Drug information for AVIANE-28

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL-28 0.02MG;0.1MG Prescription AB1  ETHINYL ESTRADIOL; LEVONORGESTREL Levonorgestrel DURAMED PHARMS BARR 75796
2004-05-27 Letter

2004-05-27 Review

2004-05-27 Label

Drug Adverse Effects information for AVIANE-28

Role code Indications Reaction # Reports
C ANTIDEPRESSANT THERAPY AMNESIA 1
C ANTIDEPRESSANT THERAPY CEREBRAL THROMBOSIS 1
C ANTIDEPRESSANT THERAPY CEREBROVASCULAR ACCIDENT 1
C ANTIDEPRESSANT THERAPY CHEST PAIN 1
C ANTIDEPRESSANT THERAPY CHOLECYSTITIS CHRONIC 1
C ANTIDEPRESSANT THERAPY COGNITIVE DISORDER 1
C ANTIDEPRESSANT THERAPY GALLBLADDER INJURY 1
C ANTIDEPRESSANT THERAPY INJURY 1
C ANTIDEPRESSANT THERAPY LEARNING DISORDER 1
C ANTIDEPRESSANT THERAPY MENTAL DISORDER 1
C ANTIDEPRESSANT THERAPY PAIN 1
C ANXIETY ABDOMINAL PAIN UPPER 2
C ANXIETY AMNESIA 1
C ANXIETY ANAEMIA 2
C ANXIETY ASTHENIA 2
C ANXIETY BILE DUCT STONE 2
C ANXIETY BILIARY COLIC 2
C ANXIETY CEREBRAL THROMBOSIS 1
C ANXIETY CEREBROVASCULAR ACCIDENT 1
C ANXIETY CHEST PAIN 1
C ANXIETY CHOLECYSTITIS CHRONIC 3
C ANXIETY CHOLELITHIASIS 2
C ANXIETY COGNITIVE DISORDER 1
C ANXIETY DIARRHOEA 2
C ANXIETY DIZZINESS 2
C ANXIETY DYSPNOEA 2
C ANXIETY EXCESSIVE SKIN 2
C ANXIETY FLANK PAIN 2
C ANXIETY FOOD INTOLERANCE 2
C ANXIETY GALLBLADDER INJURY 1
C ANXIETY GASTRITIS 2
C ANXIETY HEPATIC FUNCTION ABNORMAL 2
C ANXIETY IMPAIRED GASTRIC EMPTYING 2
C ANXIETY INJURY 1
C ANXIETY LEARNING DISORDER 1
C ANXIETY MENTAL DISORDER 1
C ANXIETY NAUSEA 2
C ANXIETY PAIN 1
C ANXIETY RASH 2
C ANXIETY REFLUX GASTRITIS 2
C ANXIETY SKIN FISSURES 2
C ANXIETY TEMPERATURE INTOLERANCE 2
C ANXIETY VOMITING 2
C ANXIETY WEIGHT INCREASED 2
C CONTRACEPTION ABDOMINAL PAIN UPPER 3
C CONTRACEPTION AMNESIA 6
C CONTRACEPTION ANAEMIA 3
C CONTRACEPTION ASTHENIA 3
C CONTRACEPTION BILE DUCT STONE 3
C CONTRACEPTION BILIARY COLIC 3
C CONTRACEPTION CEREBRAL THROMBOSIS 6
C CONTRACEPTION CEREBROVASCULAR ACCIDENT 7
C CONTRACEPTION CHEST PAIN 6
C CONTRACEPTION CHOLECYSTITIS CHRONIC 9
C CONTRACEPTION CHOLELITHIASIS 3
C CONTRACEPTION COGNITIVE DISORDER 6
C CONTRACEPTION DEEP VEIN THROMBOSIS 1
C CONTRACEPTION DIARRHOEA 3
C CONTRACEPTION DIZZINESS 3
C CONTRACEPTION DYSPNOEA 3
C CONTRACEPTION EXCESSIVE SKIN 3
C CONTRACEPTION FLANK PAIN 3
C CONTRACEPTION FOOD INTOLERANCE 3
C CONTRACEPTION GALLBLADDER INJURY 6
C CONTRACEPTION GASTRITIS 3
C CONTRACEPTION HEPATIC FUNCTION ABNORMAL 3
C CONTRACEPTION HYPOAESTHESIA 1
C CONTRACEPTION IMPAIRED GASTRIC EMPTYING 3
C CONTRACEPTION INJURY 7
C CONTRACEPTION INTERMITTENT CLAUDICATION 1
C CONTRACEPTION LEARNING DISORDER 3
C CONTRACEPTION MENTAL DISORDER 6
C CONTRACEPTION MIGRAINE 1
C CONTRACEPTION NAUSEA 3
C CONTRACEPTION OEDEMA PERIPHERAL 1
C CONTRACEPTION PAIN 6
C CONTRACEPTION PAIN IN EXTREMITY 1
C CONTRACEPTION RASH 3
C CONTRACEPTION REFLUX GASTRITIS 3
C CONTRACEPTION SKIN FISSURES 3
C CONTRACEPTION TEMPERATURE INTOLERANCE 3
C CONTRACEPTION VOMITING 3
C CONTRACEPTION WEIGHT INCREASED 3
C DEPRESSION AMNESIA 1
C DEPRESSION CEREBRAL THROMBOSIS 1
C DEPRESSION CEREBROVASCULAR ACCIDENT 1
C DEPRESSION CHEST PAIN 1
C DEPRESSION CHOLECYSTITIS CHRONIC 1
C DEPRESSION COGNITIVE DISORDER 1
C DEPRESSION GALLBLADDER INJURY 1
C DEPRESSION INJURY 1
C DEPRESSION LEARNING DISORDER 1
C DEPRESSION MENTAL DISORDER 1
C DEPRESSION PAIN 1
C DYSMENORRHOEA ABDOMINAL PAIN UPPER 1
C DYSMENORRHOEA ANAEMIA 1
C DYSMENORRHOEA ASTHENIA 1
C DYSMENORRHOEA BILE DUCT STONE 1
C DYSMENORRHOEA BILIARY COLIC 1
C DYSMENORRHOEA CHOLECYSTITIS CHRONIC 1
C DYSMENORRHOEA CHOLELITHIASIS 1
C DYSMENORRHOEA DIARRHOEA 1
C DYSMENORRHOEA DIZZINESS 1
C DYSMENORRHOEA DYSPNOEA 1
C DYSMENORRHOEA EXCESSIVE SKIN 1
C DYSMENORRHOEA FLANK PAIN 1
C DYSMENORRHOEA FOOD INTOLERANCE 1
C DYSMENORRHOEA GASTRITIS 1
C DYSMENORRHOEA HEPATIC FUNCTION ABNORMAL 1
C DYSMENORRHOEA IMPAIRED GASTRIC EMPTYING 1
C DYSMENORRHOEA NAUSEA 1
C DYSMENORRHOEA RASH 1
C DYSMENORRHOEA REFLUX GASTRITIS 1
C DYSMENORRHOEA SKIN FISSURES 1
C DYSMENORRHOEA TEMPERATURE INTOLERANCE 1
C DYSMENORRHOEA VOMITING 1
C DYSMENORRHOEA WEIGHT INCREASED 1
C HERPES VIRUS INFECTION AMNESIA 1
C HERPES VIRUS INFECTION CEREBRAL THROMBOSIS 1
C HERPES VIRUS INFECTION CEREBROVASCULAR ACCIDENT 1
C HERPES VIRUS INFECTION CHEST PAIN 1
C HERPES VIRUS INFECTION CHOLECYSTITIS CHRONIC 1
C HERPES VIRUS INFECTION COGNITIVE DISORDER 1
C HERPES VIRUS INFECTION GALLBLADDER INJURY 1
C HERPES VIRUS INFECTION INJURY 1
C HERPES VIRUS INFECTION LEARNING DISORDER 1
C HERPES VIRUS INFECTION MENTAL DISORDER 1
C HERPES VIRUS INFECTION PAIN 1
C MENORRHAGIA ABDOMINAL PAIN UPPER 1
C MENORRHAGIA ANAEMIA 1
C MENORRHAGIA ASTHENIA 1
C MENORRHAGIA BILE DUCT STONE 1
C MENORRHAGIA BILIARY COLIC 1
C MENORRHAGIA CHOLECYSTITIS CHRONIC 1
C MENORRHAGIA CHOLELITHIASIS 1
C MENORRHAGIA DIARRHOEA 1
C MENORRHAGIA DIZZINESS 1
C MENORRHAGIA DYSPNOEA 1
C MENORRHAGIA EXCESSIVE SKIN 1
C MENORRHAGIA FLANK PAIN 1
C MENORRHAGIA FOOD INTOLERANCE 1
C MENORRHAGIA GASTRITIS 1
C MENORRHAGIA HEPATIC FUNCTION ABNORMAL 1
C MENORRHAGIA IMPAIRED GASTRIC EMPTYING 1
C MENORRHAGIA NAUSEA 1
C MENORRHAGIA RASH 1
C MENORRHAGIA REFLUX GASTRITIS 1
C MENORRHAGIA SKIN FISSURES 1
C MENORRHAGIA TEMPERATURE INTOLERANCE 1
C MENORRHAGIA VOMITING 1
C MENORRHAGIA WEIGHT INCREASED 1
C MENSTRUAL CYCLE MANAGEMENT AMNESIA 6
C MENSTRUAL CYCLE MANAGEMENT CEREBRAL THROMBOSIS 6
C MENSTRUAL CYCLE MANAGEMENT CEREBROVASCULAR ACCIDENT 6
C MENSTRUAL CYCLE MANAGEMENT CHEST PAIN 6
C MENSTRUAL CYCLE MANAGEMENT CHOLECYSTITIS CHRONIC 6
C MENSTRUAL CYCLE MANAGEMENT COGNITIVE DISORDER 6
C MENSTRUAL CYCLE MANAGEMENT GALLBLADDER INJURY 6
C MENSTRUAL CYCLE MANAGEMENT INJURY 6
C MENSTRUAL CYCLE MANAGEMENT LEARNING DISORDER 3
C MENSTRUAL CYCLE MANAGEMENT MENTAL DISORDER 6
C MENSTRUAL CYCLE MANAGEMENT PAIN 6
C MOOD ALTERED AMNESIA 6
C MOOD ALTERED CEREBRAL THROMBOSIS 6
C MOOD ALTERED CEREBROVASCULAR ACCIDENT 6
C MOOD ALTERED CHEST PAIN 6
C MOOD ALTERED CHOLECYSTITIS CHRONIC 6
C MOOD ALTERED COGNITIVE DISORDER 6
C MOOD ALTERED GALLBLADDER INJURY 6
C MOOD ALTERED INJURY 6
C MOOD ALTERED LEARNING DISORDER 3
C MOOD ALTERED MENTAL DISORDER 6
C MOOD ALTERED PAIN 6
C MULTIPLE ALLERGIES CEREBROVASCULAR ACCIDENT 1
C MULTIPLE ALLERGIES HYPOAESTHESIA 1
C MULTIPLE ALLERGIES INJURY 1
C MULTIPLE ALLERGIES MIGRAINE 1
C OSTEOPOROSIS ABDOMINAL PAIN UPPER 5
C OSTEOPOROSIS AGITATION 5
C OSTEOPOROSIS ALOPECIA 5
C OSTEOPOROSIS ANAEMIA 5
C OSTEOPOROSIS ANHEDONIA 5
C OSTEOPOROSIS ANKLE FRACTURE 5
C OSTEOPOROSIS ANOREXIA NERVOSA 5
C OSTEOPOROSIS ANXIETY 5
C OSTEOPOROSIS ASCITES 5
C OSTEOPOROSIS BACK PAIN 4
C OSTEOPOROSIS BONE DENSITY DECREASED 5
C OSTEOPOROSIS BONE MARROW FAILURE 5
C OSTEOPOROSIS BONE MARROW OEDEMA 4
C OSTEOPOROSIS BONE PAIN 4
C OSTEOPOROSIS BREATH ODOUR 5
C OSTEOPOROSIS CACHEXIA 5
C OSTEOPOROSIS CEREBROVASCULAR ACCIDENT 5
C OSTEOPOROSIS COMPRESSION FRACTURE 5
C OSTEOPOROSIS CRANIAL NERVE DISORDER 5
C OSTEOPOROSIS DEAFNESS 5
C OSTEOPOROSIS DEHYDRATION 5
C OSTEOPOROSIS DENTAL CARIES 5
C OSTEOPOROSIS DEPRESSION 5
C OSTEOPOROSIS DISABILITY 5
C OSTEOPOROSIS DRY EYE 5
C OSTEOPOROSIS DRY MOUTH 5
C OSTEOPOROSIS DUODENITIS 5
C OSTEOPOROSIS DYSPNOEA 5
C OSTEOPOROSIS EAR PAIN 5
C OSTEOPOROSIS ECONOMIC PROBLEM 1
C OSTEOPOROSIS ENDOCRINE DISORDER 5
C OSTEOPOROSIS EPISTAXIS 5
C OSTEOPOROSIS EUSTACHIAN TUBE DYSFUNCTION 5
C OSTEOPOROSIS FACET JOINT SYNDROME 5
C OSTEOPOROSIS FACIAL PAIN 5
C OSTEOPOROSIS FAILURE TO THRIVE 5
C OSTEOPOROSIS FALL 5
C OSTEOPOROSIS FEELING ABNORMAL 5
C OSTEOPOROSIS FIBROCYSTIC BREAST DISEASE 5
C OSTEOPOROSIS GASTRITIS 5
C OSTEOPOROSIS HEADACHE 4
C OSTEOPOROSIS HEART RATE IRREGULAR 5
C OSTEOPOROSIS HEPATITIS 5
C OSTEOPOROSIS HYPERALDOSTERONISM 5
C OSTEOPOROSIS HYPERCORTICOIDISM 3
C OSTEOPOROSIS HYPERTENSION 5
C OSTEOPOROSIS HYPERTHYROIDISM 5
C OSTEOPOROSIS HYPOAESTHESIA 5
C OSTEOPOROSIS HYPOGLYCAEMIA 5
C OSTEOPOROSIS HYPOMETABOLISM 5
C OSTEOPOROSIS HYPOVOLAEMIA 5
C OSTEOPOROSIS IMMUNODEFICIENCY 5
C OSTEOPOROSIS IMPAIRED GASTRIC EMPTYING 5
C OSTEOPOROSIS INJURY 5
C OSTEOPOROSIS INSOMNIA 5
C OSTEOPOROSIS INTERVERTEBRAL DISC DEGENERATION 5
C OSTEOPOROSIS INTERVERTEBRAL DISC DISORDER 4
C OSTEOPOROSIS INTERVERTEBRAL DISC PROTRUSION 5
C OSTEOPOROSIS JAUNDICE 5
C OSTEOPOROSIS JOINT SWELLING 5
C OSTEOPOROSIS KIDNEY MALROTATION 3
C OSTEOPOROSIS KYPHOSIS 5
C OSTEOPOROSIS MALNUTRITION 5
C OSTEOPOROSIS MIGRAINE 5
C OSTEOPOROSIS MUCOSAL INFLAMMATION 5
C OSTEOPOROSIS MUSCLE STRAIN 5
C OSTEOPOROSIS NASAL ULCER 5
C OSTEOPOROSIS NECK PAIN 4
C OSTEOPOROSIS OBSESSIVE-COMPULSIVE DISORDER 5
C OSTEOPOROSIS OSTEOCHONDROSIS 3
C OSTEOPOROSIS OSTEOMALACIA 3
C OSTEOPOROSIS OSTEOMYELITIS CHRONIC 5
C OSTEOPOROSIS OSTEONECROSIS OF JAW 5
C OSTEOPOROSIS OSTEOPENIA 5
C OSTEOPOROSIS OSTEOPOROSIS 5
C OSTEOPOROSIS PAIN 5
C OSTEOPOROSIS PAIN IN EXTREMITY 4
C OSTEOPOROSIS PALPITATIONS 5
C OSTEOPOROSIS PARAESTHESIA 5
C OSTEOPOROSIS PERIODONTAL DISEASE 5
C OSTEOPOROSIS PINEAL GLAND CYST 5
C OSTEOPOROSIS RAYNAUD'S PHENOMENON 5
C OSTEOPOROSIS RENAL FAILURE CHRONIC 5
C OSTEOPOROSIS RHINITIS 5
C OSTEOPOROSIS RIB FRACTURE 5
C OSTEOPOROSIS RIGHT ATRIAL DILATATION 3
C OSTEOPOROSIS SCOLIOSIS 5
C OSTEOPOROSIS SIALOADENITIS 5
C OSTEOPOROSIS SINUS CONGESTION 5
C OSTEOPOROSIS SINUS TACHYCARDIA 5
C OSTEOPOROSIS STOMATITIS 5
C OSTEOPOROSIS SWELLING FACE 5
C OSTEOPOROSIS TIBIA FRACTURE 5
C OSTEOPOROSIS TINNITUS 5
C OSTEOPOROSIS TOOTH INFECTION 5
C OSTEOPOROSIS UNEVALUABLE EVENT 1
C OSTEOPOROSIS VERTEBRAL WEDGING 4
C OSTEOPOROSIS VISION BLURRED 5
C OSTEOPOROSIS VITAMIN A DEFICIENCY 5
C OSTEOPOROSIS VITAMIN C DEFICIENCY 5
C OSTEOPOROSIS VITAMIN D DEFICIENCY 5
C OSTEOPOROSIS WEIGHT DECREASED 5
C PAIN ABDOMINAL PAIN UPPER 1
C PAIN ANAEMIA 1
C PAIN ASTHENIA 1
C PAIN BILE DUCT STONE 1
C PAIN BILIARY COLIC 1
C PAIN CHOLECYSTITIS CHRONIC 1
C PAIN CHOLELITHIASIS 1
C PAIN DIARRHOEA 1
C PAIN DIZZINESS 1
C PAIN DYSPNOEA 1
C PAIN EXCESSIVE SKIN 1
C PAIN FLANK PAIN 1
C PAIN FOOD INTOLERANCE 1
C PAIN GASTRITIS 1
C PAIN HEPATIC FUNCTION ABNORMAL 1
C PAIN IMPAIRED GASTRIC EMPTYING 1
C PAIN NAUSEA 1
C PAIN RASH 1
C PAIN REFLUX GASTRITIS 1
C PAIN SKIN FISSURES 1
C PAIN TEMPERATURE INTOLERANCE 1
C PAIN VOMITING 1
C PAIN WEIGHT INCREASED 1
C PSORIASIS INJECTION SITE ERYTHEMA 1
C PSORIASIS INJECTION SITE HAEMATOMA 1
C PSORIASIS INJECTION SITE PAIN 1
C PSORIASIS INJECTION SITE PRURITUS 1
C PSORIASIS INJECTION SITE REACTION 1
C PSORIASIS INJECTION SITE SCAR 1
C PSORIASIS INJECTION SITE SWELLING 1
C PSORIASIS INJECTION SITE WARMTH 1
C SLEEP DISORDER AMNESIA 1
C SLEEP DISORDER CEREBRAL THROMBOSIS 1
C SLEEP DISORDER CEREBROVASCULAR ACCIDENT 1
C SLEEP DISORDER CHEST PAIN 1
C SLEEP DISORDER CHOLECYSTITIS CHRONIC 1
C SLEEP DISORDER COGNITIVE DISORDER 1
C SLEEP DISORDER GALLBLADDER INJURY 1
C SLEEP DISORDER INJURY 1
C SLEEP DISORDER LEARNING DISORDER 1
C SLEEP DISORDER MENTAL DISORDER 1
C SLEEP DISORDER PAIN 1
C SYSTEMIC LUPUS ERYTHEMATOSUS DEEP VEIN THROMBOSIS 3
C SYSTEMIC LUPUS ERYTHEMATOSUS INTERMITTENT CLAUDICATION 3
C SYSTEMIC LUPUS ERYTHEMATOSUS OEDEMA PERIPHERAL 3
C SYSTEMIC LUPUS ERYTHEMATOSUS PAIN IN EXTREMITY 3
C WEIGHT DECREASED ABDOMINAL PAIN UPPER 1
C WEIGHT DECREASED ANAEMIA 1
C WEIGHT DECREASED ASTHENIA 1
C WEIGHT DECREASED BILE DUCT STONE 1
C WEIGHT DECREASED BILIARY COLIC 1
C WEIGHT DECREASED CHOLECYSTITIS CHRONIC 1
C WEIGHT DECREASED CHOLELITHIASIS 1
C WEIGHT DECREASED DIARRHOEA 1
C WEIGHT DECREASED DIZZINESS 1
C WEIGHT DECREASED DYSPNOEA 1
C WEIGHT DECREASED EXCESSIVE SKIN 1
C WEIGHT DECREASED FLANK PAIN 1
C WEIGHT DECREASED FOOD INTOLERANCE 1
C WEIGHT DECREASED GASTRITIS 1
C WEIGHT DECREASED HEPATIC FUNCTION ABNORMAL 1
C WEIGHT DECREASED IMPAIRED GASTRIC EMPTYING 1
C WEIGHT DECREASED NAUSEA 1
C WEIGHT DECREASED RASH 1
C WEIGHT DECREASED REFLUX GASTRITIS 1
C WEIGHT DECREASED SKIN FISSURES 1
C WEIGHT DECREASED TEMPERATURE INTOLERANCE 1
C WEIGHT DECREASED VOMITING 1
C WEIGHT DECREASED WEIGHT INCREASED 1
C WHITE BLOOD CELL COUNT INCREASED ABDOMINAL PAIN UPPER 1
C WHITE BLOOD CELL COUNT INCREASED ANAEMIA 1
C WHITE BLOOD CELL COUNT INCREASED ASTHENIA 1
C WHITE BLOOD CELL COUNT INCREASED BILE DUCT STONE 1
C WHITE BLOOD CELL COUNT INCREASED BILIARY COLIC 1
C WHITE BLOOD CELL COUNT INCREASED CHOLECYSTITIS CHRONIC 1
C WHITE BLOOD CELL COUNT INCREASED CHOLELITHIASIS 1
C WHITE BLOOD CELL COUNT INCREASED DIARRHOEA 1
C WHITE BLOOD CELL COUNT INCREASED DIZZINESS 1
C WHITE BLOOD CELL COUNT INCREASED DYSPNOEA 1
C WHITE BLOOD CELL COUNT INCREASED EXCESSIVE SKIN 1
C WHITE BLOOD CELL COUNT INCREASED FLANK PAIN 1
C WHITE BLOOD CELL COUNT INCREASED FOOD INTOLERANCE 1
C WHITE BLOOD CELL COUNT INCREASED GASTRITIS 1
C WHITE BLOOD CELL COUNT INCREASED HEPATIC FUNCTION ABNORMAL 1
C WHITE BLOOD CELL COUNT INCREASED IMPAIRED GASTRIC EMPTYING 1
C WHITE BLOOD CELL COUNT INCREASED NAUSEA 1
C WHITE BLOOD CELL COUNT INCREASED RASH 1
C WHITE BLOOD CELL COUNT INCREASED REFLUX GASTRITIS 1
C WHITE BLOOD CELL COUNT INCREASED SKIN FISSURES 1
C WHITE BLOOD CELL COUNT INCREASED TEMPERATURE INTOLERANCE 1
C WHITE BLOOD CELL COUNT INCREASED VOMITING 1
C WHITE BLOOD CELL COUNT INCREASED WEIGHT INCREASED 1
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