPIDAEMIA HEPATIC CIRRHOSIS 1
C HYPERLIPIDAEMIA HYPOALBUMINAEMIA 1
C HYPERLIPIDAEMIA HYPONATRAEMIA 1
C HYPERLIPIDAEMIA HYPOTHYROIDISM 1
C HYPERLIPIDAEMIA INGUINAL HERNIA 1
C HYPERLIPIDAEMIA INTERNATIONAL NORMALISED RATIO INCREASED 1
C HYPERLIPIDAEMIA LUNG INFILTRATION 1
C HYPERLIPIDAEMIA PAIN 1
C HYPERLIPIDAEMIA PANCYTOPENIA 1
C HYPERLIPIDAEMIA PLASMABLASTIC LYMPHOMA 1
C HYPERLIPIDAEMIA RIGHT VENTRICULAR FAILURE 1
C HYPERLIPIDAEMIA VENTRICULAR TACHYCARDIA 1
C HYPERTENSION ABDOMINAL DISTENSION 1
C HYPERTENSION ABDOMINAL PAIN UPPER 6
C HYPERTENSION ACQUIRED IMMUNODEFICIENCY SYNDROME 1
C HYPERTENSION ASCITES 1
C HYPERTENSION ATRIOVENTRICULAR BLOCK SECOND DEGREE 1
C HYPERTENSION ATRIOVENTRICULAR DISSOCIATION 1
C HYPERTENSION BRADYCARDIA 1
C HYPERTENSION DYSPEPSIA 2
C HYPERTENSION ERUCTATION 6
C HYPERTENSION FATIGUE 6
C HYPERTENSION HEPATIC CIRRHOSIS 1
C HYPERTENSION HYPOALBUMINAEMIA 1
C HYPERTENSION HYPONATRAEMIA 1
C HYPERTENSION HYPOTHYROIDISM 1
C HYPERTENSION INGUINAL HERNIA 1
C HYPERTENSION INTERNATIONAL NORMALISED RATIO INCREASED 1
C HYPERTENSION LUNG INFILTRATION 1
C HYPERTENSION NAUSEA 6
C HYPERTENSION PAIN 1
C HYPERTENSION PANCYTOPENIA 1
C HYPERTENSION PLASMABLASTIC LYMPHOMA 1
C HYPERTENSION RIGHT VENTRICULAR FAILURE 1
C HYPERTENSION VENTRICULAR TACHYCARDIA 1
C HYPERTENSION WHITE BLOOD CELL COUNT DECREASED 6
C IDIOPATHIC THROMBOCYTOPENIC PURPURA THROMBOCYTOPENIA 2
C NEUROPATHY PERIPHERAL BLOOD CREATININE INCREASED 1
C PAIN ANGINA PECTORIS 2
C PAIN FANCONI SYNDROME ACQUIRED 2
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISTENSION 6
C PRODUCT USED FOR UNKNOWN INDICATION ABORTION SPONTANEOUS 1
C PRODUCT USED FOR UNKNOWN INDICATION ACQUIRED IMMUNODEFICIENCY SYNDROME 6
C PRODUCT USED FOR UNKNOWN INDICATION ALOPECIA 1
C PRODUCT USED FOR UNKNOWN INDICATION ANGINA PECTORIS 4
C PRODUCT USED FOR UNKNOWN INDICATION ASCITES 6
C PRODUCT USED FOR UNKNOWN INDICATION ATRIOVENTRICULAR BLOCK SECOND DEGREE 6
C PRODUCT USED FOR UNKNOWN INDICATION ATRIOVENTRICULAR DISSOCIATION 6
C PRODUCT USED FOR UNKNOWN INDICATION BLOOD CHOLESTEROL INCREASED 1
C PRODUCT USED FOR UNKNOWN INDICATION BLOOD TRIGLYCERIDES INCREASED 1
C PRODUCT USED FOR UNKNOWN INDICATION BRADYCARDIA 6
C PRODUCT USED FOR UNKNOWN INDICATION CHAPPED LIPS 1
C PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 1
C PRODUCT USED FOR UNKNOWN INDICATION DRUG INTERACTION 5
C PRODUCT USED FOR UNKNOWN INDICATION FANCONI SYNDROME ACQUIRED 4
C PRODUCT USED FOR UNKNOWN INDICATION HEPATIC CIRRHOSIS 6
C PRODUCT USED FOR UNKNOWN INDICATION HEPATITIS B 8
C PRODUCT USED FOR UNKNOWN INDICATION HYPOALBUMINAEMIA 6
C PRODUCT USED FOR UNKNOWN INDICATION HYPONATRAEMIA 6
C PRODUCT USED FOR UNKNOWN INDICATION HYPOTHYROIDISM 6
C PRODUCT USED FOR UNKNOWN INDICATION INGUINAL HERNIA 6
C PRODUCT USED FOR UNKNOWN INDICATION INTERNATIONAL NORMALISED RATIO INCREASED 6
C PRODUCT USED FOR UNKNOWN INDICATION LIP EXFOLIATION 1
C PRODUCT USED FOR UNKNOWN INDICATION LIPIDS INCREASED 1
C PRODUCT USED FOR UNKNOWN INDICATION LUNG INFILTRATION 6
C PRODUCT USED FOR UNKNOWN INDICATION NEUROPATHY PERIPHERAL 10
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 6
C PRODUCT USED FOR UNKNOWN INDICATION PANCYTOPENIA 6
C PRODUCT USED FOR UNKNOWN INDICATION PHOTOPHOBIA 1
C PRODUCT USED FOR UNKNOWN INDICATION PLASMABLASTIC LYMPHOMA 6
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 10
C PRODUCT USED FOR UNKNOWN INDICATION RIGHT VENTRICULAR FAILURE 6
C PRODUCT USED FOR UNKNOWN INDICATION VENTRICULAR TACHYCARDIA 6
C PRODUCT USED FOR UNKNOWN INDICATION VISION BLURRED 1
I HIV INFECTION DRUG INTERACTION 3
I HIV INFECTION PANCREATITIS ACUTE 3
I HYPERPHOSPHATAEMIA DRUG INTERACTION 2
I HYPERPHOSPHATAEMIA PANCREATITIS ACUTE 2
I HYPERTENSION DRUG INTERACTION 2
I HYPERTENSION PANCREATITIS ACUTE 2
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