Drug information for ATRIPLA

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	600MG;200MG;300MG	Prescription	(Reference Drug)	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination	GILEAD	21937 2011-09-20 Letter 2011-09-20 Label 2010-08-11 Letter 2010-08-10 Label 2010-01-15 Letter 2010-01-08 Label 2008-10-23 Letter 2008-06-12 Label 2008-06-09 Letter 2008-03-05 Label 2008-03-04 Letter 2008-02-25 Label 2008-02-20 Letter 2006-12-13 Review 2006-07-21 Letter 2006-07-12 Label

Drug Adverse Effects information for ATRIPLA

Role code	Indications	Reaction	# Reports
PS	DRUG WITHDRAWAL MAINTENANCE THERAPY	DRUG LEVEL DECREASED	1
PS	DRUG WITHDRAWAL MAINTENANCE THERAPY	VIRAL LOAD INCREASED	1
PS	DRUG WITHDRAWAL MAINTENANCE THERAPY	VIRAL MUTATION IDENTIFIED	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	ABDOMINAL PAIN UPPER	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	CHOLECYSTITIS	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	PANCREATITIS	1
PS	HIV INFECTION	ABDOMINAL PAIN UPPER	1
PS	HIV INFECTION	ABNORMAL DREAMS	1
PS	HIV INFECTION	ABORTION	2
PS	HIV INFECTION	AGGRESSION	1
PS	HIV INFECTION	ALANINE AMINOTRANSFERASE INCREASED	1
PS	HIV INFECTION	ALOPECIA	1
PS	HIV INFECTION	ANAEMIA	4
PS	HIV INFECTION	ANION GAP INCREASED	1
PS	HIV INFECTION	ASCITES	2
PS	HIV INFECTION	ASPARTATE AMINOTRANSFERASE INCREASED	1
PS	HIV INFECTION	ASTHENOSPERMIA	1
PS	HIV INFECTION	BILIARY CIRRHOSIS PRIMARY	2
PS	HIV INFECTION	BLOOD IRON DECREASED	1
PS	HIV INFECTION	BLOOD SODIUM DECREASED	1
PS	HIV INFECTION	BONE PAIN	1
PS	HIV INFECTION	CHOLECYSTITIS	1
PS	HIV INFECTION	CONVULSION	3
PS	HIV INFECTION	CYTOLYTIC HEPATITIS	2
PS	HIV INFECTION	DEPRESSION	2
PS	HIV INFECTION	DIARRHOEA	2
PS	HIV INFECTION	DISTURBANCE IN ATTENTION	1
PS	HIV INFECTION	DIZZINESS	1
PS	HIV INFECTION	DRUG INEFFECTIVE	1
PS	HIV INFECTION	DRUG LEVEL DECREASED	1
PS	HIV INFECTION	DRUG LEVEL INCREASED	2
PS	HIV INFECTION	DYSPNOEA	1
PS	HIV INFECTION	ELECTROLYTE IMBALANCE	3
PS	HIV INFECTION	FEBRILE CONVULSION	1
PS	HIV INFECTION	FEMUR FRACTURE	1
PS	HIV INFECTION	HAEMOGLOBIN DECREASED	1
PS	HIV INFECTION	HEPATIC NEOPLASM MALIGNANT	1
PS	HIV INFECTION	HEPATOTOXICITY	1
PS	HIV INFECTION	HYPERAESTHESIA	2
PS	HIV INFECTION	ISCHAEMIC HEPATITIS	1
PS	HIV INFECTION	LACTIC ACIDOSIS	1
PS	HIV INFECTION	LOWER RESPIRATORY TRACT INFECTION	3
PS	HIV INFECTION	MALAISE	5
PS	HIV INFECTION	MATERNAL EXPOSURE DURING PREGNANCY	2
PS	HIV INFECTION	MEDICATION ERROR	1
PS	HIV INFECTION	MIGRAINE	1
PS	HIV INFECTION	NECROTISING RETINITIS	1
PS	HIV INFECTION	OEDEMA	1
PS	HIV INFECTION	OSTEOPOROSIS	1
PS	HIV INFECTION	OVERDOSE	3
PS	HIV INFECTION	PANCREATITIS	1
PS	HIV INFECTION	PANCYTOPENIA	1
PS	HIV INFECTION	PARAESTHESIA	1
PS	HIV INFECTION	PRURITUS GENERALISED	1
PS	HIV INFECTION	PULMONARY EMBOLISM	1
PS	HIV INFECTION	PYREXIA	1
PS	HIV INFECTION	RASH	1
PS	HIV INFECTION	RENAL FAILURE	4
PS	HIV INFECTION	RENAL FAILURE ACUTE	5
PS	HIV INFECTION	RESPIRATORY DISORDER	1
PS	HIV INFECTION	RHABDOMYOLYSIS	3
PS	HIV INFECTION	SEPTIC SHOCK	1
PS	HIV INFECTION	STRESS FRACTURE	1
PS	HIV INFECTION	SUPRAVENTRICULAR TACHYCARDIA	1
PS	HIV INFECTION	TERATOSPERMIA	1
PS	HIV INFECTION	TONSIL CANCER	2
PS	HIV INFECTION	TOXIC SKIN ERUPTION	2
PS	HIV INFECTION	TRANSAMINASES INCREASED	1
PS	HIV INFECTION	TRANSFERRIN DECREASED	1
PS	HIV INFECTION	VERTIGO	1
PS	HIV INFECTION	VIRAL LOAD INCREASED	1
PS	HIV INFECTION	VIRAL MUTATION IDENTIFIED	1
PS	HIV INFECTION	VOMITING	2
PS	NON-SMALL CELL LUNG CANCER	DEATH	3
PS	NON-SMALL CELL LUNG CANCER	NAUSEA	3
PS	NON-SMALL CELL LUNG CANCER	VOMITING	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	ALANINE AMINOTRANSFERASE INCREASED	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	ASPARTATE AMINOTRANSFERASE INCREASED	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	HEPATOTOXICITY	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	ISCHAEMIC HEPATITIS	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	LACTIC ACIDOSIS	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	PANCYTOPENIA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	SEPTIC SHOCK	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	TRANSAMINASES INCREASED	9
PS	PROPHYLAXIS	ANAEMIA	2
PS	PROPHYLAXIS	RENAL FAILURE ACUTE	2
PS	PROPHYLAXIS	VOMITING	2
PS	SEASONAL ALLERGY	BILIARY CIRRHOSIS PRIMARY	2
PS	SEASONAL ALLERGY	CYTOLYTIC HEPATITIS	2
PS	WEIGHT LOSS DIET	BILIARY CIRRHOSIS PRIMARY	1
PS	WEIGHT LOSS DIET	CYTOLYTIC HEPATITIS	1
SS	ANTIFUNGAL PROPHYLAXIS	ANXIETY	1
SS	ANTIFUNGAL PROPHYLAXIS	COMPLETED SUICIDE	1
SS	ANTIFUNGAL PROPHYLAXIS	DEPRESSION	1
SS	ANTIFUNGAL PROPHYLAXIS	INSOMNIA	1
SS	ANTIFUNGAL PROPHYLAXIS	NIGHTMARE	1
SS	ANTIFUNGAL PROPHYLAXIS	PARANOIA	1
SS	HIV INFECTION	ABORTION SPONTANEOUS	3
SS	HIV INFECTION	ANXIETY	9
SS	HIV INFECTION	COMPLETED SUICIDE	9
SS	HIV INFECTION	CONVULSION	9
SS	HIV INFECTION	DEPRESSION	9
SS	HIV INFECTION	INSOMNIA	9
SS	HIV INFECTION	INTRA-UTERINE DEATH	3
SS	HIV INFECTION	LIVE BIRTH	3
SS	HIV INFECTION	LOWER RESPIRATORY TRACT INFECTION	9
SS	HIV INFECTION	MATERNAL EXPOSURE DURING PREGNANCY	3
SS	HIV INFECTION	NIGHTMARE	9
SS	HIV INFECTION	PARANOIA	9
SS	HIV INFECTION	PRENATAL SCREENING TEST ABNORMAL	3
SS	MATERNAL EXPOSURE DURING PREGNANCY	CONGENITAL TERATOMA	12
SS	MATERNAL EXPOSURE DURING PREGNANCY	CRYPTORCHISM	12
SS	MATERNAL EXPOSURE DURING PREGNANCY	MATERNAL DRUGS AFFECTING FOETUS	4
SS	MATERNAL EXPOSURE DURING PREGNANCY	MATERNAL EXPOSURE DURING PREGNANCY	12
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	CONGENITAL TERATOMA	12
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	CONJUNCTIVAL HAEMORRHAGE	4
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	CRYPTORCHISM	12
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	FACIAL PARESIS	4
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	FOETAL EXPOSURE DURING PREGNANCY	12
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	PELVIC MASS	4
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	RESPIRATORY DISTRESS	4
SS	MATERNAL EXPOSURE TIMING UNSPECIFIED	SEPSIS	4
SS	NON-SMALL CELL LUNG CANCER	COUGH	3
SS	NON-SMALL CELL LUNG CANCER	NAUSEA	3
SS	NON-SMALL CELL LUNG CANCER	VOMITING	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	CAESAREAN SECTION	11
C	ANXIETY	AGGRESSION	2
C	ANXIETY	ANXIETY	2
C	ANXIETY	DEPRESSION	2
C	ANXIETY	GALLBLADDER DISORDER	2
C	ANXIETY	LIVER FUNCTION TEST ABNORMAL	2
C	ANXIETY	LOSS OF CONSCIOUSNESS	2
C	ANXIETY	SUICIDAL BEHAVIOUR	2
C	ANXIETY	VERTIGO	2
C	ARTHRITIS	DRUG INEFFECTIVE	1
C	ATRIAL FIBRILLATION	GALLBLADDER DISORDER	4
C	ATRIAL FIBRILLATION	LIVER FUNCTION TEST ABNORMAL	4
C	BIPOLAR DISORDER	ANXIETY	8
C	BIPOLAR DISORDER	DEPRESSED MOOD	8
C	BIPOLAR DISORDER	EMOTIONAL DISTRESS	8
C	BIPOLAR DISORDER	HOMICIDAL IDEATION	4
C	BIPOLAR DISORDER	NASOPHARYNGITIS	4
C	BIPOLAR DISORDER	SUICIDAL IDEATION	4
C	BIPOLAR DISORDER	VIOLENCE-RELATED SYMPTOM	8
C	BLOOD CHOLESTEROL INCREASED	DYSGEUSIA	2
C	BLOOD CHOLESTEROL INCREASED	HOT FLUSH	2
C	BLOOD CHOLESTEROL INCREASED	HYPERHIDROSIS	2
C	BLOOD CHOLESTEROL INCREASED	NAUSEA	2
C	BLOOD CHOLESTEROL INCREASED	VOMITING	2
C	COMPUTERISED TOMOGRAM	CHOKING	2
C	COMPUTERISED TOMOGRAM	COUGH	2
C	COMPUTERISED TOMOGRAM	DYSPNOEA	2
C	COMPUTERISED TOMOGRAM	FACIAL PAIN	2
C	COMPUTERISED TOMOGRAM	LACRIMATION INCREASED	2
C	COMPUTERISED TOMOGRAM	OROPHARYNGEAL PAIN	2
C	DEPRESSION	AGGRESSION	1
C	DEPRESSION	ANXIETY	1
C	DEPRESSION	DEPRESSION	1
C	DEPRESSION	DRUG INTERACTION	1
C	DEPRESSION	GALLBLADDER DISORDER	2
C	DEPRESSION	LIVER FUNCTION TEST ABNORMAL	2
C	DEPRESSION	LOSS OF CONSCIOUSNESS	1
C	DEPRESSION	MANIA	1
C	DEPRESSION	SUICIDAL BEHAVIOUR	1
C	DEPRESSION	VERTIGO	1
C	ERECTILE DYSFUNCTION	CHEST PAIN	2
C	FACTOR VIII DEFICIENCY	DRUG INEFFECTIVE	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	AGGRESSION	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	ANXIETY	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	DEPRESSION	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	LOSS OF CONSCIOUSNESS	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	SUICIDAL BEHAVIOUR	1
C	GASTROOESOPHAGEAL REFLUX DISEASE	VERTIGO	1
C	HEPATITIS C	CHILLS	2
C	HEPATITIS C	HEADACHE	2
C	HEPATITIS C	PAIN	2
C	HEPATITIS C	PYREXIA	2
C	HIV INFECTION	AGGRESSION	2
C	HIV INFECTION	ANXIETY	4
C	HIV INFECTION	DEPRESSED MOOD	2
C	HIV INFECTION	DEPRESSION	2
C	HIV INFECTION	DRUG INEFFECTIVE	2
C	HIV INFECTION	DRUG INTERACTION	1
C	HIV INFECTION	DYSPNOEA	1
C	HIV INFECTION	EMOTIONAL DISTRESS	2
C	HIV INFECTION	GALLBLADDER DISORDER	2
C	HIV INFECTION	HOMICIDAL IDEATION	1
C	HIV INFECTION	LIVER FUNCTION TEST ABNORMAL	2
C	HIV INFECTION	LOSS OF CONSCIOUSNESS	2
C	HIV INFECTION	MANIA	1
C	HIV INFECTION	NASOPHARYNGITIS	1
C	HIV INFECTION	PANIC ATTACK	1
C	HIV INFECTION	PARANOIA	1
C	HIV INFECTION	SUICIDAL BEHAVIOUR	2
C	HIV INFECTION	SUICIDAL IDEATION	1
C	HIV INFECTION	THROAT TIGHTNESS	1
C	HIV INFECTION	VERTIGO	2
C	HIV INFECTION	VIOLENCE-RELATED SYMPTOM	2
C	HIV TEST POSITIVE	DEPRESSION	1
C	HIV TEST POSITIVE	INSOMNIA	1
C	HIV TEST POSITIVE	INTENTIONAL OVERDOSE	1
C	HIV TEST POSITIVE	SUICIDE ATTEMPT	1
C	HYPERTENSION	GALLBLADDER DISORDER	6
C	HYPERTENSION	LIVER FUNCTION TEST ABNORMAL	6
C	HYPOTHYROIDISM	AGGRESSION	1
C	HYPOTHYROIDISM	ANXIETY	1
C	HYPOTHYROIDISM	DEPRESSION	1
C	HYPOTHYROIDISM	LOSS OF CONSCIOUSNESS	1
C	HYPOTHYROIDISM	SUICIDAL BEHAVIOUR	1
C	HYPOTHYROIDISM	VERTIGO	1
C	INSOMNIA	ADENOMA BENIGN	3
C	INSOMNIA	FEELING ABNORMAL	3
C	INSOMNIA	GENERALISED OEDEMA	3
C	INSOMNIA	METASTASES TO LIVER	3
C	INSOMNIA	PRODUCT QUALITY ISSUE	2
C	INSOMNIA	RETROPERITONEAL LYMPHADENOPATHY	3
C	KAPOSI'S SARCOMA	ADENOMA BENIGN	6
C	KAPOSI'S SARCOMA	FEELING ABNORMAL	6
C	KAPOSI'S SARCOMA	GENERALISED OEDEMA	6
C	KAPOSI'S SARCOMA	METASTASES TO LIVER	6
C	KAPOSI'S SARCOMA	PRODUCT QUALITY ISSUE	4
C	KAPOSI'S SARCOMA	RETROPERITONEAL LYMPHADENOPATHY	6
C	MEDICAL DIET	DRUG INEFFECTIVE	2
C	NAUSEA	AGGRESSION	1
C	NAUSEA	ANXIETY	1
C	NAUSEA	DEPRESSION	1
C	NAUSEA	LOSS OF CONSCIOUSNESS	1
C	NAUSEA	SUICIDAL BEHAVIOUR	1
C	NAUSEA	VERTIGO	1
C	NEURALGIA	GALLBLADDER DISORDER	6
C	NEURALGIA	LIVER FUNCTION TEST ABNORMAL	6
C	OEDEMA	ADENOMA BENIGN	3
C	OEDEMA	FEELING ABNORMAL	3
C	OEDEMA	GENERALISED OEDEMA	3
C	OEDEMA	METASTASES TO LIVER	3
C	OEDEMA	PRODUCT QUALITY ISSUE	2
C	OEDEMA	RETROPERITONEAL LYMPHADENOPATHY	3
C	OSTEOARTHRITIS	AGGRESSION	1
C	OSTEOARTHRITIS	ANXIETY	1
C	OSTEOARTHRITIS	DEPRESSION	1
C	OSTEOARTHRITIS	LOSS OF CONSCIOUSNESS	1
C	OSTEOARTHRITIS	SUICIDAL BEHAVIOUR	1
C	OSTEOARTHRITIS	VERTIGO	1
C	PAIN	DRUG INEFFECTIVE	2
C	PRODUCT USED FOR UNKNOWN INDICATION	ADENOMA BENIGN	3
C	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INTERACTION	1
C	PRODUCT USED FOR UNKNOWN INDICATION	FEELING ABNORMAL	3
C	PRODUCT USED FOR UNKNOWN INDICATION	GENERALISED OEDEMA	3
C	PRODUCT USED FOR UNKNOWN INDICATION	MANIA	1
C	PRODUCT USED FOR UNKNOWN INDICATION	METASTASES TO LIVER	3
C	PRODUCT USED FOR UNKNOWN INDICATION	PRODUCT QUALITY ISSUE	2
C	PRODUCT USED FOR UNKNOWN INDICATION	RETROPERITONEAL LYMPHADENOPATHY	3
C	PROSTATE CANCER	DRUG INTERACTION	1
C	PROSTATE CANCER	MANIA	1
C	RESPIRATORY TRACT IRRITATION	GALLBLADDER DISORDER	3
C	RESPIRATORY TRACT IRRITATION	LIVER FUNCTION TEST ABNORMAL	3
C	SLEEP DISORDER	DRUG INEFFECTIVE	1
C	SMOKING CESSATION THERAPY	AGGRESSION	1
C	SMOKING CESSATION THERAPY	ANXIETY	3
C	SMOKING CESSATION THERAPY	DEPRESSED MOOD	2
C	SMOKING CESSATION THERAPY	DEPRESSION	2
C	SMOKING CESSATION THERAPY	DYSGEUSIA	2
C	SMOKING CESSATION THERAPY	DYSPNOEA	1
C	SMOKING CESSATION THERAPY	EMOTIONAL DISTRESS	2
C	SMOKING CESSATION THERAPY	HOMICIDAL IDEATION	1
C	SMOKING CESSATION THERAPY	HOT FLUSH	2
C	SMOKING CESSATION THERAPY	HYPERHIDROSIS	2
C	SMOKING CESSATION THERAPY	INSOMNIA	1
C	SMOKING CESSATION THERAPY	INTENTIONAL OVERDOSE	1
C	SMOKING CESSATION THERAPY	LOSS OF CONSCIOUSNESS	1
C	SMOKING CESSATION THERAPY	NASOPHARYNGITIS	1
C	SMOKING CESSATION THERAPY	NAUSEA	2
C	SMOKING CESSATION THERAPY	PANIC ATTACK	1
C	SMOKING CESSATION THERAPY	PARANOIA	1
C	SMOKING CESSATION THERAPY	SUICIDAL BEHAVIOUR	1
C	SMOKING CESSATION THERAPY	SUICIDAL IDEATION	1
C	SMOKING CESSATION THERAPY	SUICIDE ATTEMPT	1
C	SMOKING CESSATION THERAPY	THROAT TIGHTNESS	1
C	SMOKING CESSATION THERAPY	VERTIGO	1
C	SMOKING CESSATION THERAPY	VIOLENCE-RELATED SYMPTOM	2
C	SMOKING CESSATION THERAPY	VOMITING	2
C	URINARY TRACT INFECTION	GALLBLADDER DISORDER	4
C	URINARY TRACT INFECTION	LIVER FUNCTION TEST ABNORMAL	4

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