Drug information for ANTARA (MICRONIZED)

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 130MG Prescription AB (Reference Drug) FENOFIBRATE Fenofibrate LUPIN ATLANTIS 21695
2012-03-06 Label

2012-03-05 Letter

2008-06-19 Label

2008-06-06 Letter

2007-01-23 Letter

2006-06-08 Review

2004-12-06 Letter

2004-12-03 Label
CAPSULE; ORAL 43MG Prescription AB  FENOFIBRATE Fenofibrate LUPIN ATLANTIS   "
CAPSULE; ORAL 87MG Discontinued   FENOFIBRATE Fenofibrate LUPIN ATLANTIS   "

Drug Adverse Effects information for ANTARA (MICRONIZED)

Role code Indications Reaction # Reports
C BACK DISORDER EYE PAIN 2
C BACK DISORDER EYE SWELLING 2
C BACK DISORDER VASODILATATION 2
C BLOOD CHOLESTEROL INCREASED ANXIETY 3
C BLOOD CHOLESTEROL INCREASED DEEP VEIN THROMBOSIS 3
C BLOOD CHOLESTEROL INCREASED EMOTIONAL DISTRESS 3
C BLOOD CHOLESTEROL INCREASED EYE PAIN 1
C BLOOD CHOLESTEROL INCREASED EYE SWELLING 1
C BLOOD CHOLESTEROL INCREASED INJURY 3
C BLOOD CHOLESTEROL INCREASED OEDEMA PERIPHERAL 3
C BLOOD CHOLESTEROL INCREASED PAIN 3
C BLOOD CHOLESTEROL INCREASED VASODILATATION 1
C BLOOD TRIGLYCERIDES INCREASED ANXIETY 2
C BLOOD TRIGLYCERIDES INCREASED DEEP VEIN THROMBOSIS 2
C BLOOD TRIGLYCERIDES INCREASED EMOTIONAL DISTRESS 2
C BLOOD TRIGLYCERIDES INCREASED INJURY 2
C BLOOD TRIGLYCERIDES INCREASED OEDEMA PERIPHERAL 2
C BLOOD TRIGLYCERIDES INCREASED PAIN 2
C BRONCHITIS EYE PAIN 1
C BRONCHITIS EYE SWELLING 1
C BRONCHITIS VASODILATATION 1
C CELLULITIS MUSCLE SPASMS 1
C GLAUCOMA EYE PAIN 1
C GLAUCOMA EYE SWELLING 1
C GLAUCOMA VASODILATATION 1
C LIMB DISCOMFORT EYE PAIN 2
C LIMB DISCOMFORT EYE SWELLING 2
C LIMB DISCOMFORT VASODILATATION 2
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 1
C PRODUCT USED FOR UNKNOWN INDICATION DEEP VEIN THROMBOSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISTRESS 1
C PRODUCT USED FOR UNKNOWN INDICATION INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION MUSCLE SPASMS 4
C PRODUCT USED FOR UNKNOWN INDICATION OEDEMA PERIPHERAL 1
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 1
C SCIATIC NERVE INJURY EYE PAIN 2
C SCIATIC NERVE INJURY EYE SWELLING 2
C SCIATIC NERVE INJURY VASODILATATION 2
C THROMBOSIS COAGULOPATHY 2
C THROMBOSIS HAEMATOMA 2
C THROMBOSIS HAEMOGLOBIN DECREASED 2
C THROMBOSIS HYPOTENSION 2
C THROMBOSIS INTERNATIONAL NORMALISED RATIO INCREASED 3
C THROMBOSIS MUSCULOSKELETAL PAIN 2
C THROMBOSIS RENAL FAILURE ACUTE 2
C THROMBOSIS SKIN DISCOLOURATION 1
C THROMBOSIS SWELLING 1
C THYROID DISORDER EYE PAIN 1
C THYROID DISORDER EYE SWELLING 1
C THYROID DISORDER VASODILATATION 1
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